Cleanroom manufacturing - controlled environments
Fully Maintained Cleanrooms
With over 20 years of experience in the operation of ISO7 Class 10,000 cleanroom facilities, PolarSeal now operates 5 stand-alone and fully validated ISO7 cleanrooms across two manufacturing sites in the UK. These cleanrooms are fully maintained on both sites in accordance with ISO 14644:2015. The essential control and validation protocols involved in cleanroom manufacturing and operation have been extensively developed and are now embedded in detailed in-house Quality Operating Procedures, providing total confidence and peace of mind for your critical medical conversion products.
Our conversion capability in the cleanroom environment includes; slitting and rewinding of materials, lamination and zone lamination, and multi-layer and island placement rotary die-cutting for advanced wound care products. In addition to this, we also pack products inline with bespoke packaging machinery including tube filling to reduce customer lead times and greatly improving cost-effectiveness by removing the need for a secondary packing supplier.
Products manufactured in our cleanroom facilities include; advanced wound care products, incision films, fixation devices, ostomy componentry, diagnostic and biomedical products, electro-medical devices, liquid substances in tubes and consumer healthcare products.