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    Mark Old Corne Microbiological Validation

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    This document discusses microbiological validation. It defines validation as proving that a process consistently provides a product that meets specifications. It then summarizes various microbiological validation methods including environmental monitoring, personnel testing, process validation, and sterility testing. Key considerations for microbiological validation are the biological variability of tests, stressed/damaged organisms, appropriate incubation times and temperatures, and interpretation of results. Trend analysis is also important to identify progressive or large changes over time.

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    Mark Old Corne Microbiological Validation

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    humusdelombriz
    80 views28 pages
    This document discusses microbiological validation. It defines validation as proving that a process consistently provides a product that meets specifications. It then summarizes various microbiological validation methods including environmental monitoring, personnel testing, process validation, and sterility testing. Key considerations for microbiological validation are the biological variability of tests, stressed/damaged organisms, appropriate incubation times and temperatures, and interpretation of results. Trend analysis is also important to identify progressive or large changes over time.

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    This document discusses microbiological validation. It defines validation as proving that a process consistently provides a product that meets specifications. It then summarizes various microbiological validation methods including environmental monitoring, personnel testing, process validation, and sterility testing. Key considerations for microbiological validation are the biological variability of tests, stressed/damaged organisms, appropriate incubation times and temperatures, and interpretation of results. Trend analysis is also important to identify progressive or large changes over time.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PPS, PDF, TXT or read online from Scribd
    Download as pps, pdf, or txt
    80 views28 pages

    Mark Old Corne Microbiological Validation

    Uploaded by

    humusdelombriz
    This document discusses microbiological validation. It defines validation as proving that a process consistently provides a product that meets specifications. It then summarizes various microbiological validation methods including environmental monitoring, personnel testing, process validation, and sterility testing. Key considerations for microbiological validation are the biological variability of tests, stressed/damaged organisms, appropriate incubation times and temperatures, and interpretation of results. Trend analysis is also important to identify progressive or large changes over time.

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    Microbiological Validation

    Mark Oldcorne Wrexham Maelor Hospital

    What is Validation?

    The QA of any preparation activity is reliant on the satisfactory validation of the procedures

    Validation should demonstrate that the overall process will reproducibly provide a product that complies with its specification

    What is validation?

    Action of proving, in accordance with the principles of GMP, that any procedure, process, equipment, material, activity or system leads to the expected results

    Action of proving (and documenting) that something works

    5 Pillars of GMP

    Premises People Processes Products Procedures Profit!!!

    Overview
    Microbiological validation of Premises

    environmental monitoring cleaning and disinfection

    People

    operator broth transfer tests hand cleaning and disinfection

    Overview

    Processes

    process broth tests transfer spraying validation gassing processes

    Products

    sterility tests

    Underpinned by Procedures

    (parametric release!)

    Validation Master Plan

    Part of

    QA programme Site Master File

    Schedules Methods Responsibilities

    Microbiological Validation Methods


    Physical - AHU\filtration Microbiological - Personnel activity

    Microbiological Validation General Considerations 1

    Biological systems

    biological variability imprecision of methods low levels of contamination

    Stressed / damaged organisms

    Microbiological Validation General Considerations 2

    Growth requirements of organisms


    require universal growth media TSA + Sabs Dex

    Sequential temperature monitoring

    vs use of multiple media

    Microbiological Validation General Considerations 3

    Incubation times

    5-7 days

    but must read after day 1

    Recovery Rates for TSA and SAB plates Cherwell plates (irradiated) Exposed for 3 hours in dispensary
    60 50 40
    cfu

    30 20 10 0 0 1 2 3 4 5 6 7 Incubation Time - Days TSA 32oC SAB 25oC

    Microbiological Validation General Considerations 3

    Incubation times

    5-7 days

    but must read after day 1

    Incubation temperatures

    Bacteria - 30-32oC
    Fungi 20-25oC

    Microbiological Validation General Considerations 4

    Sterile media

    Aseptically prepared plates

    Pre-incubation less risk of false positives growth characteristics altered

    Irradiated plates

    Fertility assessment

    Microbiological Validation General Considerations 5

    Viable but non-culturable organisms (VBNC)

    Presence of non-recoverable organisms

    Results are Retrospective


    Prospective release
    Retrospective release

    Interpretation of Results

    Facilities management Investigational threshold (Alert limits) Action limit Counts ID of Organisms

    source of organism consequences of contamination presence of new organisms failure of control measures

    Trend analysis 1
    Identify progressive and gross changes

    variables

    Workspace Room Product

    Operator (not just aseptic processing)


    Operator spraying in

    Trend Analysis 2
    Methods available

    visualisation by charting and graphical methods statistical analysis

    population study software


    exception reporting

    follow up of problems limitation of variables number of exceptions (investigational or action limits) used as a measure of cleanliness

    Microbiological Environmental Methods

    Random Methods

    Settle plates Contact sampling

    Finger dabs

    Organised Methods

    Active air sampling

    *Assumptions*

    Settle Plates

    method of collection sampling area sampling time

    positioning

    trend analysis representative sample 0o, 45o and 90o

    laminar air flow consideration

    Surface Counts

    methods

    Rodac Plates Swabs Proprietary systems

    sampling area and location pickup efficiency neutralisation post sampling removal of media application pressure validation of disinfection processes

    Finger Dabs

    sampling technique
    what does it assess?

    holes in gloves poor transfer disinfection

    Active Air Sampling

    methods

    sampling efficiency - recovery rates


    impingement filtration

    disruption of air flow - isokinetic probes quantitative comparison accessibility sensitivity

    particle size sampling method

    Sterility Testing

    Ideal test? - product Test lacks sensitivity Retest only available under certain conditions Prospective vs retrospective Appropriate levels of control SAL of testing process

    Broth Transfer Testing 1

    Process transfer tests

    worst case scenario


    >batch size

    x3 initially
    6 monthly repeat

    Operator transfer tests

    Universal Broth Transfer Test Adapted operator tests or process tests

    Broth Transfer Tests 2


    Ideal test? - QA of process Statistical considerations to reach AQL


    1 in 1000 or 1 in 10,000

    Frequency? Sensitivity - do we challenge the test?

    Conclusions

    Microbiological validation indicates personnel involvement All microbiological validation methods have limitations Microbiological validation methods cannot be used in isolation and should be used holistically to gain a true picture of product assurance

    The future

    Where does the validation cult go? Next stage is validating the validation Next stage to that is validating the validation of the primary validation and so on.

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