All of this at competitive prices. Your product will never be sterilised in the same chamber as products from another customer.
Our contract sterilisation facility uses the same cabinets that we offer for sale. Consequently, a validation carried out for contract sterilisation is immediately transferrable to in house sterilisation, should a customer choose to purchase a cabinet at a later date. Alternatively, we can provide additional sterilisation capacity, should this be required.
Our contract sterilisation activities are supported by all the laboratory services that you would expect, including contract packaging. So we offer a one stop shop for all your small lot low temperature sterilisation needs.
Fast turnaround:
Because each cycle releases the EtO at the heart of the load, our cycle times are short. Cycle times vary from 3½ to 16 hours. The small amount of EtO used in an Andersen cycle also means that aeration times are reduced compared to traditional chambers. Our customers can also benefit from the special carrier arrangements we have in place. The result is that you can have you product back and ready for use or sale in four days.
There is
no calendar or specific timing, and no minimum load, for your sterilisation.
We sterilise what you need, when you need.
Small Loads:
The largest sterilisation chamber that Andersen uses is 60-litres. Our facility can run up to 10 of these cycles at one time. The result is that we are uniquely well placed to handle small lot sizes. Indeed if the volume of product you wish to sterilise is more than one pallet per day we would advise you to discuss your needs with a contract steriliser operating a large, traditional chamber.
The product needs to be appropriately packaged for EtO sterilisation and we can arrange this for you.
Customer Specific Parameters:
We treat each customer individually, as each load will be processed separately. Your products will never be sterilised in the same chamber as goods from another customer. We can vary the cycle length, gas concentration, humidity and temperature. We will also run the process challenge device (PCD) designed for you.
Gentle, high level sterilisation:
The process we use is the Andersen EOGas® system, utilising innovative gas diffusion technology. This allows a sterilisation process without strong vacuums, or direct steam injection, or a high pressure chamber. It means all our cycles are very gentle for sensitive devices.
The usual temperature for EtO sterilisation is 50°C. However, our lowest temperature cycle runs at 30°C, whilst still delivering a Sterility Assurance Level (SAL) of 10
-6.
Full laboratory support:
The Andersen laboratory is certified ISO13485:2003 / ISO9001:2008 / Annexe V Directive 93/42/EEC for validation and contract EtO sterilization according to ISO11135:2007.
We provide a full range of services, including:
We work with our partner Medipack in Belgium, approved by our Quality system, to provide assembly and conditioning in a Class 5 clean room.
Unpacking, assembling and conditioning of medical products for manufacturers, through a quality controlled process.
Conditioning from a simple pack of devices, to a set of different medical instruments. Manual and automatic conditioning is available.