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 Steris Laboratories, Minnesota, a facility registered with the FDA since 1988. Steris Laboratories incorporates a quality system that is compliant with cGMP and ISO 13485:2016.

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 and applicable federal and state regulations (Federal Drug Administration (FDA), Nuclear Regulatory Commission (NRC), Environmental Protection Agency (EPA) and Occupational Safety and Health Administration (OSHA). Our samplers are sold as aseptic devices.

QualiTru Sampling Systems maintains 3-A Standard 63-04 certification. Our 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 sampling bags are manufactured at facilities registered under ISO standard 13485: 2016 and conform to FDA Regulation 21 CFR Part 820. These products undergo a validated irradiation sterilization process to assure a sterile fluid path.

QualiTru Sampling Systems products are authorized to display the industry standard 3-A Logo, which includes an independent audit of our manufacturing practices. View 3-A Certificate. QualiTru continually educates users of our products with Standard Operating Procedures/SOPs.

ISO 9001:2015 Certified Company

112022 TruDraw Non Sterile - Technical Data Sheet