Injectable product manufacturing is booming because of the growth of new biopharmaceuticals and small molecule anticancer drugs. The requirements for contamination control will become even more stringent than today. Isolators or blow-fill-seal equipment have already replaced the conventional clean rooms and LAF-hoods in many production facilitities. Conventional microbiological monitoring methods, requiring 3 to 5 days of incubation will become inappropriate. Equipment is already available allowing real time, simultaneous viable and non-viable counting.
This book is a useful reference guide for the SMB (Small and Medium Business) pharmaceutical sector which does not have the resources to have access to such top-quality information in this field. This book therefore represents an unparalleled and unprecedented text in the field of pharmaceutical and medical device microbiology. Perhaps even more outstanding is the fact that this book not only covers subject matter and technical content which is established as best and expected practice, but also includes content regarded as possible, future and emerging technology or processes.
The results of 45 years of scientific and technological development are laid down in these 33 chapters. These chapters, all written by international experts, give a vivid picture of today’s pharmaceutical microbiology. The high standard of the chapters makes it an essential reference guide that should be on the shelf of everyone who is involved or interested in this field.
Experts from top pharmaceutical companies like Baxter, Johnson and Johnson, Amgen, Pfizer, Patheon, Sartorious, Gador, Catalent, British NHS, GE Healthcare and many more top experts from industry and academics have come together to create this collection of knowledge of Microbiology as related to Pharmaceuticals, Medical Devices and Biotechnology. The list of authors includes chair and members of USP expert committee on Microbiology and Sterility Assurance, president and senior experts in Parenteral Drug Association, ISPE and ASTM. Foreword by Hans van Doorne, Chair of EDQM, Committee on Microbiology.
ABOUT THE AUTHOR Edward C Tidswell
Edward C. Tidswell. PhD - Dr. Tidswell is the Senior Director of Sterility Assurance for Baxter Healthcare; located north of Chicago, IL (USA), Responsibilities include: Leading Baxter's research, development and implementation of new (or optimized) sterilization and aseptic technologies, qualification and validation of sterile and aseptic manufacture for parenterals and medical devices. His organization supports more than 40 facilities in this global strategic and tactical role. He has worked within bulk active pharmaceutical ingredient, vaccine and parenteral manufacturing operations for human health and animal health products in both technical and validation roles for the likes of Eli Lilly and Evans Vaccines. Dr Tidswell continues to actively publish and is a leading authority on risk, aseptic and sterile manufacture. In 2004 be received the Parenteral Society's George Sykes Memorial Award for his contribution to pharmaceutical risk assessment As a microbial physiologist Dr Tidswell retains an active interest in several areas of microbiology, which include: bacterial adhesion, quorum sensing, viability, anaerobes, and rapid microbial technologies. Since 1994 he has served on the Editorial Boards of Letters in Applied Microbiology and The Journal of Applied Microbiology In June 2010, Dr. Tidswell joined the USP expert committee on Microbiology and Sterility Assurance.
ABOUT THE AUTHOR Madhu Raju Saghee
Madhu Raju Saghee, M.Sc - Madhu Raju Saghee is working in corporate quality and sterility assurance department at Gland Pharma Limited, a producer of small volume parenterals located in Hyderabad, India. In this position, he is responsible for implementing a robust quality system, review of sterility assurance validation documents for all regulatory submissions, ensuring micro compliance and involved in qualification and validation of sterile and aseptic manufacture for parenterals. He has written many articles pertaining to regulatory compliance, quality assurance, quality risk management, cleanroom contamination control and microbiology. He is the co-author of IDMAs technical monograph, "Environmental Monitoring in Cleanrooms". Raju has a Master of Science in Microbiology from Andhra University and Master of Science in Chemistry from Nagarjuna University.
ABOUT THE AUTHOR Tim Sandle
Tim Sandle, Ph.D, CBiol, MSBiol. - Dr. Sandle is the Head of Microbiology at the UK NHS Bio Products Laboratory. Dr. Sandle is a chartered biologist and holds a first class honors degree in Applied Biology; a Masters degree in education; and obtained his doctorate from Keele University. His role involves overseeing a range of microbiological tests, batch review, microbioiogicel investigation and policy development. In addition, he is an honorary consultant with the School of Pharmacy and Pharmaceutical Sciences, University of Manchester and s a tutor for the university's pharmaceutical microbiology M.Sc course. Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control (including the ISO cleanroom standards). He is currently chairman of the PhorMIG LAL action group arid serves on the UK Blood Service cleaning and disinfection committee. He has written over eighty book chapters, peer reviewed papers and technical articles relating to microbiology. He is currently the editor of the Pharmaceutical Microbiology Interest Group Journal and runs an on-line microbiology forum. Dr. Sandle is an experienced auditor and frequently acts as a consultant to the pharmaceutical and healthcare sectors.
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