What is Process Validation ? 

Process Validation is a documented method to prove that a specific process with high probability continues to meet its predetermined specifications. 

Validation of critical processes has for many years been a requirement in the pharmaceutical industry. This has now spread to other parts of the health-care sector.

Since mid-2009 it has been mandatory to validate the sterilization process annually for all sectors of healthcare, to meet the harmonized European Standard (DS / EN ISO 17665)

A completed validation ensure that;

• The process is safe and repeatable

• The equipment is thoroughly tested

• Equipment and processes are well documented

 Process validation should be repeated yearly (called 're-validation'), this ensure that you have a clear indication of the autoclave capability even if "the ravages of time" begins to gnaw.
 
Why perform process validation ?