Validation of Rapid Methods and Systems and Validation of Sterility Test Suites and Isolators (single user digital version)
- Published
- Sep 2004
- Pages
- 33
- PDA Item Number
- 17901
- Format
- PDF Single user
- Member Price
- $55.00
- Nonmember Price
- $69.00
- Government Price
- $30.00
Please sign in or become a member to purchase items from the PDA bookstore.
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.