USP <797> New Revision Official Date November 1st, 2023
“It is important that personnel are trained and competent in air and surface sampling procedures to ensure accurate and reproducible sampling.” USP-NF <797> Official Date 01-Nov-2023.
Have your surface sampling personnel demonstrated competency?
Enverify™ Surface Sampling Competency Kit For Contact Plates and Swabs
Achieve compliance with applicable industry standards and best practices
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 for the first time. This helps 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 is available for both contact plates and 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.
Surface Sampling Competency with Enverify™
The first tool to enable demonstration of surface sampling competency is here. And just in time.
Demonstrate surface sampling competency. Take control of your sampling program.
Each Enverify™ Surface Sampling Competency Kit For Contact Plates and Swabs Includes:
3 Enverify™ Microbial-coated Test Surfaces (5.7cm dia.)
2 Enverify™ blank Test Surfaces for confirming aseptic technique (5.7cm dia.)
Product IFU
Performance Report
Certificate of Performance
How it works
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1. Perform sampling
Each operator performs sampling on five Enverify™ devices for each sampling device used at your facility.
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2. Send for analysis
The resulting contact plates are packaged per your standard procedure and sent to your lab for processing.
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3. Receive Report & Certificate
Receive a surface sampling performance report for each individual and a certificate for each person that passes.
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 three 5.7 cm diameter test surfaces coated with known quantities of a viable bacterium on them, and two 5.7 cm diameter test surfaces that are blinded blanks for confirming 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:
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Demonstrate surface sampling competency
For the first time, be able to demonstrate surface sampling competency through physical evidence and meaningful data.
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Determine percent recovery & consistency
Understanding percent recovery and consistency of recovery in sample collection is crucial to understanding your sampling data and trends
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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.
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Gain confidence in your data
Understand percent recovery, document employee training, identify opportunities for improvement, prevent issues, gain support for audits
What Does the New USP <797> Revision Say about Environmental Surface Sampling?
Surface sampling must be conducted at least monthly (Category 1 & 2 CSPs), and at least weekly (Category 3 CSPs)
“It is important that personnel are trained and competent in air and surface sampling procedures to ensure accurate and reproducible sampling.”
Section 2 - “Personnel must be trained and qualified by demonstrating knowledge and competency in core skills.” This includes surface sampling as it involves “Use of Equipment” and “Aseptic Technique.”
Section 2 - Competency must be demonstrated at least every 12 months.
Section 6 - “Sterile Compounding facilities must develop and implement written procedures for microbiological air and surface monitoring (See 17. SOPs).
Section 17 - “Designated person(s) must ensure that SOPs are appropriate and are implemented, which includes ensuring that personnel demonstrate competency in performing every procedure that relates to their job function.”