Sterility Sterilisation and Sterility Assurance for Pharmaceuticals

Sterility  Sterilisation and Sterility Assurance for Pharmaceuticals
Author: Tim Sandle
Publsiher: Elsevier
Total Pages: 362
Release: 2013-10-31
ISBN 10: 1908818638
ISBN 13: 9781908818638
Language: EN, FR, DE, ES & NL

Sterility Sterilisation and Sterility Assurance for Pharmaceuticals Book Review:

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 biopharmaceutical manufacturing process, including aseptic filling, as well as aspects of the design of containers and packaging, as well as addressing the cleanroom environments in which products are prepared. Consisting of 18 chapters, the book comprehensively covers sterility, sterilisation and microorganisms; pyrogenicity and bacterial endotoxins; regulatory requirements and good manufacturing practices; and gamma radiation. Later chapters discuss e-beam; dry heat sterilisation; steam sterilisation; sterilisation by gas; vapour sterilisation; and sterile filtration, before final chapters analyse depyrogenation; cleanrooms; aseptic processing; media simulation; biological indicators; sterility testing; auditing; and new sterilisation techniques. Covers the main sterilisation methods of physical removal, physical alteration and inactivation Includes discussion of medical devices, aseptically filled products and terminally sterilised products Describes bacterial, pyrogenic, and endotoxin risks to devices and products

Pharmaceutical Microbiology

Pharmaceutical Microbiology
Author: Tim Sandle
Publsiher: Woodhead Publishing
Total Pages: 316
Release: 2015-10-09
ISBN 10: 0081000448
ISBN 13: 9780081000441
Language: EN, FR, DE, ES & NL

Pharmaceutical Microbiology Book Review:

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

Biocontamination Control for Pharmaceuticals and Healthcare

Biocontamination Control for Pharmaceuticals and Healthcare
Author: Tim Sandle
Publsiher: Academic Press
Total Pages: 374
Release: 2018-11-30
ISBN 10: 0128149124
ISBN 13: 9780128149126
Language: EN, FR, DE, ES & NL

Biocontamination Control for Pharmaceuticals and Healthcare Book Review:

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 legislation

Validation of Pharmaceutical Processes

Validation of Pharmaceutical Processes
Author: James P. Agalloco,Frederick J. Carleton
Publsiher: CRC Press
Total Pages: 760
Release: 2007-09-25
ISBN 10: 9781420019797
ISBN 13: 1420019791
Language: EN, FR, DE, ES & NL

Validation of Pharmaceutical Processes Book Review:

Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine va

Hugo and Russell s Pharmaceutical Microbiology

Hugo and Russell s Pharmaceutical Microbiology
Author: Stephen P. Denyer,Norman A. Hodges,Sean P. Gorman
Publsiher: John Wiley & Sons
Total Pages: 496
Release: 2008-04-15
ISBN 10: 1405141034
ISBN 13: 9781405141031
Language: EN, FR, DE, ES & NL

Hugo and Russell s Pharmaceutical Microbiology Book Review:

Completely revised and updated Pharmaceutical Microbiologycontinues to provide the essential resource for the 21st centurypharmaceutical microbiologist "....a valuable resource for junior pharmacists graspingan appreciation of microbiology, microbiologists entering thepharmaceutical field, and undergraduate pharmacy students." Journal of Antimicrobial Chemotherapy ".....highly readable. The content is comprehensive, withwell-produced tables, diagrams and photographs, and is accessiblethrough the extensive index." Journal of Medical Microbiology WHY BUY THIS BOOK? Completely revised and updated to reflect the rapid pace ofchange in the teaching and practice of pharmaceuticalmicrobiology Expanded coverage of modern biotechnology, including genomicsand recombinant DNA technology Updated information on newer antimicrobial agents and theirmode of action Highly illustrated with structural formulas of organiccompounds and flow diagrams of biochemical processes

Pharmaceutical Microbiological Quality Assurance and Control

Pharmaceutical Microbiological Quality Assurance and Control
Author: David Roesti,Marcel Goverde
Publsiher: John Wiley & Sons
Total Pages: 592
Release: 2020-01-02
ISBN 10: 1119356075
ISBN 13: 9781119356073
Language: EN, FR, DE, ES & NL

Pharmaceutical Microbiological Quality Assurance and Control Book Review:

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

Risk Management and Risk Assessment for Pharmaceutical Manufacturing

Risk Management and Risk Assessment for Pharmaceutical Manufacturing
Author: Dr Tim Sandle
Publsiher: Createspace Independent Publishing Platform
Total Pages: 168
Release: 2013-06-01
ISBN 10: 9781482596144
ISBN 13: 1482596148
Language: EN, FR, DE, ES & NL

Risk Management and Risk Assessment for Pharmaceutical Manufacturing Book Review:

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
Publsiher: Grosvenor House Publishing
Total Pages: 300
Release: 2012-08-02
ISBN 10: 178148080X
ISBN 13: 9781781480809
Language: EN, FR, DE, ES & NL

The CDC Handbook A Guide to Cleaning and Disinfecting Clean Rooms Book Review:

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. The book also provides guidance on disinfectant efficacy testing. Assembled by expert practitioners, the book balances theoretical concepts with sound practical advice, and is likely to become the definitive text on keeping contamination in control within clean areas and controlled environments. With this second edition, the book is fully updated in line with the latest standards and regulations.

Russell Hugo Ayliffe s Principles and Practice of Disinfection Preservation Sterilization

Russell  Hugo   Ayliffe s Principles and Practice of Disinfection  Preservation   Sterilization
Author: Adam P. Fraise,Peter A. Lambert,Jean-Yves Maillard
Publsiher: John Wiley & Sons
Total Pages: 688
Release: 2008-04-15
ISBN 10: 0470755067
ISBN 13: 9780470755068
Language: EN, FR, DE, ES & NL

Russell Hugo Ayliffe s Principles and Practice of Disinfection Preservation Sterilization Book Review:

Highly respected, established text – a definitive reference in its field – covering in detail many methods of the elimination or prevention of microbial growth "highly recommended to hospital and research personnel, especially to clinical microbiologists, infectioncontrol and environmental-safety specialists, pharmacists, and dieticians." New England Journal of Medicine WHY BUY THIS BOOK? Completely revised and updated to reflect the rapid pace of change in this area Updated material on new and emerging technologies, focusing on special problems in hospitals, dentistry and pharmaceutical practice Gives practical advise on problems of disinfection and antiseptics in hospitals Discusses increasing problems of natural and acquired resistance to antibiotics New contributors give a fresh approach to the subject and ensure international coverage Systematic review of sterilization methods, with uses and advantages outlined for each Evaluation of disinfectants and their mechanisms of action

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
Publsiher: CRC Press
Total Pages: 280
Release: 2003-09-02
ISBN 10: 9780203305195
ISBN 13: 0203305191
Language: EN, FR, DE, ES & NL

Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices Book Review:

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 this field. The Handbook of Microbiological Quality Control provides guidance on safe microbiological practices, including laboratory design and sampling techniques. The design storage, use and quality control of microbiological culture is considered in depth. Principles of enumeration and identification of micro-organisms, using both traditional and rapid methods as well as the pharmacopoeial methods for the detection of specified organisms, are elaborated in detail. Guidance is given on laboratory methods supporting the sterility assurance system: sterility testing, bioburden testing, the use of biological indicators and environmental monitoring methods, as well as methods for detecting and quantifying endotoxins. Pharmacopoeial methods for microbiological assay and preservative efficacy testing are reviewed. Problems for those involved in disinfection and cleansing techniques and microbiological audit are discussed from a practical viewpoint. Finally, a number of pertinent case studies and worked examples illustrate problems highlighted in the text. The Handbook of Microbiological Quality Control is the essential reference source for the professional microbiologist.

Handbook of Pharmaceutical Manufacturing Formulations

Handbook of Pharmaceutical Manufacturing Formulations
Author: Safaraz K. Niazi
Publsiher: CRC Press
Total Pages: 464
Release: 2016-04-19
ISBN 10: 1420081314
ISBN 13: 9781420081312
Language: EN, FR, DE, ES & NL

Handbook of Pharmaceutical Manufacturing Formulations Book Review:

No other area of regulatory compliance receives more attention and scrutiny by regulatory authorities than the regulation of sterile products, for obvious reasons. With the increasing number of potent products, particularly the new line of small protein products, joining the long list of proven sterile products, the technology of manufacturing ster

Sterilisation of Biomaterials and Medical Devices

Sterilisation of Biomaterials and Medical Devices
Author: Sophie Lerouge,Anne Simmons
Publsiher: Elsevier
Total Pages: 352
Release: 2012-09-27
ISBN 10: 0857096265
ISBN 13: 9780857096265
Language: EN, FR, DE, ES & NL

Sterilisation of Biomaterials and Medical Devices Book Review:

The effective sterilisation of any material or device to be implanted in or used in close contact with the human body is essential for the elimination of harmful agents such as bacteria. Sterilisation of biomaterials and medical devices reviews established and commonly used technologies alongside new and emerging processes. Following an introduction to the key concepts and challenges involved in sterilisation, the sterilisation of biomaterials and medical devices using steam and dry heat, ionising radiation and ethylene oxide is reviewed. A range of non-traditional sterilisation techniques, such as hydrogen peroxide gas plasma, ozone and steam formaldehyde, is then discussed together with research in sterilisation and decontamination of surfaces by plasma discharges. Sterilisation techniques for polymers, drug-device products and tissue allografts are then reviewed, together with antimicrobial coatings for ‘self-sterilisation’ and the challenge presented by prions and endotoxins in the sterilisation of reusable medical devices. The book concludes with a discussion of future trends in the sterilisation of biomaterials and medical devices. With its distinguished editors and expert team of international contributors, Sterilisation of biomaterials and medical devices is an essential reference for all materials scientists, engineers and researchers within the medical devices industry. It also provides a thorough overview for academics and clinicians working in this area. Reviews established and commonly used technologies alongside new and emerging processes Introduces and reviews the key concepts and challenges involved in sterilisation Discusses future trends in the sterilisation of biomaterials and medical devices

British Pharmaceutical Codex

British Pharmaceutical Codex
Author: Anonim
Publsiher: Unknown
Total Pages: 329
Release: 1994
ISBN 10:
ISBN 13: UOM:39015030886520
Language: EN, FR, DE, ES & NL

British Pharmaceutical Codex Book Review:

Steam Sterilization

Steam Sterilization
Author: Jeanne Moldenhauer
Publsiher: Unknown
Total Pages: 725
Release: 2002
ISBN 10: 9781930114388
ISBN 13: 1930114389
Language: EN, FR, DE, ES & NL

Steam Sterilization Book Review:

Containment Technology

Containment Technology
Author: Hans-Jürgen Bässler,Frank Lehmann
Publsiher: Springer Science & Business Media
Total Pages: 166
Release: 2013-10-01
ISBN 10: 364239292X
ISBN 13: 9783642392924
Language: EN, FR, DE, ES & NL

Containment Technology Book Review:

This book covers all aspects of containment technology in depth and the latest developments in this exciting field are introduced. This book is a key publication to planning engineers, production managers and those interested in getting a picture of the different applications of the isolator technology. References on literature, laws, norms and guidelines will support the reader to become acquainted with the containment technology.

ANSI AAMI St79 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities

ANSI AAMI St79  Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities
Author: Aami
Publsiher: Association for the Advancement of Medical Instrumentation (AAMI)
Total Pages: 329
Release: 2013-10-01
ISBN 10: 9780010671384
ISBN 13: 0010671382
Language: EN, FR, DE, ES & NL

ANSI AAMI St79 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities Book Review:

The AAMI recommended practice, Comprehensive guide to steam sterilization and sterility assurance in health care facilities, is a breakthrough standard in terms of its scope. AAMI has updated ST79 with the release of ST79:2010/A4:2013. Of particular importance, A4:2013 provides four new figures demonstrating the wrapping of items for steam sterilization and adds an annex focused on Moisture assessment. As of Oct. 25, 2013, purchasers of ST79 will receive ANSI/AAMI ST79:2010 and A1:2010 and A2:2011 and A3:2012 and A4:2014 as a single consolidated document. Among other changes from the 2006 edition of ST79, this revised and expanded second edition of ST79 includes guidance on the use and application of Class 6 emulating indicators, a chemical monitoring device fairly new to the United States. Because ST79 essentially consolidates five AAMI steam sterilization standards (whose content was reviewed and updated to reflect current good practice prior to being incorporated into ST79), it truly is a comprehensive guideline for all steam sterilization activities in healthcare facilities, regardless of the size of the sterilizer or the size of the facility, and provides a resource for all healthcare personnel who use steam for sterilization.

Guide to Cleanrooms

Guide to Cleanrooms
Author: Dr Tim Sandle
Publsiher: Createspace Independent Publishing Platform
Total Pages: 36
Release: 2012-12-27
ISBN 10: 9781480017320
ISBN 13: 1480017329
Language: EN, FR, DE, ES & NL

Guide to Cleanrooms Book Review:

An introductory guide to cleanrooms in the life science sector.

Compounding Sterile Preparations

Compounding Sterile Preparations
Author: E. Clyde Buchanan,Phillip J. Schneider
Publsiher: ASHP
Total Pages: 481
Release: 2009-02-01
ISBN 10: 1585283312
ISBN 13: 9781585283316
Language: EN, FR, DE, ES & NL

Compounding Sterile Preparations Book Review:

Empower your staff to improve safety, quality and compliance with the help of new guidelines and standards. We’ve updated every chapter of this popular review of the fundamentals of preparing sterile products in hospital, home-care, and community pharmacy settings to reflect the most recent revisions to USP . Included are the latest guidelines for the compounding process, quality assurance methods, and comprehensive coverage of all aspects of the dispensing process. Comprehensive documentation for the guidelines is included in the appendices.Chapters new to this edition focus on: Gap analysis and action plans Safe use of automatic compounding devices Cleaning and disinfecting Radiopharmaceuticals as CSPs Allergen extracts as CSPs.

Quality Assurance of Aseptic Preparation Services Standards Handbook

Quality Assurance of Aseptic Preparation Services Standards Handbook
Author: Alison M. Beaney
Publsiher: Unknown
Total Pages: 250
Release: 2016-10-03
ISBN 10: 9780857113078
ISBN 13: 0857113070
Language: EN, FR, DE, ES & NL

Quality Assurance of Aseptic Preparation Services Standards Handbook Book Review:

Standards for unlicensed aseptic preparation in the UK, as well as practical information for implementing the standards.

Pharmaceutical Isolators

Pharmaceutical Isolators
Author: Brian Midcalf,W. Mitchell Phillips,Tim J. Coles,John S. Neiger
Publsiher: Pharmaceutical Press
Total Pages: 252
Release: 2004
ISBN 10: 9780853695738
ISBN 13: 0853695733
Language: EN, FR, DE, ES & NL

Pharmaceutical Isolators Book Review:

Pharmaceutical Isolators is a new indispensable guide to the design, construction, commissioning, maintenance, use and monitoring of pharmaceutical isolators. The current validation protocols are explained and the book includes some useful technical appendices. Written through the combined technical expertise of the Isolator Working Party, this new title will assist both experienced and new users to understand and manage this technology. The book will also be a useful reference source for auditors, inspectors and all those involved in standard setting and monitoring.