Medical and surgical device tubing components manufacturer Polyflon has announced the launch of its brand new Class 7 cleanroom.
The new 60sqm ISO 14644-1 facility, with provision for EU GMP Annex 1 Grade C operation, complements the company’s existing Class 7 cleanroom, used for Polyflon’s manufacturing of components for single-use medical and surgical devices.
Operations director Matthew Pedley said: “As a rapidly expanding part of our business it was vital for us to invest in an additional, larger, clean production cell to meet the needs of our existing medical customers but also to allow us to react to emerging opportunities still in the pipeline. Our new investment will ensure our ability to produce high quality components on a larger scale but also to support pharmaceutical/biotech clients who require components manufactured within a GMP Grade C framework”.
The official clean room opening took place on 9 April, where Pedley was joined by Rosi Monkman, business partnerships manager from Keele University. Polyflon has worked closely with Keele on a number of occasions.
Rosi Monkman added: “Keele University is delighted to have supported Polyflon during their current phase of growth with medical device support from our Business Bridge funding programme and with leadership development via the University’s Innovation Leadership programme. Polyflon’s new cleanroom will enable them to access new sectors and we are looking forward to supporting their continued growth.”
Find Polyflon on Stand J49 at Med-Tech Innovation Expo from 15-16 May 2019.