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.
Dedicated coating line
The recently installed line, which is the third at Raleigh’s dedicated 35,000ft2 manufacturing and warehousing facility, was identified as a major enhancement to its specialist production service. Plans for the new line evolved in response to demand from old and new customers, and the company’s desire for greater space and increased flexibility for its specialist coating process.
The silicone gel coating market is highly specialised and the medical organisations and manufacturers using Raleigh’s services in this field include those operating in the wound dressing area. These companies – indeed all Raleigh’s customers from the medical and healthcare sectors – require the highest standards and reliable levels of production for silicone gel coating.
The design team at Raleigh invested significant time in identifying the right facilities and environment necessary to create the best cleanroom facility. The team discussed its plans for the cleanroom with many of the leading silicone gel manufacturers to ensure that it was kitted out with the best equipment to handle existing product specifications, but also to allow for new or future developments in the product; it has built-in flexibility and potential to make the transition to work with any new silicone gels coming to market.
The resulting design is testament to this: a stand-alone facility that is a dedicated, comprehensive silicone gel medical grade production resource, which incorporates the most efficient and effective cleanroom features, production technology and expertise to increase capacity substantially. Production has capacity to run 24/7 and Raleigh is looking at a volume capacity in excess of 1,000,000m2 each year.
Compliance with ISO 14644 Class 7 means that the cleanroom has no more than 352,000 particles per m3 equal to and larger than 0.5µm.
The silicone gel production line is a self-contained unit created within an existing building, but with its own entry/exit systems that were designed by the Raleigh team based on its experience of the silicone gel coating process and requirements of a cleanroom environment.
The facility has its own air handling system constructed to eliminate potential contaminants such as dust particles.
Bio Burden testing is carried out regularly on both personnel and equipment, testing for good personal hygiene standards. Personnel changing and washing areas have a positive air pressure two-door system and are ergonomically designed for ease of use and access.
Frequent and extensive checks to ensure the high standards of clinical cleanliness expected from the products are maintained
The cleanroom provides a dedicated facility that is free from contaminants and complies with the environmental cleanliness standards as set out in ISO14644. To provide and guarantee this assurance the company runs regular checks, atmospheric and air handling tests, and has incorporated a number of physical features into the design and construction of the cleanroom to achieve this.
The walls are constructed from white PVC hygienic cladding, which is Class 1 fire rated and is commonly used to clad any area that requires a high standard of hygiene. It has proven antibacterial resistance and a track record of high durability within the commercial workplace.
There are two-door systems with positive air pressure that act as an access portal for raw materials and finished goods moving to and from the cleanroom.
Frequent and extensive checks to ensure the high standards of clinical cleanliness expected from the products are maintained.
The cleanroom provides a dedicated facility that is free from contaminants and complies with the environmental cleanliness standards as set out in ISO14644
At the time the cleanroom was commissioned, Raleigh was able to use the skilled operatives within its workforce. As the company moves towards 24/7 production, it has been recruiting additional skilled workers, adding six in the past few months. All the operatives undergo initial and regular training to maximise their technical knowledge on the products Raleigh uses, including the silicone and adhesive gels, as well as the production and manufacturing processes that underpin the company’s operation.
Silicone gel is an incredible product with some amazing technologies, and has extensive applications and uses outside the healthcare arena. The cleanroom has been designed and constructed with flexibility in mind, so that Raleigh is positioned to respond to practically any silicone gel coating requirement beyond applications and products within the healthcare and medical coatings sector.
