Grade D Medicine Manufacturing

THE CLIENT

Eramol (UK) Ltd – specialists in providing a bespoke clinical trial medicines manufacturing service that is driven by quality. Eramol offers turnkey manufacturing and packaging services including tablets, capsules and non-sterile liquids as well as matched placebo product. Due to rapid growth and increasing demand, Eramol contracted Guardtech to build and commission their second UK site. 

THE BRIEF

The client had a large, open warehouse space in which they required a suite of modular cleanrooms to enable them to manufacture pharmaceutical products including tablets, capsules and oral liquids for use in clinical trials. The site will be operating to GMP standards and subjected to MHRA inspection & accreditation. As well as the modular suite, Guardtech were tasked with building a mezzanine on top of the cleanrooms to provide scope for storage and further expansion potential.

THE KEY DESIGN SPECS

There were two critical areas that Guardtech’s Design team had to take into account in regards to the key design requirements – due mainly to the client’s impressive, rapid expansion. The plans needed to allow flexibility in accommodating manufacturing campaigns for a wide range of dosage forms, while also considering the continued future growth and expansion potential of Eramol and their activities.

THE TECH SPECS

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

Structural: GT Shell Lite PVC cladding, GT Shell Pro PIR wall panels, GT Deck Lite Vinyl floor capped & coved, GT Access Plus doors with, GT Rise Fire rapid roll doors, GT Lid Pro ceiling panels, GT Lid Lite ceiling tiles. Mezzanine floor with FR60 fire rated suspended ceiling and live loading of 4.8kN covering 406sqm. FR60 compartment wall complete with fire shutterand automatic opening double hinged door to segregate staging and goods in area, double glazed vision panels.

Utilities: Plumbing – 2 x hot & cold domestic water supplies, 2 x Saniflo drainage pumps and pipework to waste, Compressed Air.

Electrical: 24 x 13-amp sockets, 4 x 32A 3ph isolators and 13 x double RJ45 sockets flush mounted within panels, electromagnetic interlock doors, 24 x GT Lux Plus cleanroom lights installed within panelled ceiling.

Mechanical: External Air Handling Unit (AHU) ducted to H14 Terminal filters within cleanroom ceiling.

Environmental Monitoring: GT Scan Pro EMS transmitters with 21CFR Part 11 compliant Oncall Finestra software.

Furniture & Equipment: Powder-coated steel twin lockers, Grade 304 stainless steel 6 peg coat hooks, Trespa Benches on castors, stainless steel sinks.

THE CHALLENGES

Limited plant space: Because of restrictions and limitations caused by the limited plant space available an external AHU had to be craned in over the top of the building – an operation made even more tricky by the tight space around the stunning white Kent cliff-style surroundings.  

Height restrictions: Height was limited within the space, with a mezzanine needed for storage. This meant that there was limited space above the cleanroom ceiling and the ductwork design had to be worked through with extra care.

Future expansion: The building itself allows for future expansion so Guardtech’s Design team factored this into the HVAC and structural design, allowing for extra capacity and future connections.

Compartmentation wall: Cut-outs were required in the existing compartmentation wall – these needed structural calculations so fire-rated doors could be installed.

EMS installation: Guardtech installed a 21CFR Part 11 compliant environmental monitoring system featuring Cionics Finestra Oncall software.

THE RESULT

Eric Che, CEO & co-founder of Eramol, said: “It was a great experience working with Guardtech on this project. Despite numerous challenges presented by Brexit and COVID-19 pandemic, Guardtech team has delivered the build project on time and on budget. We are delighted with the quality of the cleanroom build which helps with our MHRA accreditation for the new site.”

Guardtech Group Operations Director Conor Barwise added: “It was a real pleasure to work with a dynamic company in such stunning surroundings.

 “The team approached this project with their usual dedication to meeting the highest standards – tackling all the challenges that came our way with positivity, care and consideration.

 “We were really pleased with the final result – a high-quality Guardtech Cleanrooms modular build.”