BCE Pharma Software and Compounding Consultant partners with Stratix Labs
This collaboration between BCE Pharma and Stratix Labs provides a practical solution for sterile compounding pharmacies to comply with the Canadian standards and the new USP <797> requirements for surface sampling competency demonstration by combining the Enverify™ Sampling Competency Kit with BCE Pharma’s training and consulting services.
Enverify™ is a first-of-its-kind solution that enables demonstration and documentation of surface sampling competency. It is designed for individuals who perform viable surface sampling as part of their job function. Each kit includes a combination of Enverify™ microbial-coated test surfaces and blinded sterile blanks, providing quantitative determination of recovery efficiency and confirmation of successful aseptic technique during sampling. This helps ensure that your team is in compliance with industry best practices and standards as they are enforced by accreditors and regulators. Enverify™ is compatible with contact plates and swab sampling tools.
Canadian model standards for pharmacy compounding in sterile preparations state that employees of community or healthcare facility pharmacies can conduct viable air and surface sampling provided they have undergone and successfully completed the appropriate training for this procedure. In addition, the updated editions of USP <797> on November 1st, 2023, which incorporate new directives regarding environmental monitoring and surface sampling, mandate that all individuals responsible for surface sampling undergo training and demonstrate competency at least once every 12 months. The Enverify™ Surface Sampling Competency Kit will complement BCE Pharma’s training as a practical assessment tool. Specifically designed to meet this requirement, it facilitates the evaluation of proficient sampling methods and adherence to proper aseptic techniques.
"We are excited to partner with BCE Pharma and provide Enverify™ to compound pharmacies in Canada. Viable surface sampling is a critical part of contamination control in drug manufacturing facilities. It’s crucial that personnel who perform sampling are qualified and competent. By demonstrating competency with Enverify™, facilities not only achieve compliance with applicable standards but also gain much needed confidence in the data they generate through surface sampling and the decisions they make based on that data," says Mark Mulvahill, Chief Executive Officer of Stratix Labs.
"We are pleased to announce that we are the first Canadian distributor of the Stratix Labs Enverify™ Surface Sampling Competency Kit. This offering will assist our customers in demonstrating that their personnel are employing the best practices and techniques for viable surface sampling" says Sébastien Côté, Vice President of Business Development.
About BCE Pharma: BCE Pharma is a Canadian Leader offering a quality management system as well as training and third-party assessment for sterile and non-sterile compounding. Our solutions are used Canada-wide, in the United States, as well as in Tunisia and soon-to-be in more countries to be announced. For more information visit https://bcepharma.com/
About Stratix Lab: Stratix Labs is a biomaterials company based out of St. Paul, Minnesota. Using our proprietary technology for preserving microorganisms, Stratix Labs creates innovative standard-setting products that advance microbiology in research, development, and quality control applications. For more information visit www.StratixLabs.com. Enverify™ is a trademark of Stratix Labs Corporation.
Sébastien Côté
BCE Pharma Software and Compounding Consultants
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