Medical Device Manufacturer Molding Validation – Program Development

The Challenge

A contract medical device manufacturing company wanted to add a new service, injection molding for medical devices components.  The scope of the project included qualifying a new facility including new molding equipment and instrumentation, developing and implementing a molding process validation program, and developing and implementing qualified inspection programs.

The Solution

PV was selected for this project because of their experience in developing validation programs and our existing relationship.  PV resources knowledgeable in validation partnered with the client’s resources knowledgeable in injection molding to qualify the new facility, equipment, instrumentation, molds and inspection programs.  Simultaneously we worked to develop and refine a program that could be implemented for each future mold and inspection program.

The Results

Commissioning and qualification of the facility and associated equipment was satisfactorily completed including 3 Nissei injection molding machines, a Motan material drying and delivery system, thermolators, hot runner temperature controllers, compressed air system, chilled water system, HVAC and 2 coordinate measuring machines (CMM).  Each system was qualified separately, with the exception of the mold machines and thermolators, which were qualified in groups of 1 mold machine and 2 thermolators since the thermolators are dedicated to their associated mold machine.  Verification of all systems reliably operating in conjunction was confirmed during simultaneous qualification of several molds.
A standard qualification protocol was develop and refined during qualification of fourteen medical device molds.  Qualification protocol included

  • IQ: Confirmation of Drawings (including mold attributes), Equipment, and Procedures (mold setup and operating) this addressed information dominance by ensuring accuracy of the manufacturing instructions.
  • Site Acceptance Testing (including first article inspections), this addressed setup dominance by ensuring the equipment was set up properly.
  • Benchmarking/DOE/Engineering Runs including statistical analysis and identification of key process parameters.  This process allowed the determination of statistically significant process variables and identified key variables to control thus reducing variation and increasing consistent product quality.  The outputs from these runs established the process parameters that were incorporated into work methods/procedures (Information dominance) and setup parameters (set up dominance).
  • OQ: Setup & Functional testing, High/Low Boundary Limit testing
  • PQ: Manufacturing of 3 consecutive salable lots per production procedures with increased sampling (inspected via qualified programs) with 2 different lots of material, this addressed component dominance by evaluating performance with different acceptable raw materials.

A qualification procedure for inspection programs was developed for use with the qualified coordinate measuring machines (CMM).  Each program required development of an operating procedure to provide customized instructions for setup/positioning of tooling and parts.  The CMM Operating procedure addressed information, set up and worker dominance by providing a standard methodology for performing the inspections.  Qualification of the program includes the following:

  • Measurement of critical parameters for one group of parts both manually and via the program to ensure program measurements meet expectations.
  • Inspections of parts with a known out of specification critical parameter.  Parts are rotated for inspection in each position (8 positions for an 8 cavity mold) to ensure all positions are capable of accurately identifying each out of specification parameter.
  • Inspection per procedure of the same group of parts by 3 different trained operators to ensure repeatability.

The Benefits

The client is now able to provide qualified medical device component injection molding services to support their medical device and combination product assembly services.  Additionally, the qualification of injection molding and inspection processes have greatly improved their supply chain quality and reliability by reducing the occurrence of molding defects and increasing the identification of potential molding issues prior to production of out of specification parts.

Since implementation of the qualified injection molding process, several potential new customers have audited the molding qualifications.  At least one new product has been awarded in part because of the available on-site injection molding and the robust qualification package that supports each new molded part.

For additional information, contact:
Holly Couch
Senior Validation Engineer
Performance Validation, LLC.
5420 W Southern Ave, Suite 100
Indianapolis, Indiana 46241
(317) 248-8848
(317) 445-4336 (mobile)