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Sterile Drug Products - Michael J. Akers - Bog - Taylor & Francis Ltd - Plusbog.dk

Sterile Drug Products - Michael J. Akers - Bog - Taylor & Francis Ltd - Plusbog.dk

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. -

DKK 476.00
1

Sterile Manufacturing - Sam A. Hout - Bog - Taylor & Francis Ltd - Plusbog.dk

Sterile Manufacturing - Sam A. Hout - Bog - Taylor & Francis Ltd - Plusbog.dk

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.

DKK 825.00
1

Sterile Sky - E.e. Sule - Bog - Bloomsbury Publishing PLC - Plusbog.dk

Sterile Sky - E.e. Sule - Bog - Bloomsbury Publishing PLC - Plusbog.dk

Winner of the 2013 Commonwealth Writer''s Prize for African literature. E.E. Sule''s debut novel, Sterile Sky , presents a community wrecked by religious conflict and a young boy hunting for a better future. On the day that Murtala comes of age, violent riots break out in his home city of Kano – leading to unspeakable tragedy within his own family. While chaos threatens to erase everything he holds dear, Murtala is stalked by monsters both real and imagined. A gifted student, he grows desperate to escape from the web of poverty and religious extremism that surrounds him.An immensely poignant and powerful novel, Sterile Sky captures the religious conflicts of modern Nigeria and the enduring hope for peace.''An ambitious work that tells the definitive story of an important moment in Nigeria’s sociopolitical history.'' Sanya Osha

DKK 168.00
1

Mosby's Sterile Compounding for Pharmacy Technicians - Karen Davis - Bog - Elsevier - Health Sciences Division - Plusbog.dk

Mosby's Sterile Compounding for Pharmacy Technicians - Karen Davis - Bog - Elsevier - Health Sciences Division - Plusbog.dk

Gain a complete introduction to institutional pharmacy practice and efficiently prepare for the new sterile compounding certification exam! Comprehensively covering sterile products, aseptic technique, and the workings of the sterile compounding facility, Mosby's Sterile Compounding for Pharmacy Technicians: Principles and Practice, 2nd Edition, focuses on safe and accurate practice. This edition has expanded and updated coverage to address preparation, processing, medications, technique, and documentation, with review, analysis, and application of , , and and additional content on waste management, workflow, safety and compliance, billing and reimbursement, and emergency management. Illustrations abound, and content is brought to life with an updated art program, step-by-step procedures, and technician notes and alerts. Certification review questions are included with each chapter, and online student and instructor resources round out the offering. Competency forms, lab activities, and sample compounding orders allow you to perform basic, hands-on aseptic manipulations in the lab. Mini-case scenarios promote critical thinking and application. Tech Notes, Tech Alerts, and Did You Know? boxes offer key information on-the-job success. Content modeled after ASHP curriculum for technician training. Chapter quizzes and an online sample exam offer student practice and exam preparation. Instructor support materials online, including lesson plans, PowerPoint slides, a test bank, student handouts, answer keys, an image collection, and chapter pretests. NEW! Expanded and updated content on all aspects of preparation, processing, medications, techniques, and documentation plus new content on the sterile environment; , , and ; hazardous materials and waste management; workflow, quality control; safety and compliance; billing and reimbursement; and emergency and disaster planning. NEW! Procedure boxes with step-by-step instructions, technique photos, and rationales. NEW and EXPANDED! Updated art program focuses on the sterile environment, equipment and supplies, and skills. NEW! Chapter quiz questions and a sample exam prepare students for classroom exams or the new certification credentialing exam.

DKK 605.00
1

Non-Sterile for Pharm Techs-Text and Certification Review - Denise Propes - Bog - McGraw-Hill Education - Europe - Plusbog.dk

Non-Sterile for Pharm Techs-Text and Certification Review - Denise Propes - Bog - McGraw-Hill Education - Europe - Plusbog.dk

Publisher''s Note: Products purchased from Third Party sellers are not guaranteed by the publisher for quality, authenticity, or access to any online entitlements included with the product. LEARN HOW TO PREPARE QUALITY COMPOUNDED PHARMACEUTICALS IN ANY PRACTICE ENVIRONMENT Non-Sterile Compounding for Pharmacy Technicians is written to provide pharmacy technicians with a solid foundational knowledge of non-sterile compounding and toprepare them for the Pharmacy Technician Board Certification examination. It explains in detail the tools, equipment, and documents necessary to ensurethe accurate preparation of compounded pharmaceuticals. You will find easy-to-follow, step-by-step procedures for preparing liquid, solid, and semi-solid compounded dosage forms. Each chapter includes Pharmacy Technician Board Certification-style questions, calculation exercises designed to reinforce key concepts, and discussion topics to promote creative thinking. Non-Sterile Compounding for Pharmacy Technicians covers all the concepts and processes necessary to prepare the student, novice, or seasoned pharmacy technician with the tools to enter this growing pharmacy sector, or enhance their skills in order to be successful in any non-sterile compounding practice environment.

DKK 565.00
1

Sterile Product Facility Design and Project Management - Jeffrey N. Odum - Bog - Taylor & Francis Ltd - Plusbog.dk

Sterile Product Facility Design and Project Management - Jeffrey N. Odum - Bog - Taylor & Francis Ltd - Plusbog.dk

Knowing how to deal with the regulatory issues, understanding the impacts of cleanliness, and recognizing the affect that poor facility layout will have on GMP spaces are only some of the issues an experienced Project Manager must focus on. Completely revised and updated, Sterile Product Facility Design and Project Management, Second Edition provides comprehensive guidance on how to develop and execute biotech and other sterile drug facilities based on current industry best practices. Each chapter highlights a specific issue centered on managing biotech facilities projects in a GMP environment. The author uses real-world examples of common industry practice to lead you through the idiosyncrasies of a biotech project in an effort to answer some of the more common, and often perplexing, questions that can stand in the way of success. You get a mini seminar on each topic covered. Breaking the project life-cycle into four phases, the text takes you through each phase from the Project Manager''s viewpoint. Unlike other books that cover design, technology, and validation in general terms, this book addresses the industry specific issues that make biotech facilities so costly and difficult to deliver. It puts the pieces of the puzzle together in a manner that increases your opportunity for success.

DKK 643.00
1

Handbook of Pharmaceutical Manufacturing Formulations - Safaraz K. Niazi - Bog - Taylor & Francis Ltd - Plusbog.dk

Handbook of Pharmaceutical Manufacturing Formulations - Safaraz K. Niazi - Bog - Taylor & Francis Ltd - Plusbog.dk

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 sterile products has evolved into a very sophisticated industry. Highlights from Sterile Products, Volume Six include: - formulations of sterile dosage forms, regulatory filing requirements of sterile preparations, and cGMP compliance, all of which are tied together in the final preparation of the CMC sections of regulatory applications - specifications of a manufacturing facility to manufacture compliant sterile products - NDA or aNDA filing requirements of sterile products - an alphabetical presentation of formulations of pharmaceutical products based on their generic names

DKK 477.00
1

Advanced Aseptic Processing Technology - - Bog - Taylor & Francis Ltd - Plusbog.dk

Advanced Aseptic Processing Technology - - Bog - Taylor & Francis Ltd - Plusbog.dk

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 for aseptic processing that will markedly reduce the level of contamination risk for sterile products and includes coverage on: - - The use of isolator and barrier concepts for aseptic processing and assembly. - - - The application of robotics as an alternative to gowned personnel. - - - The increasing reliance on automation to minimize or eliminate operator intervention. - - - The design, operational, monitoring and compliance changes necessary for success with advanced aseptic processing. - Advanced Aseptic Processing Technology is an essential reference for anyone working with sterile products, and is recommended for individuals in manufacturing,, compliance, regulatory affairs, microbiology, environmental monitoring, sterility testing, sterilization, validation, engineering, development, facility and equipment design, component and equipment suppliers, automation, and robotics.

DKK 477.00
1