Silicone compression and injection moulding extends clean room facilities for Arrow Medical Ltd at Kington.
Arrow Medical has introduced silicone moulding facilities as part of the clean room facilities at Kington, Herefordshire. This latest investment serves an integrated assembly unit within the clean room, one of three now totalling 3,100 sq.ft. (344 sq. m.) at Kington. The assembly unit is housed in within a 600 sq. ft. (56 sq.m.) soft wall, ISO 14644 Class 7 (US Class 10,000) clean room, accredited to FDA GMP, and ISO 13485. The new facilities can also supply components for complete medical device assembly services within all three clean rooms at Kington. Arrow Medical manufactures a variety of devices used in anaesthetic, emergency surgery, vascular, anaesthetic and cardiac sectors.
The unit assembles 'life critical products' with 100 per cent testing and complete lifetime traceability. Other assembly processes for medical manufacturing in addition to silicone rubber moulding can include UV curing, solvent-based assembly, and other bonding techniques depending on product design. The unit now handles devices and assemblies and components using many different materials, including related moulded soft and rigid polymers, bought-in metal components, polycarbonates, flexible and rigid PVC and other medical grade rubbers and silicones. The silicone rubber moulded components go direct to the assembly line without leaving the clean room and all inspection, assembly and handling is self-contained.
This new integrated assembly unit can produce a wide variety of components and products, including catheter assemblies, tubing sets and complete single use devices and inflatable products for gas and liquid handling, which meet the specifications of Class I, Class IIa and IIb and Class III medical devices.
Arrow Medical's Kington contract medical manufacturing facility now comprises three clean rooms, with silicone compression moulding, solvent and UV curing adhesive assembly. Separate units at Kington also provide cover silicone moulding & over-moulding, manual and semi-automated lines for RF (radio frequency welding), and multilayer fabric assembly, including cutting and sewing labelling, packaging, stockholding, and worldwide distribution through the sterile chain, to meet all relevant ISO 13485 and US FDA, GMP standards. All assemblies are fully identified, marked and qualified and packaged ready for use direct to the sterile delivery chain. Allprocesses are qualified to meet ISO13485: 2003, ISO 9001:2000 and other European and international standards including United States FDA GMP.
For product and service information, contact Rita Didcock at Arrow Medical Ltd on +44 (0)1544 231760 or email firstname.lastname@example.org