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Sterility, sterilisation and sterility assurance for pharmaceuticals : technology, validation and current regulations
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ISBN: 1908818638 1907568387 9781907568381 9781306177085 1306177081 9781908818638 Year: 2013 Publisher: Cambridge : Woodhead Publishing,

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Failure to adequately control any microbial challenge associated within process or product by robust sterilisation will result in a contaminated marketed product, with potential harm to the patient. Sterilisation is therefore of great importance to healthcare and the manufacturers of medical devices and pharmaceuticals. Sterility, sterilisation and sterility assurance for pharmaceuticals examines different means of rendering a product sterile by providing an overview of sterilisation methods including heat, radiation and filtration. The book outlines and discusses sterilisation technology and


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Pharmaceutical microbiology : essentials for quality assurance and quality control
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ISBN: 0081000448 0081000227 9780081000441 9780081000229 9780081000229 Year: 2016 Publisher: Amsterdam, [Netherlands] : Woodhead Publishing,

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Biocontamination Control for Pharmaceuticals and Healthcare
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ISBN: 0128149124 0128149116 9780128149126 9780128149119 Year: 2019 Publisher: Academic Press

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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. 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.--


Digital
Pharmaceutical microbiology : essentials for quality assurance and quality control
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ISBN: 9780081000441 0081000448 0081000227 Year: 2016 Publisher: Cambridge, UK Woodhead Publishing Limited

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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.

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Biocontamination control for pharmaceuticals and healthcare
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ISBN: 9780128149126 0128149124 9780128149119 Year: 2019 Publisher: London, United Kingdom : Academic Press, an imprint of Elsevier,

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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. 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.--


Book
Biocontamination Control for Pharmaceuticals and Healthcare.
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ISBN: 0443216010 0443216002 9780443216015 Year: 2024 Publisher: San Diego : Elsevier Science & Technology,

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This book, authored by Tim Sandle, provides a comprehensive guide on contamination control within healthcare environments, particularly focusing on microbiological safety in pharmaceutical manufacturing. It covers regulatory requirements, risk management, environmental monitoring, and cleanroom standards. The text is updated to reflect recent changes in global guidelines, including those from the FDA and EU GMP Annex 1. It aims to equip professionals with the necessary knowledge to implement effective contamination control strategies, ensuring safety and compliance. The book is intended for healthcare professionals, pharmaceutical manufacturers, and regulatory bodies.

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