USP <797> Pharmaceutical Compounding -- Sterile

USP <797> details EM procedures required for compounding pharmacies.  Most state Boards of Pharmacy will audit 503a Compounding Pharmacies to these standards.

  • USP <797> Criteria for Air and Surface Cleanliness
  • Air Samples

    Classification

    Cfu/cubic meter

    ISO Class 5

    > 1

    ISO Class 7

    > 10

    ISO Class 8

    > 100

    Surface Samples

    Classification

    Fingertip Sample
    (cfu/plate)

    Surface Sample
    (cfu/plate)

    ISO Class 5

    > 3

    > 3

    ISO Class 7

    N/A

    > 5

    ISO Class 8

    N/A

    > 100

  • Sampling frequency
  • USP <797> criteria is to sample at least twice a year.  Given seasonal fluctuations, inevitable fluctuations in activity, process and equipment changes – twice a year is inadequate and the USP committee will change this in the near future.

    In the meanwhile, consider sampling more frequently to get a true value of your facilities microflora.  FOCUS can help develop a rationale sampling plan, and train your staff to take samples properly.

  • Microbial Identification

FOCUS Laboratories characterizes every colony into groups, based on phenotypic characteristics.   Further identification to species level is possible via biochemical or genetic characterization. CLICK HERE for more on Microbial Identification.

USP <797> indicates that corrective actions be dictated by the identification of microorganisms recovered (at least the genus level) by an appropriate credentialed laboratory (FOCUS Laboratories).  Highly pathogenic microorganisms (Gram-negiatve rods, coagulase positive staphylococcus, molds and yeasts) can be potentially fatal to patients receiving CSP and shall be immediately remedied regardless of count.