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Author :
Publisher : Amer Soc Health-System Pharmacists
ISBN 13 :
Total Pages : 196 pages
Book Rating : 4.3/5 (91 download)
Download or read book Principles of Sterile Product Preparation written by and published by Amer Soc Health-System Pharmacists. This book was released on 1995 with total page 196 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Mike Johnston (CPhT.)
Publisher : Prentice Hall
ISBN 13 : 9780131147560
Total Pages : 0 pages
Book Rating : 4.1/5 (475 download)
Download or read book Sterile Products written by Mike Johnston (CPhT.) and published by Prentice Hall. This book was released on 2006 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Part of the Prentice Hall Pharmacy Technician Series, Sterile Products is a comprehensive book covering the complex practice of sterile product preparation and correct aseptic technique. It covers principles of aseptic technique, terms, methods, products and includes a "how-to" on standard sterile product preparations.Pharmacy Technician Students and Professionals.
Author : E. Clyde Buchanan
Publisher :
ISBN 13 :
Total Pages : 364 pages
Book Rating : 4.3/5 (91 download)
Download or read book Compounding Sterile Preparations written by E. Clyde Buchanan and published by . This book was released on 2005 with total page 364 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rev. ed. of: Principles of sterile product preparation / E. Clyde Buchanan ... [et al.]. 1995.
Author : Pamella S. Ochoa
Publisher : Jones & Bartlett Publishers
ISBN 13 : 1449678645
Total Pages : 426 pages
Book Rating : 4.4/5 (496 download)
Download or read book Concepts in Sterile Preparation and Aseptic Technique (book) written by Pamella S. Ochoa and published by Jones & Bartlett Publishers. This book was released on 2014-02-28 with total page 426 pages. Available in PDF, EPUB and Kindle. Book excerpt: Concepts in Sterile Preparations and Aseptic Technique examines the current standards and best practices for sterile compounding, along with the fundamentals of aseptic technique, in a manner accessible to pharmacy and pharmacy technician students and professionals. Beginning with a review of foundational calculations and microbiological considerations, this resource reviews compatibility, stability, engineering controls, and quality assurance and control, with pertinent information from USP Chapter incorporated throughout. With engaging case studies, tips, alerts, and accompanying video tutorials, this text facilitates student learning through a robust companion website for students as well as helpful instructor resources. Video Tutorial Topics and Procedures: HLFW Cleaning, Hand Washing, Garbing, Sterile Glove, Attaching Needle to Syringe, Accessing a Vial, Equal Pressure (Milking), Equal Pressure (Reverse Milking), Removal of Air Bubbles, Ampule Breaking, Using a Filter Needle, Using a Filter Straw, Reconstituting a Vial, Uncapping and Recapping a Needle, Capping a Syringe, Priming Infusion Set, Positive Pressure, Negative Pressure, Workflow, Incompatibility, Fingertip Testing Instructor Resources: Instructor's Manual including Lab Activities and Supply List, Answer Key for Review Questions and Case Studies, PowerPoint Presentations with 375 slides, Test Bank with 189 Multiple Choice, Fill-in-the-Blank, and Short Answer questions. Student Resources: Navigate Companion Website, including: Videos, Quizzes, Interactive Glossary, Interactive Flashcards, Crossword Puzzles, Matching Exercises, Web Links Each new text includes an online access code to the Navigate Companion Website. Electronic and eBook formats may not include access to the Navigate Companion Website. Access may also be purchased separately.
Author : Karen Davis
Publisher : Elsevier Health Sciences
ISBN 13 : 0323709818
Total Pages : 226 pages
Book Rating : 4.3/5 (237 download)
Download or read book Mosby's Sterile Compounding for Pharmacy Technicians written by Karen Davis and published by Elsevier Health Sciences. This book was released on 2019-12-01 with total page 226 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Author : Parag Kolhe
Publisher : Springer Science & Business Media
ISBN 13 : 1461479789
Total Pages : 585 pages
Book Rating : 4.4/5 (614 download)
Download or read book Sterile Product Development written by Parag Kolhe and published by Springer Science & Business Media. This book was released on 2013-10-12 with total page 585 pages. 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.
Author : E. Clyde Buchanan
Publisher : ASHP
ISBN 13 : 1585283312
Total Pages : 497 pages
Book Rating : 4.5/5 (852 download)
Download or read book Compounding Sterile Preparations written by E. Clyde Buchanan and published by ASHP. This book was released on 2009-02-01 with total page 497 pages. Available in PDF, EPUB and Kindle. Book excerpt: Empower your staff to improve safety, quality and compliance with the help of new guidelines and standards. We’ve updated every chapter of this popular review of the fundamentals of preparing sterile products in hospital, home-care, and community pharmacy settings to reflect the most recent revisions to USP . Included are the latest guidelines for the compounding process, quality assurance methods, and comprehensive coverage of all aspects of the dispensing process. Comprehensive documentation for the guidelines is included in the appendices.Chapters new to this edition focus on: Gap analysis and action plans Safe use of automatic compounding devices Cleaning and disinfecting Radiopharmaceuticals as CSPs Allergen extracts as CSPs.
Author : Michael J. Akers
Publisher : CRC Press
ISBN 13 : 1420020560
Total Pages : 516 pages
Book Rating : 4.4/5 (2 download)
Download or read book Sterile Drug Products written by Michael J. Akers and published by CRC Press. This book was released on 2016-04-19 with total page 516 pages. 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 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.
Author : Igor Gorsky
Publisher : Academic Press
ISBN 13 : 012809446X
Total Pages : 300 pages
Book Rating : 4.1/5 (28 download)
Download or read book Principles of Parenteral Solution Validation written by Igor Gorsky and published by Academic Press. This book was released on 2019-11-27 with total page 300 pages. Available in PDF, EPUB and Kindle. Book excerpt: Principles of Parenteral Solution Validation: A Practical Lifecycle Approach covers all aspects involved in the development and process validation of a parenteral product. By using a lifecycle approach, this book discusses the latest technology, compliance developments, and regulatory considerations and trends, from process design, to divesting. As part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin, this book incorporates numerous case studies and real-world examples that address timely problems and offer solutions to the daily challenges facing practitioners in this area. Discusses international and domestic regulatory considerations in every section Features callout boxes that contain points-of-interest for each segment of the audience so readers can quickly find their interests and needs Contains important topics, including risk management, the preparation and execution of properly designed studies, scale-up and technology transfer activities, problem-solving, and more
Author : Patricia C Kienle
Publisher :
ISBN 13 : 9781585286812
Total Pages : pages
Book Rating : 4.2/5 (868 download)
Download or read book The Sterile Compounding Answer Book written by Patricia C Kienle and published by . This book was released on 2020-10 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : American Society of Health-System Pharmacists
Publisher : ASHP
ISBN 13 : 1585282324
Total Pages : 111 pages
Book Rating : 4.5/5 (852 download)
Download or read book Compounding Sterile Preparations: Ashp's Video Guide to Chapter Workbook written by American Society of Health-System Pharmacists and published by ASHP. This book was released on 2009-01-07 with total page 111 pages. Available in PDF, EPUB and Kindle. Book excerpt: An essential component of your competency assessment and training program, the companion guide and assessment record contains: In-dept review material to highlight and reinforce the video presentation, exercises to enhance understanding of key concepts, summary checklists, assessment questions, and an individual assessment record to document completion of the program.
Author : Alison M. Beaney
Publisher :
ISBN 13 : 9780857113078
Total Pages : 0 pages
Book Rating : 4.1/5 (13 download)
Download or read book Quality Assurance of Aseptic Preparation Services written by Alison M. Beaney and published by . This book was released on 2016 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Quality Assurance of Aseptic Preparation Services Standards Handbook (also known as the Yellow Guide) provides standards for unlicensed aseptic preparation in the UK, as well as practical information to aid implementation of the standards. The handbook delivers essential standards in a practical way and in a format that will be useful for pharmacy management, staff working in aseptic preparation units and those whose role it is to audit the services. The accompanying support resources help with understanding the complexities of relevant topics including microbiology, radiopharmaceuticals, advanced therapy medicinal products, technical (quality) agreements and capacity planning. All the standards have been revised and updated for this 5th edition. The text is produced on behalf of the Royal Pharmaceutical Society (RPS) and the NHS Pharmaceutical Quality Assurance Committee. New in this edition: Replaces the 4th edition standards and forms the basis for an ongoing audit program in the NHS Many new and revised standards Greater emphasis on Pharmaceutical Quality Systems; the responsibilities of pharmacy management, Chief Pharmacists (or equivalent), has been expanded in line with developments in Good Manufacturing Practice Reformatted into 2 parts: standards and support resources. This is a new collaboration between the RPS and NHS. Since the previous edition the RPS has become the professional body for pharmacists and pharmaceutical scientists. RPS launched these standards as part of a library of professional standards and a programme of work to create standards for all areas of pharmacy. The Handbook is essential for pharmacists, hospital pharmacy management and technical services teams, and auditors of unlicensed NHS hospital pharmacy aseptic preparation services in the UK, pharmacists and regulators. The text is used to inform standards used in several other countries.
Author : Sarwar Beg
Publisher : Academic Press
ISBN 13 : 0128163720
Total Pages : 448 pages
Book Rating : 4.1/5 (281 download)
Download or read book Pharmaceutical Quality by Design written by Sarwar Beg and published by Academic Press. This book was released on 2019-03-27 with total page 448 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (QbD) concept implemented by regulatory agencies to ensure the development of a consistent and high-quality pharmaceutical product that safely provides the maximum therapeutic benefit to patients. The book walks readers through the QbD framework by covering the fundamental principles of QbD, the current regulatory requirements, and the applications of QbD at various stages of pharmaceutical product development, including drug substance and excipient development, analytical development, formulation development, dissolution testing, manufacturing, stability studies, bioequivalence testing, risk and assessment, and clinical trials. Contributions from global leaders in QbD provide specific insight in its application in a diversity of pharmaceutical products, including nanopharmaceuticals, biopharmaceuticals, and vaccines. The inclusion of illustrations, practical examples, and case studies makes this book a useful reference guide to pharmaceutical scientists and researchers who are engaged in the formulation of various delivery systems and the analysis of pharmaceutical product development and drug manufacturing process. Discusses vital QbD precepts and fundamental aspects of QbD implementation in the pharma, biopharma and biotechnology industries Provides helpful illustrations, practical examples and research case studies to explain QbD concepts to readers Includes contributions from global leaders and experts from academia, industry and regulatory agencies
Author : James P. Agalloco
Publisher : CRC Press
ISBN 13 : 1420019791
Total Pages : 760 pages
Book Rating : 4.4/5 (2 download)
Download or read book Validation of Pharmaceutical Processes written by James P. Agalloco and published by CRC Press. This book was released on 2007-09-25 with total page 760 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : David Roesti
Publisher : John Wiley & Sons
ISBN 13 : 1119356075
Total Pages : 594 pages
Book Rating : 4.1/5 (193 download)
Download or read book Pharmaceutical Microbiological Quality Assurance and Control written by David Roesti and published by John Wiley & Sons. This book was released on 2020-01-02 with total page 594 pages. Available in PDF, EPUB and Kindle. Book excerpt: Relying on practical examples from the authors’ experience, this book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals. Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks
Author : David B. Troy
Publisher : Lippincott Williams & Wilkins
ISBN 13 : 9780781746731
Total Pages : 2452 pages
Book Rating : 4.7/5 (467 download)
Download or read book Remington written by David B. Troy and published by Lippincott Williams & Wilkins. This book was released on 2006 with total page 2452 pages. Available in PDF, EPUB and Kindle. Book excerpt: For over 100 years, Remington has been the definitive textbook and reference on the science and practice of pharmacy. This Twenty-First Edition keeps pace with recent changes in the pharmacy curriculum and professional pharmacy practice. More than 95 new contributors and 5 new section editors provide fresh perspectives on the field. New chapters include pharmacogenomics, application of ethical principles to practice dilemmas, technology and automation, professional communication, medication errors, re-engineering pharmacy practice, management of special risk medicines, specialization in pharmacy practice, disease state management, emergency patient care, and wound care. Purchasers of this textbook are entitled to a new, fully indexed Bonus CD-ROM, affording instant access to the full content of Remington in a convenient and portable format.
Author : Ryan Forrey
Publisher : ASHP
ISBN 13 : 1585286508
Total Pages : 1069 pages
Book Rating : 4.5/5 (852 download)
Download or read book Compounding Sterile Preparations written by Ryan Forrey and published by ASHP. This book was released on 2023-11-13 with total page 1069 pages. Available in PDF, EPUB and Kindle. Book excerpt: The latest edition of Compounding Sterile Preparations by Ryan A. Forrey, Lindsey B. Amerine, and Angela W. Yaniv reflects the latest advancements in the field, providing you with an indispensable resource to navigate the complex landscape of sterile compounding. New in this Edition: Updated Standards: All chapters have undergone extensive revisions to align with the most recent literature and the revised USP standards. USP Chapter : Now includes information on radiopharmaceutical compounding in USP Chapter . Expanded Knowledge Base: Two brand-new chapters covering Allergenic Extracts and Corrective and Preventative Action (CAPA) Plans.
