Quality Overview

Quality Policy

SaniSure companies are committed to the highest level of quality in the manufacture, distribution, and support of our products. Quality compliance to our customer requirements and satisfaction shall underlie all of our efforts in design, manufacturing, sales, and support.

Quality Management System

Our quality management system is certified to the ISO 9001 standard. We apply cGMP guidelines, where applicable, throughout our manufacturing operations.

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Independent Third Party Audit Verification Through Rx 360

The SaniSure Camarillo facility has successfully completed a comprehensive Rx-360 audit (Audit #JA-3016, October 2024). This audit covered:

  • Single Use Systems
  • Supply Chain Security
  • ISO 9001:2015 requirements

As part of our commitment to quality and transparency, potential and existing customers can access our complete audit report through Rx-360’s licensing program. This third-party audit validation can help streamline your supplier qualification process and reduce the need for additional on-site audits.

For information about accessing our Rx-360 audit report, please contact your SaniSure representative or visit www.rx-360.org

Environmental Monitoring

Our routine Environmental Monitoring program ensures our assemblies are manufactured in a clean and controlled environment. The program entails weekly internal testing including air, surfaces, and technician cleanroom gown.

Our cleanrooms are annually certified by a qualified testing service provider, ensuring our manufacturing environments meet the acceptance criteria set forth by the applicable ISO and USP standards.

Complaint Process

To submit a customer complaint, please fill out the Customer Complaint Form and email it to the relevant location listed below.

United States:

Europe:

Change Notifications

To submit any change notifications, please send an email to the relevant location listed below:

United States:

Europe:

General Quality Requests

Requests for quality documentation such as questionnaires, material information, and agreements, as well as audit schedules, can be done via the relevant location listed below:

United States:

Europe:

Want to learn more about our biomanufacturing solutions?

With a global footprint, SaniSure® is committed to developing and manufacturing high-quality single-use components and solutions.

Reach out to us to learn more!

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