Contamination Control in Practice

Contamination Control in Practice
Author: Matts Ramstorp
Publisher: John Wiley & Sons
Total Pages: 202
Release: 2008-06-25
Genre: Science
ISBN: 3527612610

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Contamination control has received great interest and found increasing use within several industrial branches including microelectronics, pharmaceuticals, food and beverages using various concepts of contamination control in their production, purification or packaging process. The book supplies a holistic view of contamination control, presenting the different types of contaminants in a summarized form. The focus is on how to protect products and processes from external contamination and also on different ways to take care of and control contaminants generated in the process. The aim is to eliminate them from a product or a process flow (e.g. through filtration), or to render them harmless (e.g. through sterilisation by moist heat). Product purity or the cleanliness of process flows are often complex matters and hard to define in easily understood terms. This book covers a variety of different techniques used in order to achieve and maintain certain overall cleanliness levels for both microbiological or inanimate particle contaminants. It supplies basic knowledge including validation aspects for industrial branches working with increased demands of cleanliness, for instance water purification, steam, pressurized gases and different flows in a process together with finished products.

CC013. 2 Calibration Procedures and Guidelines for Select Equipment Used in Testing Cleanrooms and Other Controlled Environments

CC013. 2 Calibration Procedures and Guidelines for Select Equipment Used in Testing Cleanrooms and Other Controlled Environments
Author: Institute of Environmental Sciences and Technology. Contamination Control Division
Publisher: Institute of Environmental Sciences and Technology
Total Pages: 23
Release: 2006-01-01
Genre: Air sampling apparatus
ISBN: 9780974731391

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Introduction to Contamination Control and Cleanroom Technology

Introduction to Contamination Control and Cleanroom Technology
Author: Matts Ramstorp
Publisher: John Wiley & Sons
Total Pages: 179
Release: 2008-07-11
Genre: Science
ISBN: 3527613137

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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.

Principles and Practices of Contamination Control and Cleanrooms

Principles and Practices of Contamination Control and Cleanrooms
Author: C. K. Moorthy
Publisher: Anshan Pub
Total Pages: 240
Release: 2004
Genre: Medical
ISBN: 9781904798064

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This book addresses a long felt need in the industry for coherent information on “contamination control, cleanrooms and biosafety” and offers insights, guidance and assistance to ensure that practices and procedure are in step with current norms. It develops and refines the concept of an integrated micro contamination control. It focuses on the environmental expectations and testing for continued compliance as laid down in: *ISO 14644 Standards for Cleanrooms; *ISO 146 Final Draft International Standards for Biological Monitoring & Control; * MCA Orange Guide December 2002; *USFDA Draft Guidelines for Sterile Drug Products by Aseptic Processing; *WHO Guidelines for Sterile Pharmaceutical Preparations.

Microbiological Contamination Control in Pharmaceutical Clean Rooms

Microbiological Contamination Control in Pharmaceutical Clean Rooms
Author: Nigel Halls
Publisher: CRC Press
Total Pages: 198
Release: 2016-04-19
Genre: Medical
ISBN: 1420025805

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Contamination control in pharmaceutical clean rooms has developed from a jumble of science and engineering, knowledge of what has worked well or badly in the past, dependent upon the technology available at the time the clean room was built and subsequent technological developments. Surrounding it all is a blanket of regulations. Taking a multidisc

Microbial Contamination Control in Parenteral Manufacturing

Microbial Contamination Control in Parenteral Manufacturing
Author: Kevin Williams
Publisher: CRC Press
Total Pages: 671
Release: 2004-05-20
Genre: Medical
ISBN: 113553621X

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This reference surveys emerging trends, concepts, and procedures used in the characterization and control of contaminants; the sterile production of traditional drugs and biologics; the design, construction, and validation of new parenteral facilities; and the monitoring of clean environments-vividly illustrating the routes by which products, proce

Biocontamination Control for Pharmaceuticals and Healthcare

Biocontamination Control for Pharmaceuticals and Healthcare
Author: Tim Sandle
Publisher: Elsevier
Total Pages: 510
Release: 2024-02-09
Genre: Medical
ISBN: 0443216010

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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