Finding the Right USP <797> Media-Fill Test Kit
Use our comparison chart to clarify how USP <797> Categories 1, 2, and 3 differ across compounding environments, BUD limits, requalification intervals, and typical use. This resource enables your team to select the appropriate IVQA media-fill test kit and plan training and documentation with confidence.
| Category | Compounding environment | BUD limits | Common facilities & use cases | Competency requalification | Key controls / notes |
|---|---|---|---|---|---|
| Category 1 | ISO 5 PEC in a Segregated Compounding Area (SCA) (unclassified room). No cleanroom suite required |
≤ 12 h at room temp ≤ 24 h refrigerated |
Allergy & immunotherapy practices; veterinary pharmacies; outpatient clinics; smaller 503A pharmacies compounding under SCA conditions. |
Every 6 months (aseptic manipulation media-fill, post-GFT, surface sampling). Garbing competency: every 6 months. |
Only Category 1 preparations may be compounded in an SCA. Place the PEC away from doors, windows, and traffic. |
| Category 2 | ISO 5 PEC inside a cleanroom suite (ISO 7 buffer + ISO 8 anteroom). | BUDs > 12 h at room temp and > 24 h refrigerated (per USP <797> tables/conditions). | 503A pharmacies (independent/community); hospital inpatient & health-system cleanrooms; home-infusion providers; oncology/infusion centers. |
Every 6 months (aseptic manipulation media-fill, post-GFT, surface sampling). Garbing competency: every 6 months. |
Follow cleanroom suite requirements (e.g., PEC placement/air classification). Pre-sterilization steps using non-sterile components occur in ISO 8 or better. |
| Category 3 | Cleanroom suite as in Category 2 plus enhanced controls and testing. | Extended BUDs beyond Category 2 (within USP <797> limits when all added controls are met). | Large compounding operations; 503B outsourcing facilities; health-system cleanrooms pursuing extended dating. |
Every 3 months (aseptic manipulation media-fill, post-GFT, surface sampling). Garbing competency: every 3 months. |
No exposed skin; sterile outer garments; stricter environmental/personnel monitoring and additional testing requirements. |
Buying tips
- Use one kit per technician for initial qualification and at each interval (Category 1/2: every 6 months; Category 3: every 3 months).
- COA included: Every IVQA media-fill test kit ships with a Certificate of Analysis. Each lot is growth-promotion verified and sterility-tested.
- Abbreviations: BUD = Beyond-Use Date; PEC = Primary Engineering Control; SCA = Segregated Compounding Area.