Understanding Medical Validation & Melt Temperature

The Medical Validation Procedure is very critical to verify that the system offers repeatability, assurance of accuracy, and a high degree of quality, according to a release from MTMS.  The company said to meet these requirements, manufacturers use a three step validation process described as Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ).  These procedures help qualify Tooling, Materials, Equipment, Systems, and Processes. The goal is to validate that the entire life cycle of the program is repeatable and traceable with a high confidence level that the quality repeats from lot to lot and year to year, MTMS said. 

The focus of this discussion will be on the injection molding process. MTMS noted that there are four major variables that control the process; melt temperature, fill speed, pack pressure and cooling rate.  Three of the variables are easy to duplicate from run to run.  However, measuring Melt Temperature has always been a mystery, as it is difficult to measure accurately.  Molders agree that melt temperature measurement remains one of the “last frontiers” of injection process control. “You can’t control what you can’t measure” is a fundamental axiom, and the problem here is the lack of an accurate, repeatable, practical, and generally accepted method of measuring the melt temperature.

MTMS said a new system is now available called the “Melt Temperature Measurement System (MTMS). There are two major principles that define the system.  They are: 1) an insulated cup is used the keep the purge molten so it can be measured before it solidifies, 2) there is a defined flow path in the system that forces the molten material over the thermocouple probe.  A high speed pyrometer records the peak temperature.  It is fast, repeatable and easy to use. Gage R&R studies have been successfully completed.

MTMS pointed out that OEM Medical Companies should ask “in house molders” and “contract molders” if they are monitoring and documenting melt temperatures.  Contract or Custom molders should be monitoring and documenting melt temperature as a Standard Operating Procedure (SOP) to improve your Medical Validation Procedures.