Within the medical device world there is a need to validate the passivation process. But what does that mean, and how does that work? Validation is the process of insuring that the passivation process you use will reproduce repeatable and predictable results every time a batch of parts is run through the process. By validating the process […]
Why are automated systems easier to process validate than manual equipment?
Process control and stability are critical aspects to regulated medical device and aerospace processes. It is important to ensure that a process has input and output variable limits which are defined and fully tested during process design, Equipment Qualification (IQ), Operational Qualification (OQ) and Process Qualification (PQ) validation testing. Setting up a proper DOE (Design […]