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USP <797> sets practice standards to ensure that compounded sterile preparations are of a high quality and free of contamination. Many of these guidelines are directed at air quality monitoring and analysis.
Criterion can assist you in your compliance efforts with reliable environmental monitoring and analysis, a vital component in meeting USP <797> requirements in your commercial or hospital pharmacy, clinic or physician's office. We can perform the monitoring for Class 5 and Class 7 areas, including the screening and analysis of viable bacteria and fungi in the air, gloved fingertips, surface contact plates and non-viable particulates.
We can also provide guidance in rating Level 5 clean rooms as low, medium, or high risk, though the final decision must be made by the Lab Manager.
Aseptic techniques are followed on all sampling and analysis methods. Criterion personnel use pharmacy garb.
A report will be issued detailing sample locations, results, recomendations, if any, collection methods and time after compounding activities, if any.
Call us today and speak to a Certified Industrial Hygenist about how Criterion can be an effective part of your USP <797> compliance team.
Our Monitoring Technology:
Laser Particle Counter for evaluation of clean room efficiency for non-viable particle sampling.
Volumetric Impaction Sampling on sheep's blood Tryptic Soy Agar for bacteria sampling.
Volumetric Impaction Sampling for fungi with Malt Extract Agar (MEA) This process is required for high risk compounding only.
Contact Plates and Swabs for surface sampling and 9mm plates SB TSA for finger-tip sampling. While sometimes performed in-house, Criterion can fulfill this testing if requested.We do not perform the media fill tests that USP<797> reccomends be performed under the direction of the Lab Manager.
