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.
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
LAB 797 offers various types of biological media for your sampling needs. All media sold by LAB 797 is sterile, gamma-irradiated, and includes a certificate of quality and growth promotion (documents available by request). Media is used to support the growth of bacteria, molds, and yeast. We offer four types of media that are in stock and ready to ship to your facility.
TSA (Tryptic Soy Agar) Air Plates
Used for growth of bacteria, but can also grow molds and yeasts
85mm plates ideal for use with impaction air samplers
TSA (Tryptic Soy Agar) Contact Plates
Used for growth of bacteria, but can also grow molds and yeasts
Contains Lecithin and Polysorbate-80 for neutralization of chemicals used for cleaning
Ideal for use for fingertip sampling and surface sampling
Can also be used in SAS air samplers
SDA (Sabouraud Dextrose Agar) Air Plates
Used for growth of molds and yeasts
85mm plates ideal for use with impaction air samplers
SDA (Sabouraud Dextrose Agar) Contact Plates
Used for growth of molds and yeasts
Contains Lecithin and Polysorbate-80 for neutralization of chemicals used for cleaning
Ideal for use for fingertip sampling and surface sampling
Can also be used in SAS air samplers
LAB 797 also offers media-fill solutions by request. This can include TSB (Tryptic Soy Broth), as well as other items such as bags, ports, needles, and vials.