ISO7 Medical Device

THE CLIENT

BioPharma – a solutions provider to the Life Sciences, Pharmaceutical and Biotech industries. They hold UK distribution agreements for a portfolio of market-leading manufacturers, supplying a range of Medical Device products for single-use systems and cell & gene therapy, including aseptic connectors, bioprocess bags, isolator transfer systems and mixers & pumps.

THE BRIEF

Guardtech were tasked with facilitating BioPharma Dynamics’ expansion into a new dedicated ISO7 purpose-built cleanroom facility to provide a full single-use assembly design-to-supply service, facilitating their commitment to provide quality customer service and support with improved lead times.

THE SOLUTION

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

Structural: GT Shell Plus PIR Wall Panels, GT Shell Lite, GT Lid Plus Ceiling Grid & Tiles, GT Access Lite, GT Deck Pro.

Electrical: 13-amp sockets contained within three-compartment PVC trunking, electro-magnetic door interlocks with status indicators, LED lighting units suspended in the ceiling grids with emergency packs.

Mechanical: GT Flow Plus Fan Filter Units, GT Air Plus Ceiling Mounted VRF.

Monitoring: GT Scan Pro environmental monitoring system – in-room LED screens with Temperature, Humidity & Pressure sensors.

Furniture & equipment: Two stainless steel transfer hatches, contamination control flooring, stainless steel emergency escape panel.

THE CHALLENGES

Tight budget: The client was keen to be as considered and meticulous as possible with their budget, so value proposition and maximisation was key in this build. This presented us with the challenge of selecting appropriate products at the best possible prices to suit their needs and requirements, delivering high quality and strong performance in a cost-effective manner.

Creative design: The design stage allowed our team to flex their creative muscles when, upon completion of a site survey, we realised that the client’s original briefing could be improved. We managed to double the footprint, with very little comparative increase in costs, by repurposing the host room with cladding on the brick walls to create a much more integrated facility than we would have delivered simply by essentially ‘dropping in a modular box’.

Air conditioning relocation: The client had originally intended to scrap their air conditioning system, but our innovative team instead stripped the suspended ceiling, relocated the units and then recommissioned them to save the client more funds.

Awkward host room: This gave the team the opportunity to demonstrate their creative cleanroom wisdom once again ­– we concealed pillars in the room and repurposed them as a large return air plenum, squaring off the room while ensuring a clean return air path. We then flush-mounted sockets on the rear wall and run containment in the return air voids.

THE RESULT

Joe Brennan, BioPharma Dynamics Managing Director, said: “Without the patience and support of my co-founders in the early days, along with the dedication and hard work of the whole team since, we would not have been able to achieve this milestone. It makes me very proud to be able to bring this exciting new phase of our growth to the North West.”

Guardtech Operations Director Conor Barwise added: “We were delighted to undertake this project for a great company making impressive strides in the Life Sciences industry. 

 “This build allowed our Design and Installation teams to show off their creative qualities, devising inventive solutions to various issues and helping to ensure that the client achieved really good value for the budget they allocated to the project.