When validation is required

When validation is required

Full process validation needs to be performed:

• at installation or commissioning
• annually
• if any part of the process is changed in a way that could affect the outcome, such as introducing an ultrasonic cleaner, changing packaging systems, major repairs, or changes to loading configurations.

Validation needs to include:

• reviewing all reprocessing protocols, for example pre-cleaning, packaging, storage
• assessing staff competency in following procedures
• validating other equipment such as washer-disinfectors annually.