Arrow Medical Ltd has commissioned a single use medical device production unit, with UV curing and assembly lines, which brings total cleanroom assembly facilities to 3,100 sq.ft. (344 sq. m.) at Kington, Herefordshire.
The new UV curing and assembly lines, accredited to FDA GMP, and ISO 13485, are housed within a new 600 sq. ft. (56 sq.m.) soft wall, ISO 14644 Class 7 (US Class 10,000) clean room built by Connect 2 Cleanrooms. Arrow Medical will be producing a variety of single use devices used in anaesthetic, emergency surgery and cardiac sectors and building complex inflatable systems from components using a variety of materials, including flexible and rigid PVC.
The new facility provides complete product assembly for 'life critical products' built from many complex components using UV curing technologies, with complete traceability throughout the product lifetime allied to 100 per cent testing inside the clean room. The production lines include a MSI130 pad printer for the printing of product details onto even complex curved products, multiple adhesive dispensing units and assembly workstations, supported by Dymax UV curing lamps with light guides and Intertronics UV 300 conveyorised UV curing units. Products are sealed into pouches using a Riverside Shaw seal unit. Lot and expiry date details are printed onto the pouch using a Domino G100 inkjet printer.
The new soft wall unit includes an illuminated transparent ceiling to ensure high light levels (1000 lux) providing optimum operator conditions for assembly of small and complex devices. Complete air handling and air conditioning systems are also installed, with HEPA filters, maintaining over 100 air changes per hour. The complete system includes programmable day/night controls to achieve high levels of energy efficiency.
"Staff training has been a critical and substantial part of investment in this project" commented Rita Didcock, Managing Director, Arrow Medical. "High quality standards and demanding production rates for the next generation of single use devices require a very consistent production culture to meet the triple challenges of clinical performance, high yield and traceability while complying with our customers' stringent delivery performance and quality requirements."
Arrow Medical's Kington contract medical manufacturing facility now includes three clean rooms, using solvent and UV curing adhesive assembly, manual and semi-automated lines for RF (radio frequency welding), and multilayer fabric assembly, including cutting and sewing. Support units cover silicone moulding & over moulding and complete sterile product assembly. Arrow Medical's team at Kington also provides labelling, packaging, stockholding, and worldwide distribution through the sterile chain, to meet all relevant ISO 13485 and US FDA, GMP standards.