Tim Sandle - Böcker
Pharmaceutical Microbiology
Essentials for Quality Assurance and Quality Control
1 954 kr
Skickas inom 7-10 vardagar
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 scenarios1 728 kr
Skickas inom 7-10 vardagar
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. This key part of controlling risk escalation can lead to the contamination of medicinal products, hence necessary tracking precautions are essential. Regulatory authorities have challenged pharmaceutical companies, healthcare providers, and those in manufacturing practice to adopt a holistic approach to contamination control. New technologies are needed to introduce barriers between personnel and the environment, and to provide a rapid and more accurate assessment of risk. This book offers guidance on building a complete biocontamination strategy.
Provides the information necessary for a facility to build a complete biocontamination strategy Helps facilities understand the main biocontamination risks to medicinal products Assists the reader in navigating regulatory requirements Provides insight into developing an environmental monitoring program Covers the types of rapid microbiological monitoring methods now available, as well as current legislation1 741 kr
Skickas inom 7-10 vardagar
Biocontamination Control for Pharmaceuticals and Healthcare, Second Edition 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 covers 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), this new edition expands coverage of quality risk management and contains completely new examples to help professionals bridge the gap between regulation and implementation. This book offers professionals in pharma quality control and related areas guidance on building a complete biocontamination strategy.
Includes the most current regulationsContains 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 StrategyOffers practical guidance on building a complete biocontamination strategySterility, Sterilisation and Sterility Assurance for Pharmaceuticals
Technology, Validation and Current Regulations
2 457 kr
Skickas inom 7-10 vardagar
643 kr
Skickas inom 5-8 vardagar
Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals
Technology, Validation and Current Regulations
2 032 kr
Skickas inom 7-10 vardagar
478 kr
Skickas inom 5-8 vardagar
483 kr
Skickas inom 5-8 vardagar
621 kr
Skickas inom 5-8 vardagar
621 kr
Skickas inom 5-8 vardagar
621 kr
Skickas inom 5-8 vardagar
621 kr
Skickas inom 5-8 vardagar
621 kr
Skickas inom 5-8 vardagar
621 kr
Skickas inom 5-8 vardagar