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21st Sep 2011

Giving Medical Device Manufacturers Affordable Options for Business Growth

Increasing demands from the global market for ultra high quality medical devices are driving medical device manufacturers to seek cost effective and prompt solutions to contamination control for all stages of device production from manufacture and assembly to packaging. Whilst purpose built, static cleanrooms may offer a solution for some, for others a more flexible, rapid response, modular cleanroom unit may offer a better solution and enable them to meet the requirements of individual contracts, production variations, specialist activities, budgets and time restrictions, giving them a competitive advantage.

Below, specialist cleanroom manufacturer and installer, Connect 2 Cleanrooms outline how their bespoke modular units can help companies build their business and keep capital expenditure at a minimum. UK based Haemonetics Corporation has utilised a modular cleanroom solution from Connect 2 Cleanrooms to develop a niche business opportunity that meets the global demand for premium quality medical devices. Whilst specialist medical dressing manufacturer, Focus Product Developments Ltd. has invested in a purpose built cleanroom to give them significant improvements in operational flexibility and further opportunities to create new and profitable business.

‘Our various structures are intended for medical device manufacturers that need to adapt a non-clean area to a cleanroom environment in which particles of dust and microbial growth are controlled. By adopting a mini-environment design we focus on the immediate area that needs to be controlled. By dealing with a small area the costs can be kept low, making Connect 2 Cleanrooms’ structures very cost effective.’ Explains Joe Govier, Managing Director, Connect 2 Cleanrooms.

‘Our mobile cleanrooms give manufacturers the clean environment they need to meet manufacturing standards and allow them the flexibility to meet changing production demands and the opportunity to add value to their products by implementing classified area status production methods; all for relatively low capital investment.’

Injection Moulding Operations – Haemonetics

Haemonetics, a global leader in blood processing technology, automated blood and plasma collection systems and associated devices and consumables, has recently installed a bespoke cleanroom enclosure over a fully automated, precision, plastics moulding machine and robot. This moulding machine and robotic handling unit are utilised in the manufacture of medical device components destined for a quality led market. The moulded plastic component is a key part of a single use centrifuge used in blood processing and its cosmetic and cleanliness quality is critical.

‘Because of the position of the injection moulding machine and robot on the site and our need to have ready access for tool changing, Haemonetics needed a bespoke designed unit. As we run a five day, 24 hour operation, it was also essential that our supplier could install the equipment on the weekend. The initial response from Connect 2 Cleanrooms was very quick, they had an excellent design for the cleanroom and their pricing was very competitive.’ Says Kenny Brown, Manufacturing Process Engineer, Haemonetics, Bothwell, Scotland.

The 3m x 3m x 2m modular cleanroom is designed to control the airborne particulate using HEPA filtration to facilitate air changes within the room 84 times per hour. This creates a highly focused mini environment with a concentration of contamination control at the point of risk when the component is automatically removed from the moulding clamp to the product transfer conveyor. The localised approach keeps the main risk of contamination from motors, granular feed systems, and personnel to the outside of the clean zone.
The bespoke modular cleanroom design is constructed around a free standing frame using clear, softwall panels and is fitted with additional lighting and an integral filter monitoring system that ensures that air quality levels are maintained at all times. Because the cleanroom is freestanding no building control or planning permission was needed, installation time is quick and capital expenditure costs are relatively low.

Haemonetics’s original compliance criteria was to achieve production within a minimum Class 7 controlled environment and formed part of the company’s business plan of continuous improvement and development, anticipating and keeping them ahead of market demands.

‘We are genuinely impressed by Connect 2 Cleanrooms and the cleanroom unit which to date has produced results even better than we asked for by achieving a minimum ISO 14644-1 room classification, Class 6 (US Federal 1,000), making it ten times cleaner than we had anticipated. This means we are well within the current compliance requirements for high end markets.

We were confident that Connect 2 Cleanrooms could meet our criteria as, Joe Govier, Connect 2 Cleanrooms, had a thorough understanding of injection moulding processes, which meant he knew all the potential problems that had to be allowed for.

The installation and validation of the cleanroom was completed one Saturday in April, so we did not have to disrupt production schedule, which was perfect for us.’

Plastics Welding and Assembly – Focus Product Developments Ltd

‘When we needed a cleanroom validatable to ISO 14644-1 Class 7 in order to manufacture a new dressing we approached Connect 2 Cleanrooms for their bespoke designs on a free standing structure around a high frequency plastic welder.’ explains Dr. Craig Barson, Focus Product Developments Ltd., Halifax, West Yorkshire.

‘Our second purchase of a cleanroom enclosure from Connect 2 Cleanrooms is linked to the original structure to provide pre- process contamination control and allow us to offer the very best environmental conditions for the manufacture of the Class 2 device.’

The 4.5m X 4.3m X 2.2m, softwall cleanrooms are located within a clean environment and deliver monitorable/validateable environments compliant with Class 2 device manufacture. They are free standing and can be moved elsewhere on/off site, should this be required in future. Requiring no planning permission and with the option to move them off site, the cleanrooms offer a highly flexible and financially beneficial alternative to static cleanroom designs.

‘With this relatively small but important investment, Focus Product Developments now have an established, proven controlled environment that can be further utilised for the development and manufacture other Class 2 devices both for our own ranges and for customer contracts, which is a great opportunity for business growth.’ Said Dr. Craig Barson.

With a range of standard and no-standard designs available, Connect 2 Cleanroom can offer medical device manufacturers the most appropriate cleanroom for their requirements, from small, single cell units to large interconnected units for full production facilities.

‘We offer all our customers, regardless of the size of their cleanroom requirements, the same high quality service and supply. By working closely with customers and utilising our expertise and experience we can ensure that not only does the cleanroom meet specific needs but that this is done in the most cost effective way. We can also supply specialist cleanroom furniture, accessories and consumables giving medical device manufactures a single source supply for all their cleanroom needs.’ Confirms, Joe Govier.

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