The highest manufacturing standards & procedures
QualiTru products are manufactured and assembled by strategic partners who maintain the highest manufacturing standards for quality and professionalism in the industry. Components from our septum devices that come in contact with your sample are made from food grade contact materials. These materials comply with liquid contact components of the Food Code of Federal Regulations (CFR) for the Food and Drug Administration (FDA), Title 21, Paragraph 177.26. Our septa are manufactured with partners that are registered ISO 9001 companies and are audited on a regular basis for adherence to their management systems.
Though QualiTru’s products are not medical devices, we maintain high standards for quality for assembling our devices. Our septum devices are assembled and sterilized by Biotest Laboratories, Minnesota, a facility registered with the FDA since 1988. Biotest Laboratories incorporates a quality system that is compliant with cGMP, ISO 13485:2005, ISO/IEC 17025, and EN/ISO 17665. This strategic partner hosts frequent external audits from its customers demonstrating its ability to manufacture medical devices and related services that consistently meet customer requirements. Their accreditations cover laboratory testing, assembly, packaging, validation and sterilization of customer-supplied products. The Aseptic Samplers are sterilized in compliance with ISO 11135-1:2007 and applicable Federal and state regulations (FDA, NRC, EPA and OSHA). Our samplers are sold as aseptic devices.
QualiTru Sampling Bags are manufactured at facilities registered under ISO standard 13485: 2003 and conform to FDA Regulation 21 CFR Part 820. These products undergo a validated irradiation sterilization process to assure a sterile fluid path.
QualiTru stainless steel products are manufactured at metal fabrication facilities with extensive experience in the machining processes needed to meet QualiTru’s standards for both 7-port & 12-port fittings. These products are manufactured under a rigorous quality system that incorporates ISO guidelines.
QualiTru products are authorized to display the industry standard 3-A logo (www.3-A.org), which includes an independent audit of our manufacturing practices.
QualiTru continually educates users of QualiTru products with Standard Operating Procedures / SOPS (English and Spanish).
For more information, contact us at 651-501-2337 or email@example.com.