USP General Chapter <797> has been in-place for about three months and many pharmacies are scrambling to put the finishing touches on their quality management programs. Compliance to the new standards has not come without growing pains as pharmacists continue to focus on incorporating best practices into their compounding operations. One of the resulting challenges is the need for pharmacy to augment policy and procedures, including how the pharmacy will handle the processing of personnel competency, aseptic work practices, and required media fill samples.
Increase in Testing
The USP General Chapter mentions these critical media samples:
- Media fill challenge testing
- Verification of compounding accuracy and sterilityn
- Viable and nonviable environmental air sampling (ES) testingn
- Gloved fingertip samplingn
- Finished preparation release checks and tests
Historically, the majority of pharmacies have left quality testing (e.g., environmental monitoring and cleanroom testing) to outside providers. However, with the volume and type of testing now required, this is no longer practical or cost effective. The additional need for processing of personnel competencies, aseptic work practices, and required media fill samples mean a significant increase in the amount of testing for pharmacies producing CSPs.
Hospital-based pharmacies that previously benefited by having their in-house pathology laboratories process media samples are moving to processing their own media testing units for numerous reasons. An in-house pathology lab represents an advantage when a culture and sensitivity (C&S) of a positive test sample is required; however, it is not a requirement for routine testing.
Benefits of having an incubator in the pharmacy include:
- Decreased costs compared to outside testing
- Confidence in the reliability of the results
- Decreased turnaround time for results (since the pharmacy only processes its own samples)
- Use of the process as a learning tool
The main objective of USP General Chapter <797> is to prevent harm to patients. Harm can result from many factors including the microbial contamination (non-sterility) of CSPs provided by your pharmacy. All personnel engaged in these operations must thoroughly familiarize themselves with these requirements, the use of all supplies, and the use of equipment before attempting any quality testing and the interpretation of the results.
Having said this, it is important to recognize that just as personnel training, proper equipment and constant vigilance in the compounding process is required to produce a safe CSP, the proper focus and training with respect to media testing is crucial in carrying out and proper interpretation of these results.
It is critical that your pharmacy have all the necessary materials and equipment to properly carry out testing before embarking on this process. The selection of a suitable incubator is a major piece of the equipment selection. Making the proper selection of an incubator amid the numerous choices available can be daunting. See Figure 1 for features and functions to consider when making your incubator selection. Please note that the incubator requirements and tolerances set forth in USP General Chapter <797> have been harmonized with USP General Chapter <71> — Sterility Testing and USP <1116> — Microbiological Evaluation of Clean Rooms and Other Controlled Environments.
The advent of changes introduced by USP <797> has resulted in the pharmacy augmenting their policies and procedures. Proper equipment and constant vigilance in the compounding process is required to produce a safe CSP. Proper focus and training in the media testing process is crucial in carrying out and interpreting testing results. The processing of personnel competency, aseptic work practices, and required media fill samples has increased the need for an incubator in the pharmacy.
David l Thomas, RPh, MBA, is a principal of LDT Health Solutions, Inc., a quality management consulting company. Mr. Thomas previously served as the director of information technology operations for SoluNet, LLC. Mr. Thomas served as the manager of implementation and technology development for Baxter Healthcare and as the technology systems manager for Baxter’s COMPASS Group. Before his 15-year tenure with Baxter, Dave held hospital practice and management positions for five years. Dave is a graduate of St. Louis College of Pharmacy.
Lou Diorio, RPh, is a principal of LDT Health Solutions, Inc., a quality management consulting company. Lou is a graduate of Long Island University’s Schwartz College of Pharmacy, where he is also an adjunct professor of pharmacy practice and preceptor of pharmacy students. He is also the 2008-2009 chair of APhA’s Academy of Practice and Management, Section on Administrative Practice. Lou has practiced in and managed pharmacies in hospital, home care, and retail settings.
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