Avenue Invests in New Class 8 Cleanroom

Avenue Mould Solutions has announced the completion of its new
300m2 Class 8 (Class 100,000) Cleanroom. 

The new facility, which currently houses five moulding machines, is already producing short-run and pilot production components for a number of blue-chip customers. 

MD, Felim McNeela, explains the reasons for this latest development; “We have seen an increasing demand for on-site testing, validation, early-stage and pilot production, driven by an escalating rate of new product introduction.

Previously we provided Cleanroom services through the use of softwall modular cleanroom enclosures.  As demand has continued to grow we are now delighted to have constructed our new, fixed-wall 300m2 Cleanroom.  This has been designed to meet the ISO14644-2:2002 standard and is  fully equipped with Netstal moulding machines, with capacity from 50 tonne to 240 tonne, together with auxiliary equipment and robotic take-off facilities.

Because Avenue is such a highly specialised sub-contract supplier (ISO13485:2003 accredited), in addition to providing customers with the benefit of fully accredited process optimization and validation services, the company is now also able to offer short-run production for clinical trials and launch-stock.  Furthermore, if required, customers’ own moulding machines can be temporarily installed in the Cleanroom to facilitate testing, process optimization and validation of both mould and moulding machine.

As the company is keen to point out, the new Cleanroom is just the latest stage in an ongoing programme of continuous improvement that has made Avenue an international leader in its field; with a robotised toolroom equipped to machine parts to tolerances of +/- 1 micron.  This investment in hardware is fully supported by a software and skills infrastructure, for example Moldflow software is routinely used to optimize both component and mould design. Added to this, Avenue has built up, over the 25 years since its inception, an exceptionally highly qualified and skilled team of mould designers and tool makers.

Within the medical and pharmaceutical sector Avenue has particular expertise in the areas of drug delivery devices, including inhalers and pen-type injectors, airway management – with tracheal and laryngeal devices, medical filtration systems, syringe components, needle protection devices and IV administration set components.