USP <797> Environmental Monitoring Services

USP Chapter <797> Pharmaceutical Compounding Sterile Preparations (CSP) provides minimum practice and quality standards to prevent microbial contamination of CSPs. This chapter applies to all facilities which prepare, store, and/or transport CSPs, such as hospitals and other healthcare institutions, treatment clinics, pharmacies, physician offices, and 503B outsourcing facilities. We support the following USP <797> monitoring and competency requirements:

Air
  • Sample Locations:
    • Each classified area during dynamic operating conditions, collecting 1000 liters of air with an impaction sampler.
  • Frequency: every 6 months for category 1 and 2 CSPs; monthly for category 3 CSPs
  • Media: Tryptic soy agar (TSA) for single plate method; TSA plus fungal media or second TSA for dual plate method
  • Action levels:
    • ISO Class CFU/m³ air
      5 >1
      7 >10
      8 >100
Surface
  • Sample Locations:
    • Required: each classified area, including each room and the interior of each ISO Class 5 PEC and pass-through chambers connecting to classified areas.
    • Best practice: equipment contained within the PEC, staging or work areas near the PEC, frequently touched surfaces.
  • Frequency: Monthly for category 1 and 2 CSPs; Weekly for category 3 CSPs
  • Media: Tryptic soy agar (TSA) with neutralizers.
  • Action levels:
    • ISO Class CFU/media device
      5 >3
      7 >5
      8 >50
Gloved Fingertip
  • Sample:
    • Gloved fingertip and thumb pads
  • Frequency:
    • Initial garbing: 3 consecutive evaluations
    • Ongoing garbing: every 6 months for category 1 and 2 CSPS; every 3 months for category 3 CSPs
    • Post media fill: initial then every 6 months for category 1 and 2 CSPS; every 3 months for category 3 CSPs
  • Media:Tryptic soy agar (TSA) with neutralizers
  • Action levels:
    • Failure of any of the 3 initial garbing evaluations requires repeat testing until successful completion of 3 in a row
    • Activity CFU/both hands
      Post Garbing >0
      Post Media Fill >3
Media Fill
  • Sample:
    • Vials, bags, syringes; simulating most difficult aseptic compounding procedures performed
  • Frequency:
    • Media fill: initial then every 6 months for category 1 and 2 CSPS; every 3 months for category 3 CSPs 3 consecutive evaluations
    • Gloved fingertip and surface sample: perform immediately following media fill
  • Media: Tryptic soy broth (TSB) for media fill; tryptic soy agar (TSA) with neutralizers for post media fill fingertip and surface samples
  • Action levels:
    • Activity Action Level
      Media Fill Growth (turbidity)
      Gloved Fingertip >3 CFU/both hands
      Surface (ISO 5) >3/media device
Monthly Surface Sampling Kits
We offer a convenient Monthly Surface Sample Kit that includes everything you need for surface sample collection and shipping. Analysis is included in the price.
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Competency Testing – Surface Sampling
We offer Enverify™ Surface Sampling Competency Kits to evaluate sample collection efficiency and aseptic technique to help you comply with USP <797> competency requirements.
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Competency Testing – Colony Counting
We offer Confirm Count Colony Count Competency Test to assess media reading skills to help you comply with USP <797> competency requirements.
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  • ISO 17025 accredited, CGMP/GLP compliant
  • Lab open on Saturdays
  • Industry best turnaround time
  • Rental equipment available (SAS Single and Dual Head)

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U.S. Micro-Solutions, Inc. is pleased to provide our clients with rental equipment for field sampling.

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