What is USP <797>?
USP <797> refers to chapter 797 “Pharmaceutical Compounding – Sterile Preparations,” in the USP National Formulary. It is the first set of enforceable sterile compounding standards issued by the United States Pharmacopeia (USP). USP <797> describes the guidelines, procedures and compliance requirements for compounding sterile preparations and sets the standards that apply to all settings in which sterile preparations are compounded.
Air Sampling per USP <797>
- An appropriate environmental sampling plan for shall be developed based on risk assessment.
- Air sampling shall be performed at least SEMIANNUALLY as part of the re certification of facilities and equipment.
- A sufficient volume of air 400 to 1,000 liters should be tested.
- An environmental sampling program for viable airborne particles MUST be developed and implemented in all classified areas.
- Active air sampling of all ISO-classified areas must be conducted at least MONTHLY during typical operating conditions.
- A volume of 1,000 ( 1 cubic meter) liters shall be tested.
Fingertip Sampling per USP <797>
- Low and Medium Risk compounding personnel shall be tested annually.
- High Risk compounding personnel shall be tested semi-annually.
- All compounding personnel shall successfully complete initial glove testing ( zero CFU per two hands) no fewer than three times before allowed to compound CSPs.
- All persons performing compounding must successfully complete an initial competency evaluation, including visual observation and gloved fingertip/thumb sampling (zero CFUs) no fewer than three times before being allowed to compound CSPs, to demonstrate that they can perform the procedure consistently.
- After the initial competency evaluation, compounding personnel must successfully complete gloved fingertip/thumb sampling quarterly (no more than a total of three CFUs).
Media Fill Sampling per USP <797>
Pharmaceutical Compounding is currently categorized by Risk Level: Low, Medium and High.
For Low and Medium Risk level compounding:
- A media fill test is performed at least annually by each person authorized to compound (low or medium) risk level CSP’s.
For High Risk level compounding:
- A media fill test is performed at least semiannually by each person authorized to compound high risk level CSP’s.
Incubate media-filled vials at 20°–35° for a minimum of 14 days. If two temperatures are used for incubation of media-filled samples, incubate the filled containers for at least 7 days at the lower temperature (20°–25°) followed by 7 days at 30°–35°. Failure is indicated by visible turbidity or other visual manifestations of growth in the medium in one or more container–closure unit(s) on or before 14 days. Investigate media-fill failures to determine possible causes (e.g., sterilizing filter failure). Document and discuss investigational findings with personnel before any re-testing.
- Collapsing of the three risk categories ( Low, Medium and High Risk) into two categories: Category 1 and Category 2
- Proposed frequency for both Category 1 and Category 2 level compounding is Quarterly