A TECHNO-ECONOMIC NEWS MAGAZINE FOR MEDICAL PLASTICS AND PHARMACEUTICAL INDUSTRY
Our 26th Year of Publication
Page  6 of 6

Cover Story

Simplifying Set-Up of Plastics Clean-Rooms

 

Hybrid Cleanrooms are typically installed to minimize costs or to adapt to building design constraints. The cost to build, run and maintain true cleanroom conditions can be high and so the smaller they are, the less they cost and the easier it is to maintain the necessary cleanliness. Hybrid rooms are designed so that most of the particulate-generating equipment is kept outside the clean environment. Polymer dryers, blenders, and vacuum conveyers, for instance, would be installed outside and plumbed or connected to processing equipment inside the cleanroom. Thus, standard equipment can be spec’d without cleanliness concerns. In some cases, even the processing machines operate outside of the room and only molded or extruded components enter the room under controlled conditions for final processing. This arrangement can pose a design and installation challenge but considerable money can be saved by not having to buy or maintain special equipment.

 

PEACE OF MIND

Conair has used the MedLine trade name previously to cover downstream extrusion equipment designed especially for producing precision tubing including multi-lumen heart and brain catheters. Now the registered trademark has been extended to encompass the full range of medical auxiliaries, including not only downstream extrusion, but also material-handling, drying, blending/feeding and heat-transfer equipment.

In all, Conair offers over 40 models across the five equipment families with 170 fully configurable variations to match the complexity of the environment and/or regulatory standards.

Machines are factory calibrated to meet regulatory requirements, labeled and certified. 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.

Besides the mechanical and finishing features like non-ferrous fittings, powder coating of cabinets, stainless-steel components, HEPA filters and chemical-resistant HMI screens, many MedLine products also have control and data-gathering capabilities that are indispensable to clean-room operation and documentation. For instance, a Material Vision Proofing or MVP system provides critical verification in central resin distribution systems. The Drying Monitor 3 delivers early alert notification should drying conditions drift beyond critical set-points. Blenders can be equipped with SQL data-gathering packages and the FLX conveying control has an alarm history log.

What the MedLine label signifies to the medical plastics industry is peace-of-mind. When a processor selects a piece equipment with a MedLine label on it, whether it is designed from the ground up for cleanroom applications or it is a part of a 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.

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