Quality

A Culture Dedicated to Quality

We are driven to fulfill our customers’ needs with the highest quality and care to enable their success. Quality is a defining priority at Sterigenics. From the top down and bottom up, everyone plays a critical role in “doing the job right.” We put our complete focus on safety, quality, and making the connection between the products we sterilize and the people who depend on them. We take this responsibility very seriously. Each employee practices our Quality Policy: Do the job right, the first time and every time!

Download Quality Management System Certificates

Global Regulatory Compliance

We are committed to assisting our customers to ensure global regulatory compliance related to their sterilization processes. We strive to work collaboratively with global regulators whether it is through working on standards committees with the regulators, providing training to regulators, or through our day-to-day interactions with our regulators. With our global expertise, we can assist with registrations, listings, submissions, or qualifications in all of the regions we serve in order to ensure a smooth transition of customer products into their chosen markets.

Facilities in our global network are registered with the Food and Drug Administration (FDA) and comply with the latest requirements for device, drug, tissue, food, and tobacco registrations, and GDUFA self-identification for API & FDF manufacturers.

Our quality system is designed to comply with FDA medical device, pharmaceutical, and food requirements as well as ISO 9001 / 13485 / 17025 as required or other global quality system requirements as applicable to the product.

A Relentless Pursuit of Improvement

We are committed to ensuring the continued suitability and effectiveness of our quality management system, which includes the following global initiatives to evaluate and refine key programs on an ongoing basis:

Quality objectives established for each site
Corporate and site internal audits
Annual management reviews at each site and globally across all sites
CAPA program

Data Acquisition and Analysis

Using proprietary, state-of-the-art data acquisition systems, databases, and applications, Sterigenics continually gathers extensive process data from key equipment and tests.

Data is centrally maintained and can be accessed and analyzed by users in functional groups and locations as required.
Validated software allows for automated run review for load release, process/equipment validation, statistical process control, and predictive maintenance activities.

Committed to Supporting Customer Quality Programs

Your partnership is important to us, which is why we honor customized quality agreements and keep all regulatory and ISO certifications up to date, including:

Regulatory Certificates
Eudralex GMP
JPAL Foreign Manufacturer Accreditation
Other local certifications as required