Biocontamination Control For Pharmaceuticals And Healthcare

Biocontamination Control for Pharmaceuticals and Healthcare outlines a biocontamination strategy that tracks bio-burden control and reduction at each transition in classified areas of a facility. The first edition of the book covered many of the aspects of the strategy, but the new official guidance signals that a roadmap is required to fully comply with its requirements. Completely updated with the newest version of the EU-GPM (EN17141) the new edition expands the coverage of quality risk management and new complete examples to help professionals bridge the gap between regulation and implementation. Biocontamination Control for Pharmaceuticals and Healthcare offers professionals in pharma quality control and related areas guidance on building a complete biocontamination strategy. Includes the most current regulations Contains three new chapters, including Application of Quality Risk Management and its Application in Biocontamination Control, Designing an Environmental Monitoring Programme, and Synthesis: An Anatomy of a Contamination Control Strategy Offers practical guidance on building a complete biocontamination strategy

This book offers practical applications addressing the specifics of contamination, including particle origination, characterization, identification, and elimination, with a special focus on quality considerations. Written by an industry expert, this material offers a clear and concise understanding of particle populations and their control in stability, efficacy, and predictability in the manufacture of healthcare products. Complete with a full-color insert of micrographs illustrating commonly encountered particulate matter and over eighty figures, tables, and charts. Features

Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control presents that 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. 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

Microbiological matters continue to exercise considerable influence on product quality. In both the pharmaceutical and medical device industries, products of greater sophistication, along with evolving regulatory requirements, are elevating the challenges related to maintaining microbiological integrity. Updated to reflect technological and regulatory changes, the Guide to Microbiological Control in Pharmaceuticals and Medical Devices, Second Edition covers thoseprincipal aspects of microbiology that arerelevant to the preformulation, formulation, manufacturing, and license application stages involved with the production of pharmaceuticals and medical devices. In recognition of the diverse disciplines involved in pharmaceutical and medical device production, this work provides a brief introduction to microbiology geared towards the nonmicrobiologist. Covering good manufacturing practice in the control of contamination, the text explores quality control, the preservation of formulations, and principles of sterilization, including microbiological-specific considerations for biotechnological products and other medical devices. It also provides additional materials on package integrity and contamination risks in clean rooms. The editors have produced a companion text, the Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices (see reverse), which when paired with the Guide offers a complete theoretical and practical treatment of microbiological control. This book provides a comprehensive distillation of information concerning methodology and regulations that would otherwise remain scattered throughout the literature. It allows scientists from many fields to address potential problems in advance and implement suitable strategies at the earliest stages of development.

This book explores the relationships between biological contaminants and human health, as well as providing in-depth information of numerous biological contaminants found in diverse settings such as homes, hospitals, businesses, and schools. The current literature study has provided qualitative and quantitative data on bio-contaminants in these diverse indoor contexts. The main objective of this book is to investigate the pattern of morbidity among the people living in industrial, commercial, and residential due to poor air quality. Furthermore, biological sampling data obtained from indoor sites in different seasons provides seasonal adverse health problems explainations. The current study’s findings may aid in the development and implementation of preventative public health programs, as well as the creation of recommendations aimed at creating better indoor settings.

The essential pharmaceutics textbook One of the world’s best-known texts on pharmaceutics, Aulton's Pharmaceutics offers a complete course in one book for students in all years of undergraduate pharmacy and pharmaceutical sciences degrees. Thoroughly revised, updated and extended by experts in their fields and edited by Professors Kevin Taylor and Michael Aulton, this new edition includes the science of formulation, pharmaceutical manufacturing and drug delivery. All aspects of pharmaceutics are covered in a clear and readily accessible way and extensively illustrated throughout, providing an essential companion to the entire pharmaceutics curriculum from day one until the end of the course. Fully updated throughout, with the addition of new chapters, to reflect advances in formulation and drug delivery science, pharmaceutical manufacturing and medicines regulation Designed and written for newcomers to the design and manufacture of dosage forms Relevant pharmaceutical science covered throughout Includes the science of formulation and drug delivery Reflects current practices and future applications of formulation and drug delivery science to small drug molecules, biotechnology products and nanomedicines Key points boxes throughout Over 400 online multiple choice questions