Personnel competency requirements

Personnel competency is critical to maintaining aseptic conditions. Individuals must demonstrate proper technique through initial qualification and ongoing requalification.

Gloved Fingertip Testing (GFT)

Evaluates hand hygiene and aseptic technique. Acceptance criteria include 0 CFU after garbing and ≤3 CFU after media fill testing. Dual incubation is required. Agar plates (e.g., TSA) for gloved fingertip testing must contain neutralizing agents (e.g. lecithin and polysorbate) and are incubated at 30 to 35°C for no less than 48 hours followed by incubation at 20 to 25°C for no less than additional 5 days. All microbial colonies are counted and reported.

Media fill testing

Simulates aseptic compounding using sterile growth media. Any microbial growth indicates failure. Media fill vials are incubated at 20 to 25°C for 7 days followed by incubation at 30 to 35°C for additional 7 days. Any observed microbial growth before or at completion of the incubation time triggers failure of the test.

Viable Surface Sampling Competency Testing (Enverify™ Kits)

Viable Surface Sampling Competency Testing using Enverify™ kits is designed to evaluate and document the proficiency of personnel performing environmental surface monitoring under USP <797>. The Enverify™ system provides pre-prepared, sterile contact plates with Tryptic Soy Agar (TSA) and neutralizers, allowing staff to demonstrate correct sampling technique, labeling, documentation, and aseptic handling. During competency evaluation, personnel simulate real-world sampling of ISO 5 - 8 surfaces, ensuring consistent plate contact pressure, coverage area, and post-sampling handling.

The test results verify the sampler’s ability to collect valid and representative microbial data without introducing contamination. Successful completion confirms that individuals are qualified to perform routine viable surface sampling in accordance with USP <797> standards, supporting both regulatory compliance and quality assurance within sterile compounding environments.

• Product Information
• Enverify™ Technician Sampling Performance Report
• Enverify™ Example Certificate 
  
  

Environmental Monitoring (EM)

Environmental Monitoring (EM) is a cornerstone of aseptic control within sterile compounding areas, as defined by USP <797>. It ensures that compounding environments meet ISO cleanliness standards:
- ISO 5: Direct Compounding Area
- ISO 7: Buffer room
- ISO 8: Anteroom
It includes viable air sampling, surface sampling, and non-viable particle monitoring performed at regular intervals - monthly, quarterly or semi-annually depending on CSP category. Frequency increases after maintenance or contamination events.

Viable surface sampling

Surface sampling evaluates microbial contamination on work surfaces and equipment. Category 1 & 2 require monthly sampling; Category 3 requires weekly sampling and post-batch testing. The main media type is contact plates or media paddles. Swabs are only allowed for uneven surfaces. Dual incubation is used, and microbial identification is required when action levels are exceeded. Alternatively, two samples per location can be collected for concurrent incubation at each of the two temperatures.

Viable air sampling

Air sampling for the certification of cleanrooms includes nonviable particle counts on site (ISO14644) as well as air monitoring for viable particles, i.e. microbial contamination.  For category 1 and 2 compounding, viable particles must be collected at least every six months via volumetric sampling as part of the re-certification of the facility. For category 3 compounding viable air testing is required at least every 3 months. A minimum of one air sample is needed for each classified area with sample volume of 1000 liters or more on general microbial growth medium (e.g., Tryptic Soy Agar, TSA). Dual incubation is used, and microbial identification is required when action levels are exceeded. Alternatively, two samples per location can be collected for concurrent incubation at each of the two temperatures.

Non-Viable Particle Limits

Summary of USP <797> Microbial Testing Parameters

_{* Category 1 – Short beyond use date (≤ 12 h room temp / ≤ 24 h refrigerated); Category 2 – Extended beyond use date; requires cleanroom environment; Category 3 – Longest beyond use date; requires enhanced monitoring and sterility testing
** cfu = colony forming units}