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Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices / Tidswell, Edward C.; Saghee, Madhu Raju & Sandle, Tim (Eds.)
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Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices
Tidswell, Edward C.; Saghee, Madhu Raju & Sandle, Tim (Eds.)
 
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  Book ID : 38168
  ISBN-10 : 81-906467-4-5 / 8190646745
  ISBN-13 : 978-81-906467-4-1 / 9788190646741
  Place of Publication : Delhi
  Year of Publication : 2011
  Edition : (First Edition)
  Language : English
  xxiv, 964p., Index, 29 cm.
   
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 CONTENTS
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CONTENTS:-

PART: 1 The Impact of Microorganisms in Pharmaceutical and Medical Device Manufacture :
1. The Essentials of Pharmaceutical Microbiology. by Tim Sandle and Madhu Raju Saghee. a. Introduction. b. Overview of Pharmaceutical Microbiology. c. Manufacturing Environments. d. Results. e. Microbiology Laboratories. f. Conclusion. g. References.
2. Relevance of Microorganisms in Pharmaceutical Processing. by Ossama M. El-Tayeb. a. Introduction. b. Historical Review of the Involvement of Microbiology with Pharmaceutical Practice. c. Historical Review of Science-Based Pharmaceutical. d. Sterilization and Microbiological Quality Control. e. The Broader Picture of Microorganisms and Pharmaceutical Manufacturing: Challenges, Solutions and Pharmacopoeial Guidance. f. Current Pharmacopoeial Guidance. g. Batch. h. The Future. i. References.
3. Microbial Contamination and Spoilage. by David G. Allison. a. Introduction. b. Sources of Microbial Contaminants. c. Raw Materials. d. Synthetic Raw Materials. e. Water. f. Microbial Contamination from the Manufacturing Environment. g. Factors affecting Microbial Spoilage of Pharmaceutical Products. h. Consequences of Microbial Growth. i. Microbiological Control of Raw Materials. j. Summary. k. References.
4. Microbiological Considerations in Medical Device Industry. by Martell Winters. a. Introduction. b. The Medical Device Microbiology Life Cycle. c. Inherent and Accumulated Microbial Contamination. d. Product Design Microbiology. e. Raw Material and Component Microbiology. f. Shipping and Storage of Raw Materials and Components. g. Environmental Microbiology. h. Product Assembly Microbiology. i. Cleaning of Products. j. Packaging Process Microbiology. k. Sterilization Process Microbiology. l. Product Use Microbiology. m. Medical Device Microbiological Contamination. n. Controlling Product Bioburden. o. Aseptic Technique. p. No Magic Answers for Bioburden Control. q. Use of Bioburden Testing to Improve Manufacturing Microbiology. r. Use of Sterility Testing to Improve Manufacturing Microbiology. s. Microorganisms of Concern. t. Microbiological Challenges for Products with Tissue Components. u. References.

PART: 2 Aspects of Microbiological Quality Control :
5. Selection of Microbiological Culture Media and Testing Regimes. by Tim Sandle. a. Introduction. b. Types of Culture Media. c. Media Manufacture. d. Quality Control of Culture Media. e. Conclusion. f. References.
6. Microbial Identification. by Ziva Abraham. a. Importance of Microbial Identification. b. Isolation of Microorganisms. c. Staining Methods. d. Microscopy. e. Pre-Differentiation or Confirmation. f. Taxonomy, Classification, Identification and Nomenclature. g. Phenotypic Microbial Identification Systems. h. Automation in Microbial Identification. i. Genotypic Systems. j. Fungal Identification. k. Conclusion. l. Acknowledgements. m. References.
7. Microbial Examination of Non-sterile Products. by Jaymie Tomes and Florence Wu. a. Introduction. b. The Limitations and Values of Microbial Enumeration Tests. c. Product Sampling for Microbial Examination. d. Media Growth Promotion Test. e. Method Suitability Test. f. Enumeration Methods. g. Media and Incubation. h. Colony Counting and Interpretation of the Results. i. Tests for Specified Microorganisms. j. Setting Microbial Limits for Non-Sterile Pharmaceuticals and Raw Materials. k. Conclusions. l. References.
8. Practical Approaches to Sterility Testing. by Tim Sandle. a. Introduction. b. The Sterility Test. c. Sterility Test Method Validation. d. Training Programme. e. Validation Documentation. f. Summary. g. References.
9. Microbial Aspects in Cleaning Validation. by Andrew Walsh. a. Introduction. b. Regulatory Aspects of Cleaning. c. Cleaning Agents. d. Cleaning Procedures. e. Solid Dosage Forms. f. Semi-solid Dosage Forms. g. Hold Time Studies. h. Microbial Testing in Cleaning Validation. i. Conclusion. j. Acknowledgements. k. References.
10. Validation of Microbiological Methods. by Sandy Rubio. a. Introduction. b. Scope. c. Strategy for Validation. d. Protocol Considerations. e. Maintaining Status of Validated Methods. f. Case Study. g. Conclusion. h. References.
11. Selection and Validation of Disinfectants. by Paul Viña, Sandy Rubio and Tim Sandle. a. Introduction. b. Types of Disinfectants. c. Selection of Disinfectants. d. Validation of Disinfectants. e. Continued Evaluation of Disinfectant Effectiveness. f. Conclusion. g. References. h. Further Reading.
12. Auditing a QC Microbiology Laboratory. by Andy Martin. a. Introduction. b. What is an Audit and Why Should They be Performed. c. General Principles of the Audit Process. d. Auditing the QC Microbiology Laboratory, What to Look For. e. Auditing Techniques to Get the Most from your Audit. f. Reporting the Audit. g. Final Thoughts. h. References.
13. Quality Assurance in a Microbiology Laboratory. by Christophe Barcella. a. Introduction. b. Quality Management, QA and QC Principles. c. Laboratory Quality Manual. d. Laboratory Staff Qualifications and Training. e. Laboratory Environment. f. Standard Operating Procedures, Methods and Protocols. g. Laboratory Notebooks, Log Books and Records. h. Information Technology and Computer Systems Validation. i. Archiving Requirements. j. Reference Standards and Samples. k. Solutions, Reagents and Culture Media. l. Instruments and Equipment. m. Laboratory QA Assessments/Audits & External Quality Assurance. n. Conclusion. o. References.

Part: 3 Measuring and Testing for Microorganisms :
14. Environmental Monitoring. by Tim Sandle. a. Introduction. b. Cleanrooms. c. Microbiological Environmental Monitoring. d. Establishing an Environmental Monitoring Programme. e. Personnel. f. Summary. g. References.
15. Microbial Content Testing of Pharmaceutical and Biotechnologically Derived Products. by Dilip Ashtekar and Tim Sandle. a. Introduction. b. General Methods for the Quantitative Determination of Viable Count. c. Evaluation of Results by Various Enumeration Methods. d. Dilutions. e. Replicate Plate Counts. f. Selection of Method for the Enumeration of Microbial Count. g. Estimating Number of Micro-Organisms in Suspension for Use in Bioburden . h. Bioburden Testing. i. Microbial Limit test (MLT). j. Spreaders. k. Suitability of the Enumeration Method in the Presence of Product. l. Test for Specified Organisms. m. Applied Aspects of Bioburden Testing. n. Conclusions. o. References.
16. Bacterial Endotoxins Test. by Masakazu Tsuchiya. a. Introduction. b. History of Bacterial Endotoxins Test. c. Endotoxin. d. Limulus Amebocyte Lysate. e. Bacterial Endotoxins Test in Pharmacopoeias. f. Validation of Bacterial Endotoxins Test. g. Practical Suggestions for the Bacterial Endotoxins Test. h. Curve. j. References. k. Acknowledgment. l. Appendix A (Example of Standard Operating Procedure for Gel-Clot Method).
17. Antimicrobial Effectiveness Testing. by Scott V. W. Sutton. a. Introduction. b. The Purpose of the AET. c. Development of the USP Test. d. Demonstration of Method Suitability. e. Other considerations in preservation. f. Investigations. g. Summary/Conclusions. h. References.
18. Monitoring of Microbiological Quality Attributes of Water for Pharmaceutical Use. by Dilip Ashtekar. a. Introduction. b. Water Types. c. Regulatory Requirements. d. Water System Description. e. Water System Validation. f. Water System Monitoring. g. Water Data Trending Requirements. h. Conclusions. i. References.
19. Investigation of Microbiological Data Deviations. by Mónica Lagomarsino. a. Introduction. b. Microbiological Data Deviations. c. Objectives of the Investigation. d. Acceptance Criteria. e. General Process for the Investigation. f. Laboratory Investigation. g. Full-Scale Investigation. h. A Case Study. i. Conclusion. j. References. k. Recommended Bibliography.
20. Alternative Microbiological Methods and New Pharmaceutical Microbiology Curriculum. by Claudio D. Denoya. a. Introduction. b. A "Rapid" History of Microbiology. c. Today's Microbiology: The Fundamentals of "Traditional" Microbiology. d. The New Microbiological Technology Wave for the QC Lab: Alternative and Rapid . e. Metabolic or Growth Based Technologies. f. Viability Based Technologies. g. Technologies Based on Cell Component Analysis. h. ARMMs and the Pharmaceutical Industry. i. AMM, PAT, and Regulatory Status. j. Microbiology Curricula. k. The Skill Sets of a Pharmaceutical Quality Control (QC) Microbiologist. l. Curricula Surveys. m. The Disparity between the Tertiary Microbiology Curricula and the Needs of the . n. n Interesting Step Forward: The United States Professional Science Master''''''''s . o. Conclusions and Recommendations. p. Acknowledgments. q. References.
21. The Implementation of Rapid Microbiological Methods. by Michael J. Miller. a. Microbiology Trapped In the 19th Century. b. New Technologies for Pharmaceutical Manufacturing. c. An Introduction to Rapid Microbiological Methods. d. RMM Applications. e. Strategy for Implementation. f. Validating Rapid Microbiological Methods. g. Implementation and Secondary Site Qualification. h. RMMS and the Regulatory Environment. i. FDA Perspectives. j. EMA Perspectives. k. Changing Acceptance Levels and Specifications. l. Regulatory Summary. m. Developing a Business Case for RMMS. n. Chapter Summary. o. Acknowledgement. p. References.
22. Risk Management in Pharmaceutical Microbiology. by Tim Sandle. a. Introduction to Risk Assessment and Risk Management Process. b. Regulatory Views and Guidelines on Risk Management. c. The Basics of Risk Assessment. d. Advantages and Disadvantages of Risk Assessment. e. Risk Assessment and Risk Management Methodologies. f. References.

Part: 4 Sterilization and Sterility Assurance :
23. Sterility. by Edward C. Tidswell. a. Introduction. b. Origins of Sterilization. c. The Microbial Challenge. d. Consequences of Non-Sterility and Lack of Asepsis. e. What Does Sterile Mean and Can We Test It?. f. Conclusion. g. References.
24. Process Selection for Sterile Products. by James Agalloco. a. Introduction. b. Terminal Sterilization and Adjunct Processing. c. Aseptic Processing. d. Conclusion. e. References.
25. Microbial Contamination Control in Pharmaceutical Manufacturing. by Matts Ramstorp. a. Pharmaceutical Cleanrooms and Clean Zones. b. Cleanroom Cleanliness. c. Measuring Cleanliness within Pharmaceutical Cleanrooms. d. Microbiological Contaminants and GMP. e. Pharmaceutical Cleanroom Ventilations Systems. f. Ventilation Filter for Pharmaceutical Cleanrooms. g. Cleanrooms and Clean Zones. h. Pharmaceutical Cleanroom Production Systems. i. Cleaning and Disinfection of a Pharmaceutical Cleanroom. j. Cleanroom Garments. k. Personal Hygiene and Personal Responsibility. l. Acknowledgement. m. References.
26. Aseptic Process Simulations/Media Fills. by Marco Budini and Francesco Boschi. a. Introduction. b. Documentation. c. Media Selection. d. Frequency and Number of Runs. e. Size and Duration of Runs. f. Line Speed and Container Size. g. Closure Type. h. Process/Line Configuration and Set-up. i. Fill Volume. j. Number of Persons and Activities. k. Interventions. l. Line Clearance. m. Environmental and Personnel Monitoring. n. Other Worst Case Scenarios. o. Cleaning after Process Simulation. p. Incubation and Inspection of Filled Units. q. Growth Promotion Test. r. Interpretation of Results – Acceptance Criteria. s. Invalidation and Abortion of Process Simulation Runs. t. Investigation of Process Simulation Contaminations/Failures. u. Conclusions. v. References.
27. Biological Indicators for Sterilization. by Russ Nyberg. a. Description. b. Performance Qualification of Biological Indicators. c. BI Use in Parenteral Product Loads. d. Use of a Process Challenge Device (PCD). e. Selection of BIs. f. Contracting for 3rd Party D-Value Testing. g. Rapid Read-out Biological Indicators. h. Conclusion. i. References.
28. Moist Heat Sterilization. by Michael Sadowski. a. Introduction. b. Sterile Products. c. History of Sterilization with Heat. d. Mechanisms of Spore Heat Resistance And Inactivation. e. Inactivation of Spores Using Moist Heat Sterilization Processes. f. Pharmaceutical Products. g. Selection of a Moist Heat Sterilization Process Type. h. Product or Item Loading Patterns. i. Biological Indicators for the Development and Qualification of Moist Heat Sterilization Processes. j. Determination of The Hardest to Sterilize Solution Formulation or Item/Component. k. The Liquid Products Master Solution Approach. l. The Process Challenge Device (PCD) Approach for Porous/Hard Goods. m. Determination of Hardest To Sterilize Locations or Cold Spots Used For . n. Use of Chemical Indicators. o. Development Moist Heat Sterilization Processes. p. Validation of The Moist Heat Sterilization Process. q. Routine Monitoring and Control of the Moist Heat Sterilization Process. r. Product and Process Change Control. s. Sterile Product Release Process. t. Conclusion. u. Acknowledgement. v. References.
29. Sterilization and Depyrogenation by Dry Heat. by Madhu Raju Saghee and Gary R. Mitchel. a. Introduction. b. Functions of Dry Heat. c. Thermodynamical Aspects of Heat Transfer in Dry Heat Processes. d. Destruction of Microorganisms and Endotoxins by Dry Heat. e. Types of Dry Heat Sterilization/Depyrogenation Processes. f. Validation and Ongoing Control. g. Conclusion. h. References. i. Acknowledgements. j. Appendix A (Example of an outline for an Installation Qualification protocol). k. Appendix B (Example of an outline for Operational and Performance Qualification protocols).
30. Radiation Sterilization. by Mark A. Seybold and John A. Williams. a. Introduction. b. History of Radiation Sterilization. c. Types of Radiation Sterilization. d. Microbial Inactivation. e. Validation. f. Materials Qualification. g. Process Validation. h. Routine Monitoring And Control. i. Maintaining Process Effectiveness. j. Conclusions. k. References.
31. Sterilization by Filtration. by Maik W. Jornitz and Theodore H. Meltzer. a. Introduction to Sterilizing Filtration. b. Filtration Parameters. c. Filter Types. d. Filter Materials. e. Filter Construction. f. Filter Validation. g. Filter Integrity Testing. h. Filtration Applications. i. References.
32. Sterilization by Ethylene Oxide. by Gerry A. O'Dell. a. Introduction. b. Factors Affecting the Lethality of EO Sterilization. c. The EO Sterilization Process. d. Product and Process Definition for EO Sterilization. e. EO Sterilization Validation. f. Routine monitoring of the EO sterilization process. g. Demonstrating the Ongoing Effectiveness of the EO Sterilization Process. h. Summary. i. References.
33. Maintaining Sterility. by Michelle A. Luebke & Bonnie J. Heredia. a. Introduction to Maintaining Sterility. b. Medical Product Packaging System Development. c. Microbiological Versus Physical Integrity Test Methods. d. Test Method Correlation. e. Test Method Sensitivity. f. Test Method Validation. g. Sterile Medical Product Classification. h. Sterile Barrier System Classification. i. Sterile Barrier Integrity Test Methods. j. Summary. k. References.
34. Index.

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 DESCRIPTION
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Injectable product manufacturing is booming because of the growth of new biopharmaceuticals and small molecule anticancer drugs. The requirements for contamination control will become even more stringent than today. Isolators or blow-fill-seal equipment have already replaced the conventional clean rooms and LAF-hoods in many production facilitities. Conventional microbiological monitoring methods, requiring 3 to 5 days of incubation will become inappropriate. Equipment is already available allowing real time, simultaneous viable and non-viable counting.

This book is a useful reference guide for the SMB (Small and Medium Business) pharmaceutical sector which does not have the resources to have access to such top-quality information in this field. This book therefore represents an unparalleled and unprecedented text in the field of pharmaceutical and medical device microbiology. Perhaps even more outstanding is the fact that this book not only covers subject matter and technical content which is established as best and expected practice, but also includes content regarded as possible, future and emerging technology or processes.

The results of 45 years of scientific and technological development are laid down in these 33 chapters. These chapters, all written by international experts, give a vivid picture of today's pharmaceutical microbiology. The high standard of the chapters makes it an essential reference guide that should be on the shelf of everyone who is involved or interested in this field.

Experts from top pharmaceutical companies like Baxter, Johnson and Johnson, Amgen, Pfizer, Patheon, Sartorious, Gador, Catalent, British NHS, GE Healthcare and many more top experts from industry and academics have come together to create this collection of knowledge of Microbiology as related to Pharmaceuticals, Medical Devices and Biotechnology. The list of authors includes chair and members of USP expert committee on Microbiology and Sterility Assurance, president and senior experts in Parenteral Drug Association, ISPE and ASTM. Foreword by Hans van Doorne, Chair of EDQM, Committee on Microbiology.

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