Biocontamination Control for Pharmaceutical and Healthcare

Biocontamination control concerns the risks to medicinal products from microorganisms, microbial by-products, and particulates. The risks of biocontamination in a well-designed facility stem from transfer on people and material surfaces, airborne contamination, and via utilities and interfaces. Biocontamination Control for Pharmaceutical and Healthcare outlines elements in a biocontamination strategy that tracks through a facility with bio-burden control and reduction at each transition in classified areas; this is a key part of controlling risk escalation to contaminating medicinal products. Regulatory authorities have challenged pharmaceutical and healthcare sectors, and those involved in Good Manufacturing Practice (GMP), to adopt a holistic approach to contamination control. Established ways of assessing contamination are limited, and therefore risk-based approaches are required. As well as using risk to assess types of contamination and where contamination can arise, 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 an up to date and complete biocontamination strategy. Provides the information for a facility to build a complete biocontamination strategy Allows a facility to understand the main biocontamination risks to medicinal products Assists the reader in navigating regulatory requirements and reducing process risks Provides insight into developing an environmental monitoring programme Covers the types of rapid microbiological monitoring methods now available, as well as current legislation

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  • Author : Tim Sandle
  • Publisher : Academic Press
  • Pages : 250 pages
  • ISBN : 9780128149119
  • Rating : 4/5 from 21 reviews
CLICK HERE TO GET THIS BOOKBiocontamination Control for Pharmaceutical and Healthcare

Biocontamination Control for Pharmaceutical and Healthcare

Biocontamination Control for Pharmaceutical and Healthcare
  • Author : Tim Sandle
  • Publisher : Academic Press
  • Release : 15 January 2019
GET THIS BOOKBiocontamination Control for Pharmaceutical and Healthcare

Biocontamination control concerns the risks to medicinal products from microorganisms, microbial by-products, and particulates. The risks of biocontamination in a well-designed facility stem from transfer on people and material surfaces, airborne contamination, and via utilities and interfaces. Biocontamination Control for Pharmaceutical and Healthcare outlines elements in a biocontamination strategy that tracks through a facility with bio-burden control and reduction at each transition in classified areas; this is a key part of controlling risk escalation to contaminating medicinal products. Regulatory authorities

Biocontamination Control for Pharmaceuticals and Healthcare

Biocontamination Control for Pharmaceuticals and Healthcare
  • Author : Tim Sandle
  • Publisher : Academic Press
  • Release : 30 November 2018
GET THIS BOOKBiocontamination 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. 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

Risk Management and Risk Assessment for Pharmaceutical Manufacturing

Risk Management and Risk Assessment for Pharmaceutical Manufacturing
  • Author : Dr Tim Sandle
  • Publisher : Createspace Independent Publishing Platform
  • Release : 01 June 2013
GET THIS BOOKRisk Management and Risk Assessment for Pharmaceutical Manufacturing

This book presents an overview of risk management and risk assessment for those working in the pharmaceutical and healthcare sectors. An understanding of risk management and risk assessment is today becoming a prerequisite for those working in quality control and quality assurance, and for those active in pharmaceuticals and medical devices, Quality Risk Management it is a mandatory requirement. The book expands upon this subject through a series of case studies, utilizing tools like HACCP and FMEA.

The CDC Handbook - A Guide to Cleaning and Disinfecting Clean Rooms

The CDC Handbook - A Guide to Cleaning and Disinfecting Clean Rooms
  • Author : Dr. Tim Sandle
  • Publisher : Grosvenor House Publishing
  • Release : 02 August 2012
GET THIS BOOKThe CDC Handbook - A Guide to Cleaning and Disinfecting Clean Rooms

The Cleaning and Disinfection handbook is aimed at those working within the pharmaceutical and healthcare sectors around the world, as well as providing valuable information for students and for the general reader. The book provides comprehensive detail on different types of disinfectants and their modes of action; explains the problems of microbial destruction and resistance; introduces cleaning techniques and the latest safety regulations; expounds upon the application of cleaning within healthcare and pharmaceutical environments, noting current national and international standards.

Pharmaceutical Microbiological Quality Assurance and Control

Pharmaceutical Microbiological Quality Assurance and Control
  • Author : David Roesti,Marcel Goverde
  • Publisher : John Wiley & Sons
  • Release : 02 January 2020
GET THIS BOOKPharmaceutical Microbiological Quality Assurance and Control

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

Pharmaceutical Microbiology

Pharmaceutical Microbiology
  • Author : Tim Sandle
  • Publisher : Woodhead Publishing
  • Release : 09 October 2015
GET THIS BOOKPharmaceutical Microbiology

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

WHO Guidelines for Indoor Air Quality

WHO Guidelines for Indoor Air Quality
  • Author : World Health Organization
  • Publisher : WHO Regional Office Europe
  • Release : 07 May 2021
GET THIS BOOKWHO Guidelines for Indoor Air Quality

Microbial pollution is a key element of indoor air pollution. It is caused by hundreds of species of bacteria and fungi, in particular filamentous fungi (mould), growing indoors when sufficient moisture is available. This document provides a comprehensive review of the scientific evidence on health problems associated with building moisture and biological agents. The review concludes that the most important effects are increased prevalences of respiratory symptoms, allergies and asthma as well as perturbation of the immunological system. The document

Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals

Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals
  • Author : Tim Sandle
  • Publisher : Elsevier
  • Release : 31 October 2013
GET THIS BOOKSterility, Sterilisation and Sterility Assurance for Pharmaceuticals

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 the

Safe Management of Wastes from Health-care Activities

Safe Management of Wastes from Health-care Activities
  • Author : World Health Organization
  • Publisher : World Health Organization
  • Release : 07 May 2021
GET THIS BOOKSafe Management of Wastes from Health-care Activities

This is the second edition of the WHO handbook on the safe, sustainable and affordable management of health-care waste--commonly known as "the Blue Book". The original Blue Book was a comprehensive publication used widely in health-care centers and government agencies to assist in the adoption of national guidance. It also provided support to committed medical directors and managers to make improvements and presented practical information on waste-management techniques for medical staff and waste workers. It has been more than ten

Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices

Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices
  • Author : Rosamund M. Baird,Norman A. Hodges,Stephen P. Denyer
  • Publisher : CRC Press
  • Release : 02 September 2003
GET THIS BOOKHandbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices

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 providing a wealth of microbiological information not only on the practical issues facing the company microbiologist today, but also the underlying principles of microbiological quality assurance. All the chapters have been written by leading experts in

Equipment Qualification in the Pharmaceutical Industry

Equipment Qualification in the Pharmaceutical Industry
  • Author : Steven Ostrove
  • Publisher : Academic Press
  • Release : 13 June 2019
GET THIS BOOKEquipment Qualification in the Pharmaceutical Industry

Equipment Qualification in the Pharmaceutical Industry provides guidance and basic information for the preparation of a quality qualification program. It has been noted that there is a general lack of understanding in the industry, especially for those new to the industry, as to what constitutes a compliant qualification program. Even experienced professionals have felt a lack of security in reaching a compliant state. This book outlines a guideline for the preparation and execution of qualification protocols including the installation (IQ),

Microbial Limit and Bioburden Tests

Microbial Limit and Bioburden Tests
  • Author : Lucia Clontz
  • Publisher : CRC Press
  • Release : 14 October 2008
GET THIS BOOKMicrobial Limit and Bioburden Tests

In recent years, the field of pharmaceutical microbiology has experienced numerous technological advances, accompanied by the publication of new and harmonized compendial methods. It is therefore imperative for those who are responsible for monitoring the microbial quality of pharmaceutical/biopharmaceutical products to keep abreast of the latest changes. Microbial Limit and Bioburden Tests: Validation Approaches and Global Requirements guides readers through the various microbiological methods listed in the compendia with easy-to-follow diagrams and approaches to validations of such test methodologies.

Current Air Quality Issues

Current Air Quality Issues
  • Author : Farhad Nejadkoorki
  • Publisher : BoD – Books on Demand
  • Release : 21 October 2015
GET THIS BOOKCurrent Air Quality Issues

Air pollution is thus far one of the key environmental issues in urban areas. Comprehensive air quality plans are required to manage air pollution for a particular area. Consequently, air should be continuously sampled, monitored, and modeled to examine different action plans. Reviews and research papers describe air pollution in five main contexts: Monitoring, Modeling, Risk Assessment, Health, and Indoor Air Pollution. The book is recommended to experts interested in health and air pollution issues.

Biosafety in the Laboratory

Biosafety in the Laboratory
  • Author : Division on Engineering and Physical Sciences,Commission on Physical Sciences, Mathematics, and Applications,Committee on Hazardous Biological Substances in the Laboratory,National Research Council
  • Publisher : National Academies Press
  • Release : 01 January 1989
GET THIS BOOKBiosafety in the Laboratory

Biosafety in the Laboratory is a concise set of practical guidelines for handling and disposing of biohazardous material. The consensus of top experts in laboratory safety, this volume provides the information needed for immediate improvement of safety practices. It discusses high- and low-risk biological agents (including the highest-risk materials handled in labs today), presents the "seven basic rules of biosafety," addresses special issues such as the shipping of dangerous materials, covers waste disposal in detail, offers a checklist for administering