Medical manufacturing suppliers are expected to be able to innovate while maintaining required quality and safety standards. Quality controls are as impor- tant as nimble problem-solving abilities. Columbia Plastics, where we focus on in- jection molding, knows these challenges well, as the following example shows. Our customer came to us with the
challenge of making a curved camera housing for one-time use inside the body. Te camera unit is reusable and is to be inserted inside the housing. Te housing must protect both the patient and the camera from any form of contamination. Tis prevents cross contamination between patients and also ensures the camera electronics are kept clean. Te curve in the design is to provide the ability to slip into the abdominal cavity and be strong enough to maneuver and hold organs in order to see around them. Te housing must also include irrigation and suction lines to enable the surgeon to see clearly. Tese lines must be trimmed to the correct length and angle aſter being connected to the standard Luer fittings. Te angle of the arc along with
the camera locking feature, clamping rod and suction and irrigation lines mandated the unit be made in halves and assembled. Te assembly required a clear lens, the holder rod, the irrigation and suction lines along with their Luer fittings to be hermetically sealed to the handle and to support 25 lbs (11.25 kg) on the end of the clamping rod. In order to comply with Class 2
requirements for medical devices, we chose an ultraviolet curing adhesive that would withstand the electron beam
radiation used for sterilization. No ad- hesive was allowed on the lens or on the side of the part so it was applied roboti- cally to ensure a consistent volume and complete coverage. In order to avoid any adhesive leakage onto the outside of the housing it was necessary to make light- weight tooling to guide the two halves of the housing together. It was also criti-
F. Brian Holmes, CMfgE
Vice President and General Manager Columbia Plastics Ltd. Surrey, BC, Canada
way to do that was to hold the light in the same robot and follow the path of the adhesive dispensing with a suitable offset. Te holder bar was molded in a
highly filled polymer to replace the originally designed stainless steel unit. Tis allowed for electron beam steriliza- tion without creating radiation shadows on the part, and also reduced the weight of the assembled unit without com- promising the required strength. Te combined cost reduction for production and sterilization was $8 per unit. In order to ensure proper function-
cal to ensure the parts came together properly and completely the first time to prevent any air pockets forming in the adhesive. An air pocket could allow a failure in the seal. Since the lens was required to be made separately to ensure the optical properties it had to be assem- bled to the main housing as well. Te fact that it sits on a perpendicular plane required a separate assembly process in order to access the sealing geometry.
Evaluation of the potential risks allowed us to develop economical test methods.
To ensure complete curing of the ad-
hesive we ran a portable ultraviolet light around the sealing area. Te procedure was designed to provide the whole joint with the same exposure so the curing would be equal in all areas. Te simplest
ing of the part in use, every unit needs to be tested to ensure the hermetic seal and physical strength requirements are met. Aſter the part is assembled, each unit is clamped into a fixture by the clamping bar and loaded with a 30-lb (13.5-kg) weight on the end of the unit. We then confirm the hermetic seal using a test unit we designed and built to pressurize the part and detect any pressure loss. All of the testing had to be calibrated to traceable standards as well. Once this test is completed, the unit
was sealed in a vacuum-formed tray and sent for sterilization and onto the customer for distribution. Te process development for this
product entailed utilizing six-sigma tech- niques to map the process. Failure modes and effects analysis (FMEA) was used to confirm all risks had been addressed. Te evaluation of the potential risks allowed us to develop economical test methods to validate the product’s ability to function reliably in the operating theatre.