797 ENVIRO CONTROL
Environmental Viable Monitoring Services
USP797 requires viable testing of your facility on a regular basis. The updated mandate is requiring monthly air and surface microbial testing, quarterly glove testing, and yearly media fill testing . Proper microbial testing is completed during your operation and will not disrupt your compounding practices. Proper gowning protocols are met to ensure sterility of testing and active procedures.
Let 797 Enviro Control test your facility with our stringent, aseptic testing protocol. Our samples are tested by one of the top laboratories in the nation with initial results within a few days. Fast response time ensures your facilities ability to meet an action plan or continue sterile compounding knowing your current aseptic techniques are successful.
Contact us today for pricing and to place your facility on our 2021 schedule.
USP<797>/ISO/Annex1 ENVIRONMENTAL MONITORING
Viable Air Impaction and Surface Sampling
Tracking your cleanroom facilities viable monitoring results will provide you with the insight your pharmacy needs to be USP<797>/ISO/Annex1/cGMP compliant.
Validate your SOP practices and personnelles adherence to proper gowning, disinfectant, and CSP techniques.
Documenting Viable Monitoring is vital to your pharmacies protocol. 797 Enviro Control utilizes on the of top labs in the nation and will provide immediate findings (action levels) within a weeks notice and final reporting within 3 weeks. (Our lab views plates daily.)
Alerting initial growth can assist you in documenting a proactive action plan. If there are microbial/fungal findings, 797 Enviro Control will provide identification to the genius level and assist in tracking the possible contaminant.
Testing USP<797> and <800> Sterile Compounding Facilities
Medical Device Cleanrooms
Biological Production Cleanrooms
AIR IMPACTION SAMPLING
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SAS air impaction sampler tests for ISO 5 at 1,000L/min and ISO7/8 at 500L/min.
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797 Enviro Control uses 80mm TSA plates to ensure proper air sampling.
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Strict adherence to gowning/gloving protocol by technician
SURFACE SAMPLING
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TSA w/Lecithin contact plates are used for surface sampling. The lecithin will inactivate disinfectants that could lead to false reads.
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Surfaces to be tested are work surfaces, door handles, carts, sinks, material pass-throughs, and hoods(LAFW, BSC, PEC)
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Strict adherence to proper gowning/gloving protocol by technician
TSA SINGLE PLATE METHOD
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Single Plate Sampling for bacterial and fungal growth
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Counts and Genus Identification
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Notification within four days if growth
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Completed Report in 3 weeks
UTILIZING AN ISO 17025 ACCREDITED LABORATORY
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ISO 17025 accredited by AIHA-LAP, LLC
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Daily Inspection of Media
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Rapid Turn Around for Reporting
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Assists in analyzing microbial growth sources
CONTACT US
306 Bryces Ln
Elizabeth, Allegheny County 15037
USA
412-996-1851
