As of November 1, 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 report 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.
Molds are identified by LAB 797 using various protein analysis and staining techniques. It is highly recommended that your pharmacy take action according to your SOP (Standard Operating Procedure) upon receiving such results.
Below are some common molds that may be on your reports.
Cladosporium sp.
Commonly isolated indoors or outdoors, usually on plant material
Species have dark green-black colonies
Grows well on surfaces where moisture is present
Rarely pathogenic in humans, but may cause allergies and nail infections
Penicillium sp.
Isolated in the environment and common in food spoilage and drug production
Species have blue-green-yellow-brown colonies
Grows well on surfaces where moisture is present
An opportunistic pathogen, but can cause allergies
Aspergillus sp.
Isolated in the environment, usually on soil and plant material
Species have green-brown colonies
Grows well in many conditions, including high-salinity or minimal nutrient areas
An opportunistic pathogen that may cause serious pulmonary infections
Trichophyton sp.
Isolated from soils, humans, or animals
Species have white-orange-brown colonies
Grows well in moist conditions
The largest cause of infections of the nails, hair, and skin
Occasionally, a mold may not be able to be identified to the genus-level using standard laboratory techniques. These molds are classified as “Non-Sporulating Fungi”, due to the lack of spore structures present. These are still considered pathogenic.
Recommendations for your cleanroom upon pathogenic results include:
Review all SOP’s in regards to personnel garbing and aseptic technique
Properly clean and disinfect any object entering controlled areas and limit any unnecessary items such as cardboard and packaging
Disinfect the sink frequently and check for any surface contamination
Ensure laminar flow of air within all spaces of the cleanroom
Ensure that minimum air changes per hour are met or exceeded
Do not store objects in controlled areas- objects that slow air flow increase the risk of contamination