The latest revision of USP <797> goes into effect November 01, 2023 and one of the most impactful changes is a move from twice annual surface sampling to minimum 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?
- 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?
- 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 your samples. Call FOCUS with any questions.
- Pack the cooler and ship back to FOCUS Laboratories.
- What we do:
- 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. If action levels are exceeded, we will perform microbial identification* in accordance with USP <797>.
- 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?:
- How?:
Once a month we will mail you a refrigerated cooler with:
The kit has all the components necessary for you to sample your own surfaces.
We will receive your box and take care of all the complicated microbiology work:
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.
Call or email us today to set up a subscription.
*Microbial Identification is performed at an additional charge. FOCUS will obtain approval from client before proceeding with microbial identification.
