Increases cleanroom assembly facilities in Hertfordshire, UK
The Kington, Herefordshire plant now has three cleanrooms
Contract medical device manufacturer Arrow Medical has commissioned a single-use production unit, with UV curing and assembly lines, which brings the firm’s total cleanroom assembly facilities to 344m2 at its plant in Kington, Herefordshire.
The FDA GMP- and ISO 13485-accredited lines are housed within a new 56m2 soft wall, ISO 14644 Class 7 (US Class 10,000) cleanroom built by Connect 2 Cleanrooms, based in Kirby Lonsdale, Cumbria.
Arrow Medical will be producing a variety of single-use devices used in the anaesthetic, emergency surgery and cardiac sectors and building complex inflatable systems from components using materials such as flexible and rigid PVC.
The soft wall cleanroom includes an illuminated transparent ceiling to ensure light levels of 1000 lux and provide suitable conditions for the assembly of small and complex devices.
Complete air handling and air conditioning systems are also included, with HEPA filters, maintaining more than 100 air changes per hour. Programmable day/night controls are also installed to achieve high levels of energy efficiency.
The new facility provides complete product assembly for products built from complex components using UV curing technologies, with complete traceability throughout the product’s life allied to 100% testing inside the cleanroom.
The production lines include a pad printer for adding product details onto 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.
“Staff training has been a critical and substantial part of investment in this project,” said Rita Didcock, managing director of Arrow Medical.
“High quality standards and demanding production rates for the next generation of single-use devices require a 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 facility now includes three cleanrooms, 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 and overmoulding and complete sterile product assembly.