Silicone gel adhesive coating is increasingly being used by medical device producers. Peter Turton, MD of Raleigh Coatings, describes a new bespoke cleanroom facility built specifically for the production of silicone gel adhesive products for medical applications.
A new self-contained cleanroom facility, complete with a dedicated silicone gel adhesive coating line, provides Raleigh Coatings and its customers with a bespoke stand-alone production facility for the delivery of high quality medical grade adhesive coatings, undertaken to cleanroom standards that are compliant with ISO 14644 Class 7.
In the planning since 2010, construction of the new facility and commissioning of the bespoke clean line was completed in December 2012. It represents a substantial outlay for the company and forms the latest investment in a continual programme that underpins its commitment to the coating and conversion industry and to ensuring that its facilities are among the most modern in the UK.
The new cleanroom incorporates an integrated high clean preparation and production environment within a building that has been ergonomically designed using walls, fixtures and fittings frequently seen in hygienic food production areas to achieve clinical, contamination-free standards. High levels of cleanliness are enhanced by a dedicated entry/exit system and washing facilities for its skilled operatives.
Founded in 1989, and based in Eccleshall, Staffordshire, Raleigh has more than 20 years of experience working with medical coatings for the healthcare industries and its specialist services include: contract coating for single, double and self-wound systems using a variety of adhesives, substrates and liners; cleanroom coating; slitting and converting; silicone gel coating; and a full design and bespoke development service.
Interest has risen from medical organisations across the world and they increasingly demand a lab-bench to final production service for silicone gel, aqueous- and solvent-based coatings. Raleigh is one of a few UK organisations to offer a specialist ‘pilot line’ facility that enables coatings to be tested in production conditions at a fraction of the cost prior to moving to full production.
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