solutions for device manufacturers

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.

IN HOUSE

In house sterilisation

Sterilise your products without heat, moisture, or abrasive chemicals

Process control.
 Products remain within the environment of your own facilities. Remove the uncertainty over the temperature, humidity and environmental chemical exposure associated with transport to a contract sterilisation location.

Operational planning.
 Retain the ability to adjust your production schedule at short notice, to fit your customers’ requirements. In house sterilisation gives you the flexibility to optimise your production operation.

Fast prototyping.
 Development times for new products can be dramatically shortened. A variant can be sterilised ready for testing within 24 hours. The small chambers mean no need to wait for a full load.

Cheaper cycles.
 When you invest in a steriliser you not only save the cost of the contract cycle, you also save the cost of the transport to and from the contract sterilisation location.

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OUTSOURCE

Sterilisation Services

Not quite ready to purchase a steriliser? Outsourcing can be the solution

Flexible capacity.
 You can send us your goods as often as you want, when you want. No schedule. Our small chambers mean your goods will never be sterilised in the same chamber as goods from another customer and you do not have to wait for full loads.

ISO 13485 certified.
 Contract sterilisation allows you immediate access to two ISO 13485 certified facilities. These quality systems can support the assembly of your CE marking dossier and FDA 510(k) submission.

Operational simplicity.
 Avoid the complexities of cabinet installation, quality management system updating and operator training. These are issues you may wish to avoid, for now, especially if your future plans are uncertain.

No capital expenditure.
 This technology will always cost considerably less than any other low temperature sterilisation technology, because of the elegance of the Andersen concept. However, even that cost is avoided with contract sterilisation.

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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.

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