Concepts in Sterile Preparation and Aseptic Technique (book) PDF Download

Author: Pamella S. Ochoa
Publisher: Jones & Bartlett Publishers
ISBN: 1449678645
Category : Medical
Languages : en
Pages : 426

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Book Description
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:
Publisher: Amer Soc Health-System Pharmacists
ISBN:
Category : Medical
Languages : en
Pages : 196

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Book Description

Author: Parag Kolhe
Publisher: Springer Science & Business Media
ISBN: 1461479789
Category : Medical
Languages : en
Pages : 590

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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: Mike Johnston
Publisher: Prentice Hall
ISBN: 9780135109649
Category : Asepsis and antisepsis
Languages : en
Pages : 0

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Book Description
1 Introduction to Sterile Products 2 USP, Compounding Areas, and Equipment 3 Aseptic Calculations 4 Properties of Sterile Products 5 Aseptic Technique 6 Sterile Product Preparations 7 Total Parenteral Nutrition (TPN) 8 Chemotherapy 9 Quality Control and Assurance Appendix A Terminology and Abbreviations Appendix B Common Intravenous Medications Appendix C Training and Validation Forms Appendix D Instructions for Left-Handed Personnel Appendix E Institutional IV Certification Test

Author: Igor Gorsky
Publisher: Academic Press
ISBN: 012809446X
Category : Medical
Languages : en
Pages : 300

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Book Description
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: Michael J. Akers
Publisher: CRC Press
ISBN: 1420020560
Category : Medical
Languages : en
Pages : 517

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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: Patricia C Kienle
Publisher:
ISBN: 9781585286812
Category :
Languages : en
Pages :

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Book Description

Author: E. Clyde Buchanan
Publisher: ASHP
ISBN: 1585283312
Category : Medical
Languages : en
Pages : 497

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Book Description
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: Karen Davis
Publisher: Elsevier Health Sciences
ISBN: 0323709818
Category : Medical
Languages : en
Pages : 226

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Book Description
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: Alison M. Beaney
Publisher:
ISBN: 9780857113078
Category : Asepsis and antisepsis
Languages : en
Pages : 0

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Book Description
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.