ISO8 Medical Device

THE CLIENT

GA Health – the home of infection prevention in endoscopy. GA Health design, develop, and manufacture Medical Device products including a wide range of high-performance valves, connectors and tubing. Using decades of experience and industry knowledge, GA Health strive to improve lives through increasing the efficiency and reducing the infection possibilities in endoscopic procedures.

THE BRIEF

Under instruction from NSP Expert Lab Solutions, Guardtech’s Irish distributor, we were contracted to support the delivery of a new facility in Mullingar, Ireland for Medical Device production, designing and constructing a modular turnkey solution utilising Fan Filter Units (FFUs) within a clean plenum.

THE TECH SPECS

A Controlled Environment designed, installed, cleaned and commissioned by Guardtech built to the following specification:

Structural: GT Shell Plus PIR Wall Panels, GT Shell Fire, GT Lid Lite Ceiling Grid & Tiles, GT Access Plus Power-Coated Steel Doors, GT Deck Plus Vinyl Floor Capped & Coved.

Electrical: 13amp double sockets three-compartment trunking. Three-phase power. Door interlocks.

Mechanical: Filtration provided by H14 HEPA filters powered by fan filter units.

Monitoring: GT Lite Magnehelic gauges measuring pressure only.

Furniture: Stainless steel sink with stainless steel pre-rinse tap, stainless steel handwash basins, stainless garment hanger, stainless steel stepover benches, hand dryers.

THE CHALLENGES

COVID-19: This build took place towards the back end of 2020 and was completed around March 2021 – right in the midst of the global COVID-19 pandemic. This presented both the Guardtech Cleanrooms and NSP Expert Lab Solutions with a number of challenges. As well as the understandable issues regarding staff welfare and safety related to attendance on site, there were a number of other factors that made this a challenging project:

Department Of Justice: Travel to Ireland was restricted at this stage of the pandemic – we therefore had to be notably flexible, diligent and professional to ensure we could get the right people over from the UK at the right times to ensure deadlines were met and the project delivery didn’t stall.

Supply Issues & Brexit: There were a number of shipping issues due a combination of the pandemic and Brexit which meant the team had to be adaptable with their scheduling and installation processes. Procurement of certain materials was compromised and lead times were lengthy and unreliable, but both the Guardtech and NSP teams worked together to overcome all the hurdles we faced to deliver an excellent modular cleanroom on time and on budget.

THE RESULT

Graham Devitt, Managing Director at NSP, said: “We have been thrilled to be the representatives and distributors for Guardtech in Ireland.

“Over our years in operation, we have carved out a distinctive name associated with expertise, efficiency, and excellence. We are careful to partner with brands who can meet our high standards in these areas, and Guardtech exceeds every time.

“Our teams collaborate seamlessly, bringing quality service and finish to our clients. We wholeheartedly recommend Guardtech for excellence in products, design and end-to-end service.”