Our professionals began preparing this procedure manual in 2004 to aid pharmacists/hospitals in complying with USP 797. Two components of compliance exist; first, the physical environment, hoods/workbenches that must be present and certified for use. Second, and equally important, the procedures that need to be in place for personnel to follow while compounding. This manual provides a complete, easy-to-follow accounting of those procedures in an easy to use format.
A Gap Analysis is easily performed by first downloading the risk assessment tool from USP 797, completing the survey questions to identify where the gaps in service exist for each level of solutions prepared; Low Risk, Medium Risk, and High Risk Levels.
Personnel who prepare sterile compounds should be provided with the appropriate training from qualified personnel, audio-video instructional sources, and professional publications in the principles and practices of aseptic techniques before they begin to compound.
The pharmacy provides initial and on-going evaluation of the performance of pharmacists, pharmacy technicians, and students in the aseptic preparation of infusion admixtures.
All parenteral admixtures, including hyper alimentation requiring the Pharmacy's preparation will be performed in the ISO 5 environment of the buffer room employing aseptic technique. The following procedure should be followed in the preparation of any parenteral admixture. If a technician prepares the solution, all of his/her work must be supervised and checked by a pharmacist.
The pharmacy compounding area will be cleaned on a regular basis due to the critical nature of preparing sterile products. Cleaning will be documented on the Admixture Room Quality Assurance Record.
Cleaning of ALL surfaces and equipment (walls, counters, fixture, worktables, BSC, etc.) will be carried out utilizing approved disinfectant/detergents.
Compounding work surfaces will be tested on a monthly basis using the QI Medical EnviroTest. Other sampling media vendors include: Biotest Diagnostic Corporation, Hardy Diagnostics, and Q.I. Medical Incorporated.
Surface sampling will be performed monthly at the end of the compounding day for each worktable and Biological Safety Cabinet. Sampling will be performed even if no compounding has occurred during the week.
Worktables and biological safety cabinet air quality will be tested on a monthly basis using the QI Medical EnviroTest. Air sampling will provide information on the operational effectiveness of the buffer room and biological safety cabinet air filtration system.
References: Kastango, ES. Blueprint for implementing USP Chapter 797 for compounding sterile preparations, AM J Health - Syst Pharm. 2005; 62, 1283 Documentation to be considered in Quality Assurance Program:
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