Publications by Tim Sandle

Publications by Tim Sandle
This page lists all of my major publications.
Note: some of the listed publications are available as reprints free of charge, for others a
nominal reprint charge is required ($25). Please email me if you would like a copy of any of the
papers or chapters listed (timsandle@btinternet.com or tim.sandle@bpl.co.uk)
Books
1. Saghee, M.R., Sandle, T. and Tidswell, E.C. (Eds.) (2011): Microbiology and Sterility
Assurance in Pharmaceuticals and Medical Devices, New Delhi : Business Horizons
2. Sandle, T. (2011): Two extremes? Flexible working in Europe: A study of differences in

Flexible Working Time between two European Plasma Fractionators in Britain and the
Netherlands, Saarbrucken: VDM Publishing, IBSN 978-3-639-34965-8
3. Sandle, T. (2012). The CDC Handbook: A Guide to Cleaning and Disinfecting

Cleanrooms, Grosvenor House Publishing: Surrey, UK (2nd edition published in 2016)
Second edition:
Sandle, T. (2016). The CDC Handbook: A Guide to Cleaning and Disinfecting

Cleanrooms, 2nd Edition, Grosvenor House Publishing: Surrey, UK
4. Sandle, T. (2012). Pharmaceutical Microbiology Glossary, Microbiology Solutions: UK

(Kindle only eBook ASIN: B0092G1246)
5. Sandle, T. (2012). E-Guide to Cleanrooms, Microbiology Solutions: UK (Kindle only

eBook ASIN: B009IXFJ92)
6. Sandle, T. and Saghee, M.R. (2013). Cleanroom Management in Pharmaceuticals and

Healthcare, Euromed Communications: Passfield, UK
Second edition:
Sandle, T. and Saghee, M. R. (Eds) Cleanroom Management in Pharmaceuticals and

Healthcare, 2nd Edition, Euromed Communications, Passfield, U.K. (2017)
7. Sandle, T. (2013) Sterility Testing of Pharmaceutical Products, PDA / DHI, River Grove,
IL, USA
8. Sandle, T. (2013). Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals:

Technology, Validation and Current Regulations, Woodhead Publishing Ltd.:
Cambridge, UK (ISBN 1 907568 38 7)
9. Sandle, T. (2014) Data Review and Analysis for Pharmaceutical Microbiology,
Microbiology Solutions, UK. ISBN 9781492235217
10. Sandle, T. and Vijayakumar, R. (2014) Cleanroom Microbiology, DHI/PDA: Bethesda,

MD, USA, ISBN: 1933722843
11. Hanlon. G. and Sandle, T. (Eds.) (2015) Industrial Pharmaceutical Microbiology:

Standards and Controls, 4th edition, Euromed Communications: Passfield, UK
Next edition:
Sandle, T. (2019) Industrial Pharmaceutical Microbiology: Standards & Controls, 5th

edition, Euromed Communications, Passfield, UK
12. Sandle, T. (2016) Pharmaceutical Microbiology: Essentials for Quality Assurance and
Quality Control, Woodhead Publishing, Cambridge, UK
13. Sandle, T. (2016) Introducing Cleanrooms, Microbiology Solutions: USA, ISBN: 978-
1533-16078
14. Sandle, T. (2016) Risk Assessment and Management for Healthcare Manufacturing:
Practical Tips and Case Studies, PDA / DHI, Bethesda, MD, USA.
15. Sandle, T. (2017) Sterilization: Establishing the Process, PDA/DHI, River Grove, Il,
USA (e-book)
16. Sandle, T. (2017) Sterilization: Practical Approaches, PDA/DHI, River Grove, Il, USA
(e-book)
17. Chesca, A., Cengiz, M. and Sandle, T. (Eds.) (2017) Theory and Practice of Disease
Diagnosis, LAP LAMBERT Academic Publishing, Germany, ISBN-13: 978-3330084384
18. Sandle, T. and Tidswell, E. C. (Eds.) (2017) Aseptic and Sterile Processing: Control,
Compliance and Future Trends, DHI/PDA, Bethesda, MD, USA, ISBN: 9781942911128
19. Friedman, B.A., Ginsbury, K., Lowery, S. A., Mueller, M., Sandle, T. and Settineri, F.
(2017) Environmental Monitoring, Volume 1: Establishing the process, PDA / DHI
books, Bethesada, U.S. (e-book)
20. Sandle, T. and Moldenhauer, J. (2017) Cleaning and Cleanrooms, PDA / DHI books,
Bethesada, U.S. (e-book)
21. Sandle, T. (2018) Microbiological Culture Media: A Complete Guide for Pharmaceutical
and Healthcare Manufacturers, DHI/PDA, Bethesda, MD, USA, ISBN Number:
9781942911159
22. Sandle, T. (2018) Risk Management Library Volume 4: Practical Approaches to Risk
Assessment and Management Problem Solving: Tips and Case Studies, PDA/DHI, River
Grove, Il, USA. (e-book)
23. Vesper, J. L. and Sandle, T. (2018) GMP in Practice: Regulatory Expectations for the
Pharmaceutical Industry, 5th edition, DHI/PDA Books, River Grove, Illinois, U.S. ISBN
Number: 9781942911289
24. Sandle, T. (2019) Biocontamination Control for Pharmaceuticals and Healthcare,

Academic Press, London, UK
25. Sandle, T. (2019) Sandle's Pharmaceutical Microbiology Dictionary, Microbiology

Solutions, UK, ISBN-13: 978-1090773197
26. Chesca, A. and Sandle, T. (2019) Histology Systems - short atlas, Globe Edit (Lambert
Academic Publishing), London, ISBN: 978-613-9-41468-0
27. Sandle, T. and Sandle, J. (2019) Audit and Control for Healthcare Manufacturers: A
Systems-Based Approach, PDA / DHI Books, River Grove, IL, USA (ISBN: 978-1-
942911-36-4)
Booklets and monographs
1. Sandle, T. and Boschi, F. (2006): ‘Environmental Monitoring Handbook’,

Advanstar, Duluth, USA (HBEM06). Published in July 2006
(http://www.industrymatter.com/environmentalmonitoringhandbook.aspx)
2. Sandle, T. (editor) (2010): ‘Current Perspectives on Environmental Monitoring: Pharmig

Review Number 1’, Published by Pharmaceutical Microbiology Interest Group,
UK. ISBN 978-0-9560804-1-7
3. Sandle, T., Saghee, M.R. and Ramstrop, M. (2010): Environmental Monitoring and
Cleanrooms, IDMA-APA Guideline, Technical Monograph No.5, Indian Drug
Manufacturers Association, Mumbai
4. Sandle, T. (2011). Polls Apart? Flexible working in the European Pharmaceutical

Sector, Microbiology Solutions: UK (Kindle only eBook ASIN: B0090RIK6K)
5. Roberts, J. and Sandle, T. (2011). A Guide to Microbiology Laboratories in the

Pharmaceutical Industry. Pharmaceutical Microbiology Interest Group, Pharmig:
Stanstead Abbotts, UK
6. Upton, A. and Sandle, T. (2012). Best Practices for the Bacterial Endotoxin Test: A
Guide to the LAL Assay, Pharmaceutical Microbiology Interest Group: Stanstead Abbotts,
UK
7. Sandle, T. (2016) Guide to cleanroom operation and contamination control,
Pharmaceutical Microbiology Interest Group: Stanstead Abbotts, UK (ISBN: 978-0-
9560804-6-2)
8. Blount, R., Gaurdi, L., Morwood, K. and Sandle, T. (2017) Pharmig Guide to
Disifectants and their us in the pharmaceutical industry, Pharmig, Stanstead Abbotts, UK
9. Sandle, T. (2017) Pharmig Guide to Cleanroom Operation and Contamination Control,

Pharmig, Stanstead Abbotts, UK
10. Lovatt, A. and Sandle, T. (2018) Guide to Bacterial Identification, Pharmig, Stanstead
Abbotts, UK ISBN: 9978-0-9560804-8-6
Contributor to:
IVT (2017) Utility Qualification Vol. II, Institute of Validation Technology, USA:
• Biodecontamination of Cleanrooms and Laboratories Using Gassing Systems - Tim

Sandle
• Validation and Assessment of Computerized System Software in a Pharmaceutical
Facility - Tim Sandle
• Risk Consideration for Aging Pharmaceutical Facilities - Tim Sandle
• Microbiological Assessment of Compressed Gases in Pharmaceutical Facilities - Tim
Sandle
• Sanitization of Pharmaceutical Facilities - Tim Sandle
• The Rouging Effect in Pharmaceutical Water Systems: Causes and Strategies for
Prevention - Tim Sandle
• Control of WFI and Clean Steam Systems for Bacterial Endotoxins - Tim Sandle
• Ensuring Sterility: Autoclaves, Wet Loads, and Sterility Failures - Tim Sandle
Editor of IVT (2018) Essential Microbiology for GXP Compliance, Institute of Validation
Technology, USA: http://www.ivtnetwork.com/article/essential-microbiology-gxp-compliance
Book chapters
1. Sandle, T. ‘Selection and use of cleaning and disinfection agents in pharmaceutical

manufacturing’ in Hodges, N and Hanlon, G. (2003): Industrial Pharmaceutical
Microbiology Standards and Controls, Euromed Communications, England
Revised and updated:
Sandle, T. (2014) Selection and use of Cleaning and Disinfection Agents in

Pharmaceutical Manufacturing. In Handlon, G. and Sandle, T. (Eds.) Industrial
Pharmaceutical Microbiology: Standards & Controls, Euromed Communications,
Passfield, UK, 9.1–9.32
Sandle, T. (2019) Selection and use of cleaning and disinfection agents in pharmaceutical
manufacturing. In Sandle, T. (Ed.) Industrial Pharmaceutical Microbiology: Standards &
Controls, 5th edition, Euromed Communications, Passfield, UK, pp11.1-11.32
2. Sandle, T. ‘Best practices for microbiological documentation’ in Hodges, N and Hanlon,

G. (2009): Industrial Pharmaceutical Microbiology Standards and Controls, Euromed
Communications, England, Supplement 9, S9.1 – S9.24
3. Sandle, T. (2010): Best practices in microbiology laboratory training in Hodges, N. and

Hanlon, G. Industrial Pharmaceutical Microbiology: Standards and Controls,
Supplement 11, ppS11.1 to S11.16
Sandle, T. (2014) Best Practices in Microbiology Laboratory Training. In Handlon, G.

and Sandle, T. (Eds.) Industrial Pharmaceutical Microbiology: Standards & Controls,
Euromed Communications, Passfield, UK, 2.1-2.24
Sandle, T. (2019) Best practices in microbiology laboratory training. In Sandle, T. (Ed.)

Industrial Pharmaceutical Microbiology: Standards & Controls, 5th edition, Euromed
Communications, Passfield, UK, pp2.1-24
4. Sandle, T. (2010): 'The Media Kitchen: Preparation and Testing of Microbiological

Culture Media'. In Sutton, S. (ed.): Laboratory Design: Establishing the Facility and
Management Structure, Parenteral Drug Association, Bethesda, MD, United States, ISBN
1-933722-46-0, pp269-293
5. Sandle, T. and Saghee, M. R. (2011): ‘The Essentials of Pharmaceutical Microbiology’,

in Saghee, M.R., Sandle, T. and Tidswell, E.C. (Eds.) (2011): Microbiology and Sterility
Assurance in Pharmaceuticals and Medical Devices, New Delhi: Business Horizons,
pp1-30
6. Sandle, T. (2011): ‘Selection of Microbiological Culture Media and Testing Regimes’ in

Saghee, M.R., Sandle, T. and Tidswell, E.C. (Eds.) (2011): Microbiology and Sterility
pp101-120
7. Sandle, T. (2011): ‘Practical Approaches to Sterility Testing’ in Saghee, M.R., Sandle, T.

and Tidswell, E.C. (Eds.) (2011): Microbiology and Sterility Assurance in
Pharmaceuticals and Medical Devices, New Delhi: Business Horizons, pp173-192
8. Vina, P., Rubio, S. and Sandle, T. (2011): ‘Selection and Validation of Disinfectants’, in
Saghee, M.R., Sandle, T. and Tidswell, E.C. (Eds.) (2011): Microbiology and Sterility
pp219-236
9. Sandle, T. (2011): ‘Environmental Monitoring’ in Saghee, M.R., Sandle, T. and Tidswell,
E.C. (Eds.) (2011): Microbiology and Sterility Assurance in Pharmaceuticals and
Medical Devices, New Delhi: Business Horizons, pp293-326
10. Ashtekar, D. and Sandle, T. (2011): ‘Microbial Content Testing of Pharmaceutical and
Biotechnologically Derived Products’ in Saghee, M.R., Sandle, T. and Tidswell, E.C.
(Eds.) (2011): Microbiology and Sterility Assurance in Pharmaceuticals and Medical
Devices, New Delhi: Business Horizons, pp327-362
11. Sandle, T. (2011): ‘Risk Management in Pharmaceutical Microbiology’ in Saghee, M.R.,

Sandle, T. and Tidswell, E.C. (Eds.) (2011): Microbiology and Sterility Assurance in
Pharmaceuticals and Medical Devices, New Delhi: Business Horizons, pp553-588
12. Sandle, T. (2011). ‘Assessment of Culture Media in Pharmaceutical Microbiology' in

Hodges, N and Hanlon, G. (2011 rev.): Industrial Pharmaceutical Microbiology
Standards and Controls, Euromed Communications, England, Supplement 10
13. Sandle, T. and Lamba, S. S. "Effectively Incorporating Quality Risk Management into
Quality Systems". In Saghee, M.R. (2012) Achieving Quality and Compliance Excellence
in Pharmaceuticals: A Master Class GMP Guide, New Delhi: Business Horizons, pp89-
128
14. Sandle, T. (2012). "Qualification and Validation". In Saghee, M.R. (2012) Achieving
Quality and Compliance Excellence in Pharmaceuticals: A Master Class GMP Guide,
New Delhi: Business Horizons, pp169-206
15. Sandle, T. and Saghee, M.R. (2012). "Compliance Aspects of Sterile Manufacturing". In
Saghee, M.R. (2012) Achieving Quality and Compliance Excellence in Pharmaceuticals:
A Master Class GMP Guide, New Delhi: Business Horizons, pp517-560
16. Sandle, T. (2012). ‘Environmental Monitoring: a practical approach’ In Moldenhauer, J.

Environmental Monitoring: a comprehensive handbook, Volume 6, PDA/DHI: River
Grove, USA, pp29-54
17. Sandle, T. (2012). ‘Introduction’. In Sandle, T. (2012). The CDC Handbook: A Guide to
Cleaning and Disinfecting Cleanrooms, Grosvenor House Publishing: Surrey, UK, ppxv-
xxi
18. Sandle, T. (2012). ‘Cleaning and Disinfection’. In Sandle, T. (Ed.). The CDC Handbook:
A Guide to Cleaning and Disinfecting Cleanrooms, Grosvenor House Publishing: Surrey,
UK, pp1-31
19. Sandle, T. (2012). ‘Application of Disinfectants and Detergents in the Pharmaceutical

Sector’. In Sandle, T. (Ed.). The CDC Handbook: A Guide to Cleaning and Disinfecting
Cleanrooms, Grosvenor House Publishing: Surrey, UK, pp168-197
20. Sandle, T. (Ed.). ‘Validation of Disinfectants’. In Sandle, T. (2012). The CDC Handbook:
A Guide to Cleaning and Disinfecting Cleanrooms, Grosvenor House Publishing: Surrey,
UK, pp241-261
21. Sandle, T. (2013) Risk Management in Sterile Environments. In Thomas, P. (Ed.) Aseptic
Manufacturing - a road map to excellence, Pharmaceutical Manufacturing, USA, pp3-9
(http://www.pharmamanufacturing.com/assets/wp_downloads/pdf/dpt.pdf)
22. Sandle, T. and Saghee, M.R. (2013). ‘Introduction’. In: Sandle, T. and Saghee, M.R.
(Eds.) Cleanroom Management in Pharmaceuticals and Healthcare, Euromed
Communications: Passfield, UK
(revised for second edition: pp1-6)
23. Sandle, T. (2013). ‘History and development of cleanrooms’. In: Sandle, T. and Saghee,
M.R. (Eds.) Cleanroom Management in Pharmaceuticals and Healthcare, Euromed
Communications: Passfield, UK
24. Sandle, T. and Saghee, M.R. (2013). ‘Cleanroom certification and ongoing compliance’.
In: Sandle, T. and Saghee, M.R. (Eds.) Cleanroom Management in Pharmaceuticals and
25. Midcalf, B, Neiger, J. and Sandle, T. (2013). ‘Fundamentals of pharmaceutical isolators’.

In: Sandle, T. and Saghee, M.R. (Eds.) Cleanroom Management in Pharmaceuticals and
26. Sandle, T., Budini, M. and Rajesh, T. (2013). ‘Airflow studies and airflow mapping’. In:
Sandle, T. and Saghee, M.R. (Eds.) Cleanroom Management in Pharmaceuticals and
27. Sandle, T. and Saghee, M.R. (2013). ‘Environmental monitoring in cleanrooms’. In:

28. Sandle, T. and Saghee, M.R. (2013). ‘Cleaning and disinfection practices’. In: Sandle, T.
and Saghee, M.R. (Eds.) Cleanroom Management in Pharmaceuticals and Healthcare,
Euromed Communications: Passfield, UK
29. Sandle, T. and Saghee, M.R. (2013). ‘Auditing cleanroom operations’. In: Sandle, T. and
Saghee, M.R. (Eds.) Cleanroom Management in Pharmaceuticals and Healthcare,
Euromed Communications: Passfield, UK
30. Sandle, T. and Saghee, M.R. (2013). ‘Developments in cleanroom technology’. In:
31. Sandle, T. (2013). 'Dimorph and Filamentous Fungi'. In Mascellino, M. T. (Ed.) Bacterial
and Mycotic Infections in Immunocompromised Hosts: Clinical and Microbiological
Aspects, OMICS Group Inc.: Henderson, NV, USA. In print:
http://esciencecentral.org/ebooks/bacterial-mycotic-infections/pdf/dimorph-filamentous-
fungi.pdf
32. Sandle, T. (2013). Contamination Control Risk Assessment in Masden, R.E. and
Moldenhauer, J. (Eds.) Contamination Control in Healthcare Product Manufacturing,
Volume 1, DHI Publishing, River Grove: USA, pp423-474
33. Sandle, T. (2013). Contamination Control: Cleanrooms and Clean Air Devices,
Encyclopedia of Pharmaceutical Science and Technology, Fourth Edition, Taylor and
Francis: London, pp634 - 643 (http://dx.doi.org/10.1081/E-EPT4-120050223)
34. Sandle, T. (2013). Microbial Control of Pharmaceuticals, Encyclopedia of

Pharmaceutical Science and Technology, Fourth Edition, Taylor and Francis: London,
pp2122-2132 (http://dx.doi.org/10.1081/E-EPT4-120050301)
35. Sandle, T. and Saghee, M.R. (2014). Basic Concepts of GMP Requirements. In Saghee,
M.R. (Ed.) Pharmaceutical Regulatory Inspections, Euromed Communications:
Passfield, UK, pp1-76
36. Barr, D. and Sandle, T. (2014). System Based Approach to Inspections. In Saghee, M.R.
(Ed.) Pharmaceutical Regulatory Inspections, Euromed Communications: Passfield, UK,
pp119-182
37. Brutsche, A. and Sandle, T. (2014). Preparing and Management of International

Inspections. In Saghee, M.R. (Ed.) Pharmaceutical Regulatory Inspections, Euromed
Communications: Passfield, UK, pp285-328
38. Sandle, T., Saghee, M.R. and Barr, D. (2014) Handling and responding to post
inspectional observations. In Saghee, M.R. (Ed.) Pharmaceutical Regulatory Inspections,
Euromed Publications, Passfield, UK, pp329-360
39. Sandle, T. (2014). Preparing for Regulatory Inspections of Sterile Facilities: the Focal
Points. In Saghee, M.R. (Ed.) Pharmaceutical Regulatory Inspections, Euromed
Communications: Passfield, UK, pp361-462
40. Sandle, T. (2014). ‘Microbial Identification: Laboratory Techniques and Methods. In

Chesca, A. (Ed.) Methods for Diseases: Diagnostic with Applicability in Practice,
Lambert Academic Publishing, Germany, pp15-26
41. Sandle, T., 2014. Biochemical and Modern Identification Techniques:

Enterobacteriaceae, Coliforms, and Escherichia Coli. In: Batt, C.A., Tortorello, M.L.
(Eds.), Encyclopedia of Food Microbiology, 2nd edition, vol 1. Elsevier Ltd, Academic
Press, pp. 232–237
42. Sandle, T., 2014. Biochemical and Modern Identification Techniques: Food-Poisoning
Microorganisms. In: Batt, C.A., Tortorello, M.L. (Eds.), Encyclopedia of Food
Microbiology, 2nd edition, vol 1. Elsevier Ltd, Academic Press, pp. 238–243
43. Sandle, T., 2014. Laboratory Design. In: Batt, C.A., Tortorello, M.L. (Eds.),
Encyclopedia of Food Microbiology, vol 2. Elsevier Ltd, Academic Press, pp. 393–401
44. Sandle, T., 2014. Fungi: Classification of the Peronosporomycetes. In: Batt, C.A.,
Tortorello, M.L. (Eds.), Encyclopedia of Food Microbiology, vol 2. Elsevier Ltd,
Academic Press, pp. 44–53
45. Sandle, T., 2014. Trichoderma. In: Batt, C.A., Tortorello, M.L. (Eds.), Encyclopedia of
Food Microbiology, vol 3. Elsevier Ltd, Academic Press, pp. 644–646
46. Sandle, T. (2014) Bacterial Diseases and their Diagnosis. In Chesca, A. (Ed.) Techniques
and Procedures for Disease Diagnostic, Lambert Academic Publishing, Saarbruken,
Germany, pp31-60
47. Sandle, T. (2014) Best Practices in Microbiology Laboratory Training. In Handlon, G.

and Sandle, T. (Eds.) Industrial Pharmaceutical Microbiology: Standards & Controls,
Euromed Communications, Passfield, UK, 2.1-2.24
48. Sandle, T. (2014) The Use of Culture Media in Pharmaceutical Microbiology. In Hanlon,
G. and Sandle, T. (Eds.) Industrial Pharmaceutical Microbiology: Standards & Controls,
Euromed Communications, Passfield, UK, 3.1–3.26
Sandle, T. (2019) Use of culture media in pharmaceutical microbiology. In Sandle, T.

(Ed.) Industrial Pharmaceutical Microbiology: Standards & Controls, 5th edition,
Euromed Communications, Passfield, UK, pp4.1-4.26
49. Sandle, T. (2014) Microbiology of Pharmaceutical Grade Water. In Hanlon, G. and
Sandle, T. (Eds.) Industrial Pharmaceutical Microbiology: Standards & Controls,
Euromed Communications, Passfield, UK, 10.1–10.19
Sandle, T. (2019) Microbiology of pharmaceutical grade water. In Sandle, T. (Ed.)

Industrial Pharmaceutical Microbiology: Standards & Controls, 5th edition, Euromed
Communications, Passfield, UK, pp12.1-12.20
50. Sandle, T. (2014) Biological Indicators, In Hanlon, G. and Sandle, T. (Eds.) Industrial
Pharmaceutical Microbiology: Standards & Controls, Euromed Communications,
Passfield, UK, 16.1–16.26
Sandle, T. (2019) Biological indicators. In Sandle, T. (Ed.) Industrial Pharmaceutical

Microbiology: Standards & Controls, 5th edition, Euromed Communications, Passfield,
UK, pp19.1-19.28
51. Sandle, T. (2014) Containment System Integrity: Microbial Challenges for Sterile
Products. In Hanlon, G. and Sandle, T. (Eds.) Industrial Pharmaceutical Microbiology:
Standards & Controls, Euromed Communications, Passfield, UK, 18.1–18.13
Sandle, T. (2019) Containment system integrity: microbial challenges for sterile products.
In Sandle, T. (Ed.) Industrial Pharmaceutical Microbiology: Standards & Controls, 5th
edition, Euromed Communications, Passfield, UK, pp21.1-21.16
52. Sandle, T. (2014) The Regulatory Control and Quality Assurance of Immunological
Products. In Hanlon, G. and Sandle, T. (Eds.) Industrial Pharmaceutical Microbiology:
Standards & Controls, Euromed Communications, Passfield, UK, 22.1–22.14
Sandle, T. (2019) Regulatory control and assurance of immunological products. In

Sandle, T. (Ed.) Industrial Pharmaceutical Microbiology: Standards & Controls, 5th
53. Sandle, T. (2015) Cleanroom Design. In Moldenhauer, J. (Ed.) Environmental

Monitoring: a Comprehensive Handbook, Volume 7, pp3-28
54. Sandle, T. (2015) Bacterial Endotoxin Testing using the Limulus Amebocyte Lysate
Assay. In Kőszegi, T. and Chesca, A. (Eds.) Laboratory Techniques with Applicability in
Medical Practice, Lambert Academic Publishing, pp19-32
55. Sandle, T. (2015) Investigating Sterility Test Failures. In McCullough, K.Z. and
Moldenhauer, J. (Eds.) Microbial Risks and Investigations, DHI/PDA, River Grove,
USA, pp261-290
56. Sandle, T. (2015) Contamination Control Risk Assessment. In McCullough, K.Z. and
Moldenhauer, J. (Eds.) Microbial Risks and Investigations, DHI/PDA, River Grove,
USA, pp783-836
57. Contributor to Masden, R. E. and Jornitz, M. W. (2015) Lessons of Failure: When things
go wrong in pharmaceutical manufacturing, PDA/ DHI Books, Bethesda, MD, USA
58. Sandle, T. (2016) Antibiotic / Antimicrobial Resistance. In Boslaugh, S. (Ed.) The Sage
Encyclopedia of Pharmacology and Society, Volume 1, Sage Publications: Los Angeles,
pp136-139
59. Sandle, T. (2016) Antimalarials. In Boslaugh, S. (Ed.) The Sage Encyclopedia of

Pharmacology and Society, Volume 1, Sage Publications: Los Angeles, pp190-192
60. Sandle, T. (2016) Drug-Resistant Diseases. In Boslaugh, S. (Ed.) The Sage Encyclopedia
of Pharmacology and Society, Volume 2, Sage Publications: Los Angeles, pp546-550
61. Sandle, T. (2016) European Medicines Agency. In Boslaugh, S. (Ed.) The Sage
pp593-596
62. Sandle, T. (2016) Lyme Disease. In Boslaugh, S. (Ed.) The Sage Encyclopedia of
63. Sandle, T. (2016) Medicines and Healthcare Products Regulatory Agency (UK). In
Boslaugh, S. (Ed.) The Sage Encyclopedia of Pharmacology and Society, Volume 2, Sage
Publications: Los Angeles, pp899-902
64. Sandle, T. (2016) National Institute For Biological Standards and Control. In Boslaugh,
S. (Ed.) The Sage Encyclopedia of Pharmacology and Society, Volume 3, Sage
Publications: Los Angeles, pp948-950
65. Sandle, T. (2016) Smallpox Eradication. In Boslaugh, S. (Ed.) The Sage Encyclopedia of
66. Sandle, T. (2016) U.S. Pharmacopeial Convention. In Boslaugh, S. (Ed.) The Sage
pp1503-1505
67. Sandle, T, (2016) Tests for Antimicrobial Effectiveness, Chesca, A. and Cengiz, M.
(Eds.) Theory and Practice for Medical Diagnosis, Lambert Academic Publishing,
Germany, pp7-19
68. Sandle, T. (2016) ISO 14644 Parts 1 and 2 - The revised cleanroom standard and
contamination control. In Madsen, R. E. and Moldenhaurer, J. (Eds.) Contamination
Control in Healthcare Product Manufacturing, Volume 4, DHI, River Grove, USA, pp3-
32
69. Sandle, T. (2016) Risk of microbial spores, prevention measures and disinfection
strategies. In Madsen, R. E. and Moldenhaurer, J. (Eds.) Contamination Control in
Healthcare Product Manufacturing, Volume 4, DHI, River Grove, USA, pp59-95
70. Sandle, T. (2016) Disinfectants in the Pharmaceutical Industry. In Cardoso, A. S.,

Almeida, C. M. M., Cordeiro, T. C. and Gaffney, V.J. (Eds.) Disinfectants: Properties,
Applications and Effectiveness, Nova Science Publishers, New York, pp109-142
71. Sandle, T. (2017) Clean room design principles: Focus on particulates and microbials. In
Esteves, S. C., Varghese, A. C., and Worrilow, K. C. (Eds.) Clean Room Technology in
ART Clinics: A Practical Guide, CRC Press, Boca Raton, U.S., pp75-91
72. Hallworth, M., Sahee, M.R. and Sandle, T. (2017) Cleanroom standards and GMP
requirements. In Sandle, T. and Saghee, M. R. (Eds.) Cleanroom management in
pharmaceuticals and healthcare, 2nd edition, Euromed Communications, Passfield, UK,
Cleanroom standards and GMP requirements, pp25-44
73. Sandle, T. (2017) Bow Street Runners. In Robertiello, G. (Ed.) In The Use and Abuse of
Police Power in America: Historical Milestones and Current Controversies, ABC-CLIO
Books, U.S., pp13-15
74. Sandle, T. (2017) Southern Slave Patrols. In Robertiello, G. (Ed.) In The Use and Abuse
of Police Power in America: Historical Milestones and Current Controversies, ABC-
CLIO Books, U.S., pp15-17
75. Sandle, T. (2017) Environmental Control and Environmental Monitoring in Support of

Aseptic Processing. In Sandle, T. and Tidswell, E. C. (Eds.) Aseptic and Sterile
Processing: Control, Compliance and Future Trends, DHI/PDA, Bethesda, MD,
USA, ISBN: 9781942911128, pp447-540
76. Sandle, T. (2017) The Sterility Test: Current Practice and Future Applications. In Sandle,
T. and Tidswell, E. C. (Eds.) Aseptic and Sterile Processing: Control, Compliance and
Future Trends, DHI/PDA, Bethesda, MD, USA, ISBN: 9781942911128, 645-702
77. Sandle, T. (2017) Application of ISO 14644 Parts 1 and 2 for cleanroom contamination
control. In Moldenhauer, J. (Ed.) Environmental Monitoring: A Comprehensive
Handbook, Volume 8, DHI Publoshing / PDA, River Grove, IL, USA, pp3-22
78. Sandle, T. (2017) Environmental monitoring: a practical approach’. In Friedman, B.A.,

Ginsbury, K., Lowery, S. A., Mueller, M., Sandle, T. and Settineri, F. (2017)
Environmental Monitoring, Volume 1: Establishing the process, PDA / DHI books,
Bethesada, U.S., pp23-48
79. Sandle, T. (2018) Microbiological Control and Testing for Phase Appropriate GMP. In
Deeks, T. (Ed.) Phase Appropriate GMP for Biological Processes: Pre-clinical to
Commercial Production, PDA / DHI Books, Arlington Heights, IL, U.S.
80. Sandle, T. (2018) Sterility Assurance in Early Phase Development. In Deeks, T. (Ed.)
Phase Appropriate GMP for Biological Processes: Pre-clinical to Commercial
Production, PDA / DHI Books, Arlington Heights, IL, U.S.
81. Sandle, T. (2018): Burkholderia cepacia complex: Characteristics, products risks and
testing requirements. In Reber, D. and Griffin, M. (Eds.) Microbial Control and
Identification, DHI/PDA books, River Grove, USA, pp197-230. ISBN Number:
9781942911272
82. Sandle, T., Chesca, A. and Abdulina, G. (2018) Digital advances in modern pathology,
Bulletin of Karaganda University, Biology. Medicine. Geography Series, Vol. 90, No.2,
pp86-93, ISSN 2518-7201
83. Sandle, T. (2019) Disinfectants and Biocides. In Moldenhauer, J. (Ed.) Disinfection and
Decontamination A Practical Handbook, CRC Press, Boca Raton, pp7-34
84. Sandle, T. (2018) Personnel Monitoring for Controlled Environments. In Masden R. E.

and Moldenhauer, J. M. (Eds.) Contamination Control in Healthcare Product
Manufacturing, Vol.5, pp357-400
85. Dolman, J. and Sandle, T. (2019) The role of the Qualified Person in microbiological
quality assurance. In Sandle, T. (Ed.) Industrial Pharmaceutical Microbiology:
Standards & Controls, 5th edition, Euromed Communications, Passfield, UK, pp7.1-7.14
86. Sandle, T. (2019) Microbiology identification strategy for pharmaceutical microbiology.

In Sandle, T. (Ed.) Industrial Pharmaceutical Microbiology: Standards & Controls, 5th
87. Sandle, T. (2019) Who has access to your DNA data?, Derricourt, J. (Ed.) Digital
Journal: Twenty Years of Real News, PhotoTelegram Press Publishers, Canada
Papers in peer reviewed journals
1. Sandle, T. (2003): The use of a risk assessment in the pharmaceutical industry –

the application of FMEA to a sterility testing isolator: a case study, European Journal of
Parenteral and Pharmaceutical Sciences, 8(2): 43-49
2. Sandle, T. (2004): Practical Approaches to Sterility Testing, Journal of Validation
Technology, 10 (2): 131 – 141
3. Sandle, T. (2004): An Approach for the Reporting of Microbiological Results from Water
Systems, PDA Journal of Pharmaceutical Science and Technology, 58 (4): 231 – 237
(Pub Med http://www.ncbi.nlm.nih.gov/pubmed/22293526)
4. Sandle, T. and Skinner, K. (2005): Examination of the optimal cultural conditions for the
microbiological analysis of a cold demineralised water system in a pharmaceutical
manufacturing facility, European Journal of Parenteral and Pharmaceutical Sciences, 10
(1): 9-14
5. Sandle, T. (2006): Environmental Monitoring Risk Assessment, Journal of GXP

Compliance, 10 (2): 54-73 (Link:
http://www.gxpandjvt.com/ivtnews/templates/templateblank.aspx?articleid=1444&zoneid=18)
6. Sandle, T. (2006): The use of polymeric flooring to reduce contamination in a cleanroom

changing area, European Journal of Parenteral and Pharmaceutical Sciences, 11 (3): 75-
80
7. Tours, N. and Sandle, T. (2008) Comparison of dry-heat depyrogenation using three

different types of Gram-negative bacterial endotoxin, European Journal of Parenteral
and Pharmaceutical Sciences, 13 91): 17-20
8. Sandle, T. (2010) Selection of active air samplers, European Journal of Parenteral and
Pharmaceutical Sciences, 15 (4): 119-124
(Note: The EJPPS paper is different to the paper on air-samplers published in The Journal
(both 2010)).
9. Sandle, T. (2011). A study of a new type of swab for the environmental monitoring of
isolators and cleanrooms (the Heipha ICR-Swab), European Journal of Pharenteral and
Pharmaceutical Sciences, 16 (2): 42-48
10. Sandle, T. (2011): A Review of Cleanroom Microflora: Types, Trends, and Patterns,
PDA Journal of Pharmaceutical Science and Technology, 65 (4): 392-403 (Pub Med:
http://www.ncbi.nlm.nih.gov/pubmed/22293526)
11. Sandle, T. and Saghee, M. R. (2011): Some considerations for the implementation of
disposable technology and single-use systems in biopharmaceuticals, Journal of
Commercial Biotechnology, 17 (4): 319–329 doi: 10.1057/jcb.2011.21 (view here:
http://www.palgrave-journals.com/jcb/journal/vaop/ncurrent/abs/jcb201121a.html)
12. Sandle, T. (2011): A Practical Approach to Depyrogenation Studies using Bacterial

Endotoxin, Journal of GXP Compliance, 15 (4): 90-96 (electronic version:
http://www.ivtnetwork.com/gxp-journal/journal-of-gxp-compliance-2687)
13. Sandle, T. (2011): Evaluation of two different types of contact plates for microbiological
environmental monitoring, European Journal of Parenteral and Pharmaceutical
Sciences, 16 (4): 116-120
14. Sandle, T. (2012): Sterility Test Failure Investigations, Journal of GxP Compliance, Vol.
16, No.1, electronic version: http://www.ivtnetwork.com/gxp-journal/journal-of-gxp-
compliance-2011
15. Vijayakumar, R., Sandle, T. and Manoharan, C. (2012). A review of fungal

contamination in pharmaceutical products and phenotypic identification of contaminants
by conventional methods, European Journal of Parenteral and Pharmaceutical Sciences,
17 (1): 4-19
16. Sandle, T. and Saghee, M.R. (2012). Application of Sterilization by Gamma Radiation
for Single-Use Disposable Technologies in the Biopharmaceutical Sector, Journal of
GXP Compliance, 16 (2): 1-10, electronic journal: http://www.ivtnetwork.com/gxp-
journal/journal-of-gxp-compliance-2010
17. Vijayakumar, R., Kannan, V.V., Sandle, T., and Manoharan, C. (2012). In vitro
Antifungal Efficacy of Biguanides and Quaternary Ammonium Compounds against
Cleanroom Fungal Isolates, PDA Journal of Pharmaceutical Science and Technology,
May/June 2012, Vol. 66, No. 3: 236-242
18. Sandle, T. (2012). Examination of air and surface particulate levels from cleanroom mats
and polymeric flooring, European Journal of Parenteral and Pharmaceutical Sciences
2012; 17(3): 110-11
19. Sandle, T. (2012). Application of Quality Risk Management To Set Viable

Environmental Monitoring Frequencies in Biotechnology Processing and Support Areas,
PDA Journal of Pharmaceutical Science and Technology, 66 (6): 560 - 579
20. Sandle, T. (2012). Container Closures for Pharmaceutical Preparations: A review of

Design and Test Considerations, BioPharm International, 25 (12): 32-36
21. Sandle, T., Leavy, C. and Needham, G. (2012). A Risk Matrix Approach for Media
Simulation Trials, Journal of Validation Technology, 18 (4): 70-78
22. Sandle, T. and Tours, N. (2013). Validation and Operation of a Sterility Testing Isolator:
a Study Proposal, Journal of validation Technology, 19 (1): 1-10, on-line edition
available at: http://www.ivtnetwork.com/article/peer-reviewed-validation-and-
operation-sterility-testing-isolator-study-proposal
23. Sandle, T. and Skinner, K. (2013). Study of psychrophilic and psychrotolerant

microorganisms isolated in cold rooms used for pharmaceutical processing, Journal of
Applied Microbiology, 114 (4), 1166—1174
24. Sandle, T. (2013). In situ study of particles generated from the use of pharmaceutical
grade cleanroom wipes, European Journal of Parenteral and Pharmaceutical Sciences,
Vol. 18, No.1, pp5-11
25. Sandle, T. (2013). Bacterial Adhesion: an Introduction, Journal of Validation

Technology, 19 (2): 1-10, on-line: http://www.ivtnetwork.com/article/bacterial-adhesion-
introduction
26. Tim Sandle, Kerry Skinner, Jennifer Sandle, Barbara Gebala, Pavitra Kothandaraman
(2013): Evaluation of the GEN III OmniLog® ID System microbial identification system
for the profiling of cleanroom bacteria, European Journal of Parenteral &
Pharmaceutical Sciences 18(2): 44-50
27. Sandle, T., Skinner, K. and Yeandle, E. (2013). Optimal conditions for the recovery of
bioburden from pharmaceutical processes: a case study, European Journal of Parenteral
and Pharmaceutical Sciences, 18 (3): 84-91
28. Gebala, B. and Sandle, T. (2013). Comparison of different fungal agar for the
environmental monitoring of pharmaceutical-grade cleanrooms, PDA J Pharm Sci
Technol.;67(6):621-33
29. Sandle, T. (2013). Pharaohs and Mummies: Diseases of Ancient Egypt and Modern
Approaches, Journal of Ancient Diseases & Preventive Remedies, 1 (4): e110. doi:
10.4172/2329-8731.1000e110
30. Sandle, T. (2013). Global Strategies for Elimination of Leprosy: A Review of Current
Progress, Journal of Ancient Diseases & Preventive Remedies, 1 (4): e112. doi:
10.4172/2329-8731.1000e112
31. Sandle T (2014) Novel Methods to Address Antimicrobial Resistance. SOJ Microbiol
Infect Dis 2(1): 2-3 (see here: http://symbiosisonlinepublishing.com/microbiology-
infectiousdiseases/microbiology-infectiousdiseases11.pdf)
32. Sandle, T. (2014) Variations in the Resistance of Biological Indicators Used to Assess
Sterilization, Journal of Validation Compliance, 20 (1): 1-10 (at:
http://www.ivtnetwork.com/printpdf/article/variations-resistance-biological-indicators-
used-assess-sterilization)
33. Sandle, T. (2014) Examination of the Order of Incubation for the Recovery of Bacteria
and Fungi from Pharmaceutical Cleanrooms, International Journal of Pharmaceutical
Compounding, 18 (3): 242 – 247
34. Sandle, T., Banenko, D., Lavrinenko, A., Azizov, I. and Chesca, A. (2014) The current
state of PCR approach in detection and identification of carbapanem hydrolysis β-
lactamases genes, European Journal of Parenteral and Pharmaceutical Sciences, 19 (1):
153-164
35. Sandle, T., Leavy, C., Jindal, H. and Rhodes, R. (2014) Application of rapid
microbiological methods for the risk assessment of controlled biopharmaceutical
environments, Journal of Applied Microbiology, 116 (6): 1495-1505
36. Chesca, A., Sandle, T. and Gyurka, G.A. (2014) Study on the incidence of certain
neoplastic diseases, Acta Medica Transilvanica, 2 (2): 168 – 172
37. Sandle, T. (2014) Approaching the Selection of Rapid Microbiological Methods, Journal
of Validation Technology, 20 (2): 1010. Published on-line:
http://www.ivtnetwork.com/article/approaching-selection-rapid-microbiological-methods
Reprinted in: 2018 - SPECIAL EDITION: Essential Microbiology for GXP Compliance,
pp12-18
38. Sandle, T. (2014) The Lean Laboratory and Its Application for the Review of
Environmental Monitoring Samples, Journal of Validation Technology, 20 (2): 1-10.
Published on-line http://www.ivtnetwork.com/article/lean-laboratory-and-its-application-
review-environmental-monitoring-samples
39. Sandle, T. (2014) The Test for Sterility of Medicinal Products, International Journal of
Microbiology and Allied Sciences, 1 (1): 1-9 (at: http://www.ijomas.com/wp-
content/uploads/2014/08/Editorial1-Issue1.pdf)
40. Sandle, T. (2014) Sterile Ophthalmic Preparations and Contamination Control, Journal
of GXP Compliance, 18 (3): 1-5
41. Sandle, T. (2014) Sanitation of Pharmaceutical Facilities, Journal of GXP

Compliance, 18 (3): 6-10
42. Chesca, A. and Sandle, T. (2014) Functional Lung Disease, Acta Medica Transilvanica, 2
(3): 42-44
43. Sandle, T. (2014) The Possible Origins of Tuberculosis in South America, Journal of
Ancient Diseases & Preventive Remedies, 2 (2): 1-2
44. Sandle, T. (2014) Santitization of Pharmaceutical Facilities, Journal of GXP Compliance,

18 (3): pp1-5
45. Chesca, A. and Sandle, T. (2014) Data on the examination of functions in pulmonary
disease, Acta Medica Transilvanica, 2 (3): 208 – 210
46. Sandle, T. (2014) Good Documentation Practice, Journal of Validation Technology, Vol.
20, Issue 3, pp1-11
47. Sandle, T., Vijayakumar, R., Saleh Al Aboody, M. and Saravanakumar, S. (2014) In vitro
fungicidal activity of biocides against pharmaceutical environmental fungal isolates,
Journal of Applied Microbiology, 117 (5): 1267 – 1273
48. Sandle, T. (2014) Assessment of the suitability of R3A agar for the subculture of
microorganisms isolated from pharmaceutical water systems, European Journal of
Parenteral and Pharmaceutical Sciences, 19 (3): 85-94
49. Sandle, T. (2014) Emergence of New Antibiotics, J J Microbiol Pathol., 1(1): 001
50. Sandle, T. (2014) The Antibiotic Crisis and the Need for New Forms of Antibiotics, EC
Microbiology, 1 (1): 1-3
51. Sandle, T., Azizov, I., Babenko, D., Lavrinenko, A., Chesca, A. (2014) Comparative
Evaluation of Traditional Susceptibility Testing for MRSA with the PCR Approach,
Advances in Microbiology, 4, 1204-1211 http://dx.doi.org/10.4236/aim.2014.416130
52. Sandle, T. (2014) People in Cleanrooms: Understanding and Monitoring the Personnel
Factor, Journal of GXP Compliance, 18 (4): 1-5
53. Sandle, T. (2015) Dracunculiasis and the Long Decline of an Ancient Disease, Journal of
Ancient Diseases & Preventive Remedies, 2 (3): 1-2
54. Sandle, T., Vijayakumar, R. , Saleh A Aboody, M. and Saravanakumar, S. (2015) In vitro
fungicidal activity of biocides against pharmaceutical environmental fungal isolates: a
response to the Letter of Rout and Humphreys (2015), Journal of Applied Microbiology,
118, 779-780
55. Sandle, T., Leavy, C. and Rhodes, R. (2015) Assessing airborne contamination using a
novel rapid microbiological method, European Journal of Parenteral & Pharmaceutical
Sciences, 19(4): 131-142
56. Sandle, T. (2015) Teixobactin: A New Class of Antibiotic, SOJ Microbiology &
Infectious Diseases, 3 (1): 1-2 (http://symbiosisonlinepublishing.com/microbiology-
infectiousdiseases/microbiology-infectiousdiseases28.pdf)
57. Sandle, T., Gyurka, G.A. and Chesca, A. (2015) Medical conditions regarding heart
failure, ACTA Medica Transilvanica, 20(1):39-41
58. Sandle, T. (2015) Exhuming Skeletal Remains: How Cholera Deaths of the Past Could
Shine a Blue Light of Hope, Journal of Ancient Diseases & Preventive Remedies, 3 (1):
http://dx.doi.org/10.4172/2329-8731.1000e121
59. Sandle, T. (2015) The Rouging Effect in Pharmaceutical Water Systems: Causes and
Strategies for Prevention, Journal of GXP Compliance, 19 (1): 1-10:
http://www.ivtnetwork.com/article/rouging-effect-pharmaceutical-water-systems-
causes-and-strategies-prevention
60. Sandle, T. (2015) Assessing Non-endotoxin Microbial Pyrogens in Relation in

Pharmaceutical Processing, Journal of GXP Compliance, 19 (1): 1-10:
http://www.ivtnetwork.com/article/assessing-non-endotoxin-microbial-pyrogens-
relation-pharmaceutical-processing
61. Sandle, T. (2015): Aseptic Transfer Risk Assessment: A Case Study, Journal of
Validation Technology, 21(1): 1-10 Online: http://www.ivtnetwork.com/article/aseptic-
transfer-risk-assessment-case-study
62. Sandle, T. (2015): Risk Considerations for Installation of a New Autoclave in a

Pharmaceutical Manufacturing Facility, Journal of Validation Technology, 21(1): 1-10
Online: http://www.ivtnetwork.com/article/risk-considerations-installation-new-
autoclave-pharmaceutical-manufacturing-facility
63. Sandle, T. “Human Microbiome of the Skin: Advances in Metagenomics”. EC

Microbiology 1.3 (2015): 162-165.
64. Sandle, T. “From Head to Toe: Mapping Fungi across Human Skin”. EC Microbiology
2.1 (2015): 211-213
65. Sandle, T. (2015) Towards a Rapid Sterility Test?, Microbial & Biochemical Technology,
7 (4): 216-217 doi:10.4172/1948-5948.1000209
66. Sandle, T. (2015) Ensuring Sterility: Autoclaves, Wet Loads, and Sterility Failures,
Journal of GXP Compliance, 19 (2): 1-10 http://www.ivtnetwork.com/article/ensuring-
sterility-autoclaves-wet-loads-and-sterility-failures
67. Chesca, A., Gyurka, A., and Sandle, T. (2015) Data concerning the incidence of
respiratory pathology in different seasonal periods, Archives of the Balkan Medical
Union, 50 (2): 208-212
68. Sandle, T. (2015) Settle plate exposure under unidirectional airflow and the effect of
weight loss upon microbial growth, European Journal of Parenteral & Pharmaceutical
Sciences 2015; 20(2): 45-50
69. Sandle, T. (2015) Incidences and Treatments for Buruli Ulcer, Journal of Ancient
Diseases & Preventive Remedies, 3 (2): 1000e122 (http://dx.doi.org/10.4172/2329-
8731.1000e122)
70. Sandle, T. (2015) Characterizing the Microbiota of a Pharmaceutical Water System-A

Metadata Study, SOJ Microbiology & Infectious Diseases, 3 (2): 1-8
71. Chesca, A., Sandle, T., Babenko, D. and Azzov, I. (2015) Structural aspects regarding
surgical pathology of children, Annals of the Romanian Society for Cell Biology, 14 (9):
65-69 doi: 10.ANN/RSCB-2015-0024:RSCB
72. Cheşcă, A., Luculescu, M.C., Sandle, T. (2015) Considerations of melanocytic nevi in
children, Annals of the Romanian Society for Cell Biology, 19 (2): 19 - 22 doi:
10.ANN/RSCB-2015-0001:RSCB
73. Antonella Cheşcă, Tim Sandle, Dmitriy Babenko (2015) Ethical and Legal Aspects of
Mediation and the Involvement of Mediators in Conflicts Solution, Journal Plus
Education, 12 (A): 14-19
74. Sandle, T. (2015) Settle plate exposure under unidirectional airflow and the effect of
weight loss upon microbial growth, European Journal of Parenteral & Pharmaceutical
Sciences, 2015; 20 (2): 45-50
75. Sandle, T. (2015) FDA Signals a New Approach for Analytical Method Validation,
Journal of Validation Technology, 21 (2): 1-5
Also published in IVT Network Analytical Method Validation Vol. IV, 2017
76. Sandle, T. (2015) Assessing Process Hold Times for Microbial Risks: Bioburden and
Endotoxin, Journal of GXP Compliance, Vol. 19, Issue 3, Oct 2015, pp1-9
77. Sandle, T. (2015) Microbiological Assessment of Compressed Gases in Pharmaceutical

Facilities, Journal of Validation Technology, Vol. 21, Issue 2, August 2015, pp1-8
pp51-56
78. Vijayakumar, R., Saleh Al-Aboody, M. and Sandle, T. (2015) A review of melanized
(black) fungal contamination in pharmaceutical products—incidence, drug recall and
control measures, Journal of Applied Microbiology, 120(4): 831-841
doi:10.1111/jam.12888
79. Sandle, T. (2015) Advances in Rapid Pathogen Detection, Journal of Microbiology &
Experimentation, 2 (5): 00063. DOI: 10.15406/jmen.2015.02.00063
80. Sandle, T. (2015) Microbiological Identification with MALDI-TOF MS, Journal of

Validation Technology, 21 (3): 1-10 at:
http://www.ivtnetwork.com/article/microbiological-identification-maldi-tof-ms
pp33-38
81. Sandle, T. and Satyada, R. (2015) Assessment of the disinfection of impaction air
sampler heads using 70% IPA, as part of cleanroom environmental monitoring, European
Journal of Parenteral and Pharmaceutical Science, 20 (3): 94-99
82. Sandle, T. (2015) Approaching Microbiological Method Validation, Journal of GXP

Compliance, 19 (4): 1-15
Also published in IVT Network Analytical Method Validation Vol. IV, 2017
83. Sandle, T. (2015) Searching for Antimicrobials in the Unlikeliest of Places, J Pharm
Microbiol, 1 (1): 1-3
84. Chesca, A., Sandle, T., Babenko, D. and Azizov, A. (2015) Structural issues of the
tegument regions adjacent to the melanocytic nevi, Annals of the Romanian Society for
Cell Biology, 20 (1): 7-10
85. Sandle, T. (2016) Risk-Based Approach to Internal Quality Auditing, Journal of

Validation Technology, 22 (1): 1-10
86. Sandle, T. (2016) Bacteriophages offer an Antimicrobial Solution, Journal of

Microbiology & Experimentation, 3 (1): 1-2 (DOI: 10.15406/jmen.2016.03.00077)
87. Sandle, T. and Satyada, R. (2016) Determination of the cleaning efficiency for glassware
in the pharmaceutical microbiology laboratory, European Journal of Parenteral and
Pharmaceutical Sciences, 21 (1): 20- 28
88. Chesca, A., Chesca, S.A., Sandle, T., Babenko, D., and Azizov, I. (2016) Alzheimer's
Medical Considerations, Archives of the Balkan Medical Union, 51 (1): 90-93
89. Cheşcă A., Cheşcă S. A., Sandle T. (2016) Medical data regarding functional exploration
in lung pathology, Clinical Medicine, 78 (1): 67-71
90. Sandle, T. and Satyada, R. (2016) Determination of the cleaning efficiency for glassware
in the pharmaceutical microbiology laboratory, European Journal of Parenteral &
Pharmaceutical Sciences; 21(1): 16-22
91. Vijayakumar, R., Al-Aboody, M. S., AlFonaisan, M. K., Sandle, T. (2016) In vitro
susceptibility of multidrug resistant Pseudomonas aeruginosa clinical isolates to common
biocides, International Journal of Research in Pharmaceutical Sciences, 7 (1): 110-116
92. Babenko, D., Amirbekova, Z., Turmuhambetova, A., Sandle, T. and Chesca, A. (2016) In
silico comparison serotyping and genotyping methods for Chlamydia trachomatis, Annals
of Romanian Society for Cell Biology, Vol. XX, Issue 2, 2016, pp. 1 – 4
93. Akhmaltdinova, L.L., Azizov, I., Sandle, T., Gyurka, A.G. and Chessca, A. (2016) Use of
flow cytometry for the evaluation of disinfectant effectiveness, Archives of the Balkan
Medical Union, 51 (2): 213-215
94. Sandle, T. (2016) Risk Assessment for Intervention Scoring in Relation to Aseptic
Processing, Journal of Validation Technology, 22 (2): 1-10
95. Sandle, T. (2016) Risk Consideration for Aging Pharmaceutical Facilities, Journal of
Validation Technology, 22 (2): 11-20
pp69-75
96. Sandle T. The Importance of Water Activity for Risk Assessing Pharmaceutical Products,
J Pharm Microbiol. 2016, 2 (1): 1-2
97. Cheşcă A., Sandle T., Gyurka G. (2016) A. Medical considerations regarding chronic
obstructive pulmonary disease, Medicine and Ecology, 79 (2): 91-94
98. Gyurka A. G., Cheşcă S. A., Sandle T. (2016) Statistical study on cardiopulmonary
diseases, Medicine and Ecology, 79 (2): 95-98
99. Sandle, T. (2016) Designing Aseptic Process Simulations: The Time and Container
Number Conundrum, Journal of GxP Compliance, 20 (3): 1-12
100. Lavrinenko, A., Tishkambayevi, Y., Serbo, Y., Shambilova, N., Azizov, I., Sandle, T.,
Gyurka, A. and Chesca, A. (2016) Prevalence of urinary Tract Infections in Pregnant
Women, Archives of the Balkan Medical Union, 15 (3): 307-310
101. Sandle, T. (2016) Control of WFI and Clean Steam Systems for Bacterial Endotoxins,
Journal of GxP Compliance, 20 (4): 1-15
102. Babenko, A., Turmuhambetova, A., Sandle, T. and Chesca, A. (2016) In silico
comparison of molecular typing methods for characterization of Staphylococcus aureus,
Acta Medica Mediterranea, 32: 1021-1027
103. Vijayakumar, R., Al- Aboody, M. S., AlFonaisan, M. K., Alturaiki, W.,
Mickymaray, S., Premanathan, M., Alsagaby, S. A. and Sandle, T. (2016) Determination
of minimum inhibitory concentrations of common biocides to multidrug-resistant gram-
negative bacteria, Applied Medical Research, 2 (3): 56-62 (DOI:
10.5455/amr.20161012082036)
104. Babenko, D., Omarkulov, B., Azizov, I., Sandle, T., Moraru, D. and Chesca, A.
(2016) Evaluation of sequence based typing methods (SPA and MSLT) for clonal
characterization of Staphylococcus aureus, Acta Medica Mediterranea, 32: 1851-1856
105. Sandle, T. (2016) Data Integrity Considerations for the Pharmaceutical

Microbiology Laboratory, Journal of GXP Compliance, 20 (6): 1-12
pp24-32
106. Chescha, A., Sandle, T. and Gyurka, G. A. (2016) Considerations on the

structures involved in the control of transmission mechanism mediated of calcium
pulses, Annals of The Romanian Society for Cell Biology, 21 (1): 1-6
107. Cheşcă A., Cheşcă S. A., Sandle T. (2016) An approach on chronic obstructive
pulmonary disease, Medicine and Ecology, 80 (3): 116-119
108. Cheşcă A., Ciomeica A., Sandle T. Structural aspects on pathologic appendix
versus normal appendix, Medicine and Ecology, 80 (3): 120-123
109. Sandle, T. (2017) Biodecontamination of Cleanrooms and Laboratories Using

Gassing Systems, Journal of GxP Compliance, 21 (1): 1-12 -
http://www.ivtnetwork.com/article/biodecontamination-cleanrooms-and-laboratories-
using-gassing-systems
pp95-103
110. Vijayakumar, R., Al- Aboody, M.S., Alturaiki, W. and Sandle, T. (2017) Review
on endotoxin mediated toxic anterior segment syndrome (TASS) in ophthalmic products-
Outbreaks, product recall and testing limits, European Journal of Parenteral and
Pharmaceutical Science, 22 (1): 20-25
111. Chesca, A. and Sandle, T. (2017) Structural aspects of tonsillitis, Medicine and
Ecology, 82 (1): 112-114
112. Chesca, A. and Sandle, T. (2017) A new approach related to structural aspects of
pathological appendix versus normal appendix, Medicine and Ecology, 82 (1): 115-118
113. Sandle, T. (2017) Santitization of Pharmaceutical Facilities, IVT Special Edition

Utility Qualification Volume II, pp56-62
114. Sandle, T. (2017) Validation and Assessment of Computerized System Software

in a Pharmaceutical Facility, IVT Special Edition Utility Qualification Volume II, pp13-
20
115. Babenko, D., Turmuhambetova, A., Sandle, T., Pestrea, A.A., Moraru, D. and
Chesca, A. (2017) In silica comparison of different types of MLVA with PFGE based on
Pseudomonas aeruginosa genomes, Acta Medica Mediterranea, 33: 607-612
116. Vijayakumar, R., Al-Aboody, M.S., Alturaiki, W., Suliman A. Alsagaby, S.A.,
Sandle, T. (2017) A study of airborne fungal allergens in sandstorm dust in Al-Zulfi,
central region of Saudi Arabia, Journal of Environmental and Occupational Science, 6
(1): 27-33 (DOI: 10.5455/jeos.20170120094512)
117. Sandle, T. (2017) Design and control of pharmaceutical water systems to

minimize microbial contamination, Pharmaceutical Engineering, 37 (4): 44-48
118. Akhayeva, A., Azizov, I., Kenzhetayeva, T., Zhupenova, D., Sandle, T., Gyurka,
A. G., Pestrea, S.A. and Chesca, A. (2017) Diagnostic value of IL-6 for community
acquired pneumonia in children, Archives of the Balkan Medical Union, 52 (2): 11-14
119. Sandle, T. (2017) Design and Control of Pharmaceutical Water Systems to

Minimize Microbiological Contamination, Pharmaceutical Engineering, 37 (4): 44-48
120. Sandle, T. (2017) Pharmaceutical Microbiology: Current and Future Challenges,

Journal of GxP Compliance, 21 (4): 1- 5:
http://www.ivtnetwork.com/article/pharmaceutical-microbiology-current-and-future-
challenges
121. Sandle, T. (2017) Matrix Approach for the Qualification of a Pharmaceutical

Facility Autoclave, Journal of GxP Compliance, 21 (4): 1- 10:
http://www.ivtnetwork.com/article/matrix-approach-qualification-pharmaceutical-
facility-autoclave
122. Sandle, T. (2017) Microbial Identification strategy for pharmaceutical

microbiology, Journal of GxP Compliance, 21 (4): 11-20:
http://www.ivtnetwork.com/article/microbial-identification-strategy-pharmaceutical-
microbiology
123. Sandle, T. (2017) Microbiological Aspects of Cleaning Validation, Journal of

GxP Compliance, 21 (5): 1-12, at: http://www.ivtnetwork.com/article/microbiological-
aspects-cleaning-validation
pp40-50
124. Sandle, T. (2017) Sterilization of Microbiological Culture Media, Journal of GxP

Compliance, 21 (5): 13-22, at: http://www.ivtnetwork.com/article/microbiological-
aspects-cleaning-validation
125. Tidswell, E. C. and Sandle, T. (2017) Microbiological Test Data - Assuring Data
Integrity, PDA J Pharm Sci Technol; 72 (1): 2-14 doi:10.5731/pdajpst.2017.008151
126. Sandle, T. (2017) Validation Requirements for Gaseous Sterilization Using

Ethylene Oxide, Journal of Validation Technology, 23 (5): 1-10
pp88-94
127. Sandle, T. (2017) Distribution of Particles Within the Cleanroom: A Review of

Contamination Control Considerations, Journal of GXP Compliance, 21 (6), 1-10:
http://www.ivtnetwork.com/article/distribution-particles-within-cleanroom-review-
contamination-control-considerations
pp104-109
128. Sandle, T. (2017) Pharmaceutical Water Systems: Temperatures of Operation and

Maintaining Control, Journal of GXP Compliance, 21 (6), 11-20:
http://www.ivtnetwork.com/article/pharmaceutical-water-systems-temperatures-
operation-and-maintaining-control
129. Sandle, T. (2017) Liquid Immersion Microbial Challenge Tests: Microbial

Testing for Container Closure Integrity, Journal of Validation Technology, 23 (6): 1-10
(see: http://www.ivtnetwork.com/article/liquid-immersion-microbial-challenge-tests-
microbial-testing-container-closure-integrity)
pp110-116
130. Sandle, T. (2018) New Guidance for Sterile Products Manufacture is Coming:
Review of EU GMP Annex 1, Journal of GxP Compliance, 22 (1): 1-10
(http://www.ivtnetwork.com/article/new-guidance-sterile-products-manufacture-
coming-review-eu-gmp-annex-1)
131. Marflitt, A. and Sandle, T. (2018): Evaluation of Readycult® Coliforms 100

Presence/Absence Test for the screening of coliforms and Escherichia coli in
pharmaceutical water samples, European Journal of Parenteral and Pharmaceutical
Science, 22 (4): 118-125
132. Sandle, T., Chesca, A., Akhayeva, A. S., Marchenko, A. B. (2018) Apoptosis
versus necrosis, SciFed Journal of Chronic Diseases, 1 (1): 1-4
133. Sandle, T. (2018) Automated, Digital Colony Counting: Qualification and Data
Integrity, Journal of GxP Compliance, 22 (1): 1-10
134. Sandle, T. (2018) Investigating and Addressing Fungal Contamination in

Pharmaceutical Cleanrooms, Journal of GxP Compliance, 22 (1): 1-10
pp57-65
135. Sandle, T. and Chesca, A. (2018) General Data on Cell Membrane and Membrane
Traffic, SF J Anal Biochem 1 (2): 1-3
136. Satyada, R. and Sandle, T. (2018) Rationale for the selection of microbial
monitoring locations on personnel working in aseptic processing areas, European Journal
of Pharmaceutical Science and Technology, 23 91): 17-23
137. Chesca, A., Sandle, T. Babenko, D. and Azizov, I. (2018) Hepatic steatosis versus
normal liver in optical microscopy, Annals of Romanian Society for Cell Biology Vol.
XXI, Issue 3: 58 – 62
138. Vijayakumara, R., Sandle, T., Al-Aboodya, M. S., AlFonaisana, M.K., Alturaikia,
W., Mickymaraya, S., Premanathana, M., Alsagabya, S.A. (2018) Distribution of biocide
resistant genes and biocides susceptibility in multidrug-resistant Klebsiella pneumoniae,
Pseudomonas aeruginosa and Acinetobacter baumannii — A first report from the
Kingdom of Saudi Arabia, Journal of Infection and Public Health, online:
https://doi.org/10.1016/j.jiph.2018.05.011
139. Sandle, T. (2018) Disinfectant Efficacy Testing for Fungi on Non-Porous

Surfaces: A Case Study, Journal of GxP Compliance, 22 (4): 1-12
140. Sandle, T. (2018) Use of Hazard Analysis and Critical Control Points (HACCP) -
Part 1: Assessing Microbiological Risks, Journal of GxP Compliance, 22 (4): 1-12
141. Chesca, A., Sandle, T., Akhayeva, A.S., and Marchenko, A. B. (2018) Medical
data on COPD, Medicine and Ecology, 86 (1), pp82-85 at:
http://repoz.kgmu.kz/bitstream/handle/123456789/275/Chesca_Medical_data.pdf?sequen
ce=1
142. Sandle, T. (2018) The Human Microbiome and the implications for cleanroom
control, European Journal of Parenteral and Pharmaceutical Science, 23 (3): 89-98
143. Sandle, T. (2018) Airflow Velocities and Cleanrooms: How fast, how slow, and
where to measure?, Journal of GXP Compliance, 22 (6): 1-10
144. Sandle, T. (2018) Out-of-Specification Laboratory Investigations: New Look at

an Old Issue, Journal of GXP Compliance, 22 (6): 1-10
145. Vijayakumar, R. and Sandle, T. (2019) A review on biocide reduced

susceptibility due to plasmid‐borne antiseptic‐resistant genes—special notes on
pharmaceutical environmental isolates, Journal of Applied Microbiology, 126 (4): 1011-
0122
146. Sandle, T. (2019) Cleanroom Particle Counting: Assessing Data for Trends and
Patterns, Journal of GxP Compliance, 23 (2): 1-10
147. Sandle, T. (2019) Use of Hazard Analysis and Critical Control Points (HACCP) –
Part 2: Determining Environmental Monitoring Locations, Journal of GxP Compliance,
23 92): 1-10
148. Sandle, T. (2019) Disinfectant efficacy testing for bacterial endospores against
hydrogen peroxide, Chemico Oggi (Chemistry Today), 37 (2): 60-65
149. Sandle, T. (2019) Addressing Bacterial Endotoxin Contamination Incidences in

WFI Systems: A Review of Case Studies, Journal of GXP Compliance, 23 (3): 1-10 at:
http://www.ivtnetwork.com/article/addressing-bacterial-endotoxin-contamination-
incidences-wfi-systems-review-case-studies
150. Abd El-Baky RM, Sandle T, John J, Abuo-Rahma GE, Hetta HF (2019) A novel
mechanism of action of ketoconazole: inhibition of the NorA efflux pump system and
biofilm formation in multidrug-resistant Staphylococcus aureus, Infection and Drug
Resistance, 12: 1703-1708
151. Sandle, T. (2019) Use of Acclimatized Microorganisms in Validation Studies,

Journal of Validation Technology, 25 (3): http://www.ivtnetwork.com/article/use-
acclimatized-microorganisms-validation-studies
University courses
Sandle, T. Environmental Monitoring Module for University of Manchester School of Pharmacy

PMAT MSc course (100,000 word module divided into nine units). First edition: 2007; revised
2011 and in 2013
Sandle, T. Sterility and Sterility Assurance Module for University of Manchester School of
Pharmacy PMAT MSc course. Written in 2013.
Sandle, T. Introduction to Pharmaceutical Microbiology for University of Manchester School of

Pharmacy PMAT MSc course. Written in 2013.
Tim Sandle is the tutor for each of the above courses.
Training materials
Training CDs produced for Pharmig (Pharmaceutical Microbiology Interest Group):
Sandle, T. and Alexander, B. (2011). Electronic Pack 1: Best Practices in Microbiological

Documentation, Pharmaceutical Microbiology Interest Group, Pharmig: Stanstead Abbotts, UK
Sandle, T. and Alexander, B. Electronic Pack 2: Setting up and managing an effective training
programme in the microbiology laboratory, Pharmaceutical Microbiology Interest Group,
Pharmig: Stanstead Abbotts, UK
Technical articles
Sandle, T. Environmental Monitoring in a Sterility Testing Isolator, PharMIG Newsletter No.1,

March 2000
Sandle, T. Microbiology Web-sites - A Survey, Institute of Science Technology Journal, July
2000
Sandle, T. Microbiological Culture Media: Designing a Testing Scheme, PharMIG News No.2,
August 2000
Sandle, T. Performance characteristics of Automated LAL Tests, PharMIG News No. 4, April
2001
Sandle, T. Repeatability and Precision - Necessary Factors in Standard Testing?, PharMIG

News, No.5, August 2001
Sandle, T. Conference Report: 2001, PharMIG News No. 7, December 2001
Sandle, T. LAL Test Method - Which Technique?, PharMIG News No.10, October 2002
Sandle, T. Particle Monitoring and Control, Pharmaceutical Manufacturing and Packaging

Sourcer, Spring 2003, pp8-11(extract
http://www.samedanltd.com/magazine/15/issue/82/article/1854)
Sandle, T. The Changing Role of the Pharmaceutical Microbiologist, PharMIG News, Issue 12,
June 2003
Sandle, T. Cleanroom Monitoring – What, Where and How Often?, PharMIG News, Issue 13,
September 2003, pp9 – 12
Sandle, T. General Considerations for the Risk Assessment of Isolators used for Aseptic
Processes, Pharmaceutical Manufacturing and Packaging Sourcer, Samedan Ltd, Winter 2004,
pp43-47 (extract http://www.samedanltd.com/magazine/15/issue/60/article/1367)
Sandle, T. 50 Years of Providing the Lifeblood of the Nation, Around Radlett: The Newsletter of
Aldenham Parish Council, No. 63, Spring 2004, p5
Sandle, T. ‘Review of Current Approaches for the Validation of Disinfectants’, PharMIG News,
No. 15, March / April 2004, pp10-15
Sandle, T. Fifty Years of Continuous Achievement: The History of the Bio Products Laboratory
(BPL), Internal BPL Publication, April 2004 (limited print run: 1, 500 copies)
Sandle, T. Three Aspects of LAL Testing: Glucans, Depyropgenation and Water System
Qualification. PharMIG News No. 16. June / July 2004, pp3-12
Sandle, T. A Golden Jubilee: BPL at 50, Circulation, August 2004, NationalBlood Service
Magazine, p8
Sandle, T. Training within the Microbiology Laboratory, PharMIG News, Issue 17, October
2004, pp3-6
Sandle, T. (2004) ‘Gram’s Stain: History and Explanation of the Fundamental Technique of
Determinative Bacteriology’, IST Science and Technology Journal, April 2004 (No. 54), pp3-4
Sandle, T. Notable Scientists Who Worked Locally, Around Radlett: The Newsletter of
Aldenham Parish Council, No. 66, Christmas 2004, p6
Sandle, T. Microbiological Environmental Monitoring in Clean Areas: Using Risk

Assessment, Pharmaceutical Manufacturing and Packaging Sourcer, Winter 2004, pp105-107
Sandle, T. Gram’s Stain: History and Explanation of the Fundament Technique of Determinative
Bacteriology, PharMIG News, Issue 18, January 2005, pp5-6
Sandle, T. Book ending surface sampling – In Defence of Swabs, PharMIG News, Issue 19,
April 2005, pp8-9
Sandle, T. ‘Keeping It Clean’, Circulation, National Blood Service, August 2005, p10
Sandle, T. A Microbiological Risk Assessment Case Study, PharMIG News, Issue 20, July 2005,
pp6-9
Sandle, T. Some Reflections on Trend Analysis, PharMIG News, Issue 21, October 2005, pp12-
15
Sandle, T. Active Air Sampling – The Selection Process Made Easy, Pharmaceutical
Manufacturing and Packaging Sourcer, Winter 2005, pp30-33
Sandle, T. Understanding Clean Air Devices, Science Technology Journal, April 2005, pp3 – 5
Sandle, T. Constructing an Environmental Monitoring Programme: Part 1,PharMIG News, Issue

22, February 2006, pp2-6
Sandle, T. A final floor show for bugs’, Cleanroom Technology, April 2006, 12 (4): 19-21
Sandle, T. Constructing an Environmental Monitoring Programme: Part 2,PharMIG News, Issue

23, May 2006, pp2-7
Sandle, T. Evaluation of two different types of contact plate, PharMIG News, Issue 24, pp4-7
Sandle, T. Micro Management: Monitoring the Cleanroom Environment,Pharmaceutical

Manufacturing and Packaging Sourcer, Autumn 2006, pp64-66
Sandle, T. Use of Risk Assessment to Assess Environmental Monitoring Data: Part
One, PharMIG News, Issue 25, pp8-11
Skinner, K. and Sandle, T. (2006): How Effective are Swabs? An Examination of Swab
Recovery, PharMIG News, Issue 25, pp4-5
Sandle, T. Selection of Laboratory Disinfectants: Part One’, Science Technology Journal,

Institute of Science Technology, Summer 2006, pp16-18
Ross, S. and Sandle, T. (2007): Air Pattern Analysis of a Filtration Transfer,PharMIG News,
Issue 26, pp3-4

Two, PharMIG News, Issue 26, 2007, pp9-15

Three, PharMIG News, Issue 27, pp7-13
Sandle, T. Selection of Laboratory Disinfectants: Part Two, Science Technology Journal,

Institute of Science Technology, Spring 2007, pp5-7
Sandle, T. A Breath of Fresh Air: the validation of active air sampling, Pharmaceutical
Manufacturing and Packaging Sourcer, Summer 2007, pp8-12 (extract:
http://www.samedanltd.com/magazine/15/issue/82/article/1854)
Sandle, T. Microbiology and the World Wide Web - Revisited, PharMIG News, Issue 28, pp10-
11
Sandle, T. Some Considerations on the Use of Endotoxin Indicators in Depyrogenation

Studies, Pharmaceutical Microbiology Forum Newsletter, Vol. 13, No. 10, November 2007, pp2-
11
Sandle, T. Calling Time on the Pyrogen Test, PharMIG News, Issue 29, 2007, pp03-04
Tours, N. and Sandle, T. A Comparative Study of Different Methods of Endotoxin

Destruction, Pharmig News, Issue 30, March 2008, pp4-8.
Sandle, T. and Skinner, K. ‘A Practical Example Arising from the Harmonization of the
Microbial Enumeration Method for Water’, Pharmaceutical Microbiology Forum Newsletter,
Vol. 14, No.4, pp2-5
Roberts, J. and Sandle, T. ‘Assessment of the Potassium Hydroxide Test as a Complimentary

Test for the Gram-stain’, Pharmig News, No. 31, June 2008, pp1-4
Sandle, T. The Sterility Test and other changes to the European Pharmacopeia,
6th edition, Pharmig News, No. 32, September 2008, pp1-3
Sandle, T. Biological Safety: The despatch of microbial cultures, Pharmig News, No. 32,
September 2008, pp5-7
Sandle, T. A method to determine the effect of dehydration on agar plates and microbial
recovery, The Institute of Science and Technology Journal, Spring 2008, pp24-27
Sandle, T. Calculation of warning (alert) and action levels for a water system, Pharmig
News, No.33, December 2008, pp1-4
Sandle, T. Book Review: Guide to Microbiological Control in Pharmaceuticals and Medical

Devices, 2nd edition edited by Stephen Denyer and Rosamund Baird, Pharmig News, No.33,
December 2008, pp9
Sandle, T., Roberts, J. and Skinner, K. (2009): 'An examination of the sample hold times in the
Microbiological Examination of Water Samples', Pharmaceutical Microbiology Forum
Newsletter, Vol. 15, No.2, pp2-7
Sandle, T. (2009): 'Biological Indicators for Steam Sterilisation', Pharmig News, No.34, pp10-14
(updated and reproduced on-line at: http://microbiologystudents.com/article.php?article_id=198,
6th December 2010 for ‘Microbiology Students’)
Sandle, T. and Roberts, J. The microbiologist’s dilemma: optimising time, temperature and
culture media, Pharmig News, Issue 35, 2010, pp1-5
Sandle, T. The assessment of air -cleanliness in cleanrooms and cleanzones using optical particle
counters, The Journal, Institute of Science and Technology, Winter 2009, pp4-7
Sandle, T. Cleanroom Operator Training: An Approach for Basic Hygiene, Pharmig News, Issue
37,2010, pp1-9
Sandle, T. Microbiology and the World Wide Web, Pharmaceutical Microbiology Forum
Newsletter, Vol. 15, Number 11, 2010, pp2-5
Sandle, T. ‘Introduction to Antimicrobials’, Pharmig News, Issue 39, 2010, pp5-7
Sandle, T. (2010): 'Choosing Disinfectants', Cleanroom Technology, August 2010, 18 98): 11-13
Also published at: http://www.schulke.co.uk/media/28/128-
disinfectants_in_pharmaceutical_industry_tim_sandle.pdf
Sandle, T. (2010): PIC/S Guide on Aseptic Processing, Pharmaceutical Microbiology Forum

Newsletter, Vol.16, No.2, pp10-11
Sandle, T. ‘Selection of Active Air-Samplers’, The Journal, Institute of Science and Technology,
Summer 2010, pp25-31
Note: A version of the paper was included on the BioSciences Quality Testing Forum (BioQT)
website: http://www.bioqtforum.com/Selection-of-active-air-samplers (accessed 15th September
2010)
Sandle, T. (2010): ‘Effective and Efficient Hand Sanitisation’, Inside Hospitals, December 2010
(reproduced on-line at: http://www.inside-hospitals.co.uk/ under features, infection prevention,
schulke)
Sandle, T. (2010): 'Cleaning Cleanrooms', Cleanroom Technology, December 2010, pp22-24

(reproduced on-line at: http://www.cleanroom-
technology.co.uk/technical/article_page/Cleaning_cleanrooms/57871) [26th November 2010]
Sandle, T. (2010): ‘Changes to the European Pharmacopoeia: 2008 - 2010’, Pharmaceutical

Microbiology Forum newsletter, Vol. 16, No.12, December 2010, pp10-14
Sandle, T. (2010): "Medical and social development of the English and Welsh Blood Service: the
evolving status of venepuncture", Wellcome History, Issue 45, pp17-18
Sandle, T. (2010): "Training within the Microbiology Laboratory", Global BioPharmaceutical

Resources Inc. Newsletter, December 2010, pp1-11 (available to view at:
http://www.gbprinc.com/pdf/TrainingWithinTheMicrobiologyLaboratory.pdf)
Sandle, J. and Sandle, T. (2011): ‘Infection Control in Healthcare’, Pharmig News, Number 42,
pp3-6
Sandle, T. (2011): ‘A review of current developments in cleanroom standards’, Pharmig News,

Number 42, pp12-14
Sandle, T. (2011): 'Investigating Sterility Test Failures', Global BioPharmaceutical Resources

Inc. Newsletter, February 2011, pp1-16
(http://www.gbprinc.com/pdf/InvestigatingSterilityTestFailures.pdf)
Sandle, T. (2011) "Glucans and the Bacterial Endotoxin Test", Global Pharmaceutical
Resources Inc Newsletter, April 2011, pp1-12 (available at:
http://www.gbprinc.com/pdf/Whitepaper041411-4.pdf)
Sandle, T. (2011): 'Selection of active air samplers', Clean Air and Containment Review, Issue 5,
pp8-10
[Note: The paper is an alternate version of the one published in the EJPPS, 2010]
Sandle, T. (2011): 'The Consequence of Failure to Monitor Air Quality in Cleanrooms: A Case
Study', Pharmig News No. 43, pp3-7
Sandle, T. (2011): ‘Biological Indicators for Steam Sterilization: Failure Investigations’,
Pharmaceutical Microbiology Forum Newsletter, Vol. 17, No.5, pp2-8
Sandle, T. (2011): 'History and development of microbiological culture media', The

Journal (Institute of Science and Technology), Winter 2010-2011, pp10-14
Sandle, T. (2011): 'Microbial recovery on settle plates in unidirectional airflow cabinets', Clean
Air and Containment Review, Issue 6, pp8-10
Sandle, T. (2011): 'Advances in Cleanroom Technology', Process India, Vol. 1, No.3, pp42-44
Sandle, T. (2011): ‘Container-Closures for Pharmaceutical Preparations’, GBPR, Inc. Newsletter,

August 2011, pp1-6 (available at: http://www.gbprinc.com/pdf/GBPRContainerClosures.pdf)
Sandle, T. (2011): “Maintaining hygiene: keeping surfaces clean”, Inside Hospitals, August
2011, p40
Sandle, T. (2011). 'Validating surface cleaning agents', Cleanroom Technology, September 2011,
19 (9): 15-18
Sandle, T. (2011): "Characterization of Microbial Contamination in Pharmaceutical Facilities",

Global BioPharmaceutical Resources Inc. Newsletter, September 2011, pp1-15 (available at:
http://www.gbprinc.com/pdf/GBPRCharacterization092311.pdf)
Sandle, T. (2011). "Risk Management in Pharmaceutical Microbiology", Pharmaceutical

Manufacturing, September 2011, Vol 10, Issue 8: 30-36
(http://www.scribd.com/doc/95778970/PM-Sept2011)
Sandle, T. (2011): "Sterility Test Requirements for Biological Products", Pharmaceutical

Microbiology Forum Newsletter, Vol. 17, No.8, pp5-14 (available at:
http://www.microbiologyforum.org/PMFNews/PMFNews.17.08.1108.pdf)
Sandle, T. (2011): "Environmental Monitoring: Corrective and Preventative Actions", Global

BioPharmaceutical Resources Inc. Newsletter, October 2011, pp1-18 (available at:
http://www.gbprinc.com/pdf/GBPROctober2011NewsletterFeaturedArticleIssue2.pdf)
Sandle, T. (2011): Keeping Hands and Surfaces Clean, Arab Medical Hygiene, Issue 3, pp11-17
Sandle, T. (2011): "Cleanrooms and Air Quality – A Risk-Based Approach", Global

Biopharmaceutical Resources Inc. Newsletter, December 2011, pp1-13 (available at:
http://click.icptrack.com/icp/relay.php?r=37671113&msgid=1460557&act=RAB6&c
=623139&destination=http%3A%2F%2Fwww.gbprinc.com%2Fpdf%2FGBPRDece
mber2011FeaturedArticle.pdf)
Sandle, T. (2012) "Recent Developments in European Regulatory Requirements:
Issues Affecting the Microbiologist", Pharmaceutical Microbiology Forum
Newsletter, Vol. 18, No.1, pp5-15 (available
at: http://www.microbiologyforum.org/PMFNews/PMFNews.18.01.1201.pdf)
Sandle, T. and Sandle, J. (2012). “Data Analysis – Shewhart Chart”, Pharmig News, Number 46,
pp2-5
Sandle, T. (2012). “Cleanrooms and Clean Air”, Arab Medical Hygiene, Issue 4, pp19-25
Sandle, T. (2012). "Approaching Risk Assessment: Tools and Methods", Global

Biopharmaceutical Resources Inc. Newsletter, February 2012, pp1-23 (available at:
http://www.gbprinc.com/pdf/GBPRFebruary2012FeaturedArticle.pdf)
Sandle, T. (2012). Cleanroom Cleaning and Disinfection: Eight Steps for Success, Controlled
Environments Magazine, March 2012 (http://www.cemag.us/print/5636)
Sandle, T. (2012). “Introducing Antimicrobials”, Arab Medical Hygiene, Issue 5: 37-41
Sandle, T. (2012). “Airflow visualisation in an aseptic facility”, Cleanroom Technology, May

2012, 20 (5): 13-17
Sandle, T. (2012). Real-time counting of airborne particles and microorganisms: a new

technological wave?, Clean Air and Containment Review, Issue 9, pp4-6
Sandle, T. (2012). Microbiological control and monitoring of cleanrooms: Revised USP <1116>
chapter, Clean Air and Containment Review, Issue 11, pp22-23
Sandle, T. (2012). “A new wave of sporicidal disinfectants”, Clean Air and Containment Review,
Issue 10, pp10-13
Sandle, T. (2012). “Isolators in international GMP guidelines”, Clean Air and Containment
Review, Issue 10, pp21-23
Sandle, T. (2012). Speedier automated microbial methods for environmental monitoring of

cleanrooms, Clean Air and Containment Review, Issue 12.
Sandle, T. and Saghee, M.R. (2012). “Application of Sterilization by Gamma Radiation for
Single-Use Disposable Technologies in the Biopharmaceutical Sector”, Pharmaceutical
Technology, Supplement: Bioprocessing and Pharmaceutical Manufacturing, May 2012, S20-
S27
(http://digital.findpharma.com/nxtbooks/advanstar/pt_201205_supp/index.php?startid=s30#/20)
Sandle, T. and Saghee, M. R. (2012). “Cleanroom Technology: Setting the

Scene”, Pharmaceutical Manufacturing and Packaging Sourcer, May 2012, pp38-42
Sandle, T. (2012). The Characterization of Microbial Contamination’, Pharmig News Number
47, pp2-4
Sandle, T. (2012). FDA: Sterility Test Requirements for Biological Products, Pharmig News
Number 47, pp5-8
Sandle, T. (2012). Pyrogens, Endotoxin and the LAL Test: An Introduction in Relation to
Pharmaceutical Processing, Global BioPharmaceutical Resources Newsletter, May 2012, pp1-16
(http://www.gbprinc.com/pdf/GBPRMay2012FeaturedArticle.pdf)
Sandle, T. (2012). Pharmaceutical Microbiology and Pharmig, Innovations For Success, Issue
29, summer 2012, p35 (http://viewer.zmags.com/publication/ec07d7ab#/ec07d7ab/34)
Sandle, T. and Saghee, M.R. (2012). Application of Sterilization by Gamma Radiation for
Single-Use Disposable Technologies in the Biopharmaceutical Sector, Pharmaceutical
Technology, Volume 36, Issue 5, pp. s20-s30
Sandle, T. (2012). “A silver lining? The use of antimicrobial bandages”, Arab Medical Hygiene,
Issue 6, July 2012, pp19-25
Sandle, T. (2012). "Sanitization of Pharmaceutical Facilities", Global BioPharmaceutical

Resources Inc. Newsletter, July 2012, pp1-14
Sandle, T. (2012) "Contamination Control Underfoot", Controlled Environments, Vol. 15, No.7,
pp10-11 (http://www.cemag.us/print/6121)
Sandle, T. (2012). "Practical Selection of Cleanroom Disinfectants", Hospital Pharmacy Europe,

Issue 63, pp39-41
Also as:
Sandle, T. (2012). “Desinfektionsmittel – Auswahl für den Einsatz in der Pharmaindustrie”, IAB
Cleanroom GmbH website: http://www.iab-reinraumprodukte.de/info-
portal/fachartikel/desinfektionsmittel-pharmaindustrie.html (published 301st July 2012)
Sandle, T. (2012). Good practices for microbiology laboratories, GMP Review, Vol. 11, No.3,
October 2012, pp6-8
Reprinted in Logfile:
Sandle, T. (2013) Good practices for microbiology laboratories, Logfile, 1, pp1-4

(https://www.gmp-publishing.com/media/files/leitartikel_2013/LOGFILE-1-2013-good-
practices-for-microbiology-labs.pdf)
Sandle, T. and Saghee, M.R. (2012). “Cleanroom Technology: Inside the Box” Pharmaceutical
Manufacturing and Packaging Sourcer, Summer 2012, pp54-57
Sandle, T. (2012). “Introduction to particle counting”, Pharmig News, Number 48, pp6-9
Sandle, T. (2012). “Cleaning endoscopes: Considering the risks and benefits of enzymatic and
non-enzymatic detergents”, Inside Hospitals, June 2012, pp14-15
Sandle, T. (2012). ‘Introduction to Particle Monitoring’, Pharmig News, Issue 48, pp6-9
Sandle, T. (2012). An Air of Safety: The application of cleanrooms and clean air devices within
the hospital setting, European Medical Hygiene, Issue 1, pp11-17
Sandle, T. (2012). Wipe study measures particle shedding, Cleanroom Technology, September
2012, 20 (9): 26-29
Sandle, T. (2012). ‘Detergent choices for endoscope reprocessing’, The Clinical Services
Journal, Volume 11, Issue 8, pp71-75
Sandle, T. (2012). European Pharmacopeia Proposes Revision to Biological Indicators Chapter,

Pharmaceutical Microbiology Forum Newsletter, Vol. 18, No.5, pp4-7
Sandle, T. (2012). Ensuring Contamination Control: The validation of disinfectants, European

Medical Hygiene, November 2012, pp33-39
Sandle, T. (2012). Pharmig History: A Potted Guide (1992-2012), Conference Paper provided to
delegates at the 2012 Pharmig Conference (Chipping Norton, UK).
Sandle, T. (2012). Making the grade in filters, Cleanroom Technology, December 2012, 20 (12):
19-20
Sandle, T. (2012). Review of FDA warning letters for microbial bioburden issues (2001-2011),
Pharma Times, Vol. 44, No.12, pp29-30
Sandle, T. (2012). Making the grade in filters, Cleanroom Technology, December 2012, pp19-20
Sandle, T. (2012). Utilisation de la gamma, Salles Propes, Issue 81, pp42-54
Sandle, T. and Saghee, M.R. (2012). Gamma irradiation cleans up, Medical Device
Developments, October 2012, reproduced on-line at: http://www.medicaldevice-
developments.com/features/featuregamma-rays-irradiation/
Sandle, T. (2013). Revised FDA Guidance on Pyrogens and Endotoxin, Pharmig News, Number
51, p10
Sandle, T. (2013). Pharmig hosts successful twentieth anniversary conference, Pharmig News,
Number 51, p4-5
Sandle, T. (2013). Electron beam processing: A rapidly developing sterilisation technology,
European Medical Hygiene, February 2013, pp9-13
Sandle, T. (2013). Variability and the LAL assay, Pharmaceutical Microbiology Forum
Newsletter, Vol. 19(1), pp4-12
Sandle, T. (2013). New guidance for environmental monitoring in cleanrooms, GMP Review,
Vol. 11, No.4, pp9-11
Sandle, T. (2013). Sandle, T. (2013). Biocontamination control - Moves toward a better standard,
Cleanroom Technology, 21 (4): 14-15. Online: http://www.cleanroom-
technology.co.uk/technical/article_page/Biocontamination_control__moves_toward_a_better_sta
ndard/87172
Sandle, T. (2013). Avoiding Dilution Error With the LAL Assay, Pharmaceutical Microbiology
Forum Newsletter, Vol. 19(2), pp2-13
Sandle, T. (2013). 'A new ray of hope to address water pollutants', Industry 2.0, Vol. 12, Issue 8,
pp33
Sandle, T. (2013). Revision of ISO 14698 - Biocontamination control: Personal reflections on

what might be desirable, Clean Air and Containment Review, Issue 14, pp20-21
Republished in Pharmig News: Sandle, T. (2013). ISO 14968 – biocontamination control

standard revision, Pharmig News Number 51, pp6-8
Sandle, T. (2013). 20 years of Microbiology, Cleanroom Technology, March 2013, 21 (3): 24-25
Sandle, T. (2013). Bacteria and temperature of growth: a simple introduction, Pharmig News
Number 51, pp2-3.
Siew, A. (2013): Ensuring Sterility of Parenteral Products: an interview with James Agalloco,
Tim Sandle and Benoit Verjans, Pharmaceutical Technology, Vol. 37, Number 4, pp62-67
Sandle, T. (2013). Single-Use: Sterile Disposable Technology, Industry 2.0, Vol.12, Issue 9,
pp45-47
Wilder, C., Sandle, T. and Sutton, S. (2013). Implications of the Human Microbiome on
Pharmaceutical Microbiology, American Pharmaceutical Review, 16 (5): pp17-21
Also: June 2013, on-line publication: http://www.americanpharmaceuticalreview.com/1504-

White-Papers-Application-Notes/140112-Implications-of-the-Human-Microbiome-on-
Pharmaceutical-Microbiology/?catid=6262
Sandle T (2013) Could the ‘Black Death’ Become a Re-Emerging

Infectious Disease? J Anc Dis Prev Rem 1: e104. doi:10.4172/jadpr.1000e104
Sandle, T. (2013). Automated Microbial Identifications: A comparison of USP and EP
approaches, American Pharmaceutical Review, 16 (4): 56-61
Sandle, T. (2013): Risk assessment and monitoring of cleanrooms, Hospital Pharmacy Europe,
May / June 2013, pp54-56
Sandle, T. (2013). FDA Guidance on pyrogens and endotoxin, GMP Review, 12 (2): 7-9
Sandle, T. (2013). Understanding cleanroom microflora, The Journal: the Official Journal of the
Institute of Science and Technology, Summer 2013, pp35-45
Sandle, T. (2013). Avoiding Contamination of Water Systems, The Clinical Services Journal, 12
(9): 33-36
Sandle, T. (2013) Risk Management in Sterile Environments. In Thomas, P. (Ed.) Aseptic

Manufacturing - a road map to excellence, Pharmaceutical Manufacturing, USA, pp3-9
(http://www.pharmamanufacturing.com/assets/wp_downloads/pdf/dpt.pdf)
Sandle, T. and Sandle, J. (2013). An Important Aspect of Healthcare: Outlining the many
considerations of infection control, Arab Medical Hygiene, October 2013, pp34-39
Sandle, T. (2013): Pharmaceutical Product Impurities: Considering Beta Glucans, American

Pharmaceutical Review, 16 (5) Special Edition Supplement 'Furthering Pharmaceutical
Microbiology': 16-19
Sandle, T. (2013). Skin cleaning before cathererisation, Inside Hospitals, October 2013, pp40-41
Sandle, T. (2013). Water Quality Concerns: Contamination control of hospital water systems,
European Medical Hygiene, November 2013, pp14-19
Sandle, T. (2013). USP updates: cleanrooms and sterilization, Clean Air and Containment
Sandle, T. (2013). Single-use technology for biopharma, Cleanroom Technology, 21 (12): 15-19
Sandle, T. (2013). A comparative study of different methods of endotoxin destruction, American

Pharmaceutical Review, Supplement on Endotoxin Detection: techniques and developments,
November 2013, pp15-17
Sandle, T. (2013). Using an antimicrobial skin cleanser before catheterisation, Journal of

Community Nursing, Vol. 27, No.5, pp30-34
Sandle, T. (2013). Innovations in Cleanroom Technology, Pharma Times, 45 (12): 14-15
Sandle, T. (2014) Recent changes to bacterial taxonomy, Micrographia Today, 1 (1): 31-36
Sandle, T. (2014) Modern Approaches to Pharma Cleanroom Design, Controlled Environments,
17 (1): 8-10
Sandle, T. (2014). Biologics and biosimilars: the regulatory environment, Clean Air and
Containment Review, Issue 17, pp20-21
Sandle, T. (2014) Selection of Laboratory Disinfectants, Lab World Magazine, 3 (2): 17-22
Sandle, T. (2014) Fungal contamination of pharmaceutical products: the growing menace,

European Pharmaceutical Review, 19 (1): 68-71
Sandle, T. (2014) The rise of antimicrobial resistant microorganisms, Microbiology World, Issue
2, pp10-16
Sandle, T. (2014) EU GMP Annex 15 Revisions: Improving Qualification and Validation,

Cleanroom Technology, April 2014, pp14-16
Sandle, T. (2014) Revision to EU GMP Annex 15: Qualification and Validation, Clean Air and
Containment Review, Issue 18, pp22-23
Sandle, T. (2014) WHO updates endotoxin guidance for parenteral products, GMP Review, 13
(1): 7-8
Sandle, T. (2014) Selecting cleanroom disinfectants, La Vague, Issue 42, pp28-31
Sandle, T. (2014) Assessment of Culture Media in Pharmaceutical Microbiology, American

Pharmaceutical Review, June 2014:
http://www.americanpharmaceuticalreview.com/Specialty/Microbiology/Featured-
Articles/163589-Assessment-of-Culture-Media-in-Pharmaceutical-Microbiology/?catid=6262
Sandle, T. (2014) Examination of air and surface particulate levels from cleanroom mats and
polymeric flooring, Pharmig News 56, pp2-8
Sandle, T. (2014) Applying spectrophotometric monitoring to risk assessments in

biopharmaceutical cleanrooms, Clean Air and Containment Review, Issue 20, pp22-25
Sandle, T. (2014) Non-sterile pharmaceutical manufacturing: USP chapter in development,

Clean Air and Containment Review, Issue 19, pp19-20
Sandle, T. (2014) Quality control of hospital water systems, Microbiolz India, Issue 7, pp20-25
Sandle, T. (2014) Medicines and the Microbiome, The Medicine Maker, Issue 1, p18-19:
http://themedicinemaker.com/issues/2100-a-medicine-manufacturing-odyssey/medicines-and-
the-microbiome/
Sandle, T. (2014) Quality Control of Hospital Water, The Clinical Services Journal, 13 (8): 47-
51
Sandle, T. (2014) Variability and Test Error with the LAL Assay, American Pharmaceutical
Review, October 2014, pp1-5: http://www.americanpharmaceuticalreview.com/Featured-
Articles/167404-Variability-and-Test-Error-with-the-LAL-Assay/
Sandle, T. (2014) Are alcohol wipes effective in the presence of protein?, The Dentist, October
2014, pp92-94
Sandle, T. (2014) Pharmacopeial changes in relation to pyrogens and endotoxin, GMP Review,
13 (3): 10- 12
Sandle, T. (2014) Review Of cGMPs For Sterile Manufacturing, GMP Insight, Issue 1, pp2-4
Sandle, T. (2014) A Practical Approach to the Selection of Cleanroom Disinfectants, Pharma

Focus Asia, Issue 21, pp27-30 (http://www.pharmafocusasia.com/articles/practical-approach)
Sandle, T. (2014) The Risk of Bacillus cereus to Pharmaceutical Manufacturing, American

Pharmaceutical Review, 17 (6): pp-pp
Sandle, T. (2014) Taking on the Resistance, Laboratory News, March 2014, pp8-10:
http://www.labnews.co.uk/features/taking-on-the-resistance/
Sandle, T. (2015) Auditing Cleanrooms, Cleanroom Technology, February 2015, pp66-68
Sandle, T. (2015) Cleanroom wipes, European Medical Hygiene, February 2015, pp24-29
Sandle, T. (2015) Cleanroom Disinfectants, Cleanroom Technology, January 2015, pp10-11

(interview:
http://flickread.com/edition/html/index.php?pdf=54ba1a26714b8&dm_i=8EU,358EB,AW0FAO,
B9QJX,1#62
Sandle, T. (2015) Cleanroom Wipes, European Medical Hygiene, Issue 9, pp24-29
Sandle, T. (2015) Real-time biological particle counting in environmental monitoring, European

Pharmaceutical Review, Vol. 20, Issue 2, pp39-42
Sandle, T. (2015) Sanitization of Pharmaceutical Facilities, Pharmig News, number 59, pp2-7
Sandle, T. (2015) FDA opens up review into hand disinfectants, GMP Review, 14 (2): 8-9
Sandle, T. (2015) Innovations in cleanrooms and environmental monitoring, Cleanrooms:

Express Pharma Special Supplement, July 2015, pp12-14
Sandle, T. (2015) Contamination control guidances under review, Clean Air and Containment
Sandle, T. (2015) European Sterile Products Guidance Under Review, American Pharmaceutical
Review, September / October 2015: 1-4
Sandle, T. (2015) Current Methods and Approaches for Viral Clearance, American
Pharmaceutical Review, September / October, Volume 18, 2015: 1-4
Sandle, T. (2015) FDA issues revised guidance for analytical method validation, GMP Review,
14 (3): 8-10
Sandle, T. (2015) Importance of Risk Assessment for a Aseptic Transfer in Pharmaceutical

Compounding, Clean Air and Containment Review, Issue 24, pp18-23
Sandle, T. (2015) Safe use of disinfectants and detergents in cleanrooms, Innovation Into Success
(quarterly journal of UKSPA), Issue 38, pp81-84
Sandle, T. (2015) Embracing Rapid Microbiology, The Medicine Maker, Issue 12, pp18-19
Sandle, T. (2015) 10 Most influential microbiologists of the 21st Century, Microbioz India, Vol.
2, Issue 21, pp8-14: http://www.microbiozindia.com/top-10-most-influential-microbiologist-of-
21st-century.htm
Sandle, T. 2015 Development of a biocontanination control strategy, Cleanroom Technology, 23

(11), 25 - 30
Sandle, T. (2015) Current Developments with Disposable Technology and Single-Use Systems
for Aseptic Processing, BioPharma Asia, 4 (6): 5-11
Sandle, T. (2016) Calling time on the General Safety Test, GMP Review, 14 (4): 11-13
Sandle, T. (2016) Standards and controls for skin disinfection, The Clinical Services Journal, 15
(2): 25-28
Sandle, T. (2016) New estimates of microbial numbers in our bodies, Microbioz India, Vol. 3,
pp9-13
Sandle, T. (2016) Pharmaceutical Facility Sanitization: Best Practices Considered, American

Pharmaceutical Review, March 2016, pp1-5
Sandle, T. (2016) Beneath the surface of new cleanliness standard ISO 14644-13, Cleanroom
Technology, April 2016, pp27-28
Sandle, T. (2016) Pharmaceutical Facility Sanitization: Best Practices Considered, American

Pharmaceutical Review, 19 (2): 32-29
Sandle, T. (2016) Изучение микрофлоры воды, используемой для фармацевтических целей,

- анализ метаданных (Placing sedimentation plates in a unidirectional air flow and the effect of
the weight loss (dry agar) on the growth of microbes), Чистые помещения и технологические
среды [Cleanrooms and technological environments], 56 (4): 46-53
Sandle, T. (2016) Размещение седиментационной пластины в однонаправленном

воздушном потоке и влияние потери массы (высыхания агара) на рост микробов (The
study of the microflora of water used for pharmaceutical purposes, - meta analysis), Чистые
помещения и технологические среды [Cleanrooms and technological environments], 56 (4):
30-39
Sandle, T. (2016) Revision to cleanroom standard: ISO 14644 Parts 1 and 2, GMP Review, 15
(1): 4-7
Sandle, T. (2016) Key Criteria for the Selection of Rapid and Alternative Microbiological
Methods, American Pharmaceutical Review, 19 (3): 46-48
Sandle, T. (2016) Improving microbiological assurance for bioburden tests, European

Sandle, T. (2016) New EMA draft guideline on sterilisation of the medicinal product, GMP
Review, 15 (2): 6-8
Vijakumar, R. and Sandle, T. (2016) Bacterial endotoxin contamination and testing limits in
ophthalmics, European Pharmaceutical Review, 21 (4): 16-18
Sandle, T. (2016) Top Cleanroom Advances, The Medicine Maker, July / August 2016 (issue 7),
pp403-404
Sandle, T. (2016) The importance of detergent selection, The Clinical Services Journal, 15 (8):
72-74
Sandle, T. (2016) Removal of Endotoxin from Protein in Pharmaceutical Processes, American

Pharmaceutical Review, 19 (8): 1-5 (http://www.americanpharmaceuticalreview.com/Featured-
Articles/190810-Removal-of-Endotoxin-from-Protein-in-Pharmaceutical-Processes/)
Sandle, T. (2016) Evaluation of Quaternary Ammonium Compound Disinfectants against

Mycobacteria in Dental Practices, Dental Update, 43, 723-726
https://doi.org/10.12968/denu.2016.43.8.723
Sandle, T. (2016) Risk of Microbial Spores in Cleanrooms. Part 1: Introduction to Microbial

Spores and Survival Mechanisms, Clean Air and Containment Review, 28, pp4-6
Sandle, T. (2016) The development of cleanrooms: an historical review. Part 1: From civil war to
safe surgical practice, The Journal – Institute of Science & Technology, Autumn 2016, pp41-47
(ISSN 2040-1868)
(Republished in Sandle, T. and Moldenhauer, J. (2017) Cleaning and Cleanrooms, PDA / DHI
books, Bethesada, U.S. (e-book)).
Sandle, T. (2017) The European approach to disinfectant qualification, La Vague, No. 52, pp45-
48
Sandle, T. (2017) Risk of microbial spores to cleanrooms: Part 2: Selection of sporicidal

disinfectants, Clean Air and Containment Review, Issue 29, pp14-16
Sandle, T. (2017) Establishing a Contamination Control Strategy for Aseptic Processing,

American Pharmaceutical Review, 20 (3): 22-28
Sandle, T. (2017) Effective cleaning and disinfection of dental practices, Dental Practice
Magazine, March 2017, pp58-66
Sandle, T. (2017) Practice disinfection, The Dentist, 33 (1): 34-35
Sandle, T. (2017) Cleaning and disinfection of dental practice surfaces, Dental Nursing, 13 (2):
86-87
Sandle, T. (2017) Risk assessment and pharmaceutical processing hazards, Microbioz India 3
(3): 10-18
Sandle, T. (2017) Microbiological monitoring of pharmaceutical water systems, European

Sandle, T. (2017) The development of cleanrooms: an historical review – Part 2– The path
towards international harmonisation, IST The Journal, Summer 2017, pp1-5
Republished in: Sandle, T. and Moldenhauer, J. (2017) Cleaning and Cleanrooms, PDA / DHI
books, Bethesada, U.S. (e-book)
Sandle, T. (2017) European Pharmacopoeia revises Biological Indicator Chapter, GMP Review,
16 (1): 4-6
Sandle, T. (2017) Designing cleanroom equipment for particulate control, Cleanroom News,
Issue 2, pp22-23 (Turkish publication: "Parçacık kontrolü için temiz oda tasarımı"). at:
http://www.cleanroomnews.org/sayi-2
Sandle, T. (2017) Antimicrobial copper surfaces in hospitals, The Clinical Services Journal, 16
(6): 47-51
Sandle, T. (2017) MHRA annual deficiency review highlights sterility assurance issues, GMP
Review, 16 (2): 4-7
Sandle, T. (2017) Assessment of Bacterial Endotoxin by Fluorescent Labeling, American

Pharmaceutical Review, Endotoxin Supplement, October 2007, pp1-3
Sandle, T. (2017) Applying design and construction standards to cleanroom builds, Cleanroom
Technology, 25 (8): 16-18
Sandle, T. (2017) The people factor: investigating the gown, European Pharmaceutical Review,
22 (4): 23-26
Sandle, T. and Leavy, C. (2017) A focus on regulatory trends: MHRA annual deficiency review,
Pharmig News, Issue 69, pp2-5
Sandle, T. (2017) Revisions made to European Pharmacopoeia sterilisation chapters, Clean Air
and Containment Review, Issue 32, pp18-20
Sandle, T. (2017) New Technologies for Pathogen Detection and Identification, The Scientific
Ravi 2016, Government College University, Lahore, pp9-11
Sandle., T. (2017) Combining copper with effective hygiene, Health Estate Journal, October
2017, pp43-46
Sandle, T. (2017) The Problem of Biofilms and Pharmaceutical Water Systems, American
Pharmaceutical Review, 20 (7): http://www.americanpharmaceuticalreview.com/Featured-
Articles/345440-The-Problem-of-Biofilms-and-Pharmaceutical-Water-Systems/
Sandle, T. (2018) Pharmig presents ‘hot topics’ to the Adriatic region, Pharmig News, Issue 70,
pp9-10
Sandle, T. (2018) Draft revision of EU GMP Annex 1 Manufacturing of Sterile Medicinal

Products for targeted consultation: implications for cleanrooms, Clean Air and Containment
Sandle, T. (2018) Annex 1 calls for a contamination control strategy, GMP Review, 16 (3): 4-7
Sandle, T. (2018) Strategy for the adoption of single-use technology, European Pharmaceutical
Review, 23 (1): 43-45
Sandle, T. (2018) Pharmig’s response to EU GMP Annex 1 draft concept paper, Pharmig News,
71, pp4-7
Sandle, T. (2018) Insight into Pharmig’s new e-learning module, Pharmig News, 71, pp7-9
Sandle, T. (2018) Brexit uncertainty for pharmaceutical companies, Pharmig News, Issue 72,
pp5-6
Sandle, T. (2018) Microbiology Risk Management (QRM): a practical approach meeting,

Pharmig News, Issue 72, pp2-4
Saghee, M. and Sandle, T. (2018) Proposed EU Guidelines to GMP Annex 1: main changes that
trigger enhancements to your sterility assurance programme, GMP Review, 17 (1): 4-8
Sandle, T. (2018) Phase Appropriate GMP for Biological Systems, PDA Letter Summer
Reading, PDA Letter, July / August 2018, p28
Sandle, T. (2018) Effective cleaning. The Dentist, 34 (5): 82-83
Sandle, T. (2018) Editorial: Importance of Microbial Contamination Control, SPECIAL

EDITION: Essential Microbiology for GXP Compliance: 3-6
Sandle, T. (2018) New Developments with Sterile Disposable Technology and Single-Use
Systems for Aseptic Processing, BioPharma Asia, July / August, pp30-34
Sandle, T. (2018) Avoiding environmental monitoring ‘false negatives’: overcoming disinfectant

residues with culture media neutralisers, European Pharmaceutical Review, 23 (4): 18-21
Vesper, J. and Sandle, T. (2018) Hot Read: GMP in Practice, PDA Letter, Vol. LIV, No. 9, pp35-
37
Sandle, T. (2018) Endotoxin Testing as a Detection Method for Bacterial Biofilms, American
Pharmaceutical Review, 21 (8), Endotoxin Supplement, pp1-3. Online:
https://www.americanpharmaceuticalreview.com/Featured-Articles/354079-Endotoxin-Testing-
as-a-Detection-Method-for-Bacterial-Biofilms/
Sandle, T. (2018) Effective training for keeping cleanrooms clean, Cleanroom Technology, 26
(11): 36-37
Sandle, T. (2018) Burkholderia cepacia complex: review of origins, risks and test
methodologies, European Pharmaceutical Review, 23 (5): 30-32
Sandle, T. (2018) E-learning module from Pharmig supports Annex 1 disinfection requirements,
Clean Air and Containment Review, Issue 36: 20-23
Sandle, T. (2018) Medical device QMS harmonisation: FDA to align with ISO 13485, GMP
Review, 17 (3): 4-8
Sandle, T. (2019) Pharmig membership survey, Pharmig News, Issue 74, pp9-12
Sandle, T. (2019) Advances in antimicrobial research, Microbioz India, 5 (2): 14-22
Sandle, T. (2019) Applying Data Integrity Principles to the Cleanroom, American

Pharmaceutical Review, 22 (2): 34-37, at:
https://www.americanpharmaceuticalreview.com/Featured-Articles/359476-Applying-Data-
Integrity-Principles-to-the-Cleanroom/?catid=6262
Sandle, T. (2019) Focusing on the Operator: Reducing Facility Environmental Contamination,
American Pharmaceutical Review, 22 (3): 12-17
Cundell, T., Peacos, P., Sandle, T. and Moldenhauer, J. (2019) Contamination Control
Roundtable, American Pharmaceutical Review, 22 (3): 44-47
Sandle, T. (2019) Pharmaceutical microbiology: current and future challenges, Pharmig News,
Issue 75, pp12-15
Sandle, T. (2019) Best practices for microbiological control, Pharmig News, Issue 75, pp6-7
Sandle, T. (2019) The answer is? FDA publishes final data integrity Q&A, GMP Review, 17 (4):
4-7
Sandle, T. (2019) Sterilisation medicinal products, active substances, excipients and primary
containers, GMP Review, 18 (1): 4-7
Sandle, T. (2019) How to switch ‘bad science’ for ‘good science’? (and what makes for a good
science paper and how to approach writing a science article), The Journal (Institute of Science
and Technology), Summer 2019, pp14-20
Technical articles (internet and on-line published articles)
Sandle, T. Microbiology and the Internet, PharMIG web-site(www.PharMIG.org.uk), November

1999
Sandle, T. ‘Update on Bacterial Taxonomy’, internet only article, published in the members’
section of PharMIG (www.pharmig.org.uk), December 2005
Sandle, T. Dycem Flooring. On-line at: http://www.cleanroom-

technology.co.uk/story.asp?storyCode=39685 (first accessed 29th July 2006);
Also printed on-line at Lifesciences
News:http://www.lifesciencesnews.com/articleView~idArticle~73104_937924181052006.html(
10th May 2006)
And in Packaging Today at:
http://www.packagingtoday.co.uk/story.asp?storyCode=39685 (accessed 29th July 2006)
And at the Dycem website:
http://www.dycem.com/latestnews.php (accessed 10th April 2007)
Sandle, T. Selection of Active Air-Samplers, BioSciences Quality Testing Forum (BioQT)

website: http://www.bioqtforum.com/Selection-of-active-air-samplers (accessed 15th September
2010)
Sandle, T. (2010): The use of risk assessment tools for microbiological assessment of cleanroom
environments, Internet article, GMP Guru, Insight Systems Inc.,
at: http://www.insightcgmp.com/gmp-guru/risk-assessment-tools.pdf (uploaded on 27th
September 2010).
Saghee, M.R. and Sandle, T. (2010): 'Embracing quality risk management: The new paradigm',
Express Pharma, Pharma Technology Review, 16th - 30th September 2010, On-line paper at:
http://www.expresspharmaonline.com/20100930/pharmatechnologyreview02.shtml (accessed
30th September 2010)
Sandle, T. and Saghee, M.R. (2010): Advances in cleanroom technologies, Express Pharma,
16th-30th September, On-line Paper:
http://www.expresspharmaonline.com/20100930/expressbiotech13.shtml (accessed 30th
September 2010)
Sandle, T. (2010): The use of risk assessment tools for microbiological assessment of cleanroom
environments, Internet article, GMP Guru, Insight Systems Inc.,
at: http://www.insightcgmp.com/gmp-guru/risk-assessment-tools.pdf (uploaded on 27th
September 2010).
Sandle, T. (2011): Nontoxic And Nonfuming Sporicide: Science At Its Best, on-line article
published by Go1Bio (February 2011):
http://www.google.co.uk/url?sa=t&source=web&cd=51&ved=0CC8QFjAAODI&url=http%3A
%2F%2Fwww.go1bio.com%2Fclientuploads%2Fdirectory%2Fnewsdirectory%2FSTERIPLEX
%2520HC_Nontoxic%2520Nonfuming%2520Sporicide.pdf&rct=j&q=tim%20sandle&ei=K1M
QTpqpCoWY8QPCsb2eDg&v6u=http%3A%2F%2Fdualstack.ipv6-
exp.l.google.com%2Fgen_204%3Fip%3D81.156.212.12%26ts%3D1309692715373476%26auth
%3Dpds7hrga6grshaf6rlfeatpwd464noyf%26rndm%3D0.00039878398549886285&v6s=2&v6t=
8449&usg=AFQjCNHAVVyROwwVYokmK-QI3TKg5TiLIQ&cad=rja
Sandle T. (2011): “Advances in Cleanroom Technology: Manufacturing Perspective”, Process

Worldwide at: http://www.process-worldwide.com/index.cfm?pid=9963&pk=17888 (28th June
2011)
Sandle, T. (2011): 'Selection of Disinfectants for Use in the Pharmaceutical Industry', Online
article published by PharmaHireWire on 28th June 2011 at:
http://www.mypharmacareers.com/pharmajournal/archives/jun11.html
Sandle, T. (2011). “Good Practices for Pharmaceutical Microbiology Laboratories: A review of

the 2011 WHO Guidance”, Cryologics, Inc. Newsletter, August 2011 (re-printed at:
www.pharmig.blogspot.com) at: http://pharmig.blogspot.com/2011/08/good-practices-for-
pharmaceutical.html
Sandle, T. (2012). “Quality Management System”, A3P website, published 1st May 2012
(http://www.a3p.org/index.php/fr/base-documentaire/articles/203-a-la-une/3990-quality-
management-system)
Sandle, T. (2012). “Cleaning endoscopes: Considering the risks and benefits of enzymatic and
non-enzymatic detergents”, Hospital Bulletin website, published 1st July 2012 (see Hospital
Bulletin) http://www.hospital-bulletin.co.uk/features/Infection%20Prevention/shulke.htm
Sandle, T. (2012). "Desinfektionsmittel – Eine Einführung", IAB website, published 27th July
2012 (see IAB) (http://www.iab-reinraumprodukte.de/info-portal/fachartikel/desinfektionsmittel-
eine-einfuehrung.html)
Sandle, T. (2012). “Toward a Revised International Cleanroom Standard”, Controlled

Environments, on-line article August 2012, pp1-3. Available at: http://www.cemag.us/print/6201
(accessed 3rd August 2012)
Sandle, T. (2012). "Risk Management in Pharmaceutical Microbiology: at look at how HACCP

and FMEA can make a difference in the pharma micro lab.", Pharmaceutical Manufacturing
Magazine on-line: http://www.pharmamanufacturing.com/articles/2011/126.html?page=full
(accessed 9th October 2012).
Rapid Microbial Methods: A Q&A with Dr. Tim Sandle, Rapid Micro Biosystems:
http://www.rapidmicrobio.com/blog/rapid-microbial-methods-a-qa-with-dr.-tim-sandle (July
2014)
Microbiological Monitoring Roundtable - conversation with Tim Sandle and other

microbiologists, with American Pharmaceutical Review
http://www.americanpharmaceuticalreview.com/Featured-Articles/167343-Microbiological-
Monitoring-Roundtable/
Sandle, T. (2010) Cleanroom Particle Counting: The 5 Micron Issue, Pharmaceutical Online
(online publication): http://www.pharmaceuticalonline.com/doc/cleanroom-particle-counting-
the-5-micron-iss-0001
50th Anniversary of LAL Reagent Development (2014). Interview with John Dubczak, Tim
Sandle and Lakiya Wimbish for American Pharmaceutical Review at:
http://www.americanpharmaceuticalreview.com/Featured-Articles/158760-50th-Anniversary-of-
LAL-Reagent-Development/
Tim Sandle - participant (2016) LAL Roundtable, American Pharmaceutical Review, 19(6): 47-
51 http://www.americanpharmaceuticalreview.com/Featured-Articles/239887-LAL-Roundtable/
Tim Sandle Q&A - in conversation with Institute of Validation Technology, April 2017 at:
http://www.ivtnetwork.com/article/meet-ivt-board-tim-sandle
Sandle, T. (2017) Risk and Microbiological Contamination, PDA Letter, Volume LIII (7), (July
2017, pp8 at: https://www.pda.org/pda-letter-portal/archives/full-article/pda-summer-reading-
for-2017
Brief Interview with Dr. Tim Sandle (Editor) - Journal of Ancient Diseases & Preventive
Remedies at: https://www.omicsonline.org/editor-interview/tim-sandle-ancient-diseases-
preventive-remedies.pdf
Sandle, T. (2018) Data Integrity Considerations for Conventional and Rapid Microbiological
Methods, Rapid Microbiology online: http://www.rapidmicrobiology.com/news/data-integrity-
considerations-for-conventional-and-rapid-microbiological-methods/
Sandle, T. (2018) Risk considerations for the installation of a new pharmaceutical facility
autoclave, Sterilize.IT at: https://www.sterilize.it/process/risk-considerations-for-the-
installation-of-a-new-pharmaceutical-facility-autoclave/
Clean facilities round-table - Tim Sandle was a participant in the American Pharmaceutical
Review Clean Facilities Roundtable, December 2918, with Tony Cundell, Claire Briglia, Paula
Peacos, David Jones, Tim Sandle, Poonam Bhende, and Donald Singer. Link:
https://www.americanpharmaceuticalreview.com/Featured-Articles/357567-Clean-Facilities-
Roundtable/
Sandle, T. (2019) Rapid diagnostic device to test bacterial responses to various drug
combinations, Antimicrobial Review Insights, online article at: https://www.amr-
insights.eu/towards-a-rapid-diagnostic-device-capable-of-testing-bacterial-responses-to-various-
drug-combinations/
Sandle, T. (2019) Bacterial Endotoxin Risks to Pharmaceutical Water Systems: Three Case
Studies, Rapid Microbiology. Online article at: https://www.rapidmicrobiology.com/news-
temp-link/Mjg0Mw
Sandle, T. (2019) - Aging Analytics, feature on Tim Sandle’s journalism relating to aging and
science, featuring:
1. Essential Science: Methylene Blue as an anti-aging treatment

2. Big deal for AI-powered longevity biotechnology
3. Anti-diabetic drug slows ageing and lengthens lifespan
4. Interview: Is Alzheimer’s caused by bacteriophages?
In , Top-100 Journalists Covering Advanced Biomedicine and Longevity, Aging Analytics

Agency, p168 at: http://analytics.dkv.global/data/pdf/Longevity-Journalists/Report.pdf
Sandle, T. (2019) Big Investments for Human Microbiome Research, BioPharma Trend at:
https://www.biopharmatrend.com/post/91-big-investments-for-human-microbiome-research/
(published April 25th 2019)
Sandle, T. (2019) New Liposome Treatment for Community-acquired Pneumonia, BioPharma

Trend at: https://www.biopharmatrend.com/post/93-new-liposome-treatment-for-community-
acquire-pneumonia/ (published 14th May 2019)
Sandle, T. (2019) Genetic test for antimicrobial resistance, BioPharma Trend at:
https://www.biopharmatrend.com/post/95-genetic-test-for-antimicrobial-resistance/ (published 27th
May 2019)
Sandle, T. (2019) Robust Quality Audits Are The Solution To Avoiding Expensive Recalls, DHI
Publishing at: http://dhibooks.com/press-releases/SandleArticle1.pdf (published 1st May 2019)
Sandle, T. (2019) A New Method Reveals Clues About Spread of Antimicrobial Resistance,
BioPharma Trend at: https://www.biopharmatrend.com/post/101-careless-disposal-of-medicines-
increases-antimicrobial-resistance/ (published on July 8th 2019)
Sandle, T. (2019): Digital Transformation of Pharmaceuticals and Healthcare, Institute of

Validation Technology Blog, published July 2019.
Technical guides
Author of Pharmig LAL Fact Sheet Series (series editor). 2005 -2007 (sheets 1 to 6) [re-designed
and re-printed 2010]
Technical adviser to publication: Microbiological Control for Non-Sterile Pharmaceuticals,

published by Pharmig and PQG, 2008
Author of Pharmig Microorganism Fact Sheets. 8 full colour sheets relating to the Microbial
Examination of Non-Sterile Products, written by Tim Sandle and issued in November 2013.
Author of Pharmig Microorganism Fact Sheets. 8 full colour sheets relating to the Objectionable
Microorganisms, written by Tim Sandle and issued in November 2014.
Contributing author / editor to PHSS (2014) Bio-contamination, Technical Monograph No. 20,
Pharmaceutical and Healthcare Sciences Society, Wiltshire, U.K. https://phss.site-
ym.com/store/ViewProduct.aspx?id=3427062
PDA Technical Report #69: Bioburden and Biofilm Management in Pharmaceutical

Manufacturing Operations, 2015
PDA Technical Report #70: Fundamentals of Cleaning and Disinfection Programs for Aseptic
Manufacturing Facilities, 2015
Contributing author to The Cosmetic, Toiletry and Perfumery Association & Pharmig
(2015) Rapid and Alternative Microbiological Methods, published by the CPTA, London
Author of Pharmig Microorganism Fact Sheets. 8 full colour sheets relating to pharmaceutical
important fungi, written by Tim Sandle and issued in November 2015.
Author of Pharmig Microorganism Fact Sheets. 8 full colour sheets relating to important
environmental isolates, written by Tim Sandle and issued in November 2016
Author of Pharmig Microorganism Fact Sheets. 8 full colour sheets relating to the Water
Microbiota, written by Tim Sandle and issued in November 2018
Written conference papers
Sandle, T. Cleanroom Monitoring – What, When and How Often, included in Pharmaceutical
Cleanrooms conference pack for the ‘Cleanrooms 2003 Conference’ 16 – 19th March 2003,
Cambridge
Sandle, T. Sterility Testing – A Practical Approach. Written paper presented to PharMIG

Microbiological Methods Validation Conference, St. Albans, 4th June 2003
Sandle, T. Points to Consider In Performing Risk Assessments Of Isolators Used For Aseptic
Processes. Written paper presented to the AUDITS 13 conference, organised by La Calhene,
Brussels, 16th September 2003
Sandle, T. Current Practices in Sterility Testing. Written paper presented to Institute of

Validation Technology Microbiology Event of the Year, December 2003, Dublin
Sandle, T. Sterility Testing – A Practical Approach (Revised). Written paper presented

to PharMIG Microbiological Methods Validation Conference,Dublin, 25th March 2004
Sandle, T. Three Aspects of LAL Testing: Glucans, Depyropgenation and Water System
Qualification. Written paper presented to PharMIG Endotoxin Course, Waltham Abbey, 3rd June
2004.
Sandle, T. Microbiological Environmental Monitoring in an Isolator Used for Aseptic Filling or

Sterility Testing, written paper presented to the La Calhene Audits 15 Conference, Brussels,
21st September 2004
Sandle, T. Environmental Monitoring Risk Assessment. Written paper presented to Institute of

Validation Technology Microbiology Event of the Year’, Amsterdam, November 2004
Sandle, T. The Use of Risk Assessment in Developing a Viable Environmental Monitoring

Programme. Written paper presented to Pharmaceutical Cleanrooms 2005, Cambridge,
September 2005
Sandle, T. A guide to the Pharmaceutical Microbiology Interest Group Web Forum, paper
presented to the PharMIG Conference, 23rd November 2005
Sandle, T. The Distribution of Microbiological Data, Written Paper for the PharMIG Irish
Conference, Cork, 7th June, 2006
Alexander, B. and Sandle, T. Managing a Microbiology Laboratory Training Programme, a
PharMIG training package (issued to delegates with the one-day workshop papers on 29th March
2007)
Sandle, T. Applying Failure Mode and Effects Analysis (FMEA) to a Sterility Testing Isolator: A
Case Study, written paper included with the PharMIG Risk Based Management in
Pharmaceutical Microbiology, 27th June 2007
Reports and working papers
Sandle, T. (2011): ‘Pharmig Conference Summary: November 2010’, Pharmig News, Number
42, pp10-11
Contributing interview to ‘Ensuring Sterility of Parenteral Products’, along with James Agalloco
and Benoît Verjans. Published in Pharmaceutical Technology, April 2013, pp2-6
Cox, B. (2013). Are Cleanrooms Clean? Human Microbiome Project Raises Some
Questions, The Gold Sheet, 47 (11): 16-18 - a review of Tim Sandle's 2013 PDA Microbiology
presentation
Dzhaksybayev, A. and Sandle, T. (2018) The history of the development of the regulation of
land relations after gaining the independence of the Republic of Kazakhstan, Working Paper.
DOI: 10.13140/RG.2.2.32226.02243
Interviews
An interview with Tim Sandle, conducted by Pharmaceutical Bioprocessing

(http://www.future-science.com/doi/pdf/10.4155/pbp.13.64):
Sandle, T. (2014). Pharmaceutical Microbiology, Pharmecutical Bioprocessing; 2(1): 17–21
Interview with Tim Sandle for Microbiology Today by Saumyadip Sarkar: Sakar, S. (2014)
Portrait - an interview with Dr. Tim Sandle, Micrographia Today, 1 (2): 16-20, see:
http://www.wethemicrobiologist.in/uploads/9/4/5/2/9452624/06._magazine_feb_-_mar_1.pdf
Rapid Microbial Methods: A Q&A with Dr. Tim Sandle (Rapid Micro BioSystems, 2014), see:
https://www.rapidmicrobio.com/blog/rapid-microbial-methods-a-qa-with-dr.-tim-sandle
Interview with Microbioz India, April 2015 at: http://www.microbiozindia.com/business-

news/an-interview-with-dr-tim-sandle.htm#sthash.NNRYuVnD.dpbs
Meet the IVT Board: Tim Sandle, (Institute of Validation Technology, 2017) interview at:
http://www.ivtnetwork.com/article/meet-ivt-board-tim-sandle
Interview with Digital Journal, by Markos Papadotos “Dr. Tim Sandle discusses career as a
scientist and journalist”, (2018) at: http://www.digitaljournal.com/tech-and-science/science/dr-
tim-sandle-discusses-career-as-a-scientist-and-journalist/article/514692
Artificial Intelligence to Improve Cancer Diagnosis in NHS – Interview with Tim Sandle,
microbiologist (2018), see:
https://www.researchgate.net/publication/325402241_Artificial_Intelligense_to_Improve_Cance
r_Diagnosis_in_NHS_-_Microbiologist
An interview with Dr. Tim Sandle – Microbiology Society – at:

https://microbiologysociety.org/membership/meet-our-members/an-interview-with-dr-tim-
sandle.html (March 2019)
Video
Cleanroom facility of the future - Tim Sandle was featured in the American Pharmaceutical
Review video ‘Clean facility of the future’. See:
https://www.americanpharmaceuticalreview.com/Clean-Facility-of-the-Future/
Regulatory updates
Tim Sandle writes a quarterly column on regulatory updates for Pharmig News. The series began
in 2008 and continues to date.
Poster abstract
Poster abstract ‘Assessing airborne contamination using a novel rapid microbiological method’
by Tim Sandle, Clare Leavy and Rachel Rhodes. Published in Helapet Newsletter, Issue 4, 2015,
p2.
Notes
[1] This paper was featured in a book about marketing:
Title Principles of direct and database marketing

Author Alan Tapp
Edition 4, illustrated
Publisher Pearson Education, 2008
ISBN 0273713027, 9780273713029
Length 517 pages

Publications by Tim Sandle - July 2019

Uploaded by

Copyright:

Available Formats

Publications by Tim Sandle - July 2019

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Publications by Tim Sandle - July 2019

Uploaded by

Copyright:

Available Formats

This page lists all of my major publications.

2. Sandle, T. (2011): Two extremes? Flexible working in Europe: A study of differences in

3. Sandle, T. (2012). The CDC Handbook: A Guide to Cleaning and Disinfecting

Sandle, T. (2016). The CDC Handbook: A Guide to Cleaning and Disinfecting

4. Sandle, T. (2012). Pharmaceutical Microbiology Glossary, Microbiology Solutions: UK

5. Sandle, T. (2012). E-Guide to Cleanrooms, Microbiology Solutions: UK (Kindle only

6. Sandle, T. and Saghee, M.R. (2013). Cleanroom Management in Pharmaceuticals and

Sandle, T. and Saghee, M. R. (Eds) Cleanroom Management in Pharmaceuticals and

8. Sandle, T. (2013). Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals:

10. Sandle, T. and Vijayakumar, R. (2014) Cleanroom Microbiology, DHI/PDA: Bethesda,

11. Hanlon. G. and Sandle, T. (Eds.) (2015) Industrial Pharmaceutical Microbiology:

Sandle, T. (2019) Industrial Pharmaceutical Microbiology: Standards & Controls, 5th

24. Sandle, T. (2019) Biocontamination Control for Pharmaceuticals and Healthcare,

25. Sandle, T. (2019) Sandle's Pharmaceutical Microbiology Dictionary, Microbiology

Booklets and monographs

1. Sandle, T. and Boschi, F. (2006): ‘Environmental Monitoring Handbook’,

2. Sandle, T. (editor) (2010): ‘Current Perspectives on Environmental Monitoring: Pharmig

4. Sandle, T. (2011). Polls Apart? Flexible working in the European Pharmaceutical

5. Roberts, J. and Sandle, T. (2011). A Guide to Microbiology Laboratories in the

9. Sandle, T. (2017) Pharmig Guide to Cleanroom Operation and Contamination Control,

• Biodecontamination of Cleanrooms and Laboratories Using Gassing Systems - Tim

1. Sandle, T. ‘Selection and use of cleaning and disinfection agents in pharmaceutical

Revised and updated:

Sandle, T. (2014) Selection and use of Cleaning and Disinfection Agents in

2. Sandle, T. ‘Best practices for microbiological documentation’ in Hodges, N and Hanlon,

3. Sandle, T. (2010): Best practices in microbiology laboratory training in Hodges, N. and

Revised and updated:

Sandle, T. (2014) Best Practices in Microbiology Laboratory Training. In Handlon, G.

Sandle, T. (2019) Best practices in microbiology laboratory training. In Sandle, T. (Ed.)

4. Sandle, T. (2010): 'The Media Kitchen: Preparation and Testing of Microbiological

5. Sandle, T. and Saghee, M. R. (2011): ‘The Essentials of Pharmaceutical Microbiology’,

6. Sandle, T. (2011): ‘Selection of Microbiological Culture Media and Testing Regimes’ in

7. Sandle, T. (2011): ‘Practical Approaches to Sterility Testing’ in Saghee, M.R., Sandle, T.

11. Sandle, T. (2011): ‘Risk Management in Pharmaceutical Microbiology’ in Saghee, M.R.,

12. Sandle, T. (2011). ‘Assessment of Culture Media in Pharmaceutical Microbiology' in

16. Sandle, T. (2012). ‘Environmental Monitoring: a practical approach’ In Moldenhauer, J.

19. Sandle, T. (2012). ‘Application of Disinfectants and Detergents in the Pharmaceutical

(revised for second edition: pp1-6)

(revised for second edition: pp7-24)

(revised for second edition: pp155-170)

25. Midcalf, B, Neiger, J. and Sandle, T. (2013). ‘Fundamentals of pharmaceutical isolators’.

(revised for second edition: pp171-212)

(revised for second edition: pp361-376)

(revised for second edition: pp401-432)

(revised for second edition: pp553-568)

(revised for second edition: pp569-581)

34. Sandle, T. (2013). Microbial Control of Pharmaceuticals, Encyclopedia of

37. Brutsche, A. and Sandle, T. (2014). Preparing and Management of International

40. Sandle, T. (2014). ‘Microbial Identification: Laboratory Techniques and Methods. In

41. Sandle, T., 2014. Biochemical and Modern Identification Techniques:

47. Sandle, T. (2014) Best Practices in Microbiology Laboratory Training. In Handlon, G.

Revised and updated:

Sandle, T. (2019) Use of culture media in pharmaceutical microbiology. In Sandle, T.

Revised and updated:

Sandle, T. (2019) Microbiology of pharmaceutical grade water. In Sandle, T. (Ed.)

Sandle, T. (2019) Biological indicators. In Sandle, T. (Ed.) Industrial Pharmaceutical

Revised and updated:

Revised and updated:

Sandle, T. (2019) Regulatory control and assurance of immunological products. In