Surface sampling competency with Enverify™

The Enverify™ Viable Surface Sampling Competency Kit provides a precise quantity of microorganisms, coated and preserved onto the target area for sampling evaluation, and includes a combination of Enverify™ microbe-coated test surfaces and blinded sterile blanks.

This kit enables you, for the first time, to determine percent recovery and consistency of recovery for your sampling method and personnel. Surface sampling competency can now be physically demonstrated and documented for each individual performing the task.

This helps ensure that your team is in compliance with industry best practices and applicable standards such as USP General Chapter <797> Pharmaceutical Compounding—Sterile Preparations, USP <1116> Microbiological Control and Monitoring of Aseptic Processing Environments, cGMP, and EU GMP Annex 1.

Each Enverify™ Viable Surface Sampling Competency Kit includes:

• 3 Enverify™ Microbial-coated test surfaces (5.7cm dia.)
• 2 blinded-blank Enverify™ Test Surfaces for confirming aseptic technique (5.7cm dia.)
• Instructions for use
• Performance report
• Certificate of Performance

Product brochure

Instructions for use

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Requirements for environmental surface sampling in <797>

• Surface sampling must be conducted at least monthly for Category 1 & 2 compounded sterile preparations (CSPs), and at least weekly for Category 3 CSPs.
• Section 2 – “Personnel must complete training and be able to demonstrate knowledge of principles and competency of skills.” This includes surface sampling as it involves “Use of Equipment” and “Aseptic Technique.”
• 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.”