Book Library

Read or Download Book Online

Download: [PDF] sterile drug products

Sterile Drug Products

Sterile Drug Products PDF

Get Book

Author: Michael J. Akers
Publisher: CRC Press
ISBN: 1420020560
Size: 45.72 MB
Format: PDF, ePub, Docs
Category : Medical
Languages : en
Pages : 516
View: 7045

Book Description: 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 book is based on the courses he has delivered for over three decades, to over 3000 participants, and is intended to remain relevant for the indefinite future even as new technologies and new applications of old technologies become common. This is an ideal reference book for those working directly and indirectly with sterile dosage forms, be it product development (formulation, package, process, analytical), manufacturing, quality control, quality assurance, regulatory, purchasing, or project management. This book is also intended as an educational resource for the pharmaceutical and biopharmaceutical industry and pharmacy schools, providing basic knowledge and principles in four main areas of parenteral science and technology: Product development, including formulation, packaging, and process development. Manufacturing, including basic teaching on all the primary unit operations involved in preparation of sterile products and the underlying importance of contamination control. Quality and regulatory, including the application of good manufacturing practice regulations, aseptic processing guidelines, and unique quality control testing methods for the sterile dosage form Clinical aspects, including administration, potential hazards, and biopharmaceutics of sterile products in a clinical setting.


Guidance For Industry

Guidance for industry PDF

Get Book

Author:
Publisher:
ISBN:
Size: 62.10 MB
Format: PDF, Mobi
Category : Asepsis and antisepsis
Languages : en
Pages : 59
View: 1509

Book Description:


Sterile Pharmaceutical Products

Sterile Pharmaceutical Products PDF

Get Book

Author: Kenneth E. Avis
Publisher: CRC Press
ISBN: 9780935184815
Size: 50.10 MB
Format: PDF
Category : Medical
Languages : en
Pages : 432
View: 3125

Book Description: 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.


Assurance Of Sterility For Sensitive Combination Products And Materials

Assurance of Sterility for Sensitive Combination Products and Materials PDF

Get Book

Author: Byron Lambert
Publisher: Academic Press
ISBN: 0128050829
Size: 76.57 MB
Format: PDF
Category : Technology & Engineering
Languages : en
Pages : 252
View: 7557

Book Description: Assurance of Sterility for Sensitive Combination Products and Materials: New Paradigms for the Next Generation of Medical Devices and Pharmaceuticals discusses the medical device industry and existing challenges regarding the exciting new world of sensitive combination products (SCPs) and their terminal sterilization. This book reassesses the current assumptions to assure the patient's best interests are met in the development of increasingly rigorous sterilization methods used to counteract MRSA and other 'super-bugs'. In addition, the book discusses the special challenges faced with implantable medical devices, sterilization requirements and further methods needed for material selection and the design process. This book is unique in taking a holistic, end-to-end approach to sterilization, with a particular focus on materials selection and product design. Introduces sterilization principles at the material selection and design stages Addresses the industry need for new sterilization processes for new medical devices and biomaterials Provides guidance to select the appropriate sterilization technique for newly developed sensitive combination products Examines forward thinking tactics for matching new developments in material compatibility with possible regulatory and QSR strategies


Cleanrooms

CleanRooms PDF

Get Book

Author:
Publisher:
ISBN:
Size: 18.60 MB
Format: PDF, ePub, Docs
Category :
Languages : en
Pages : 50
View: 5876

Book Description: A central resource of technology and methods for environments where the control of contamination is critical.


Handbook Of Pharmaceutical Manufacturing Formulations

Handbook of Pharmaceutical Manufacturing Formulations PDF

Get Book

Author: Safaraz K. Niazi
Publisher: CRC Press
ISBN: 1420081314
Size: 63.48 MB
Format: PDF, ePub, Docs
Category : Medical
Languages : en
Pages : 464
View: 2445

Book Description: 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