Bacteria are identified at LAB 797 using MALDI-TOF MS, a method of mass spectrometry. This allows us to quickly identify any potential contaminants on environmental samples from your facility. It is highly recommended that your pharmacy take action according to your SOP (Standard Operating Procedure) upon receiving such results.
Below are some common contaminants isolated from cleanroom facilities:
Bacillus sp.
Closely related to: Priestia sp., Paenibacillus sp., Metabacillus sp., Niallia sp.
As of November 1, 2023, full compliance to the revised USP 797 is expected. Below is a quick guide to the changes, and LAB 797 is here to help you and your pharmacy navigate.
Media Fill and Personnel Testing: Personnel compounding Category 1 and 2 CSPs must test initially and every 6 months. Personnel compounding Category 3 CSPs must test initially and every 3 months.
Dual Incubation: Dual incubation, or the use of general-use media in both low and high incubation temperatures, is now an acceptable method for recovering both bacterial and fungal contaminants. This is a great, cost-effective option for pharmacies! Dual Incubation is also required for personnel samples.
ISO Class Action Limits: Air Sampling limits remain the same as previously. Surface Sampling limits have changed. See https://www.lab797.com/faqsfor details on the current action limits.
Increased Surface Sampling: Monthly surface sampling throughout all ISO-classified areas is now recommended for most pharmacies. This can be done internally
No Pathogenic Species: Pathogenic species, such as molds, yeasts, and Gram-negative rods, are no longer action items.
Certification: Done externally every 6 months.
Reminders
USP 800 is enforceable as of November 1, 2023
USP 797 is enforceable November 1, 2023
Let LAB 797 help you navigate through these changes in USP 797. We can create custom environmental and personnel sampling solutions for your pharmacy to make compliance easy. Custom solutions include recurring shipping of surface/personnel plates, custom media-fill testing kits, and quick identification and results.
Occasionally, your pharmacy and clean room reports may have unwanted results. What can you and your pharmacy do about these results?
There are many potential sources for contamination in a clean room. USP 797 describes common sources of contamination, with an emphasis that human operators working in classified areas are often responsible. Below are some recommendations to assist in eliminating sources of contamination and reducing CFU counts to below the appropriate action levels.
Training: Have pharmacy technicians review internal SOPs in regards to personnel garbing and aseptic technique
Cleaning: Properly disinfect and clean any object entering the classified areas
Supplies: Only essential supplies for a day’s operations should be brought into the controlled areas. Cardboard and packaging should never be brought into any classified areas
Carts: Carts must be cleaned each time before entering a classified area
Sinks: Any sinks should be disinfected frequently and checked for surface contamination regularly
Set a Schedule: Cleaning schedules should at least meet the minimum requirements outlined in USP <797>
What to Use: Cleaning agents should be used per the manufacturer's recommendations and should leave no residue. Cleaning cloths, mops, wipes, etc. should be low-lint and must be re-sterilized before reuse
Air Flow: Take necessary actions to ensure unidirectional flow of air from the PEC through the Buffer Areas into the Ante Room
Air Changes: Ensure that minimum air changes per hour are met or exceeded Example: 30 ACPH in ISO Class 7 areas (of which 15ACPH can be recirculating from the PEC)
Storage: Avoid storing objects in the classified areas; Any objects that slow air flow or provide a surface for particles to accumulate will increase the risk of contamination
LAB 797 is here to help with your compliance. If you have further questions about your results, please contact us.