IQ/OQ/PQ Validations

packageBoth Mar-Lee Medical and Mar-Lee Packaging and Consumer Products utilize mold and process validations to ensure the highest quality and the most consistent products. Molding medical devices in particular requires constant attention to detail and an adherence to strict quality standards. Plastic medical products and plastic parts used in medical devices must function properly 100% of the time.

Molders must not only consistently produce acceptable parts but must readily provide documentation confirming the quality of every molded part. One important step in ensuring consistent, high quality molded parts is to clearly define a successful and reliable injection molding process for each part prior to production. That’s why molding processes often undergo detailed validation and qualification to ensure their consistent adherence to customer quality standards before the production even begins.

medicalConsumer Products Mold and Validation. There is no better way to ensure these standards than with the use of IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) validations. Mar-Lee utilizes these detailed validations to ensure proper testing and documentation of the molding processes long before the parts reach the production stage. This involved series of tests demonstrates both to us and to the customer, in a clearly documented format, that the parts will be molded according to a clear and defined process window. It ensures that each part will consistently fit within each and every specified parameter in a predictable and reliable manner.

IQ3Consumer Products Molding and Testing. The Installation Qualification is the first stage in the process validation. It ensures that the mold is capable of producing product that conforms to dimensional, performance, and cost requirements. A number of sample parts, determined by a customer agreement with Mar-Lee, are produced while the molding process is adjusted until acceptable parts are produced. A specific number of acceptable sample parts are then inspected by Mar-Lee quality personnel for customer-defined dimensions to ensure they are within tolerances. If the parts meet all dimensional, cost, and performance analyses then the parts are released to begin the OQ.

IQ4Consumer Products Molding and Testing. The Operational Qualification is utilized to define and demonstrate the process window for creating acceptable parts. The high, low, and nominal processes are determined by completing multiple runs in which process temperatures, pressures, velocities, and times are all varied from the initial process defined by the IQ. This creates a reproducible range of process specifications that in turn ensures the production of parts that consistently conform to dimensional, performance, and visual inspection requirements.

Consumer Products Molding and Testing. The Performance Qualification is then used to validate the injection molding process derived from the IQ and OQ tests. The PQ consists of three separate runs, all completed at the nominal process settings established by the Operational Qualification. The machine being used is shut down and allowed to cool after each run before beginning the next. This ensures that quality parts can be produced in larger numbers well within tolerance guidelines at all stages of the accepted molding process. Critical dimensions are inspected by quality personnel and all final physical and functional testing is completed both by Mar-Lee and the customer during the PQ.

botarmOnce all requirements have been met and all records and reports are completed, the molding process can be approved for production. Official records and reports are produced during each of the qualification runs. These include a complete description of actual parameter settings used during the qualification, actual inspection results, any deviations and their reasons, and a summary and conclusion of the results of the qualification. These documents and reports ensure that all validation is documented for reference by both Mar-Lee and the customer. The IQ, OQ, and PQ tests are extremely important tools for Mar-Lee as a top-quality molder. We ensure consistent production of the highest quality parts that have been put to test under the most stringent guidelines which comprise the valuable IQ, OQ, and PQ tests.