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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 […]
Manual Process Equipment Validation - FAQ
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Semi-Automated Inline Citric Passivation Solution with Data Tracking
For one medical device manufacturer, the design of a citric passivation solution faced two major challenges: The manufacturing process required performing a water-break test after cleaning parts, before proceeding to passivation. This meant that they could not use a fully automated passivation solution. The system had to have data tracking for quality control purposes. Semi-Automated […]