Shameless promotion - sort of
Many of you know that Tim Sandle is a tutor on some of our modules for Pharmaceutical Microbiology. It was great today to find out that Tim's new book has been published: “Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control.”
This book is designed to provide pharmaceutical microbiologists with everything they need to know, from regulatory filing and GMP information, to laboratory design and management, compendia tests, and the risk assessment tools and techniques for both sterile and non-sterile products.
The book seems so comprehensive that it would almost take away the need to study the MSc modules that Tim tutors! Thankfully however, you don't get the personal support, tuition or opportunity to attend our annual summer school when you get the book. It does however look like a good background resource to help you move from a pass mark to a distinction - and to help you excel in your roles!
The key features are:
Contains the applications of pharmaceutical microbiology in sterile and non-sterile products
- Presents the practical aspects of pharmaceutical microbiology testing
- Provides contamination control risks and remediation strategies, along with rapid microbiological methods
- Includes bioburden, endotoxin, and specific microbial risks
- Highlights relevant case studies and risk assessment scenarios
Description
Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control presents the latest information on protecting pharmaceutical and healthcare products from spoilage by microorganisms, and protecting patients and consumers. With both sterile and non-sterile products, the effects can range from discoloration to the potential for fatality.
The book provides an overview of the function of the pharmaceutical microbiologist and what they need to know, from regulatory filing and GMP, to laboratory design and management, and compendia tests and risk assessment tools and techniques. These key aspects are discussed through a series of dedicated chapters, with topics covering auditing, validation, data analysis, bioburden, toxins, microbial identification, culture media, and contamination control.
Table of contents
Chapter 1: Introduction to Pharmaceutical Microbiology
Chapter 2: Microbiology and Pharmaceuticals
Chapter 3: GMP, regulations and standards
Chapter 4: Laboratory management and design
Chapter 5: Microbiological culture media
Chapter 6: Basic microbiological laboratory techniques
Chapter 7: Bioburden testing
Chapter 8: Assessment of raw materials
Chapter 9: Microbial identification
Chapter 10: Assessment of pharmaceutical water systems
Chapter 11: Endotoxin and pyrogen testing
Chapter 12: Sterilisation and sterility assurance
Chapter 13: Biological indicators
Chapter 14: Antibiotic effectiveness testing and preservative efficacy testing
Chapter 15: Disinfection
Chapter 16: Cleanroom microbiology and contamination control
Chapter 17: Rapid microbiological methods
Chapter 18: Risk assessment and microbiology
Chapter 19: Manufacturing and validation
Chapter 20: Microbiological batch review
Chapter 21: Microbiological audits
Chapter 22: Microbial Challenges in the Pharmaceutical Industry
Reference:
Sandle, T. (2016) Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control, Woodhead Publishing, Cambridge, UK
Availability
The book is available from Elsevier at: https://store.elsevier.com/Pharmaceutical-Microbiology/Tim-Sandle/isbn-9780081000229/