Solutions for Medical Devices Manufacturers
Choose to purchase one of our systems or make use of our fast turnaround bespoke contract sterilisation service.
For medical devices sold as sterile, for use on humans, it is necessary to validate the sterilisation process, to demonstrate achievement of a sterility Assurance Level of 10-6, as well the absence of EtO residues. The experts at Andersen will develop the best cycle parameters appropriate to the customer’s product/load and then set out a protocol for each of the tests to be conducted. Our validations are conducted in compliance with EN ISO 14937:2009.
Whilst our normal guidance is that EtO sterilisation should not be used on drugs, the customer is responsible for assessing the performance of the device following sterilisation. Following such testing Andersen Products routinely sterilises medicated stents, using an innovative cycle running at just 30 °C.
Sterilisation of flexible endoscopes
Flexible endoscopes present special problems due to the long narrow lumens. EtO is uniquely capable of penetrating complex shapes and studies have shown that EtO will sterilise even the longest and narrowest lumens found in flexible endoscopes. EtO is the only re-sterilisation technology approved by major flexible endoscope manufacturers. In addition, additional aeration at 50 °C can reduce residual EtO levels so that the device is available for use on a patient in just 4½ hours.