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What’s the difference between Calibration and Validation

What’s the difference between Calibration and Validation?

When it comes to using steam for sterilization, it’s critical to know that the correct pressure and temperature has been reached for long enough to ensure the total destruction of any microorganisms, bacteria and spores.

All Astell autoclaves are manufactured to comply with European Directives such as PED 2014/68/EU and MDD 93/42. Each new autoclave is functionally tested and calibrated in our laboratory test area prior to dispatch. However, periodic testing of an autoclave’s performance is a recommendation and good practice for any conscientious operator. Astell Scientific offers standard functionality testing along with UKAS 17025:2005 single point calibration and multi-point (12 Pen) validation services as part of a post-purchase service offering.

Here we explain the differences between the two:

Single Point Calibration is a test which confirms that the machine is calibrated in accordance with UKAS standards to Astell Scientific’s accredited specification. This test can be carried out at multiple sterilize temperatures depending on the customer’s requirements. Upon completion, customers receive a certificate to confirm the resulting successful calibration.

Multipoint (12 Pen) Validation is a more detailed test which enables the engineer to record the temperature readings within a customer specific load and set up dedicated programs for those loads. This can be particularly advantageous when customers are sterilizing particularly difficult items. A certificate pack including detailed test results and load descriptions is supplied once the project has been completed.

In conclusion, its important that all parts of a load meet the required temperature for the time specified to achieve total sterilization of the load. Astell Scientific autoclaves undergo stringent testing to ensure they meet the high standards demanded by our notified bodies’ accreditation. In accordance with our Quality Management accreditation: ISO 9001 and 13485, our manufacturing, testing and staff training is managed through controlled documents and records. Single point calibration and multi-point (12 Pen) validation is available to customers by request.

View next topic: High power requirements vs. low power requirements on Sterilizers

View previous topic: What is Sterilization?

Astell is able to offer full IQ/OQ/PQ Validation packages Click here for details.

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