Validation of sterilisation process (Performance Qualification).
For medical devices sold as sterile, for use on humans, it is necessary to validate the sterilisation process, as specified in the European Medical Device Directive MDD 93/42. For this it is necessary to complete a series of physical and microbiological tests to demonstrate achievement of a sterility Assurance Level of 10-6 in future routine cycles, 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 ISO 11135-1:2007.
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.
Whether the customer chooses to carry out the sterilisation themselves, in-house, or to use the Andersen contract sterilisation service, it will be necessary to validate the sterilisation cycle.
Contract Sterilisation
The cycle will be run according to the parameters that were validated. The entire cycle from despatch of goods by the customer to the receipt back by the customer of sterilised goods, ready for re-use can be as low as 5 days.
This is made up of:
- One day transport from customer to Andersen.
- One day to run sterilisation cycle.
- One day transport from Andersen to customer.
- Two days Biological Indicator incubation (in parallel with return transport).
When the BI incubation is complete the customer will be provided a certificate of conformity, showing all the cycle parameters.
Should a customer wish to bring their sterilisation in-house, having started with contract sterilisation, the validation is completely portable as the cabinets we use are the same ones that we sell.
We offer a variety of contracts to suit the frequency and regularity of contract cycles that each customer requires.
In-House Sterilisation
The customer will run the cycle in accordance with the parameters set out in the validation. They are responsible for ensuring that the parameters are in line with the specification and for incubating the biological indicators.
Customers have a choice of two cabinets to use:
Series 3
- Up to 10 loads can be run independently.
- 40°C – 55°C operation.
- 16 hour cycle.
- 60 L sterilisation chamber.
Series 4
- One load run at a time.
- 30°C – 50°C operation.
- 3½ hour cycle minimum.
- 45 L sterilisation chamber.
If a customer who is running their sterilisation in house has any problem with their operation (eg staff illness), or require additional capacity, they have the reassurance of knowing their validation is portable so that they can turn to Andersen to run contract cycles for them.
We can also undertake installation and operational qualifications at the customer’s site.