The validation process is defined as the means of providing documentary evidence to establish that a process will consistently yield a product complying with its predetermined specification and quality requirements.
Typically validation will consist of a number of discrete stages, namely installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ). In addition a design qualification (DQ) element will demonstrate that the design of the sterilizer or autoclave is in compliance with the user requirement specification (URS).
Installation qualification is the process of providing documentary evidence that the sterilizer has been manufactured and installed in compliance with its specifications. Particular attention should be paid to the following key elements:
1. Verify that all required documentation has been issued and is 'as built and installed'. Documentation issued should normally include as a minimum: - pressure vessel certification, material certifications, installation drawings, electrical schematics, P&ID's, manufacturer's certificates of conformity (C of C's) and operation and maintenance manuals.
2. Verify that the installation of the equipment, its utilities, piping, wiring, and instrumentation has been installed and is in accordance with the issued drawings. All individual components should be tagged and uniquely identifiable.
3. Demonstrate all analogue temperature and pressure sensors and transducers are calibrated and within set limits of accuracy. A label should be applied adjacent to each temperature and pressure sensor with the date of calibration, certificate number and the date next calibration is due. All reference instrumentation should be calibrated to traceable national standards and calibration certificates for all instruments should be included with the validation report.
All discrepancies found between the 'as built' equipment and the specification should be documented and evaluated for possible impact on the process along with rationales for acceptance were appropriate. Any corrective actions required must be documented and carried out before commencement of the next phase of validation.
For further information and resources relating to autoclave and sterilizer technology, visit http://www.steriliser.co.uk