Sterilisation Validation

Andersen Caledonia provides a full range of validation services to show compliance with the relevant international standards. We offer a range of options from trial batch validations to full validations with dedicated cycles. Our sophisticated control system allows us to customise cycles with a high degree of accuracy. For customers validating with one of our mixed cycles we can provide dunnage to fill the chamber reducing the demand for product samples.

Our company is ISO 13485, ISO 9001 and ISO17025 certified. We are also registered with the Japanese MOH. We welcome customer audits if pre-booked with an agenda.

Our integrated facility allows us to process samples immediately after they are removed without the concerns of shipping samples to external laboratories. Our sterile packing facility allows us to pack and prepare Process Challenge Devices onsite.

Core reference standards

ISO 11135: 2007, Sterilisation of healthcare products – Ethylene Oxide - Part1: Requirements for development, validation and routine control of a sterilization process for medical devices.

ISO 10993–7 2008, Biological Evaluation of Medical Devices, Ethylene Oxide Sterilization Residuals

ISO 11138-2:2008; Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes