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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
Relying on practical examples from the authors’ experience, this book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals. Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks
The first one-volume guide to sources of contamination in pharmaceuticals and medical devices Most books dealing with contaminants in medicinal products often focus on analytical methods for detecting nonspecific impurities. Key to the work of the pharmaceutical chemist, this unique reference helps identify the sources of contamination in medicinal and pharmaceutical products and medical devices. Divided into three parts, Sources of Contamination in Medicinal Products and Medical Devices covers chemical, microbiological, and physical (particulate matter) contamination, including those originating from sterilization procedures. As compelling as a medical documentary, the book sheds light on how impurities and contaminants can enter the human body transported via a specific product or treatment. Focusing on only those medicinal products and medical devices that may lead to exposure to contaminants harmful to human health, the book offers a comprehensive, systematic look at the entire universe of medical contamination: Chemical contaminants including residual solvents, catalyst residuals, and genotoxic impurities in active pharmaceutical ingredients (APIs) Diagnostic imaging agents (i.e., radiopharmaceuticals and contrast agents) Microbiological and endotoxin contamination involving single and multiple dose products, medical devices, and biofilms Contamination from sterilization procedures, residuals from radiation sterilization, ionizing radiation on packaging materials and medical devices Medicinal gases and volatile anesthetics Biopharmaceuticals including recombinant DNA technology products Extractables and leachables from containers made of glass, plastics, and metal Each section of the book contains information on what contaminants could be expected in a particular product, and how they were generated and reached that product. With up-to-date regulatory guidelines for determining contamination, as well as methods for assessing, quantifying, avoiding and removing contaminants, Sources of Contamination in Medicinal Products and Medical Devices is essential to fully understanding the specific threats that undermine the safety of medicines and medical devices.
This authoritative reference presents an up-to-date review of the testing methods, emerging technologies, and analytical systems and procedures used to prevent the microbial contamination of pharmaceutical processes, products, and environments. It identifies new tools for sample analysis and evaluation and the impact of these advancements on the continuous supply and manufacturing of pharmaceutical products. With more than 100 tables and 430 current references, the book contains a detailed analysis of microbial contamination recalls for nonsterile and sterile pharmaceutical products, demonstrating the distribution of microorganisms worldwide and the identification by geographical regions.
Contamination control is being used by more and more industries where the highest level of cleanliness and hygiene is of vital importance. This book covers the basic principles of contamination control and cleanroom technology from a holistic point of view. It deals with cleanliness and hygiene and their effects on the outcome of a process, reflecting the latest results from both scientific and practical points of view. The following topics are covered: contaminants and how they are measured cleanrooms and clean zones cleaning and decontamination cleanroom clothing the impact of people on cleanliness. Intended as an introduction to the area of contamination control, the text is also an excellent source of knowledge for people with both theoretical and practical experience. The Swedish version has been used for a long time within the Nordic countries as a basic training textbook within the pharmaceutical, microelectronics, food and beverage, optics and many other industries.
Microbiologists working in both the pharmaceutical and medical device industries, face considerable challenges in keeping abreast of the myriad microbiological references available to them, and the continuously evolving regulatory requirements. The Handbook of Microbiological Quality Control provides a unique distillation of such material, by provi
On July 30-31, 2018, the National Academies of Sciences, Engineering, and Medicine held a workshop titled Continuous Manufacturing for the Modernization of Pharmaceutical Production. This workshop discussed the business and regulatory concerns associated with adopting continuous manufacturing techniques to produce biologics such as enzymes, monoclonal antibodies, and vaccines. The participants also discussed specific challenges for integration across the manufacturing system, including upstream and downstream processes, analytical techniques, and drug product development. The workshop addressed these challenges broadly across the biologics domain but focused particularly on drug categories of greatest FDA and industrial interest such as monoclonal antibodies and vaccines. This publication summarizes the presentations and discussions from the workshop.
Contamination control standards and techniques for all phases of the production of high-technology products are spelled out in this applications-orientated guide. Practical cleaning methods for products and process fluids are accompanied by tips on selecting operations based on economy and efficiency. Explanations of contaminant measurement devices cover operation, error sources and remedial methods. Engineers will find vital data on contaminant sources, as well as coverage of operations and procedures that aggravate contaminant effects.
A practical "how to" guide that effectively deals with the control of both contamination and ESD This book offers effective strategies and techniques for contamination and electrostatic discharge (ESD) control that can be implemented in a wide range of high-technology industries, including semiconductor, disk drive, aerospace, pharmaceutical, medical device, automobile, and food production manufacturing. The authors set forth a new and innovative methodology that can manage both contamination and ESD, often considered to be mutually exclusive challenges requiring distinct strategies. Beginning with two general chapters on the fundamentals of contamination and ESD control, the book presents a logical progression of topics that collectively build the necessary skills and knowledge: Analysis methods for solving contamination and ESD problems Building the contamination and ESD control environment, including design and construction of cleanrooms and ESD protected environments Cleaning processes and the equipment needed to support these processes Tooling design and certification Continuous monitoring Consumable supplies and packaging materials Controlling contamination and ESD originating from people Management of cleanrooms and ESD protected workplace environments Contamination and ESD Control in High-Technology Manufacturing conveys a practical, working knowledge of contamination and ESD control strategies and techniques, and it is filled with case studies that illustrate key principles and the benefits of contamination and ESD control. Moreover, its straightforward style makes the material, which integrates many disciplines of engineering and science, clear and accessible. Written by three leading industry experts, this book is an essential guide for engineers and designers across the many industries where contamination and ESD control is a concern.
This book provides an understanding of what is required to engineer and manufacture drug products. It bridges established concepts and provides for a new outlook by concentrating and creating new linkages in the implementation of manufacturing, quality assurance, and business practices related to drug manufacturing and healthcare products. This book fills a gap by providing a connection between drug production and regulated applications. It focuses on drug manufacturing, quality techniques in oral solid dosage, and capsule filling including equipment and critical systems, to control production and the finished products. The book offers a correlation between design strategies and a step-by-step process to ensure the reliability, safety, and efficacy of healthcare products. Fundamentals of techniques, quality by design, risk assessment, and management are covered along with a scientific method approach to continuous improvement in the usage of computerized manufacturing and dependence on information technology and control operations through data and metrics. Manufacturing and Quality Assurance of Oral Pharmaceutical Products: Processing and Safe Handling of Active Pharmaceutical Ingredients (API) is of interest to professionals and engineers in the fields of manufacturing engineering, quality assurance, reliability, business management, process, and continuous improvement, life cycle management, healthcare products manufacturing, pharmaceutical processing, and computerized manufacturing.