Sterilisation for Life Science Companies

Andersen Caledonia can sterilize over 250 pallets of single use medical devices a week using 2 large ethylene oxide gas chambers plus independent preconditioning and aeration rooms. Typical products processed include medical kits, drapes, gowns and disposable surgical instruments.

Mixed Ethylene Oxide Chamber Cycles
Andersen Caledonia is a pioneer in the UK in introducing mixed load ethylene oxide chambers as standard. Mixed load chambers contain pallets of a similar product type from a number of different customers This allows us to offer a flexible sterilisation service for customers who can send us a variable number of pallets without penalty or delay and a simplified and fast validation service to meet regulatory requirements. We run 2 standard mixed load cycles, the first cycle is designed for drapes, gowns and non lumen instruments, the second cycle is designed for kits including tubing or other long lumen instruments.

Custom Ethylene Oxide Cycles
For manufacturers with special sterilization requirements we provide customer specified cycles. We have invested in a state of the art control system which allows us to quickly design a cycle.

Support for Low Volume Customers
As a private independent company Andersen Caledonia Ltd understands the needs of smaller companies. We offer a flexible, rapid and cost effective ethylene oxide sterilisation solution for companies with small volumes wishing to launch a new sterile device.

Containers from Developing Countries
The Andersen Caledonia Ltd plant is located 40 miles from the large and growing container port at Grangemouth. For customers importing commodities from developing nations we offer a complete service including palletising of goods, incoming inventory check, bioburden testing and ethylene oxide sterilisation of goods all for a single price. Our service is often cheaper than alternatives close to the production site, offers an assurance of quality and the potential to register the products as manufactured in the UK from imported components.

Validation
Andersen Caledonia offers validations in conformity with EN550 and ISO11135. Our standard approach is to use a Method C half cycle protocol. By using one of our mixed cycles customers can reduce the level of testing required and the cost substantially.