Special Edition

Essential Microbiology for GXP Compliance

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

  1. Modern QC Microbiology Laboratory Design and Layout Considerations by Ratul Saha
  2. Approaching the Selection of Rapid Microbiological Methods by Tim Sandle
  3. 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  
  4. Data Integrity Considerations for the Pharmaceutical Microbiology Laboratory by Tim Sandle
  5. Microbiological Identification with MALDI-TOF MS by Tim Sandle

MICROBIOLOGICAL CONTROLS IN PHARMACEUTICAL MANUFACTURING

  1. Microbiological Aspects of Cleaning Validation by Tim Sandle
  2. Microbiological Assessment of Compressed Gases in Pharmaceutical Facilities by Tim Sandle
  3. Investigating and Addressing Fungal Contamination in Pharmaceutical Cleanrooms by Tim Sandle
  4. Developing or Updating your Environmental Monitoring Program to Meet Current Regulatory Expectations by Jeanne Moldenhauer
  5. Risk Consideration for Aging Pharmaceutical Facilities by Tim Sandle

MAKING SAFE AND EFFECTIVE MEDICINES: BIOCONTAMINATION CONTROL

  1. Objectionable Organisms by Jeanne Moldenhauer
  2. Validation Requirements for Gaseous Sterilization Using Ethylene Oxide by Tim Sandle
  3. Biodecontamination of Cleanrooms and Laboratories Using Gassing Systems by Tim Sandle
  4. Liquid Immersion Microbial Challenge Tests: Microbial Testing for Container Closure Integrity by Tim Sandle
  5. Distribution of Particles Within the Cleanroom: A Review of Contamination Control Considerations by Tim Sandle

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