USP 797 text regarding: Personnel Training and Evaluation in Aseptic Manipulation Skills
Personnel who prepare CSPs must be provided with appropriate training from expert personnel, audio-video instructional sources, and professional publications in the theoretical principles and practical skills of aseptic manipulations before they begin to prepare CSPs. Compounding personnel shall perform didactic review, and pass written and media-fill testing of aseptic manipulative skills initially; at least annually thereafter for low- and medium-risk level compounding; and semi-annually for high-risk level compounding.
Media-Fill Challenge Testing — The skill of personnel to aseptically prepare CSPs may be evaluated using sterile fluid bacterial culture media-fill validation, (i.e., sterile bacterial culture medium transfer via a sterile syringe and needle). Media-fill testing is used to assess the quality of the aseptic skill of compounding personnel. Media-fill tests represent the most challenging or stressful conditions actually encountered by the personnel being evaluated.
- Audio-Video Instruction
- Q&A with Lecturer
- Written Test
- Practical Exam with Didactic Review
- Annual Media-Fill Testing
- Annual Fingertip Sampling
- Hazardous Compounding Verification for Antineoplastic Drugs
Cancer centers and facilities providing intravenious chemotherapy have unique requirements under USP 797. Not only must they satisfy requirements of USP 797 that apply to all pharmacies but they must also be concerned with specific hazards presented by mixing of antineoplastic drugs.
Safe Compounding Verification
Staff compounding antineoplastic / cytotoxic agents should be trained to recognize and prevent exposure. AseptRx Chemo training addresses requirements of NIOSH (bulletin on antineoplastic agents) and OSHA. In addition to media-fill testing, facilities mixing antineoplastic agents can verify technique by using fluoresceins as a marker for annual evaluation of personnel.
Surface Contamination SamplingIn addition to personnel verification we also provide surface contamination testing for antineoplastic drugs.
NIOSH Bulletin on Antineoplastic Agents
1360 Union Hill Rd, 4G Alpharetta, GA