PDA Technical Report No. 39 (Revised 2007)

PDA Technical Report No. 39 (Revised 2007) PDF Author: PDA
Publisher:
ISBN: 9780939459186
Category :
Languages : en
Pages :

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PDA Technical Report No. 39 (Revised 2007)

PDA Technical Report No. 39 (Revised 2007) PDF Author: PDA
Publisher:
ISBN: 9780939459186
Category :
Languages : en
Pages :

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Book Description


PDA Technical Report No. 39

PDA Technical Report No. 39 PDF Author: PDA
Publisher:
ISBN: 9780939459117
Category :
Languages : en
Pages :

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Validation of moist heat sterilization processes : cycle design, development, qualification and ongoing control

Validation of moist heat sterilization processes : cycle design, development, qualification and ongoing control PDF Author: James P. Agalloco
Publisher:
ISBN: 9780939459155
Category :
Languages : en
Pages : 54

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Guidelines for the international packaging and shipping of vaccines

Guidelines for the international packaging and shipping of vaccines PDF Author:
Publisher: World Health Organization
ISBN: 9240015434
Category : Medical
Languages : en
Pages : 169

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Book Description
International shipping of vaccines is the first leg of the complex journey that vaccines undertake to reach the end users in a country. Particular challenges include the size and weight of packages, implementation of quality control checks at reception, ensuring environmental sustainability, and maintaining required temperatures during the journey. Although there are many possibilities of transport e.g. sea freight and terrestrial transportation, air freight currently remains the most widely used means of transport for vaccines. In recognition of this fact, these guidelines apply predominantly to the air freighting of vaccines. Transportation of vaccines from the manufacturing facility to the airport facility require the use of ground transportation, and reference is also made to the qualification of refrigerated road vehicles as well. The objective of these guidelines is to provide technical guidance to help ensure the quality of vaccines during all stages of the international air transportation process. These guidelines are applicable to all persons and institutions involved in international air shipment of vaccines from the premises of the product manufacturer to the recipient country. This includes all parties involved in shipment, vaccine manufacturers, logistics service providers (LSPs), freight forwarders, carriers and their employees. The relevant sections of these guidelines should also be considered for implementation by UN procurement agencies and other international procurement organizations, countries, donor agencies and certifying bodies.

Development of Vaccines

Development of Vaccines PDF Author: Manmohan Singh
Publisher: John Wiley & Sons
ISBN: 1118023633
Category : Medical
Languages : en
Pages : 378

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Book Description
Development of Vaccines: From Discovery to Clinical Testing outlines the critical steps, and analytical tools and techniques, needed to take a vaccine from discovery through a successful clinical trial. Contributions from leading experts in the critical areas of vaccine expression, purification, formulation, pre-clinical testing and regulatory submissions make this book an authoritative collection of issues, challenges and solutions for progressing a biologic drug formulation from its early stage of discovery into its final clinical testing. A section with details and real-life experiences of toxicology testing and regulatory filing for vaccines is also included.

Process Simulation Testing for Sterile Bulk Pharmaceutical Chemicals

Process Simulation Testing for Sterile Bulk Pharmaceutical Chemicals PDF Author:
Publisher:
ISBN:
Category :
Languages : en
Pages : 16

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Book Description


PDA Technical Report No. 28 (Revised 2006)

PDA Technical Report No. 28 (Revised 2006) PDF Author: PDA
Publisher:
ISBN: 9780939459148
Category :
Languages : en
Pages :

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Book Description


Parenteral Medications, Fourth Edition

Parenteral Medications, Fourth Edition PDF Author: Sandeep Nema
Publisher: CRC Press
ISBN: 042957472X
Category : Business & Economics
Languages : en
Pages : 2756

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Book Description
Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacturing of parenteral dosage forms, effectively balancing theoretical considerations with practical aspects of their development. Previously published as a three-volume set, all volumes have been combined into one comprehensive publication that addresses the plethora of changes in the science and considerable advances in the technology associated with these products and routes of administration. Key Features: Provides a comprehensive reference work on the formulation and manufacturing of parenteral dosage forms Addresses changes in the science and advances in the technology associated with parenteral medications and routes of administration Includes 13 new chapters and updated chapters throughout Contains the contributors of leading researchers in the field of parenteral medications Uses full color detailed illustrations, enhancing the learning process The fourth edition not only reflects enhanced content in all the chapters but also highlights the rapidly advancing formulation, processing, manufacturing parenteral technology including advanced delivery and cell therapies. The book is divided into seven sectionss: Section 1 - Parenteral Drug Administration and Delivery Devices; Section 2 - Formulation Design and Development; Section 3 - Specialized Drug Delivery Systems; Section 4 - Primary Packaging and Container Closure Integrity; Section 5 - Facility Design and Environmental Control; Section 6 - Sterilization and Pharmaceutical Processing; Section 7 - Quality Testing and Regulatory Requirements

Disinfection and Decontamination

Disinfection and Decontamination PDF Author: Jeanne Moldenhauer
Publisher: CRC Press
ISBN: 1351217011
Category : Medical
Languages : en
Pages : 254

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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. Explores new technologies that may be useful in the battle for decontamination Examines various methods of decontamination and how the methods work Addresses contamination issues for a variety of manufacturing processes and industries Describes how to detect contaminants as well as how to deal with contaminants that are present Includes methods for both decontamination (reaction) and preventing contamination (proactive)

Pharmaceutical Dosage Forms - Parenteral Medications

Pharmaceutical Dosage Forms - Parenteral Medications PDF Author: Sandeep Nema
Publisher: CRC Press
ISBN: 1420086480
Category : Medical
Languages : en
Pages : 328

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Book Description
This three-volume set of Pharmaceutical Dosage Forms: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacture of parenteral dosage forms, effectively balancing theoretical considerations with the practical aspects of their development. As such, it is recommended for scientists and engineers in the