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Partnering with 797EnviroControl will alleviate the stress of environmental monitoring.

Comprehensive Microbial Testing Protocols

USP797 mandates regular viable testing of compounding facilities to ensure ongoing compliance and the safety of compounded sterile preparations. The updated requirements include monthly air and surface microbial testing, quarterly glove testing, and annual media fill testing. All microbial testing is conducted during normal operations and is designed not to interrupt compounding activities. Strict gowning protocols are followed throughout the testing process to maintain sterility and protect both the testing environment and active procedures.

Our Aseptic Testing Service

797 Enviro Control offers thorough and aseptic testing of your facility using a stringent protocol. Samples are processed by one of the nation’s leading laboratories, with initial results available within a few days. This rapid turnaround allows your facility to promptly implement any necessary action plans or maintain sterile compounding with confidence in your current aseptic procedures.

Schedule and Pricing

Contact us today for pricing details and to secure your facility’s spot on our 2025-26 testing schedule.

Is Your Facility Ready to Partner with 797EnviroControl Viable Sampling Program?

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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.  Microbial monitoring/Trend Analysis programs will lessen the risk of contamination of the end product(s).

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:

USP797  Cleanroom Pharmacies

Medical Device Cleanrooms

Biological Production Cleanrooms

503A/B Cleanrooms

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AIR IMPACTION SAMPLING

  • SAS air impaction sampler tests for ISO 5 at 1,000L/min and ISO7/8 at 500L/min. 

  • 797 Enviro Control uses 80mm TSA plates to ensure proper air sampling.

  • Strict adherence to  gowning/gloving protocol by technician

SURFACE SAMPLING

  • TSA w/Lecithin contact plates are used for surface sampling.  The lecithin will inactivate disinfectants that could lead to false reads.

  • Surfaces to be tested are work surfaces, door handles, carts, sinks, material pass-throughs, and hoods(LAFW, BSC, PEC) 

  • Strict adherence to proper gowning/gloving protocol by technician

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TSA SINGLE PLATE METHOD

  • Single Plate Sampling for bacterial and fungal growth

  • Counts and Genus Identification

  • Notification within four days if growth

  • Completed Report in 3 weeks

UTILIZING AN ISO 17025 ACCREDITED LABORATORY

  • ISO 17025 accredited by AIHA-LAP, LLC

  • Daily Inspection of Media

  • Rapid Turn Around for Reporting

  • Assists in analyzing microbial growth sources 

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