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USP Environmental Microbiology Monitoring Services

Pace® USP 797 Environmental Monitoring Services

Pace® sample culture and analysis services help compounding pharmacies, hospitals, and other healthcare providers maintain compliance with the USP 797 guidelines to ensure the safety and efficacy of compounded sterile preparations (CSPs). Compliance areas we support include:

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What Is USP 797?

USP 797 is a set of guidelines established by the United States Pharmacopeia (USP) to ensure the safety and quality of CSPs. USP 797 covers various aspects of sterile compounding, such as personnel training, environmental monitoring, quality control procedures, and documentation. By adhering to USP 797 standards, healthcare facilities can minimize the risk of contamination, enhance patient safety, and ensure the potency of compounded medications.

Get The Guide!

Looking for an overview of USP 797 revisions? Download Navigating the Revised USP <797> Standard for Environmental Monitoring today!

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What Are The USP 797 Environmental Testing Requirements?

USP 797 requires several different types of testing to ensure product efficacy, personnel competency, and patient safety. The latest standards became official on November 1, 2023, further minimizing the risk of environmental contamination in compounded sterile preparations (CSP)

Viable Surface Sampling

According to USP 797, each classified area, including each room and the interior of each ISO Class 5 PEC (Primary Engineering Control) and pass-through chambers connecting to classified areas, must be sampled for microbial contamination using a risk-based approach. For entities compounding Category 1 and Category 2 CSPs, surface sampling of all classified areas and pass-through chambers connected to classified areas must be conducted at least monthly.

ISO ClassSurface Sampling Action Levels (cfu/media device)
5> 3
7> 5
8> 50
Viable Air Sampling

Viable air sampling is used to assess air quality within a cleanroom environment. Air samples are collected and evaluated for the presence of viable (living) microorganisms, such as bacteria, yeasts, and molds. This helps ensure the air in the compounding environment meets the required standards of cleanliness, thereby minimizing the risk of contamination.

The 2023 revisions to USP 797 increase the location requirements for viable air sampling. In addition, incubation for fungal samples now requires an incubator with cooling capabilities as the revised incubation temperature range is lower than the typical ambient room temperature in most lab environments.

ISO ClassAir Sampling Action Levels [cfu/cubic meter (1000 liters) of air/media device]
5> 3
7> 5
8> 50
Gloved Fingertip Testing

Gloved fingertip sampling is a direct assessment of the effectiveness of the garbing process, as it evaluates the cleanliness of one of the most critical parts of the attire—the gloves. In a gloved fingertip sample, compounding personnel press their gloved fingertips, including thumbs, onto a sterile agar plate, which is then incubated and assessed for microbial growth. This analysis is key to ensuring the gloves are free from microbials and that proper aseptic technique is maintained during compounding processes.

The 2023 revisions to USP 797 increase the frequency of sampling, training, and evaluation of compounding personnel. As with other revisions, these enhanced requirements are meant to ensure the quality and safety of compounded sterile preparations.

Gloved Fingertip and Thumb SamplingAction Levels
(cfu, total from both hands)
 
After garbing> 0
After media-fill testing> 3
Media Fill Test

Media fill testing, also known as simulated-use or process simulation testing, is a critical component of USP <797> compliance. By simulating the compounding process using a microbial growth medium instead of actual drug ingredients, media fill testing verifies the aseptic technique of compounding personnel and identifies potential areas of concern.

Aseptic Technique Competency Testing

Aseptic manipulation competency testing combines the above components to validate processes and personnel. Aseptic competency testing should be performed initially for all three categories. Thereafter, Categories 1 and 2 should be done at least every six months and Category 3 at least every three months. Individuals overseeing compounding personnel must also complete an annual competency manipulation. Failure of a gloved fingertip test, media fill test, or surface sample results in failure of the aseptic manipulation for that CSP personnel.

Order Sampling Kits

Pace® USP 797 Compliance Kits ensure you have the materials you need to meet the revised USP 797 sampling requirements. These kits are available on a configurable subscription basis and include all the materials needed for surface, gloved fingertip, and media fill kit sampling. Kits also include packing materials to ensure fast shipping and that samples arrive intact. All USP 797 Compliance Kits are sold through the Aerobiology ordering site. Aerobiology is a Pace® lab focused on USP 797 compliance and other environmental microbiology testing services.

Matrix
Analysis
Supplies
Air
Bacterial counts to genus level as per new revision

Fungal counts to genus level as per new revision
TSA petri plates or contact plates

SabDex petri plates or contact plates
Surface
Bacterial counts to genus level as per new revision

Fungal counts to genus level as per new revision
TSA contact plates,15x65mm

SabDex contact plates, 15x65mm
Gloved Fingertip (GFT)
Bacterial culture with counts

Fungal culture with counts
TSA petri plates, 15x100mm
Media Fill
Sterility competency for media fill (GFT and surface sampling must be performed immediately following the media fill test.)
Kits include:
Empty sterile bags
Empty sterile vials
Sterile tryptic soy broth bag
Sterile tryptic soy broth vials
Syringe(s)

Cleanroom Certification

Initial cleanroom certification involves more than environmental testing for microorganisms. Whether you are redesigning existing facilities or building new, Pace® has you covered with Cleanroom Certification Services, including:

Additional Resources

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