EMSL Analytical Offers Analysis for USP 797 Samples
New testing services help pharmacies comply with U.S. Pharmacopoeia (USP) regulations.
EMSL Analytical, a leading provider of laboratory services, recently announced they have begun to analyze samples for USP 797. Issued by the U.S. Pharmacopoeia (USP), USP 797 regulations provide a standard for all pharmacies that prepare ‘compounded sterile preparations’ (CSPs). Most pharmacies must comply with this regulation and many hospitals that operate pharmacies meeting the same criteria are also affected.
When compounding is conducted within a facility, a gap analysis should be performed in order to determine what the compliance action plan will be. In many cases, regular air as well as surface samples are necessary in order to analyze samples for any microbial contamination (i.e., fungal or bacterial presence whether viable or non-viable).
According to the USP 797 protocols, ‘a critical area must prove to meet ISO 5 classification at least once per six-month period. The frequency of determining the cleanliness class of supporting areas is also at least once per six months as recommended by USP and/or whenever renovations occur’.
When sampling for bacterial contamination, it is suggested that Tryptic Soy Agar (TSA) or comparable media be utilized. To sample for fungal contamination, it is recommended that Malt Extract Agar (MEA) or comparable media be used while testing.
“EMSL Analytical, Inc. has established a reputation for providing the highest quality analytical services in many industries and now EMSL is providing USP 797 samples with the same level of service that you’ve come to expect from EMSL,” reported Ben Sublasky, National Director of Client Services for EMSL Analytical, Inc. “We are proud to announce that EMSL is now accepting USP 797 samples,” continued Mr. Sublasky.
About EMSL Analytical, Inc.
EMSL Analytical is a nationally recognized and locally focused provider of environmental, food, and materials testing services and products to professionals and the general public. The company has an extensive list of accreditations from leading organizations as well as state and federal regulating bodies.
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