Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals
The book outlines and discusses sterilisation technology and the biopharmaceutical manufacturing process, including aseptic filling, as well as aspects of the design of containers and packaging, as well as addressing the cleanroom environments in which products are prepared. Consisting of 18 chapters, the book comprehensively covers sterility, sterilisation and microorganisms; pyrogenicity and bacterial endotoxins; regulatory requirements and good manufacturing practices; and gamma radiation.
by Tim Sandle (1st Edition)
Steam Sterilization: A Practitioner’s Guide Hardcover – 2002
This book contains pragmatic details on how to accomplish the tasks necessary for a sterility assurance program for steam sterilization processes. Each chapter author is a subject matter expert and has a minimum of 10 years of hands-on experience in the topics discussed. The authors use this experience to identify practical ways to perform research, development, validation, and production activities associated with steam sterilization.
by PhD Jeanne Moldenhauer (Editor)
Data Review and Analysis for Pharmaceutical Microbiology
This book offers a guide, drawing upon ‘real world’ examples, for the review and assessment of microbiological data. The book includes examples drawn from water monitoring, bioburden assessment, and environmental monitoring. The book serves as a guide for quality control microbiologists, quality assurance personnel, students, and those with an interest in data, graphs and statistics in general.
by Tim Sandle
The CDC Handbook: A Guide to Cleaning and Disinfection Cleanrooms
The book provides comprehensive detail on different types of disinfectants and their modes of action; explains the problems of microbial destruction and resistance; introduces cleaning techniques and the latest safety regulations; expounds upon the application of cleaning within healthcare and pharmaceutical environments, noting current national and international standards. The book also provides guidance on disinfectant efficacy testing.
by Tim Sandle (August 2, 2012)
Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control
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.
by Tim Sandle (1st Edition)