Tim Sandle
Dr. Sandle has over twenty-five years experience of microbiological research and biopharmaceutical processing. This includes experience of designing, validating and operating a range of microbiological tests including sterility testing, bacterial endotoxin testing, bioburden and microbial enumeration, environmental monitoring, particle counting and water testing. In addition, Dr. Sandle is experienced in pharmaceutical microbiological risk assessment and investigation.
Dr. Sandle is a tutor with the School of Pharmacy and Pharmaceutical Sciences, University of Manchester for the university’s pharmaceutical microbiology MSc course. In addition, Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control (including the ISO cleanroom standards). He is a committee member of the Pharmaceutical Microbiology Interest Group (Pharmig); and is a member of several editorials boards for scientific journals. He was a member of the National Blood Service advisory cleaning and disinfection committee.
Dr. Sandle has acted as a consultant, expert witness and technical advisor to sterile and non-sterile manufacturing facilities, microbiology laboratories, the medical device industry and hospitals. Dr. Sandle has also undertaken several technical writing and review projects.
Dr. Sandle has written over three hundred book chapters, peer reviewed papers and technical articles relating to microbiology. In addition, Dr. Sandle has written several books including "Sterility Testing of Pharmaceutical Products", "Risk Management and Risk Assessment for Pharmaceutical Manufacturing: A contamination control perspective" and "Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals: Technology, Validation and Current Regulations". Dr. Sandle has also edited the book "The CDC Handbook: A Guide to Cleaning and Disinfecting Cleanrooms"; and co-editing the comprehensive books "Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices" and "Cleanroom Management in Pharmaceuticals and Healthcare". Dr. Sandle has also delivered papers to over fifty international conferences.
Address: BPL, Dagger Lane, Elstree, Herts. WD6 3BX. UK
Dr. Sandle is a tutor with the School of Pharmacy and Pharmaceutical Sciences, University of Manchester for the university’s pharmaceutical microbiology MSc course. In addition, Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control (including the ISO cleanroom standards). He is a committee member of the Pharmaceutical Microbiology Interest Group (Pharmig); and is a member of several editorials boards for scientific journals. He was a member of the National Blood Service advisory cleaning and disinfection committee.
Dr. Sandle has acted as a consultant, expert witness and technical advisor to sterile and non-sterile manufacturing facilities, microbiology laboratories, the medical device industry and hospitals. Dr. Sandle has also undertaken several technical writing and review projects.
Dr. Sandle has written over three hundred book chapters, peer reviewed papers and technical articles relating to microbiology. In addition, Dr. Sandle has written several books including "Sterility Testing of Pharmaceutical Products", "Risk Management and Risk Assessment for Pharmaceutical Manufacturing: A contamination control perspective" and "Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals: Technology, Validation and Current Regulations". Dr. Sandle has also edited the book "The CDC Handbook: A Guide to Cleaning and Disinfecting Cleanrooms"; and co-editing the comprehensive books "Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices" and "Cleanroom Management in Pharmaceuticals and Healthcare". Dr. Sandle has also delivered papers to over fifty international conferences.
Address: BPL, Dagger Lane, Elstree, Herts. WD6 3BX. UK
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Without subsequent analysis, just collecting data is pointless. Data and insights are not synonyms; they are aspects of a methodology that drives business growth. A company can have millions of data points at its disposal, but putting those into perspective is the real task. Value comes from looking for patterns, peaks, troughs, trends, gaps, and so on — often through data visualization.
Patterns and insights sometimes can be revealed directly by the software that supports laboratory instruments; other times, standalone statistical software is required; and other times, an old fashioned visual check can reveal something of interest. The review process is most important. To that end, this eBook illustrates some different approaches to studying laboratory data.
In this eBook, BPI editorial advisor Tim Sandle (head of microbiology at Bio Products Laboratory) presents some different approaches to presenting and studying biopharmaceutical laboratory data. Illustrations demonstrate different sorts of data sets and how their patterns can be revealed through visual presentation — as well as what can go wrong when the wrong choices are made.
For this reason, we asked Dr. Sandle for his opinion on the effects of the new ANNEX 1 in the strategies that, with due differences, the entire industry will have to implement: from setting up new processes, to training personnel, to managing non-conformities, this particular time requires the Life Sciences industry to pay close attention.
The book traces the development of antimicrobials and contextualises the different types that are available. Later the text looks at how natural and synthetic antibacterial agents work and describes the problems that resistance present for the next generation of scientists who will be required to develop new and more effective treatments. For the generation of alternatives, an understanding of biotechnology is required and hence this subject area represents another major theme considered throughout the text.
The results of the laboratory work are part of the paraclinical investigations that help establish the diagnosis. This book explores these fields.
Chesca, A. and Sandle, T. (2021) Clinical Laboratory, Edizioni Sapienza, Italy ISBN 978-620-3-60359-0
Topics and laboratory functions that will be explored include:
New model healthcare
Ways to use digital data, including root cause investigations
Office technology
Protecting ownership security
E-learning and virtual inspections
And many more
The first volume of this two-part collection addresses building a digital company, big data analytics, advances in Process Analytical Technology electronic batch records, Block Chain, and more. Taken together, these volumes provide a clear picture of where things currently stand, where they are likely to develop, and the challenges that digital technology adopters face, in terms of practicalities and in maintaining GMP compliance.
This book provides an overview of the essential techniques, designed for the student or the interested person. Includes illustrations.
See: https://www.morebooks.shop/bookprice_offer_f2b569e0cd0b06ef26fe426085592f5e2e6d990a?locale=gb¤cy=EUR
https://www.amazon.com/dp/6203306169/ref=sr_1_1?dchild=1&qid=1614426259&refinements=p_27%3AAntonella+Chesca&s=books&sr=1-1
To make sense of what is happening in the world of pharmaceuticals and healthcare, Tim Sandle has written a new book (the first part of a two volume series). Volume one addresses digital technologies for automation and process improvement.
The book explores what each technology does, the potential use of the technology and the practical aspects for its implementation, along with the changes to culture and structure necessitated by digital transformation. This first volume covers process-centric themes and related regulatory aspects and standards.
In addition, these devices enable the isolation between the operator and the process. There are many complications with isolators, from design to qualification, and with general operation.
It certainly remains that isolators cannot prevent contamination caused by GMP deficiencies such as poor aseptic procedures and inadequate training of operators.
To address these concerns and to outline best practices, Tim Sandle has written a new Pharmig guide
Prior to examination, the specimen will have been sectioned, stained, and mounted on a microscope slide. The focus is on the four basic types of human tissues: epithelial tissue, connective tissue, muscle tissue, nervous tissue, together with subtypes, in order to assess health and disease. Histological studies can be conducted using tissue culture, where live animal cells are isolated and maintained in an artificial environment for various research projects.
The ability to visualize or differentially identify microscopic structures is frequently enhanced through the use of staining. For this purpose, staining is employed to give both contrast to the tissue as well as highlighting particular features of interest. There is often a lack of suitable reference books showing high quality histology stains for the medical student and medical practitioner to refer to. The aim of this Atlas is to provide such source material.
If designed and implemented appropriately, audits can provide valuable information for prevention of issues. The goal is to catch problems before they impact product quality, and putting patients at risk. In addition to the regulations noted, the following points will contribute to an effective audit/control program:
Systems-Based Audits and Inspections
Defining Metrics
Risk Based Approach to Quality Auditing
Auditor Techniques
Documentation and Reporting Techniques
Computerized Systems Audits and Data Integrity Requirements
Each point is developed in detail in the book, together with practical examples and applicable regulations. The latter point has become an area of increasing attention and comment by the regulatory agencies.
The book outlines why audits are important and how they feed into the quality system. The book has the objective of helping those who need to carry out audits.
Without subsequent analysis, just collecting data is pointless. Data and insights are not synonyms; they are aspects of a methodology that drives business growth. A company can have millions of data points at its disposal, but putting those into perspective is the real task. Value comes from looking for patterns, peaks, troughs, trends, gaps, and so on — often through data visualization.
Patterns and insights sometimes can be revealed directly by the software that supports laboratory instruments; other times, standalone statistical software is required; and other times, an old fashioned visual check can reveal something of interest. The review process is most important. To that end, this eBook illustrates some different approaches to studying laboratory data.
In this eBook, BPI editorial advisor Tim Sandle (head of microbiology at Bio Products Laboratory) presents some different approaches to presenting and studying biopharmaceutical laboratory data. Illustrations demonstrate different sorts of data sets and how their patterns can be revealed through visual presentation — as well as what can go wrong when the wrong choices are made.
For this reason, we asked Dr. Sandle for his opinion on the effects of the new ANNEX 1 in the strategies that, with due differences, the entire industry will have to implement: from setting up new processes, to training personnel, to managing non-conformities, this particular time requires the Life Sciences industry to pay close attention.
The book traces the development of antimicrobials and contextualises the different types that are available. Later the text looks at how natural and synthetic antibacterial agents work and describes the problems that resistance present for the next generation of scientists who will be required to develop new and more effective treatments. For the generation of alternatives, an understanding of biotechnology is required and hence this subject area represents another major theme considered throughout the text.
The results of the laboratory work are part of the paraclinical investigations that help establish the diagnosis. This book explores these fields.
Chesca, A. and Sandle, T. (2021) Clinical Laboratory, Edizioni Sapienza, Italy ISBN 978-620-3-60359-0
Topics and laboratory functions that will be explored include:
New model healthcare
Ways to use digital data, including root cause investigations
Office technology
Protecting ownership security
E-learning and virtual inspections
And many more
The first volume of this two-part collection addresses building a digital company, big data analytics, advances in Process Analytical Technology electronic batch records, Block Chain, and more. Taken together, these volumes provide a clear picture of where things currently stand, where they are likely to develop, and the challenges that digital technology adopters face, in terms of practicalities and in maintaining GMP compliance.
This book provides an overview of the essential techniques, designed for the student or the interested person. Includes illustrations.
See: https://www.morebooks.shop/bookprice_offer_f2b569e0cd0b06ef26fe426085592f5e2e6d990a?locale=gb¤cy=EUR
https://www.amazon.com/dp/6203306169/ref=sr_1_1?dchild=1&qid=1614426259&refinements=p_27%3AAntonella+Chesca&s=books&sr=1-1
To make sense of what is happening in the world of pharmaceuticals and healthcare, Tim Sandle has written a new book (the first part of a two volume series). Volume one addresses digital technologies for automation and process improvement.
The book explores what each technology does, the potential use of the technology and the practical aspects for its implementation, along with the changes to culture and structure necessitated by digital transformation. This first volume covers process-centric themes and related regulatory aspects and standards.
In addition, these devices enable the isolation between the operator and the process. There are many complications with isolators, from design to qualification, and with general operation.
It certainly remains that isolators cannot prevent contamination caused by GMP deficiencies such as poor aseptic procedures and inadequate training of operators.
To address these concerns and to outline best practices, Tim Sandle has written a new Pharmig guide
Prior to examination, the specimen will have been sectioned, stained, and mounted on a microscope slide. The focus is on the four basic types of human tissues: epithelial tissue, connective tissue, muscle tissue, nervous tissue, together with subtypes, in order to assess health and disease. Histological studies can be conducted using tissue culture, where live animal cells are isolated and maintained in an artificial environment for various research projects.
The ability to visualize or differentially identify microscopic structures is frequently enhanced through the use of staining. For this purpose, staining is employed to give both contrast to the tissue as well as highlighting particular features of interest. There is often a lack of suitable reference books showing high quality histology stains for the medical student and medical practitioner to refer to. The aim of this Atlas is to provide such source material.
If designed and implemented appropriately, audits can provide valuable information for prevention of issues. The goal is to catch problems before they impact product quality, and putting patients at risk. In addition to the regulations noted, the following points will contribute to an effective audit/control program:
Systems-Based Audits and Inspections
Defining Metrics
Risk Based Approach to Quality Auditing
Auditor Techniques
Documentation and Reporting Techniques
Computerized Systems Audits and Data Integrity Requirements
Each point is developed in detail in the book, together with practical examples and applicable regulations. The latter point has become an area of increasing attention and comment by the regulatory agencies.
The book outlines why audits are important and how they feed into the quality system. The book has the objective of helping those who need to carry out audits.
Industrial Pharmaceutical Microbiology: Standards and Controls provides clear, practical and up-to-date guidance for handling virtually every compliance and operational challenge associated with pharmaceutical microbiology.
As with other types of disinfection, the aim is not ‘sterilisation’ but to bring any bacterial density present on the gloves down to a level that is as low as possible (what is sometimes referred to as the "irreducible minimum"). Assessment, when required, is commonly through the use of agar contact plates onto the fingertips of each gloved hand (four fingers and the thumb) to create the ‘finger plate’ or ‘finger dab’. To avoid false negatives, the agar needs to be formulated with an appropriate disinfectant neutraliser.
For cleanroom and laboratory managers seeking to maximise the maintenance of asepsis, glove control is an important element. This should take the form of a good practice schema and for this to be transitioned into a training module, supported by regular prompts in practice.
In terms of what such a schema should look like, this article appraises the research that underpins an appropriate glove ‘sanitisation’ schema. This includes the central concerns of when and how effective glove disinfection is to be achieved. The key findings are that a 30 second disinfection time is suitable for both cleanroom and laboratory operations, provided a suitable technique is deployed and an alcohol-based disinfectant used. However, controls need to be in place to avoid the over disinfection of gloves since repeated applications increase the likelihood of microperforations occurring and thereby effective glove disinfection needs to be supported by a regular glove change procedure.
Sandle, T. (2023) Glove disinfection and aseptic technique: Creating a schema for the cleanroom and laboratory, European Journal of Parenteral and Pharmaceutical Sciences, 28 (2): https://doi.org/10.37521/ejpps.28201
Sandle, T. (2023) Can imperfect cleanroom surfaces affect contamination control?, RSSL Life science Series, July 2023: https://www.rssl.com/insights/life-science-pharmaceuticals/can-imperfect-cleanroom-surfaces-affect-contamination-control/
The agency defines immunotoxicity as “unintended immunosuppression or stimulation (including hypersensitivity), which can include adverse effects of exaggerated pharmacology of pharmaceuticals that are intended to function as immunomodulators.” Any applicable type of pharmaceutical, including most biologics, are within scope (however, cell and gene therapies, adjuvanted vaccines, and blood products are excluded from this guidance document).
Sandle, T. (2023) FDA Finalizes Guidance On Nonclinical Evaluation Of Pharmaceutical Immunotoxicity, Drug Discovery Online, July 2023: https://www.drugdiscoveryonline.com/doc/fda-finalizes-guidance-on-nonclinical-evaluation-of-pharmaceutical-immunotoxicity-0001
To determine the most appropriate chemicals, an understanding of the products is needed, especially with the selection of the most appropriate in-process material for the cleaning validation. This choice should be based on factors like solubility, difficulty of cleaning, the different types of equipment to be cleaned and the calculation of residue limits based on potency, toxicity, and stability.
Sandle, T. (2023): Key considerations for the selection of pharmaceutical equipment cleaning chemicals, RSSL Insights, April 2023: https://www.rssl.com/insights/life-science-pharmaceuticals/key-considerations-for-the-selection-of-pharmaceutical-equipment-cleaning-chemicals/
ISO 9001 is based on a number of quality management principles including a strong customer focus, the motivation and implication of senior management, following a process approach and with the practice of continual improvement. This article provides an anatomy of the standard, drawing out its key features.
Spirulina is most commonly utilised as a food supplement in special algal farms in outdoor tanks and bioreactors. Tim Sandle spoke with Lumen Bioscience CoFounder and CEO, Brian Finrow.
Nevertheless, mycoplasmas are common and successful pathogens that can cause infections in the lungs, joints, breasts and udders of animals (including atypical pneumonia).
Sandle, T. (2024) Mycoplasma Pneumoniae: An overview, RSSL Life Sciences, 25th October 2024: https://www.rssl.com/insights/life-science-pharmaceuticals/mycoplasma-pneumoniae-an-overview/
Sandle, T. (2024) Tips for approaching academic writing, The Tech Magazine, 5 (2): 14-18 https://istonline.org.uk/cms/wp-content/uploads/2024/11/The-Tech-Magazine-2024-Vol-5-No-2-Nov-Final-Copy.pdf
Some of the barriers are beginning to fall through advances in drug delivery technology and 2024 has seen several advancements, many of which are set to continue to progress into 2025. This article assesses five interesting innovations in drug delivery.
Sandle, T.(2024) 5 Areas Of Drug Delivery Innovation To Watch In 2025, Drug Discovery Online, 12th November 2024: https://www.drugdeliveryleader.com/doc/areas-of-drug-delivery-innovation-to-watch-in-2025-0001
Staff working in decontamination services will ensure that reusable medical devices, such as endoscopes and other surgical instruments and equipment are cleaned, sterilised, and repackaged to high standards.
Sandle, T. (2024) Understanding steam sterilisation failures, Clinical Services Journal, 23 (10): 33-37
One of the dilemmas faced by microbiologists, on the recovery of contamination at Grade A, is whether the contamination derived from the aseptic operation or from the activity of transfer in to or out of the aseptic environment. If adventitious contamination cannot be verified, the recovery could lead to a batch rejection.
A potential microbial contamination transfer risk exists with both RABS (restricted access barrier systems) and isolators, given the need to introduce materials from outside of the protective barrier. While isolators afford greater protection by virtue of providing a complete barrier and an environment that can be subjected to an automated decontamination cycle, the transfer issue still presents a concern.
This article looks at the problem of transferring materials to the aseptic core from lower controlled environments and describes a solution from Merck that significantly improves the environmental monitoring workflow through the use of the IsoBag® solution.
The function of such plants is to clean sewage and water so that they can be returned to the environment, without polluting other water sources or supplies. Wastewater plants are designed to remove solids and pollutants, break down organic matter and restore the oxygen content of treated water. Ideally, with wastewater treatment plants a pharmaceutical compound and its metabolites undergo a partial or complete mineralization or a slow biodegradation after binding on solid sludge. In poorly performing plants, pharmaceuticals pass unchanged through the wastewater treatment plant and into the general water system or into the environment³.
Key aspects of the treatment steps, together with some examples of operational problems, are discussed in this paper, together with some examples of what happens when things go wrong.
Here Dr Tim Sandle explains why understanding our own microbiomes are key to this process.
At least two viral clearance steps that either remove or inactive potential viruses are required by regulatory authorities. Standard viral clearance is achieved through heat, chromatographic separations (for example, through protein A/ion exchange columns), low-pH treatments, solvent/detergent (S/D) viral inactivation and nanofiltration.
This article considers the solvent-detergent process which is used against enveloped viruses.
Scope of Annex 1
Main changes
Contamination control strategy
Quality systems
Cleanrooms
Disinfection
Personnel
Aseptic processing
And more…
Introduction to risk assessment
What are risks?
Advantages and disadvantages of FMEA
Applying FMEA to review a sterility testing isolator – case study
Sterility testing concerns
Introduction to isolators
Isolator decontamination cycles
Biological indicators
Validation of isolator cycles
Key operational decisions
Maintaining isolators
WHERE micro-organisms are found
WHY microbiology is important at BPL
HOW microbiology affects YOU
e.g.Protocols have to be approved, Personnel have to be trained, SOP’s need to be written
Allow time between the different qualifications
e.g. close out of deviations, approval of protocols
Allow time to get equipment ready
e.g. commissioning has been performed, it is set-up and instruments are calibrated
Allow time to arrange support
e.g. SOPs are written, personnel trained, change control
What is an SOP?
What makes an SOP well written?
How to write good SOP’s
Form & Function - instructions at BPL
Building in compliance
Filtration
Dilution
Directional Air Flow
Air Movement
This presentation looks at hydrogen peroxide in the vapor or autolyzed form and considers what can result in cycle failures.
Introduction to quality risk management.
Definitions of risk.
What is the aim of environmental monitoring?
Risk management tools and techniques for environmental monitoring
This presentation reviews the current focal points from MHRA GMP inspections.
Quality of medical products (both drugs and devices) becomes a social and ethical responsibility as products are developed, produced and distributed for preventing, treating and reducing discomforts of diseases.
Colony Forming Units – what are they?
Microbiology laboratory cabinets – always work?
Media growth promotion – can it be skipped?
Microbial distribution in cleanrooms – free floating?
Environmental monitoring parameters – can they be pre-set?
Bunsen burners needed to create aseptic space– or not?
Identification results– always believable?
Culture media are of essential importance for the microbiological quality control. Or, put it in another way, without culture media there would be no microbiological QC.
Culture media are used for:
Microbiological Monitoring
Media Fills
Enumeration Tests
Test of Specified Microorganisms
Sterility Test
Microbial Identification
Types of depyrogenation
Case study: depyrogenation by dry heat
Practical tips
Why things go wrong
Variations in the approach
The void has now been filled, however, with a significant new book edited by Tim Sandle: 'The CDC Handbook – a guide to cleaning and disinfecting cleanrooms'. Not only does this book strike the correct balance between the scientific and practical, it is full of rich detail and it is easy to follow and to understand. This clarity is enhanced through the copious use of diagrams and photographs.
To help with this complex task a new book has been produced “Pharmaceutical Regulatory Inspections”, edited by Madhu Raju Saghee. The book is timely, relevant and important.
In this chapter, advances of AI within the field of microbiology are considered, focusing on technologies that are enhancing the governance of contamination control and which aid the QP in the release of medicines through a more in-depth understanding of microbiological control and risk factors.
Sandle, T. (2022) Disinfectants. In Rezaei, N.(Ed.) Encyclopedia of Infection and Immunity, Volume 4, Elsevier, pp 630-639 ISBN 9780323903035,
https://doi.org/10.1016/B978-0-12-818731-9.00206-8.
(https://www.sciencedirect.com/science/article/pii/B9780128187319002068)
It has been shown that the distance between the sites is different, so that the action of a certain ER will result in a multitude of FRs of varying lengths. Studies have shown that the sections performed by most ERs are not located on the same level on the two strands of the DNA molecule. Therefore, on a portion of several nucleotides, the ends of the fragments will be single-stranded, i.e. at one end, the nucleotides of one strand will be mismatched and at the other end, the nucleotides of the opposite strand. This mode of action is important in practice, because DNA fragments generated by the same ER, having cohesive ends, can be made to weld together, even if they come from completely different sources. In the end, recombinant DNA results.
Sandle, T. (2022) Genetic engineering techniques used in molecular diagnosis. In Chesca, A.(Ed.) Cell and Molecular Biology Applications, Lambert Academic Publishing, Republic of Moldova, pp81-106
See: https://novapublishers.com/shop/the-encyclopedia-of-bacteriology-research-developments-11-volume-set/
ISBN: 978-1-53619-240-7
The information it provides on conducting investigations that will be acceptable to regulatory investigators will be instrumental in helping you to significantly reduce regulatory risk.
In: Conducting Compliant Investigations, Edited by Jeanne Moldenhauer
The information it provides on conducting investigations that will be acceptable to regulatory investigators will be instrumental in helping you to significantly reduce regulatory risk.
In: Conducting Compliant Investigations, Edited by Jeanne Moldenhauer
For example: The Biocidal Products Regulation in the EU and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) in the US. Although this testing can provide the end user with a degree of assurance regarding the product performance, the test methods for registration used do not reflect how the disinfectant would be used in the unique setting of a pharmaceutical cleanroom. Where disinfectants are used in a GMP environment it is a regulatory expectation that:
▪ Testing is performed to demonstrate that they are fit for purpose, i.e. that they provide a sufficient level of reduction in viability for the types of organisms expected to be encountered on the surfaces on which they will be used (PIC/S PI 007-6; FDA Guidance for Aseptic Processing)
▪ Where microbial testing of surfaces in clean rooms is carried out, validation should be performed on the test method to confirm that sanitising agents do not influence the recovery of microorganisms (EU GMP Annex 15)
In this chapter the following topics are discussed:
▪ The most common methods used to prove disinfectant efficacy and selection of test parameters
▪ Validation of environmental monitoring contact plates
▪ Requirements for re-validation
▪ Considerations for qualification of disinfectants used for hand sanitisation
See: https://www.pda.org/bookstore/product-detail/6042-cleanroom-contamination-prevention-control
The chapter also considers risks, and where design and commissioning aspects can be optimized.
The importance of microbiological control in relation to the manufacture of pharmaceutical and healthcare products is the theme of this special compilation for IVT Network. The articles selected highlight the twin themes of maintaining control through the assessment of risk and the use of sound, scientific methods to assess risk. This latter area includes the use of rapid and alternative methods.
While microbiology plays a role in drug development, through the application of biotechnology (including the development of anti-infective agents and with the manufacture of pharmaceutical products), a considerable part of the role of the pharmaceutical microbiologist is with protecting pharmaceutical and healthcare products from spoilage by microorganisms and thus protecting patients and consumers. With both sterile and non-sterile products, the effects can range from discoloration to the potential for fatality.