797 Box

    The latest revision of USP <797> goes into effect December 01, 2019 and one of the most impactful changes is a move from twice annual surface sampling to monthly surface sampling for viable microbes. FOCUS Laboratories offers a turnkey solution for compounding pharmacies’ monthly sampling needs – the 797 Box.

    • What is 797 Box?
    • Once a month we will mail you  a refrigerated cooler with:

      • Triple bagged gamma irradiated agar contact plates.
      • FOCUS Laboratories COA validating growth promotion of the lot.
      • Preprinted clear labels for each sample site.
      • Prefilled chain of custody form.
      • Return shipping label.
      • How does 797 Box work?
      • The kit has all the components necessary for  you to sample your own surfaces.

        • Open the box and take inventory of contents.
        • Refrigerate the plates and freeze the gel pak until you are ready for sampling.
        • Review, date and initial, and file away the media COA.
        • Take our FREE online training course.
        • Take your samples
        • Pack the cooler and ship back to FOCUS Laboratories.
        • What we do:
        • We will receive your box and take care of all the complicated microbiology work:

          • We will properly incubate your samples in our mapped, alarmed and 24 x 7 monitored units.
          • We will enumerate and characterize microbial growth, and let you know not just how many but what kind.
          • We will issue a Certificate of Analysis when complete.
          • We are at your side to assist with any remediation that might be necessary.
          • Next month we send you another box.
          • Why?:
          • Because we are not pharmacists and would not dream of compounding sterile drug products, just as you are not a microbiologist and shouldn’t dilute your core competency.  You can FOCUS on your pharmacy, let us FOCUS on the microbiology.

            • How?:
            • The fee is $30 per plate for a minimum order of 10 plates, plus shipping and handling.  Call or email us today to set up a subscription.