Sterile product preparation for nonpharmacy personnel dennis. Concepts training and assessment for pharmacy technicians. The intent of this book is to provide a source of information for these topics. Click download or read online button to get sterile compounding and aseptic technique book now. Aseptic technique must be followed for preparing any sterile medication. Innovative techniques to ensure competency continuing education accreditation the american society of healthsystem pharmacists is accredited by the accreditation council for pharmacy education as a. Aseptic techniques for compounding nonhazardous preparations for pharmacists this activity explains first air, aseptic technique in horizontal and vertical airflow, reconstituting powders, and appropriate compounding behaviors to prevent or minimize sharps injuries. Sterile compounding initial certification requirements for.
The newest addition to our pharmacy technicians product group is sterile compounding and aseptic technique. This is not considered training for sterile product preparation or certification for aseptic technique presentation contains a broad overview of best practices associated with sterile product preparation and not all information contained within will apply to all sites all sites must comply with all protocolspecific documents. Pharmaceutical compoundingsterile preparations, usp 41. The sterile compounding and aseptic technique scat course provides an overview of methods and regulation of sterile products, as well as instruction and training for the mastery of aseptic technique and the successful production of sterile preparations. Sterile products and aseptic techniques for the pharmacy. Cacia compounding aseptic isolator cai tion, usually a chemical agent but sometimes a. Assemble the materials that you will need near a designated area for sterile product preparation. Aseptic technique checklist for sterile products prepared outside of the pharmacy for immediate use begin using within 1 hour of preparation. Nov 22, 2019 aseptic technique must be followed for preparing any sterile medication.
Concepts in sterile preparations and aseptic technique. Students used criticalthinking skills to devise appropriate strategies to compound sterile. Sterile products and aseptic techniques for the pharmacy technician 2nd edition. Guidance on the manufacture of sterile pharmaceutical. Aseptic preparation admixture preparation program includes. The author discusses various approaches that may be taken to ensure a successful training session. The chapter stratifies the compounding of all sterile products, including irrigations and ophthalmic preparations, into 3 risk levels based on the sterility of the bulk ingredients and the degree of manipulation required to make the final product. Chapter 1 5 1 sterile co m p o u n d i n g as a phar macy te c h n i c i a n le a r n i n g ob j e c t i v e s gain awareness of the historical roots of pharmacy and sterile compounding. It is designed to maintain an aseptic compounding environment within the isolator throughout the compounding and material transfer processes. As such, it is imperative that they perform as designed and that the resulting levels of. It is important that pharmacists understand fundamentals of aseptic technique, as well as current standards and best practices as they relate to sterile compounding. Sterile compounding and aseptic technique,second edition. Sterile compounding and aseptic technique is integrated in cirrus, a cloudbased learning environment designed to elevate student success and improve instructor efficiency.
Design considerations of a compounded sterile preparations course. Activities in a cleanroom include manipulations of sterile materials. Provides guidance on aseptic technique skill assessment and media fill testing. Achieving and maintaining excellence in sterile compounding.
Part of the pharmacy technician series, sterile products is a comprehensive book covering the complex practice of sterile product preparation and correct aseptic technique. Examine importance of sterility when utilizing aseptic technique to prepare iv products and the role of usp chapter 797 in maintaining infection. Determine risk level associated with various sterile compounding scenarios. Whenever medications are prepared, staff uses safety materials and equipment while preparing hazardous medications. Comprehensively covering sterile products, aseptic technique, and the workings of the sterile compounding facility, mosbys sterile compounding for pharmacy technicians. Aseptic technique is absolutely necessary for the successful establishment and maintenance of plant cell, tissue and organ cultures. Pec may not be turned off unless it will remain off for 8 or more. Aseptic technique skill assessment and media fills august 25, 2016 on vimeo join. Online resources to help reinforce the who 7step method were made. Simplified compounded sterile preparation csp microbial risk levels from three.
Aseptic techniques for compounding nonhazardous preparations. For compounding sterile preparations organizational practices employed for compounding sterile preparations are in compliance with usp standards related to sterile compounding. Updated in a brand new edition, this book covers the latest principles of aseptic technique, terms, methods, products and includes a howto on standard sterile product. Sterile compounding and aseptic technique download ebook. Horrifically poor aseptic technique completely blocking first. Guidance on the manufacture of sterile pharmaceutical products by aseptic processing 3 environment is commonly referred to as grade b. Aseptic techniques for compounding non hazardous preparations this activity explains first air, aseptic technique in horizontal and vertical airflow, reconstituting powders, and appropriate compounding behaviors to prevent or minimize sharps injuries. The course is designed to confirm understanding of usp797 principles related to sterile compounding and aseptic technique. Ashp guidelines on compounding sterile preparations. Sterile product preparation for nonpharmacy personnel. Sterile compounding also requires specific personnel training and testing, and the ability of personnel to carry out aseptic manipulations. Evolution of sterile compounding standards, 19702010. In other words, proper sterile compounding includes everything from proper hand washing and gowning and proper inspection of sterile preparations, to understanding facilities design, testing, and maintenance. Review of sterile compounding per usp 797 and related.
Principles and practice, 2nd edition, focuses on safe and accurate practice. Describe the ways that sterile compounding and aseptic technique processes may affect patient health and safety. E5662, 2018, 6 pages an indepth guide to all aspects of aseptic compounding work, including proper hand techniques and maintenance of sterile supplies and equipment, aseptic compounding technique. Aseptic technique and sterile compounding flashcards. The differences between sterile and aseptic technique are easily misunderstood, and sometimes used interchangeably. As part of paradigms pharmacy technician series, this courseware provides stepbystep instruction in sterile compounding and aseptic technique, or the aseptic preparation of compounded sterile preparations. Acquisition and retention of sterile compounding accuracy. All sterile compounding procedures in this courseware are aligned with usp chapter rev. Only the pharmacy compounds or admixes all sterile medications, intravenous admixtures, or other drugs except in emergencies or when not feasible for example, when the products stability is short. Topics include pertinent information from usp chapter 797, calculations, microbiological considerations, selection of sterile compounding equipment, engineering controls, aseptic technique, stability and compatibility considerations, quality assurance and product verification. The aseptic operations must be conducted in a controlled environment.
Choose from 332 different sets of aseptic technique sterile compounding flashcards on quizlet. Aseptic technique skills were assessed with objective, structured. Development and maintenance of a sterile compounding area, complete with sterilized equipment and supplies. In the immediate area in which sterile compounding is taking place, there must be no more than 3520. Whats the difference between sterile and aseptic technique. This is a critical area because any exposed product is vulnerable to contamination. Compounding technique,54 getting started in aseptic compounding,55 and compounding sterile preparations. Aseptic technique, sterile compounding, and iv admixture programs. Compounding aseptic isolator cai formerly referred to as an isolator or glovebox, this device provides an iso class 5 environment and is designed to maintain an aseptic compounding environment within the isolator throughout the. Prepare only 1 product at a time for safety reasons. Design considerations of a compounded sterile preparations. Sterile compounding as a pharmacy technician chapter 1 7 t he pharmacy practice of sterile compounding involves the dilution, mixing, and injection of various medication products using aseptic technique. Compounded sterile preparations laboratory is a required 1credit course that builds upon the themes of training aseptic technique typically used in health system settings and. Procedures must be in place to minimize the potential for contact with nonsterile surfaces, introduction of particulate matter or biological fluids, and mixups with other products or csps.
Gain a complete introduction to institutional pharmacy practice and efficiently prepare for the new sterile compounding certification exam. Compounded sterile preparations laboratory is a required 1credit course that builds upon the. A practical guide to aseptic technique verification pharmacy. Innovative techniques to ensure competency continuing education accreditation the american society of healthsystem pharmacists is accredited by the accreditation council for pharmacy education as a provider of continuing pharmacy education. Create a lowrisk compounded sterile product in a laminar flow hood using aseptic technique. Alabama state board of pharmacy 205 9812280 sterile. Compounding aseptic isolator caithe cai is a form of barrier isolator specifically designed for compounding pharmaceutical ingredients or preparations. These practices combine the major features of universal precautions up and body substance isolation bsi and are based on the principle that all blood, body fluids, secretions, excretions except sweat, nonintact skin, and mucous membranes may contain transmissible. The aseptic technique of each person compounding and dispensing sterile products shall be observed and evaluated as satisfactory during orientation and training and at least on an annual basis or whenever. This comprehensive program combines the concepts foundation of a textbook with the skills practice of a training manual. The course also provides an overview of the procedures and requirements for teaching the scat iv certification course once the instructors. Verification of competency in sterile product preparation. The didactic and experiential training shall include instruction, experience, and demonstrated proficiency in the following areas.
Participants must demonstrate safe and accurate preparation of a sterile parenteral admixture in a laminar air flow hood lafh with emphasis on aseptic technique and meeting the standards established by the canadian society of hospital pharmacists cshp, usp chapter 797 and. A set of practices that lowers the possibility of contamination and lowers the risk of transmission of infectious disease. The organization implements welldefined policies and procedures to guide the compounding of sterile preparations. Aseptic technique is a means of manipulating sterile products without compromising their. The in vitro environment in which the plant material is grown is also ideal for the proliferation of microorganisms. Feb 25, 2016 compounded sterile preparations laboratory is a required 1credit course that builds upon the themes of training aseptic technique typically used in health system settings and threads application of concepts from other courses in the curriculum. It includes clear stepbystep instructions and brief. Ismp guidelines for safe preparation of compounded sterile. Under aseptic conditions and using aseptic techniques, affix a sterile. Articulate principles for maintaining a low or medium risk sterile compounding environment. Background on sterile preparation compounding safety. As you work from chapter 6 to chapter 14, you progress from the most basic concepts in aseptic technique to more advanced procedures, such as tpn and chemotherapy preparation.
Compounding aseptic containment isolator caci a compounding aseptic isolator cai designed to provide worker protection from exposure to undesirable levels of airborne drug throughout the compounding and material transfer processes and to provide an aseptic environment for compounding sterile preparations. This is not considered training for sterile product preparation or certification for aseptic technique presentation contains a broad overview of best practices associated with sterile product preparation and not all information contained within will apply to all sites all. A process by which environmental or equipment bioburden is reduced to a safe level or eliminated. Acquisition and retention of sterile compounding accuracy skills. Certification procedures such as those outlined in certification guide for sterile compounding facilities cag003 2006 shall be performed by a qualified individual no less than every 6 months and whenever the device or room is relocated or altered or major service to the facility is performed. Compounding aseptic isolators cai or compounding aseptic containment isolators caci may be placed in less than iso 8 environments, if manufacturers provide documentation that the isolator meets such specifications. Development and maintenance of the skills needed to properly use a laminar airflow workbench lafw or laminar airflow hood. Aseptic technique is directly associated with these practices.
This site is like a library, use search box in the widget to get ebook that you want. Prepare only 1 product at a time for safety reasons perform any necessary pharmaceutical calculations and double. To design a comprehensive learning and assessment environment for the practical application of compounded sterile preparations using a constructivist approach. Concepts, training, and assessment for pharmacy technicians. Training for aseptic processing environments anne marie dixon merck kgaa training for aseptic processing cleanrooms must be a dynamic process to meet job requirements and industry demands. Personal protective equipment ppe osha requires the use these garments designed to protect the wearers body from injury or infection when engineering and administrative controls are not feasible or effective to reduce these risks to acceptable levels. Prepares students for passing process validation checklists. Initial orientation and training to sterile compounding didactic training and evidence of training on pnps testing documentation of observation of staff competencies hand hygiene and garbing competency including gfs on initial aseptic technique cleaning and disinfecting. Personnel should not be permitted to compound sterile preparation for use by patients. Learn aseptic technique sterile compounding with free interactive flashcards. The key distinction between the two is essential for favorable outcomes during pharmaceutical and cleanroom operations.
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