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 product/process are made from rubber articles intended for repeated use. These materials comply with the Food and Drug Administration (FDA), Title 21 Code of Federal Regulations (CFR), Part 177.2600.
Our septa are manufactured with partners that are registered International Organization for Standardization (ISO) 9001 companies and are audited on a regular basis for adherence to their management systems. Visit and follow us on Facebook and LinkedIn.
The highest manufacturing standards & procedures
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.
For more information, contact us at 651-501-2337 or firstname.lastname@example.org.