Certificates of Irradiation will be replaced with Certificates of Processing

Steris Operations Data Management System Update

Helapet Ltd, is providing this update in respect to data management changes being initiated by our Sterilisation provider, Steris. Please see attached letter from Steris for full details ^[1].

This change has been rolled out gradually throughout Steris, starting at their Daventry site, but has now been implemented at their Reading site as well. This now means that all Helapet product irradiated by Steris, UK-wide, will be affected by these changes. This change is not at the request of Helapet but is a worldwide roll-out by STERIS Applied Sterilisation Technologies (AST).

There will be no change to the actual process, just in the manner / format that data is recorded. The Certificate of Irradiation (CoI) will be replaced with a Certificate of Processing (CoP), example attached ^[2]. In addition, the format of the Detex label will change, as shown in the attachment ^[3].

Any questions, please do not hesitate to contact us.

• 1. Steris Customer Communication 19.03.18
• 2. ODMS Gamma Certificate of Processing Example
• 3. ODMS Detex Label

Mar 2022