MRO Magazine

Research and Markets: Industrial Pharmaceutical Microbiology: 2015 Standards & Controls


October 5, 2015
By Business Wire News

DUBLIN

Research and Markets (http://www.researchandmarkets.com/research/7plsd8/industrial) has announced the addition of the “Industrial Pharmaceutical Microbiology: Standards & Controls” book to their offering.

The contamination control of pharmaceutical and healthcare environments and processes, together with pre-clinical drug development labs, requires a far more holistic approach than simply choosing technologies and disinfectants. Today the microbiologist is expected to understand industrial processes and cleanrooms, and how to effectively evaluate microbial risks to products from personnel and processes.

To meet the latest regulatory expectations, the role of the microbiologist is essential. In addition there is important input requirement from quality assurance personnel, engineers, and process specialists. Whilst there is a continuing need for monitoring of the environment and conducting standardised laboratory tests, industrial pharmaceutical microbiology has moved on a great deal in the past decade. It now has to embrace microbiological audits; rapid microbiological methods; conducting risk assessments, both proactive in terms of minimising contamination, and reactive in terms of addressing microbial data deviations; and also ensuring that processes meet quality by design’ principles. In this new 600 page book a team of 24 international authorities will assist you in all your questions.

Industrial Pharmaceutical Microbiology: Standards and Control covers the entire spectrum of industrial pharmaceutical microbiology, as applicable to pharmaceuticals and healthcare. Connect instantly with regulations and current best practices on everything from disinfectants to sterility testing; environmental monitoring to hazard analysis; and from pharmaceutical processes to biological indicators. All of this is developed from an international perspective, where different regulations are compared and contrasted together with insightful commentary as to best practices.

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.

Key Topics Covered:

Part A: The Role of the Microbiologist and the Microbiology Laboratory

1. Safety in Microbiology

2. Best Practices in Microbiology Laboratory Training

3. The Use of Culture Media in Pharmaceutical Microbiology

4. Rapid Microbiological Methods and Process Analytical Technology (PAT) Jeanne Moldenhauer

5. Microbial Risk Assessments for Operational Cleanrooms

6. The Role of the Qualified Person in Microbiological Quality Assurance

7. Auditing the Pharmaceutical Microbiology Department

Part B: Microbiological Control and Industrial Processes

8. Microbiological Environmental Monitoring

9. Selection and Use of Cleaning and Disinfection Agents in Pharmaceutical Manufacturing

10 Microbiology of Pharmaceutical Grade Water

11. Biofilm Contamination in Pharmaceutical Facilities

12. Cleanrooms, Isolators and Rabs: Basic Principles, Design, Testing, Operation and Regulatory Aspects

13. Aseptic Process Simulations/Media Fills

14. Filtration

15. Sterilisation Technologies

16. Biological Indicators

17. Endotoxins and Dehydrogenation

18. Containment System Integrity: Microbial Challenges for Sterile Products

19. Challenges of Bacteriophage Therapy

Part C: Regulatory Aspects of Industrial Pharmaceutical Microbiology

20. Microbiological Quality and Regulatory Requirements for Biotherapeutics

21. The Microbiological Quality and Regulatory Requirements for Natural and Nutraceutical Products

22. The Regulatory Control and Quality Assurance of Immunological products

23. Regulatory Guidelines (Microbiology) for Veterinary Medicinal Antimicrobial Products

24. Regulatory Expectations for Non-Sterile Manufacture of Pharmaceutical Dose Forms

25. The Pharmacopoeias and Microbiology

For more information visit http://www.researchandmarkets.com/research/7plsd8/industrial

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
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Sector: Pharmaceuticals, Micro and Molecular Biology