Validation of Steam Sterilization Cycles

Validation of Steam Sterilization Cycles PDF Author: Pda Research Task Group on Steam Sterilization
Publisher:
ISBN: 9780939459001
Category :
Languages : en
Pages : 36

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Book Description

Validation of Steam Sterilization Cycles

Validation of Steam Sterilization Cycles PDF Author: Pda Research Task Group on Steam Sterilization
Publisher:
ISBN: 9780939459001
Category :
Languages : en
Pages : 36

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Book Description


Handbook of Validation in Pharmaceutical Processes, Fourth Edition

Handbook of Validation in Pharmaceutical Processes, Fourth Edition PDF Author: James Agalloco
Publisher: CRC Press
ISBN: 1000436012
Category : Medical
Languages : en
Pages : 1062

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Book Description
Revised to reflect significant advances in pharmaceutical production and regulatory expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edition examines and blueprints every step of the validation process needed to remain compliant and competitive. This book blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded work is a comprehensive analysis of all the fundamental elements of pharmaceutical and bio-pharmaceutical production processes. Handbook of Validation in Pharmaceutical Processes, Fourth Edition is essential for all global health care manufacturers and pharmaceutical industry professionals. Key Features: Provides an in-depth discussion of recent advances in sterilization Identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions Explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results New chapters include disposable systems, combination products, nano-technology, rapid microbial methods, contamination control in non-sterile products, liquid chemical sterilization, and medical device manufacture

Selected Papers on the Microbiology and Engineering of Sterilization Processes

Selected Papers on the Microbiology and Engineering of Sterilization Processes PDF Author: I. J. Pflug
Publisher:
ISBN: 9780929340050
Category :
Languages : en
Pages : 298

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Book Description


Sterile Product Development

Sterile Product Development PDF Author: Parag Kolhe
Publisher: Springer Science & Business Media
ISBN: 1461479789
Category : Medical
Languages : en
Pages : 590

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Book Description
This comprehensive book encompasses various facets of sterile product development. Key concepts relevant to the successful development of sterile products are illustrated through case studies and are covered under three sections in this book: • Formulation approaches that discuss a variety of dosage forms including protein therapeutics, lipid-based controlled delivery systems, PEGylated biotherapeutics, nasal dosage form, and vaccines • Process, container closure and delivery considerations including freeze-thaw process challenges, best practices for technology transfer to enable commercial product development, innovations and advancement in aseptic fill-finish operations, approaches to manufacturing lyophilized parenteral products, pen / auto-injector delivery devices, and associated container closure integrity testing hurdles for sterile product closures • Regulatory and quality aspects in the areas of particulate matter and appearance evaluation, sterile filtration, admixture compatibility considerations, sterilization process considerations, microbial contamination investigations and validation of rapid microbiological methods, and dry and moist heat sterilizers This book is a useful resource to scientists and researchers in both industry and academia, and it gives process and product development engineers insight into current industry practices and evolving regulatory expectations for sterile product development.

Disinfection and Decontamination

Disinfection and Decontamination PDF Author: Jeanne Moldenhauer
Publisher: CRC Press
ISBN: 1351217003
Category : Medical
Languages : en
Pages : 235

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Book Description
This book describes various methods of decontamination and how the methods work. There is a discussion of the various cleaning and disinfection methods utilized, along with details of how to qualify these methods. It also describes new technologies that may be useful in the battle for decontamination across industries. Finally, this book provides a single resource on how one can address contamination issues for a variety of manufacturing processes and industries.

Smart Food Industry: The Blockchain for Sustainable Engineering

Smart Food Industry: The Blockchain for Sustainable Engineering PDF Author: Eduardo Jacob Lopes
Publisher: CRC Press
ISBN: 1003809154
Category : Technology & Engineering
Languages : en
Pages : 337

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Book Description
Smart Food Industry: The Blockchain for Sustainable Engineering, Volume I - Fundamentals, Technologies, and Management is a comprehensive overview of the current state of knowledge about food engineering and processing, under sustainable engineering perspective. This book includes disruptive approaches that will potentially enable the food industry for the transition to sustainable production. Divided into four parts, the book explores (i) fundamentals of sustainable food, (ii) conventional technologies in the food industry, (iii) sustainabile emerging technologies in food industries, and (iv) sustainable management in food industries. The book is an invaluable reference resource for students, researchers, graduates, and professionals, in general, who wish to gain knowledge in the engineering and food processing area as well as about sustainable food industry practices.

Block’s Disinfection, Sterilization, and Preservation

Block’s Disinfection, Sterilization, and Preservation PDF Author: Gerald McDonnell
Publisher: Lippincott Williams & Wilkins
ISBN: 1496381505
Category : Medical
Languages : en
Pages : 2941

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Book Description
With more international contributors than ever before, Block’s Disinfection, Sterilization, and Preservation, 6th Edition, is the first new edition in nearly 20 years of the definitive technical manual for anyone involved in physical and chemical disinfection and sterilization methods. The book focuses on disease prevention—rather than eradication—and has been thoroughly updated with new information based on recent advances in the field and understanding of the risks, the technologies available, and the regulatory environments.

Antisepsis, Disinfection, and Sterilization

Antisepsis, Disinfection, and Sterilization PDF Author: Gerald E. McDonnell
Publisher: John Wiley & Sons
ISBN: 1555819680
Category : Medical
Languages : en
Pages : 431

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Book Description
Antisepsis, Disinfection, and Sterilization: Types, Action, and Resistance, by Gerald E. McDonnell, is a detailed and accessible presentation of the current methods of microbial control. Each major category, such as physical disinfection methods, is given a chapter, in which theory, spectrum of activity, advantages, disadvantages, and modes of action of the methods are thoroughly and clearly presented. Sufficient background on the life cycles and general anatomy of microorganisms is provided so that the reader who is new to microbiology will better appreciate how physical and chemical biocides work their magic on microbes. Other topics in the book include: Evaluating the efficacy of chemical antiseptics and disinfectants, and of physical methods of microbial control and sterilization. Understanding how to choose the proper biocidal product and process for specific applications. Classic physical and chemical disinfection methods, such as heat, cold, non-ionizing radiation, acids, oxidizing agents, and metals. Newer chemical disinfectants, including, isothiazolones, micro-and nano-particles, and bacteriophages as control agents. Antisepsis of skin and wounds and the biocides that can be used as antiseptics. Classic methods of physical sterilization, such as, moist heat and dry heat sterilization, ionizing radiation, and filtration, along with newer methods, including, the use of plasma or pulsed light. Chemical sterilization methods that use ethylene oxide, formaldehyde, or a variety of other oxidizing agents. A detailed look at the modes of action of biocides in controlling microbial growth and disrupting microbial physiology. Mechanisms that microorganisms use to resist the effects of biocides. The second edition of Antisepsis, Disinfection, and Sterilization: Types, Action, and Resistance is well suited as a textbook and is outstanding as a reference book for facilities managers and application engineers in manufacturing plants, hospitals, and food production facilities. It is also essential for public health officials, healthcare professionals, and infection control practitioners.

Steam Sterilization

Steam Sterilization PDF Author: Jeanne Moldenhauer
Publisher:
ISBN: 9781930114388
Category :
Languages : en
Pages : 725

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Book Description


Validation of Pharmaceutical Processes

Validation of Pharmaceutical Processes PDF Author: James P. Agalloco
Publisher: CRC Press
ISBN: 1420019791
Category : Medical
Languages : en
Pages : 762

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Book Description
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