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Sterile Drug Products

2016-04-19 Medical
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Release : 2016-04-19
Genre : Medical
Kind : eBook
Book Rating : 560/5 ( reviews)

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Book Synopsis Sterile Drug Products by : Michael J. Akers

Download or read book Sterile Drug Products written by Michael J. Akers. This book was released on 2016-04-19. Available in PDF, EPUB and Kindle. Book excerpt: Sterile Drug Products: Formulation, Packaging, Manufacturing, and Quality teaches the basic principles of the development and manufacture of high quality sterile dosage forms. The author has 38 years of experience in the development and manufacture of sterile dosage forms including solutions, suspensions, ophthalmics and freeze dried products. This

Sterile Pharmaceutical Products

2018-03-29 Medical
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Release : 2018-03-29
Genre : Medical
Kind : eBook
Book Rating : 864/5 ( reviews)

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Book Synopsis Sterile Pharmaceutical Products by : KennethE. Avis

Download or read book Sterile Pharmaceutical Products written by KennethE. Avis. This book was released on 2018-03-29. Available in PDF, EPUB and Kindle. Book excerpt: Sterile Pharmaceutical Products: Process Engineering Applications addresses the key concepts and applications of the sterile pharmaceutical manufacturing industry. It covers elements of the design, installation, validation, and usage of critical processes associated with sterile product manufacture. From water systems to clean-in-place systems, to sterile powder handling and robotic applications in sterile production environments, this book addresses the issues of system implementation, integration, and operations. Written by recognized experts and peer reviewed for accuracy, all chapters include references to supplemental resources and numerous illustrations.

Guideline on Sterile Drug Products Produced by Aseptic Processing

1987 Asepsis and antisepsis
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Release : 1987
Genre : Asepsis and antisepsis
Kind : eBook
Book Rating : /5 ( reviews)

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Book Synopsis Guideline on Sterile Drug Products Produced by Aseptic Processing by : Center for Drugs and Biologics (U.S.)

Download or read book Guideline on Sterile Drug Products Produced by Aseptic Processing written by Center for Drugs and Biologics (U.S.). This book was released on 1987. Available in PDF, EPUB and Kindle. Book excerpt:

Sterile Product Development

2013-10-12 Medical
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Release : 2013-10-12
Genre : Medical
Kind : eBook
Book Rating : 789/5 ( reviews)

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Book Synopsis Sterile Product Development by : Parag Kolhe

Download or read book Sterile Product Development written by Parag Kolhe. This book was released on 2013-10-12. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Guideline on Sterile Drug Products Produced by Aseptic Processing

1987
Download Guideline on Sterile Drug Products Produced by Aseptic Processing PDF Online Free

Author :
Release : 1987
Genre :
Kind : eBook
Book Rating : /5 ( reviews)

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Book Synopsis Guideline on Sterile Drug Products Produced by Aseptic Processing by : Center for Drugs and Biologics (É.-U.)

Download or read book Guideline on Sterile Drug Products Produced by Aseptic Processing written by Center for Drugs and Biologics (É.-U.). This book was released on 1987. Available in PDF, EPUB and Kindle. Book excerpt:

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