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• Identified cause and fixed Molded Vascular Implants' Brittleness - Ended Product Recall via Stress Birefringence Analysis (SBA) and Process Development ... 

Details: 

Intermittent brittleness had caused the voluntary recall of an injection molded bioresorbable vascular implant product during the first months of its Product Launch.  We identified the "molded in" root cause of intermittent brittleness with "crossed polarizers" mounted on a microscope and using SBA that ended the product's recall with a permanent fix: the use of proper molding equipment. The rapid resolution of the new product's quality problem gave the company a significant competitive advantage since it allowed this product to beat its competition by being first to market. As a result, many surgeons were trained to implant this product and this outcome accelerated this product's dominance in the market. 

• Identified cause and eliminated Molded Bioresorbable Implants' Bubble Formation - Prevented Shutdown of New Product's Launch via Micro Infrared Spectroscopy (IR) and Gas Chromatography/Mass Spectroscopy (GC/MS) Analyses ... 

Details: 

Comet-shaped bubbles were found inside some tiny bioresorbable vascular implants. The shape of the "comets" with their "heads" facing in the direction of flow indicated that they had been inflated during the injection molding cycle. Microscopic bubbles were dissected and tiny deposits of amide were found on the inner surfaces of the bubbles. Polymer-encapsulated bubbles were melted in a Thermal Desorber and the gas inside the bubbles was blown into a GC/MS. The bubbles contained Carbon Dioxide (CO2.) Thus, it was shown that the polymer pellets were contaminated with amide antistat -a processing aid - probably by being placed in plastic bags containing this amide contaminant. One of amide's properties is moisture adsorption. This adsorbed moisture was volatilized (boiled) during the injection molding process and inflated the above described comets. The steam within each comet instantly hydrolyzed the biodegradable polyester material forming CO2. Recommended proper handling and storage methods that resulted in the permanent elimination of this type of contamination. Helped the company maintain its originally planned Launch of this extremely successful and profitable medical product. 

• Identified root cause and fixed Wrinkled Molded Device - Prevented Shutdown of $100MM per year factory via rapid development of Analytical Method to Statistically Prove Cause was the supplier's Addition of Wrong Pellets to the supplied resin ...

Details:

A $100MM per year device factory was about to get shut down due to an unexplained "processing problem." The device barrels were being molded with wrinkles in them due to varying wall thickness. The polymer pellets were supposed to contain an additive enabling it to harden faster during molding. The pellets were supposed to be mixed uniformly. Created, developed and validated a unique incoming inspection method inclusive of statistical analysis that provided for the rapid measurement of chemical properties for individual resin pellets.  Statistical analysis of the generated data indicated a strongly bi-modal instead of a normal distribution of the analyzed pellet properties. The results indicated widely varying additive concentrations of individual resin pellets. This data proved that the pellets consisted of a mix of pellets with two different nominal levels of the additive; two different populations of pellets. The supplier had added two batches of pellets together; one with the correct amount of additive and one with an out-of-spec additive concentration. Since the pellets were believed to be identical as they should have been, the company processed them through its silo, hopper and molding operations without any additional mixing. Thus, the "processing problem" was caused by the vendor's use of the wrong material. Our rapid, detective identification of the root cause of the problem and our recommendations help the company continue meeting its production schedule with no slippage. 

• Identified root cause and fixed Splitting K-Resin Barrels - SBA and Process Development ...

Details:

When the Persian Gulf War was about to begin, a manufacturer needed to supply Atropine self-injectors for protecting Saudi Arabia against a possible nerve gas attack. Attempts to mold the injectors were endangered by the constant splitting of one end of its K-Resin™ barrels upon its ejection from the slightly undercut mold. There was no visible defect on the barrels.  As soon as the parts were received, we  placed them between "crossed polarizers" and then a "knitline" was instantly apparent - delineated in brilliant color - which ran down the side of the barrel and ended in the split. This phenomenon typically is the result of a polymer that is not hot enough to flow around a core pin and melt homogeneously with the same polymer that is flowing around the pin from the opposite direction. We recommended raising specific molding zone temperatures which eliminated this problem and Saudi Arabia got its Atropine Pens. 

• Identified cause and fixed Brittle Syringe Tips - SBA and Tooling Modification ...

Details:

Customer complaints for device tip breakage spiked. Records implicated a new mold. SBA showed that the tips from this new mold had excessive shear stresses due to a design fault: an improperly radiused turn of the syringe's tip. Recommended steps for correction of this design error that fixed the problem. 

• Increased Angiography Catheter Stiffness - Extrusion Process Development 

Details:

A manufacturer needed to stiffen its Angiography catheters. Through development and execution of experiments inclusive of statistical analysis at the production line an extrusion process was developed that yielded a superior catheter stiffness, the maximum stiffness this polymer could attain. 

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