Contract Manufacturing Process Development and Validation

Process Development and Validation

A carefully constructed process delivers value well beyond the time it takes to define it. But a process will only deliver this value when it is meticulously validated and well executed. Lubrizol Life Science Health (LLS Health) understands these principles.

  • Efficiency
  • Consistency
  • Control
  • Continuous improvement

We make sure these are the cornerstones of quality in every product and every run.

Process Development

Long before the production launch date is set, LLS Health’s Six Sigma certified experts will collaborate with you to develop the optimal production process — tailored for your specific project. Here, our years of medical device manufacturing expertise come together with our deep dedication to realizing your vision. And, the result is a plan that guarantees quality beyond compliance. Specific steps in this development can be expected by all customers:

  • Feasibility review with senior engineer support
  • Process flow diagram development
  • Establishment of ideal parameters — such as temperature, injection pressure, dwell and cure times, and shot weights
  • Creation of a control plan, including written operator instructions and criteria for product acceptance and rejection
  • Process failure mode effect analysis (FMEA) to evaluate potential process failures and courses of corrective action for quality assurance

Medical Device Process Validation

Once established, the production process is validated using a customized protocol specific for your product. We supply samples to support your first-article requirements. Similar samples are then measured and tested to verify that the process output meets the required specifications. Data analytics with Minitab® statistical software determine overall process capability, and a gauge reproducibility and repeatability study allows us to identify and rectify the source of any variation. If any flaws do exist in the process, they are found here and eliminated. Through our dedication to quality, we refine the process and its repeatability in order to reduce the need for inspection during production. Our complete medical device validation support ensures that you always get the results you expect.

Continuous Quality Assurance

LLS Health also recognizes that even the best process requires continual monitoring in actual production. That’s why we utilize advanced technologies such as automated vision systems and laser micrometers throughout the run. Our quality management personnel apply statistical process control and data analytics to ensure consistency and quality at every stage.