Enverify™ Surface Sampling Competency Kit (10x10 cm)

Demonstrate surface sampling competency. Take control of your sampling program.

The Enverify™ Surface Sampling Competency Kit includes a combination of Enverify™ microbial-coated test surfaces and blinded sterile blanks. This kit enables surface sampling competency for each sampling individual to be physically demonstrated and documented. This can help ensure that your team is in compliance with industry best practices and applicable standards such as USP <797>, cGMPs, EU GMP Annex 1 , and USP <1116>.

This kit containing 10x10 cm test surfaces is designed for swab sample collection devices. The bacterium coated on the Enverify™ microbial-coated surfaces is a safe-to-handle BSL1 vegetative bacterium. The standard kit includes Escherichia coli coated at a specific cell titer that enables enumerable colonies on most contact plates. Additional organisms and cell titers are available upon request.

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Surface Sampling Competency with Enverify™

The first tool to enable demonstration of surface sampling competency is here. And just in time.

Each Enverify™ Surface Sampling Competency Kit (10x10 cm) Includes:

  • 2 Enverify™ Microbial-coated Test Surfaces (10x10 cm)

  • 1 Enverify™ sterile blank Test Surface (10x10 cm) for confirming aseptic technique

  • Product IFU

  • Performance Report

  • Certificate of Performance

How it works

  • 1. Perform sampling

    Each operator performs sampling on three Enverify™ Test Surfaces for each sampling device used at your facility.

  • 2. Send for analysis

    The resulting samples are packaged per your standard procedure and sent to your lab for processing. The results are then sent to Stratix for performance analysis and reporting.

  • 3. Receive Report & Certificate

    We perform the analysis & deliver a report that details the samplers results, including percent recovery and aseptic technique results. And if the sampler passes, they will receive the Certificate of Performance.

What is surface sampling competency?

Surface sampling is a method performed by sampling personnel to determine the microbial contamination on a surface and is most commonly performed as part of an environmental monitoring program for a controlled environment. Surface sampling competency demonstration is the physical confirmation that the personnel can adequately perform the surface sampling procedure.

Why demonstrate surface sampling competency?

The act of collecting a surface sample is the foundation of generating environmental monitoring data. The data is then used to make critical decisions related to the quality of the controlled production environment. The unique sampling technique of each sampling personnel impacts the recovery efficiency (% of viable microbes recovered from a surface) and the aseptic integrity of the sample. That is, how the person takes the surface sample can impact how many microbes are recovered and can introduce false contaminants through inadequate aseptic technique. This may have important implications, for example, in cleanrooms that have specification for low levels of CFU’s, or in food safety where the detection of low levels of pathogens is paramount.

Standards that govern environmental monitoring, especially in cleanrooms, have new requirements related to these aspects of surface sampling. For example, the new revisions to USP <797> for sterile compound pharmacies now state, It is important that personnel are trained and competent in air and surface sampling procedures to ensure accurate and reproducible sampling." New revisions to EU GMP Annex 1: Manufacture of Sterile Medicinal Products now states, “Sampling methods and equipment used should be fully understood and procedures should be in place for the correct operation and interpretation of results obtained. Supporting data for the recovery efficiency of the sampling methods chosen should be available.”

How to Demonstrate Surface Sampling Competency

Ideally, surface sampling competency would be demonstrated using surface samples with known quantities of microbes on them. This is the way that most proficiency tests are performed; however, no such test surface with a specific quantity of viable microbes has been available.

To meet this need, Stratix Labs created the Enverify™ Surface Sampling Competency Kit that utilizes Enverify™ Microbial-coated Test Surfaces. This kit includes two 10x10 cm surfaces coated with known quantities of a viable bacterium on them, and one 10x10 test surface that is a blinded blank for confirming successful aseptic technique. This convenient and affordable kit allows each surface sampling personnel to demonstrate surface sampling competency including both their recovery efficiency and their aseptic technique for the first time. Each person then receives their results in a Performance Report and, if they pass, a Certificate of Performance.

Competency Testing with Enverify™ enables you to:

  • Demonstrate surface sampling competency

    For the first time, be able to demonstrate surface sampling competency through physical evidence and meaningful data.

  • Determine percent recovery & consistency

    Understanding percent recovery and consistency of recovery in sample collection is crucial to understanding your sampling data and trends

  • Identify training opportunities

    Use this kit to identify sampling personnel that may not be using the right sampling technique that might result in low recovery efficiency and/or contamination through inadequate aseptic technique.

  • Gain confidence in your data

    Understand percent recovery, document employee training, identify opportunities for improvement, prevent issues, gain support for audits