One of the major roadblocks for smaller companies is getting their existing molding equipment and plant set up for the commissioning and validation required for the installation qualification, operational qualification, and performance qualification (IQ/OQ/PQ) process. This is not limited exclusively to the molding machines, but all equipment that has an effect on the manufacturing process of the component, or device being produced: material dryers, mold heating and chilling systems, plant particulate and humidity controls, quality control instruments, robots, printers, etc.
Machine calibration and software validation are the two major components in the machine installation qualification. Having the systems in place to maintain ongoing machine calibration is crucial; however, obtaining and maintaining the software validation can be more complicated. Many equipment manufacturers are not able to supply software validation on older equipment, which leaves the molder with a basic decision—liquidate the machine or perform the validation themselves. Even with newer equipment, some manufacturers may not be able to supply the molder with the proper detailed documentation to satisfy 21 CFR Current Good Manufacturing Practice (CGMP) for Medical Devices requirements. To solve this problem, Total Molding Services validated its own machinery using internal resources. On the molding machines, this process verified alarms and all computer controlled inputs and outputs were functioning and operated in a manner consistent with their intended use.
Beyond the machinery validation, the environment the equipment is operating in must also be tightly controlled. The plant climate control system as well as the air and water systems supporting the machines must be proven to be stable at all times. Extensive ongoing maintenance logs will need to be kept to prove long-term stability. Keep in mind that in order to be CGMP compliant, a company must be able to prove that their equipment is maintained and capable of performing a long-term repeatable process. Equally as important is the execution of internal quality systems and procedures which must meet CGMP requirements to prove long-term stability of the process.
There is absolutely no room for cutting corners in the medical device manufacturing field. U.S. manufacturers switching to or entering this field must be completely committed to meeting all requirements in order to be successful.
Brian Wright is operations manager for Total Molding Services Inc. Visit Total Molding Services at www.totalmoldingservices.com.