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USP <797> / Clean Rooms
USP
<797> is a compliant regulation that governs a wide range of pharmacy policies
and procedures. Its main impetus for
compliance is to monitor microbial contamination of air and surfaces so as to
minimize health-care associated infections in patients associated with pharmaceutical
formularies (compounding sterile preparations) and in addition protect the
staff of the pharmacy. All hospital
pharmacies and satellite facilities are affected by these new requirements for
testing the air (viable bioaerosol agar sampling), surface (contact agar
plate), and gloved fingertip sampling of pharmacy personnel.
There are three risk
levels for Compounded Sterile Preparation (CSP): Low, Medium, and High.
Each category is assigned based on the potential for microbial
contamination. The high-risk level is assigned based on the potential
for not achieving sterility of the CSP.
CLASSIFICATION
RISK FOR NOT ACHIEVING STERILITY
ISO Class 5
Low Risk
ISO Class 6
Medium Risk
ISO Class 7
Medium Risk
ISO Class 8
High Risk
RECOMMENDED ACTION LEVELS FOR MICROBIAL CONTAMINATION
USP <797> states that the tables of recommended action levels are intended to be used as guidelines only, and "Action levels are determined on the basis of CFU data gathered at each sampling location and trended over time."
US Micro-Solutions, Inc. utilizes the USP <797> protocol for culturing pharmacy/clean room facilities.
ACTION LEVEL FOR AIR TESTING
Using an impaction sampler to collect sampling volume of 1000 liters of air
CLASSIFICATION
TOTAL CFU/m³
ISO Class 5
>1
ISO Class 6
>10
ISO Class 7
>10
ISO Class 8 or worse
>100
ACTION LEVEL FOR GLOVED FINGERTIP PLATES
TSA plates should be used to sampled gloved fingertips after compounding - Immediately after exiting the ISO Class 5 environment
CLASSIFICATION
TOTAL CFU/Plate
ISO Class 5
>3
ISO Class 6
Not Required
ISO Class 7
Not Required
ISO Class 8 or worse
Not Required
ACTION LEVEL FOR SURFACE SAMPLING - CONTACT PLATES
Surface sampling can be accomplished using contact plates and/or swabs. The area covered should be at least 24 cm² but no larger than 30 cm²
CLASSIFICATION
TOTAL CFU/Plate
ISO Class 5
>3
ISO Class 6
>5
ISO Class 7
>5
ISO Class 8 or worse
>100
Environmental
microbial sampling involves:
Bioaerosol sampling
with the Surface to Air Sampler (SAS) – Impaction – collection of air on a
trypticase soy agar (TSA) plate (bacteria) and/or Inhibitory Mold Agar
Plate (fungi). Recommended testing is 5-10 minutes at 100 or 180 liters of
air/minute (total volume recommended – 1000 liters of air)
Contact Rodac Agar
Plate – surface sampling - TSA plate (65 x 15 mm) with Lecithin and
Polysorbate 80 (bacteria) and Sabouraud dextrose agar (fungi).
DAB plate - gloved fingertips of pharmacy personnel
– TSA plate w. Lecithin and Polysorbate 80 and Inhibitory Mold Agar plate.
Sampling Volume of Air
& Analytical Sensitivity: Use of 1000 liters of air – increase
sensitivity & validate cleanliness of an area.
Sampling Volumes = 100 liters x 10 min. = 1000 liters
of air Analytical Sensitivity = 1 CFU / 1000mL x 1000 = 1
CFU/m3 of air
Reporting Results:
Culturable Bioaerosol - Bacteria/fungi - CFU/m3 of
air Contact
Plate - Bacteria/fungi - CFU/plate DAB Plate - CFU/plate
Need a Chain of Custody or Would You Like to View a Sample USP <797> Report?
Ship or deliver your samples along with your completed Chain of Custody/Laboratory Test Request Form to:
U.S. Micro-Solutions, Inc. 475C Willow Crossing Road Greensburg, PA 15601
Hours of Operation Monday through Friday - 8 am to 5 pm Saturday - 8 am to noon (Closed Sunday and all major holidays)
U.S Micro-Solutions, Inc. ® 1996-2011 All Rights Reserved 475-C Willow Crossing Road Greensburg, PA 15601 Telephone: 724-853-4047 Toll Free: 1-877 US MICRO
