This
publication covers the entire spectrum of industrial pharmaceutical
microbiology, as applicable to pharmaceuticals and healthcare and it has been
edited by Professor Geoff Hanlon and Dr. Tim Sandle.
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 Controls 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.
For
details and to order a copy, see: Euromed
The
chapter list is:
Part A: The Role
of the Microbiologist and the Microbiology Laboratory
1.
Safety in Microbiology
Nigel
Silman and John V Daniels
2.
Best Practices in Microbiology Laboratory Training
Tim
Sandle
3.
The Use of Culture Media in Pharmaceutical Microbiology
Tim
Sandle
4.
Rapid Microbiological Methods and Process Analytical Technology (PAT)
Jeanne
Moldenhauer
5.
Microbial Risk Assessments for Operational Cleanrooms
Tim
Eaton
6.
The Role of the Qualified Person in Microbiological Quality Assurance
John
Dolman
7.
Auditing the Pharmaceutical Microbiology Department
Andy
Martin
Part B:
Microbiological Control and Industrial Processes
8.
Microbiological Environmental Monitoring
Rosamund
M Baird
9.
Selection and Use of Cleaning and Disinfection Agents in Pharmaceutical Manufacturing
Tim
Sandle
10
Microbiology of Pharmaceutical Grade Water
Tim
Sandle
11.
Biofilm Contamination in Pharmaceutical Facilities
Alex
P Blanchard
12.
Cleanrooms, Isolators and RABS: Basic Principles, Design, Testing, Operation and
Regulatory Aspects
John
Neiger
13.
Aseptic Process Simulations/Media Fills
Marco
Budini and Francesco Boschi
14.
Filtration
Claire
Jarmey-Swan
15.
Sterilisation Technologies
Eric
Dewhurst and Eamonn Hoxey
16.
Biological Indicators
Tim
Sandle
17.
Endotoxins and Dehydrogenation
Karen
Zinc McCullough
18.
Containment System Integrity: Microbial Challenges for Sterile Products
Tim
Sandle
19.
Challenges of Bacteriophage Therapy
Alexander
Sulakvelidze
Part C:
Regulatory Aspects of Industrial Pharmaceutical Microbiology
20.
Microbiological Quality and Regulatory Requirements for Biotherapeutics
Daniel
Galbraith
21.
The Microbiological Quality and Regulatory Requirements for Natural and Nutraceutical
Products
Martin
Dennison
22.
The Regulatory Control and Quality Assurance of Immunological products
Tim
Sandle
23.
Regulatory Guidelines (Microbiology) for Veterinary Medicinal Antimicrobial
Products
Klaus
Hellmann and Peter Silley
24.
Regulatory Expectations for Non-Sterile Manufacture of Pharmaceutical Dose
Forms
Edel
Fitzmaurice
25.
The Pharmacopoeias and Microbiology
V
Fenton-May
For
details and to order a copy, see: Euromed
Posted by Tim Sandle