The Conair Group is introducing MedLine, a range of auxiliaries to help medical plastics processors select, install, commission and start up white rooms and cleanrooms faster and with less paperwork than previously possible. The company has 170 units in all for molding and extruding of medical parts. The units combine features of ISO Class 7 and 8 cleanrooms, white rooms and hybrid rooms, all configurations commonly used in the medical device and similarly regulated industries.
The new MedLine of products includes equipment for conveying and storage, resin drying, blending, heat transfer and downstream extrusion. All are based on proven Conair designs, but they have been specially sized, configured, documented and supported for use in cleanrooms and other controlled environments such as those found in cosmetics, electronics and aerospace.
Constructions use only mechanical equipment and materials that are compliant with standards for ISO 14644 cleanrooms. Depending on the application requirements, machine surfaces may be powder coated with 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 must typically generate to validate compliance of their cleanroom facilities and processes.
âWhat we are offering the medical plastics industry is peace-of-mind,â says Larry Doyle, president of Conair. âWhen a customer selects a piece equipment with a MedLine label, whether it is designed from the ground up for cleanroom applications or it is a part of our standard product line, they can be sure it has been pre-evaluated, pre-configured, pre-calibrated and is suitable to meet the requirements necessary for compliance with applicable standards.â
Major development effort
The company has used the MedLine trade name previously to cover downstream extrusion equipment especially for producing precision tubing including multilumen heart and brain catheters. Now the registered trademark has been extended to encompass the full range of medical auxiliaries.
âI know from experience how difficult, time consuming and expensive it can be to equip a cleanroom, calibrate everything and validate the process according to applicable standards and regulations,â said Matt Zelkovich, general medical manager at Conair. âWith Conairâs knowledge and years of application experience working in a medical environment, we can really help clients save time and eliminate complexity in achieving auxiliary component integration compliance. No other company I know of is doing this. It is just too complex for most equipment suppliers.â
To show off the new MedLine product line, Conair created a simulated cleanroom environment as part of their MD&M East 2015 booth. The walls and ceiling were made of FRP panels, just as a real cleanroom would be. Air-filtration equipment and ductwork were also simulated.
The Conair Group