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Cover Story

Simplifying Set-Up of Plastics Clean-Rooms

By : Medline Department, The Conair Group, USA

Navigating the highly regulated world of medical manufacturing and clean room operations can be a daunting, time-consuming task. Regulations and standards, developed by such organizations as the U.S. Food & Drug Administration, the International Organization for Standardization (ISO) and others, are many and complex. For those who want to begin manufacturing medical plastic products and components, understanding the regulatory requirements is only the first hurdle to be overcome. Then specialized facilities, including cleanrooms (Figure 1), white rooms and hybrid rooms, need to be designed and built, and processing equipment needs to be sourced with special attention not only to performance, efficiency and quality, but also to cleanliness, calibration, maintenance and record-keeping. Mistakes can result in delayed start-up, lost production, quarantined parts, rework and lack of process validation.


To simplify the process of specifying, buying, installing, qualifying and operating plastics auxiliary equipment in a clean environment, Conair has introduced a line of products – 170 units in all – for molding and extrusion of medical products (Figure 2). The new MedLine® product line 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. Here is why that’s important:



The regulations that govern today’s cleanrooms were first developed in the US Federal Standard 209E Airborne Particulate Cleanliness Classes in Cleanrooms and Clean Zones. As cleanrooms became more sophisticated, the industry recognized a need for more wide-ranging standards for cleanroom classification and testing. This led to the formation of ISO Technical Committee 209, which was tasked with the "standardization of equipment, facilities, and operational methods for cleanrooms and associated controlled environments." Today, the most common standards governing “the methods, facilities, and controls” used in manufacturing, processing, and packing of plastics medical devices are :

  • ISO 9001 – based on a number of quality management process approach and continual improvement and aimed at enhancing customer satisfaction through continual improvement of systems and processes, and conformity to customer and regulatory requirements.

  • ISO 14644 - a tiered structure that allows a specific maximum number of particles per cubic foot of air cleanliness in various classifications of cleanrooms and other controlled environments. (Similar to US Fed Std 209E.)

  • ISO 13485 – a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

  • ISO 17025 – the single most important standard for calibration and testing

  • FDA 21CFR – current good manufacturing practices (CGMP) for medical devices and pharmaceutical packaging.

These standards and regulations provide the checks and balances that lead to consistent and predictable outcomes in reduced product variation. Following their guidelines, and using good cleanroom management techniques, will help ensure quality and reduce costly mistakes in the production of medical plastics components.


In developing the MedLine family of equipment, Conair carefully considered each of these standards. Then they identified equipment features, calibration standards and documentation that can help processors get to a state of compliance faster and more easily, whether they need a single piece of equipment or a complete system.



Depending on the products being manufactured, medical plastic processors have adopted several different configurations for clean environments. Each requires a different level of clean. See Tables I and II.

A White Room is a typical entry-level clean environment meeting ISO 9 standards. Although a white room is typically air-conditioned, there is no attempt made to control particulate or air change-over. Otherwise, it is treated like a cleanroom, with gowning, hairnets and shoe covers. Typical applications would include lip-balm tubes, pill holders, medical cases, thermometer housings and the like. Although standard equipment has been used in white room environments for many years, there is increasing focus on the cleanliness and compliance. Calibration, preventive- maintenance, and installation qualification procedures are becoming more commonplace.


ISO 8 or Class 100,000 cleanroom applications – for instance, pumps, auto-injectors, blood-bag components, diagnostic and testing devices – require an approach that limits particulate generation by equipment and personnel working in the room. These rooms generally have air turnover rates of 5 to 48 times per hour in order to keep particulate levels in compliance with the standards. The equipment used in ISO 8 environments must be designed and manufactured to minimize generation of particulate, chemical vapors and airborne microbes. ISO 13485, which governs the manufacture of medical devices, generally requires this or more stringent levels of cleanliness. Equipment used in an ISO 8 environment usually is made with anodized aluminum, certain acceptable powder coatings, chemical resistant HMIs (to allow antiseptic wipe down of surfaces), and even urethane casters that allow machines to be moved for cleaning without generating rubber or vinyl particulate.


ISO 7 (Class 10,000) cleanrooms have more stringent requirements. These rooms generally have air turnover rates of greater than 60 to 90 times per hour. Humidity control is an important factor in controlling static electricity and bacteria growth. Because of this, many of these rooms also require bio-burden testing (to measure the number of micro-organisms on surfaces), antimicrobial- coated materials on room wall panels, equipment coverings and other surfaces. Room air ionization also becomes more important. This much-cleaner environment is much more suitable for pharmaceutical and sterile device packaging, syringes, vials and implantable devices. Equipment, then, needs to be designed and manufactured with consideration for these more stringent requirements. That means stainless-steel housings, castings, and covers instead of anodized aluminum, as well as FDA-complaint gasket materials and plenum-rated cabling. Particulate control is much more important and so equipment typically will be cooling-fan-free, using water cooling or remote exhaust valves. These are just a few things that need to be considered for an ISO 7 environment.



Examples of equipment being offered as part of the expanded MedLine® family of products include (from L-R) a Carousel® Plus desiccant-wheel dryer, a ResinWorks central drying system, MedLine Micro Receiver and a redesigned MedLine puller/cutter with integral conveyor.
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