As I walk the NPE2015 show floor, I'm always on the lookout for medical applications. There are quite a few, as it turns out, but one in particular that caught my attention was a mock cleanroom set up by Conair (Cranberry Township, PA) to highlight its MedLine portfolio. The installation is quite impressive, and if you are at all interested in cleanroom extrusion and molding, I encourage you to stop by booth W-2143 and check it out. And while you're there, say hello to Conair newbie Matt Zelkovich, General Manager, Medical, formerly Director of Engineering and Development at West Pharmaceutical Services. He is overseeing the extension of the MedLine portfolio, which now includes more than 170 different pieces of equipment for conveying and storage, resin drying, blending, heat transfer and downstream extrusion.
MedLine has been part of Conair's portfolio for several years. It was used to market downstream extrusion equipment designed for the production of precision medical tubing. What's new is that the name now encompasses a full range of the company's auxiliaries.
Zelkovich joined Conair in March 2014 after a decade at West Pharmaceutical, where he was responsible for setting up and validating cleanrooms across the globe. "Equipping a cleanroom and doing the calibration and validation is time consuming and expensive," says Zelkovich. "With Conair's knowledge and years of experience working in a medical environment, customers can save a whole bunch of time and money achieving component integration and compliance." Work on the MedLine expansion began some 18 months ago, but it is now under the stewardship of Zelkovich, who promises more developments to come.
The installation at NPE combines features of ISO Class 7 and Class 8 cleanrooms, white rooms and hybrid environments. It includes simulated processing machines and an array of auxiliary equipment, HEPA filtration units and other support equipment
Elements on display include:
- A climate-controlled white room, where products are made under standard HVAC conditions. A simulated molding machine is located outside of the room with HEPA filtration above the molding area. A MicroWheel dryer is mounted on the machine and molded products are conveyed into the cleanroom for further processing under controlled conditions.
- A hybrid cleanroom with a simulated extruder outside the cleanroom area. Extruded product exiting the die enters the cleanroom through a small opening in the wall and passes into a cooling tank and puller/cutter unit inside the cleanroom. These MedLine units, which were introduced several years ago for medical extrusion applications, have now been updated for cleanroom operation.
- ISO Class 7 and 8 cleanrooms with two simulated HEPA filtered blowers that deliver air, largely particulate-free, to the room. A simulated vertical-clamp injection-molding machine is serviced by a MedLine TW Premium temperature control unit and a new MedLine micro receiver mounted on the hopper of a MedLine MicroWheel dryer. A MedLine FLX material-handling control system, with a clean touch-screen display, controls delivery of dried resin from a three-hopper ResinWorks sled (located outside the cleanroom area).
MedLine equipment is constructed in compliance with ISO 14644. Depending on application requirements, machine surfaces may be powder coated in RAL 9003 signal white or made from stainless steel. All equipment is supplied with a quality and regulatory compliance package aligned with ISO and FDA requirements. Machines are factory calibrated to meet regulatory requirements, labeled and certified for one year. Installation qualification forms are supplied, ready to be filled out and filed. Preventive maintenance procedures required for regulatory compliance are also detailed, and reporting forms are provided. This documentation significantly reduces the paperwork processors typically need to generate in order to validate compliance of their cleanroom facilities and processes.