Examples of USP 797 Tasks
Examples of USP 797 Tasks
CAPS (Central Admixture Pharmacy Services) list these examples of what it will take to comply with USP 797:
- Every bottle, vial, syringe, bag, etc. brought into the clean room must be decontaminated.
- Storeroom carts can't go into the buffer room and vice versa.
- No cardboard, paper towels, or cotton items in the buffer zone or clean room.
- Minimize traffic flow into and out of the buffer zone.
- No gum, candy, or food in the buffer area.
- Arrange items in hood to avoid blocking air flow.
- Daily cleaning and sanitizing of all buffer room carts, equipment, hoods, work surfaces, and floors.
- Daily calibration and verification of accuracy of all automated compounding equipment.
- Documentation of all compounding activities.
- No makeup or jewelry.
- Scrub hands and arms to elbow.
- Hair covers, shoe covers, knee-length coats or coveralls, and gloves.
- Sterile or nonsterile gloves. (Nonsterile gloves must be sanitized with sterile filtered alcohol.)
- Re-sanitize gloves frequently with sterile filtered alcohol.
- Coveralls can be reused throughout the day, but all other items should not be reused.
- Verification of compounding activity conducted by someone other than the compounder to ensure proper measurement, reconstitution, and component usage.
- Visual inspection: no PM, no leakage, accuracy and thoroughness of labeling.
- For high-risk compounding, sterility and bacterial endotoxin testing, filter integrity testing.
- Labeling in compliance with storage and expiration dating requirements.
- Clean and sanitize anteroom weekly and shelving monthly.
- Clean and sanitize buffer room shelves at least weekly.
- Routine disinfecting and air quality testing: weekly air bio-burden for high-risk areas, and monthly for low- and medium-risk areas.
- Review of environmental monitoring and enforcement of alert and action limit contingency programs.
- Review of calibration data and enforcement of contingency programs.
- Review of cleaning logs and compounding documentation to ensure compliance, with enforcement of contingency plans for noncompliance.
- Patient monitoring and adverse event reporting.
- High-risk compounding training and documentation for all personnel involved in compounding sterile preparations initially and semiannually — written and didactic review.
- Semiannual media fills for high-risk compounding.
- Low- and medium-risk compounding training and documentation for all personnel involved in compounding sterile preparations initially and annually — written and didactic review.
- Annual media fills for low- and medium-risk compounding for all personnel involved in compounding sterile preparations.
- Room, hood, and equipment certification.
- Analysis of Quality Assurance program and effectiveness.
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