Sterile Pharmaceutical Products PDF Download
Are you looking for read ebook online? Search for your book and save it on your Kindle device, PC, phones or tablets. Download Sterile Pharmaceutical Products PDF full book. Access full book title Sterile Pharmaceutical Products by Kenneth E. Avis. Download full books in PDF and EPUB format.
Author: Kenneth E. Avis
Publisher: CRC Press
ISBN: 9780935184815
Category : Medical
Languages : en
Pages : 432
Get Book Here
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.
Author: Kenneth E. Avis
Publisher: CRC Press
ISBN: 9780935184815
Category : Medical
Languages : en
Pages : 432
Get Book Here
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.
Author: Parag Kolhe
Publisher: Springer Science & Business Media
ISBN: 1461479789
Category : Medical
Languages : en
Pages : 590
Get Book Here
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.
Author: Sam A. Hout
Publisher: John Wiley & Sons
ISBN: 1119802342
Category : Technology & Engineering
Languages : en
Pages : 372
Get Book Here
Book Description
Describes the methodologies and best practices of the sterile manufacture of drug products Thoroughly trained personnel and carefully designed, operated, and maintained facilities and equipment are vital for the sterile manufacture of medicinal products using aseptic processing. Professionals in pharmaceutical and biopharmaceutical manufacturing facilities must have a clear understanding of current good manufacturing practice (cGMP) and preapproval inspection (PAI) requirements. Sterile Processing of Pharmaceutical Products: Engineering Practice, Validation, and Compliance in Regulated Environments provides up-to-date coverage of aseptic processing techniques and sterilization methods. Written by a recognized expert with more than 20 years of industry experience in aseptic manufacturing, this practical resource illustrates a comprehensive approach to sterile manufacturing engineering that can achieve drug manufacturing objectives and goals. Topics include sanitary piping and equipment, cleaning and manufacturing process validation, computerized automated systems, personal protective equipment (PPE), clean-in-place (CIP) systems, barriers and isolators, and guidelines for statistical procedure. Offering authoritative guidance on the key aspects of sterile manufacturing engineering, this volume: Covers fundamentals of aseptic techniques, quality by design, risk assessment and management, and operational requirements Addresses various regulations and guidelines instituted by the FDA, ISPE, EMA, MHRA, and ICH Provides techniques for systematic process optimization and good manufacturing practice Emphasizes the importance of attention to detail in process development and validation Features real-world examples highlighting different aspects of drug manufacturing Sterile Processing of Pharmaceutical Products: Engineering Practice, Validation, and Compliance in Regulated Environments is an indispensable reference and guide for all chemists, chemical engineers, pharmaceutical professionals and engineers, and other professionals working in pharmaceutical sciences and manufacturing.
Author: Michael J. Akers
Publisher: CRC Press
ISBN: 1420020560
Category : Medical
Languages : en
Pages : 517
Get Book Here
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
Author: James Agalloco
Publisher: CRC Press
ISBN: 1439825440
Category : Medical
Languages : en
Pages : 495
Get Book Here
Book Description
The preparation of sterile products using aseptic processing is considered perhaps the most critical process in the pharmaceutical industry and has witnessed continual improvement over the last half century. New approaches that have transformed classical aseptic production methods are appearing almost daily. This book reviews emerging technologies
Author: Sam A. Hout
Publisher: CRC Press
ISBN: 1000406091
Category : Technology & Engineering
Languages : en
Pages : 207
Get Book Here
Book Description
This book highlights key ideas and factors to coach and guide professionals involved in learning about Sterile Manufacturing and operational requirements. It covers regulations and guidelines instituted by the FDA, ISPE, EMA, MHRA, and ICH, emphasizing good manufacturing practice and inspection requirements in the manufacturing of medicinal products. Additionally, this book provides the fundamentals of aseptic techniques, quality by design, risk assessment, and management in support of sterile operations applications. It creates a link to the implementation of business practices in drug manufacturing and healthcare and forms a correlation between design strategies including a step-by-step process to ensure reliability, safety, and efficacy of healthcare products for human and animal use. The book also provides a connection between drug production and regulated applications by offering a review of the basic elements of sterile processing, and how to remain viable with solid strategic planning. The book is a concise reference for professionals and learners in the field of sterile operations that governs primarily, pharmaceutical and medical device space, but can also extend to food and cosmetics that require clean (aseptic) manufacturing applications. It also helps compounding pharmacists and GMP inspectors and auditors.
Author: James P. Agalloco
Publisher: CRC Press
ISBN: 1420019791
Category : Medical
Languages : en
Pages : 762
Get Book Here
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
Author: Tim Sandle
Publisher: Elsevier
ISBN: 1908818638
Category : Medical
Languages : en
Pages : 370
Get Book Here
Book Description
Failure to adequately control any microbial challenge associated within process or product by robust sterilisation will result in a contaminated marketed product, with potential harm to the patient. Sterilisation is therefore of great importance to healthcare and the manufacturers of medical devices and pharmaceuticals. Sterility, sterilisation and sterility assurance for pharmaceuticals examines different means of rendering a product sterile by providing an overview of sterilisation methods including heat, radiation and filtration. The book outlines and discusses sterilisation technology and the biopharmaceutical manufacturing process, including aseptic filling, as well as aspects of the design of containers and packaging, as well as addressing the cleanroom environments in which products are prepared. Consisting of 18 chapters, the book comprehensively covers sterility, sterilisation and microorganisms; pyrogenicity and bacterial endotoxins; regulatory requirements and good manufacturing practices; and gamma radiation. Later chapters discuss e-beam; dry heat sterilisation; steam sterilisation; sterilisation by gas; vapour sterilisation; and sterile filtration, before final chapters analyse depyrogenation; cleanrooms; aseptic processing; media simulation; biological indicators; sterility testing; auditing; and new sterilisation techniques. - Covers the main sterilisation methods of physical removal, physical alteration and inactivation - Includes discussion of medical devices, aseptically filled products and terminally sterilised products - Describes bacterial, pyrogenic, and endotoxin risks to devices and products
Author: Karen Davis, AAHCA, BS, CPhT
Publisher: Elsevier Health Sciences
ISBN: 1455711276
Category : Medical
Languages : en
Pages : 157
Get Book Here
Book Description
Covering aseptic technique and how to prepare sterile products, Sterile Processing for Pharmacy Technicians ensures safety, accuracy, and correctness of medications. Reflecting American Society of Health System Pharmacists (ASHP) competencies, this comprehensive book provides principles and guidelines, laboratory exercises, and hands-on practice with actual institutional orders. Written by expert pharmacy technician educator Karen Davis, Sterile Processing for Pharmacy Technicians also provides checklists that map to ASHP competencies! Complete coverage of USP 797 guidelines, basic aseptic manipulations, and working with IVs prepares you for institutional externships and for practice. Unique! ASHP competency checklists allow accurate documentation of competencies. Lab activities allow you to perform basic, hands-on aseptic manipulations in the lab. Tech Notes provide hints that you can use on the job. Tech Alerts provide safety warnings and help you avoid common errors. Guidelines and objectives are consistent with the ASHP Model Curriculum for Technician Training. Student resources on an Evolve companion website help you review and apply what you have learned with quizzes, syringe calculations, and critical thinking exercises.
Author: Byron J. Lambert
Publisher: Academic Press
ISBN: 0128050829
Category : Technology & Engineering
Languages : en
Pages : 266
Get Book Here
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.
