Process Validation

Process validation is required when the quality of a product cannot be 100% verified (due to too many products or destructive testing). The process validation consists of three steps: Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). More detailed information, in general, on validation can be found in this article, or validation focused on medical 3D printing in this article.

Installation Qualification

At Vosfox Medical, we combine the equipment and process validation installation qualification steps. During the Installation Qualification, we check the following items:

  • Presence of equipment work insturction, utilities, tools, spare parts, instruction, manuals, drawings etc.
  • Incorporation of the equipment in the Equipment Control procedures (e.g. maintenance, calibration, cleaning)
  • Software and Firmware validation
  • Safety testing
  • Basic functionality testing

We work with test cases to check that all required test steps are done, and it standardizes part of the work to improve speed and reduce cost.

Operational Qualification

During Operational Qualification, the following activities are performed:

  • Process Development – setting rough process window. When a process is well known (e.g. pouch sealing), the development part is not existing or is limited to a few tests.
  • Design of Experient – determine the interaction between different critical process parameters and set the low-nominal-high settings. We compare the products with pre-determined (draft) specifications.
  • Verification runs at low, nominal and high settings. These tests give us flexibility in the process settings, knowing it produces good quality products.

Further, a check is done on implementing the mitigation actions of severe risks.

Performance Qualification

During the Performance Qualification, entire product batches at nominal settings are produced. All work instructions, test method validations, cleanroom validation, specifications, etc., are finalised before starting Performance Qualification.

Batches produced during PQ may, when fulfilling all product specifications, be used in clinical trials or sold commercially.