Presenting a compilation of some of the most important pharmaceutical microbiology papers to date! With an introduction by Tim Sandle, Ph.D., this e-book is broken into three sections: Modern Microbiology Laboratory Practices, Microbiological Controls in Pharmaceutical Manufacturing, and Making Safe and Effective Medicines: Biocontamination Control.
With over 100 pages of 15 information-rich articles, you will experience a range of content useful to help underpin good microbiological practices and with the development of a contamination control strategy.
MODERN MICROBIOLOGY LABORATORY PRACTICES
- Modern QC Microbiology Laboratory Design and Layout Considerations by Ratul Saha
- Approaching the Selection of Rapid Microbiological Methods by Tim Sandle
- Validation of the Growth Direct System to Perform Pharmaceutical In-process Bioburden Analysis by Aleshia Samson, Ashley Durusky, Bill Carpenter, David L. Jones, Theresa Intinarelli
- Data Integrity Considerations for the Pharmaceutical Microbiology Laboratory by Tim Sandle
- Microbiological Identification with MALDI-TOF MS by Tim Sandle
MICROBIOLOGICAL CONTROLS IN PHARMACEUTICAL MANUFACTURING
- Microbiological Aspects of Cleaning Validation by Tim Sandle
- Microbiological Assessment of Compressed Gases in Pharmaceutical Facilities by Tim Sandle
- Investigating and Addressing Fungal Contamination in Pharmaceutical Cleanrooms by Tim Sandle
- Developing or Updating your Environmental Monitoring Program to Meet Current Regulatory Expectations by Jeanne Moldenhauer
- Risk Consideration for Aging Pharmaceutical Facilities by Tim Sandle
MAKING SAFE AND EFFECTIVE MEDICINES: BIOCONTAMINATION CONTROL
- Objectionable Organisms by Jeanne Moldenhauer
- Validation Requirements for Gaseous Sterilization Using Ethylene Oxide by Tim Sandle
- Biodecontamination of Cleanrooms and Laboratories Using Gassing Systems by Tim Sandle
- Liquid Immersion Microbial Challenge Tests: Microbial Testing for Container Closure Integrity by Tim Sandle
- Distribution of Particles Within the Cleanroom: A Review of Contamination Control Considerations by Tim Sandle
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