Validation of Rapid Methods and Systems and Validation of Sterility Test Suites and Isolators (single user digital version)

Sep 2004
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This booklet covers the below 2 chapters is taken from PDA's bestselling Laboratory Validation, and offers a complete overview of a specific topic and provides practical advice for anyone interested in current aspects of laboratory validation.

Available to download immediately. Prior to purchase please view the download instructions and Terms of Usage.
Format: PDF (1 file - 14.6 MB)

Paper version is not available.

Validation of Rapid Methods and Systems

Microbiological testing is significant in the pharmaceutical laboratory for many reasons. The testing is used determine the microbiological quality and attributes of the environment, materials, utilities, and products. Unfortunately, it is also recognized for being a critical factor in determining product release times. This chapter provides guidance on the validation of the equipment, software and methods.

Validation of Sterility Test Suites and Isolators

Performance of the classical compendial sterility test provides very little information regarding whether the product is sterile. Numerous articles point out the deficiencies of the test, including the small sample size, test methods used, recovery and incubation conditions, etc. The test is incapable of showing whether a product provides a sterility assurance level (SAL). This chapter discussed the methods used to validate the sterility testing area.

Table of Contents

Validation of Rapid Methods and Systems

Table of Contents:

I. Introduction
II. Compendial Allowances for Equivalent Methods
III. Overview of Rapid Microbiology Technology

    Presence/Absence Tests
    Enumeration Tests
    Identification of Microorganisms
    Categories of New Technologies
    Growth-Based Technologies
    Viability-Based Technologies
    Artifact-Based Technologies
    Nucleic Acid-Based Technologies

X. Validation of the Test System versus Method Validation
XI. Test System Validation

    Installation Qualification (IQ)
    Operational Qualification (OQ)
    Performance Qualification (PQ) of the Test System
    Feasibility Studies
    Method Validation

X. Validation Criteria to be used in Defining Protocol Requirements
XI. Other Considerations
XII. Conclusion
XIII. References

Validation of Sterility Test Suites and Isolators

Table of Contents:

I. Introduction
II. Sterility Testing
III. Limitations of the Sterility Test Methodology
IV. The Testing Environment
V. Sterility Test Hoods and Suites
VI. Isolators

    Maintenance of Isolator Systems
    Isolator Design
    Environmental Monitoring

VII. Isolator Installation Qualification (IQ)
VIII. Isolator Operational Qualification (OQ)
IX. Isolator Performance Qualification (PQ)

    Process Description
    Sterilization of the Isolator Chamber
    Verification of Container/Closure Integrity During Sterilization
    Environmental Monitoring

X. Re-qualification of Sterility Test Isolators
XI. Conclusion
XII. References

About the Authors

About the Author

Jeanne Moldenhauer
is a Pharma Consultant with Vectech Pharmaceutical Consultants, Inc. She has over 25 years of experience in sterile process validation, regulatory affairs, and microbiology. She is an interest group leader for microbiology and environmental monitoring at PDA, chair of the Rapid Microbiology User's Group, and a member of the Scientific Advisory Board of PDA.