GMP Hygiene Facility – Pharmaceutical Manufacturer

GMP Hygiene Facility – Pharmaceutical Manufacturer

Design & build project to deliver extensive, turnkey washing facility for pharmaceutical manufacturing & laboratory equipment 

The client approached TCi to develop plans for a new wash bay, hygiene room and several environmentally-controlled clean equipment storage rooms within an existing wet manufacturing area. 

Design, costing and evaluation processes involved intense collaboration between client, contractor, services and equipment suppliers prior to commencement the 74-week refurbishment. 

The layout features segregated zones for dirty and clean equipment, controlled by positive pressure, surrounding an installation of state-of-the-art, high-pressure washing units. The entire, 565m2 facility is finished to accommodate “wet” operation with high-grade Altro Quartz resin flooring, 1100m2 Norwood antibacterial grade sterile wall covering systems, Norwood antibacterial grade clip in ceiling system with integrated, radiused transitions throughout to aid cleanability. 

Design stages

Structural and architectural design was carefully coordinated by TCi, alongside the specification of services and mechanical & electrical packages to meet the client User Requirement Specification (URS). Substantial civil engineering was also needed to survey existing and design new drainage requirements for the washing technology. 

In order to create the necessary air-handling capacity, a comprehensive HVAC system was planned to occupy a new mezzanine floor with a total of 5 independent Air Handling Units (AHUs), Steam & Condense, heat exchanger and compressed air services.

Value Engineering  

Throughout the design phase of the project and whilst keeping in line with the User Requirement Specification, TCi identified value engineering to the value of £28k. Continued collaboration with the client, end user, equipment installation team and design teams delivered considerable savings across the main Hygiene Wall Panelling System, Hygiene Partition systems, High Speed Roller Shutter and GRP doors. Using product experience and access to a broad supply chain, TCi was not only able to deliver cost savings, but also gained critical timescale benefits which ultimately mitigated risk to the programme from COVID-19 lockdown interruptions. 

Delivery

Following the installation of full containment, declassification of the area, identification of utilities and services supplying active operations within the wider factory; demolition and strip-out of the former wet manufacturing suite and adjoining rooms began. Existing critical services running through the area included the main fire-suppressant sprinkler system, security and safety alarms, and water supply, causing influence on the design and programming of the works. 

Excavations enabled the installation of drainage and erection of steel supports for the mezzanine floor whilst surface preparation took place, with the team reaching a key milestone with the completion of the loadbearing slab for the machinery sump pit on schedule. 

With the mezzanine floor complete, installation of ductwork and services progressed quickly, incorporating more than 250m of ductwork served by 5 independent air handling units to provide controlled cooling, heating, humidification and dehumidification, these in-turn supplied with heating/cooling and air filtration by additional plant. The complete system managed by an intricate set of automatic controls and balanced to achieve IQ to GMP standards. 

With services and shell prepared, the installation of hi-tech sterile wall cladding system and resin flooring proceeded with the use of a custom technique perfected with the client to provide a gentle, 90 degree radius between surfaces. An Armstrong-Burgess tile ceiling system was also installed throughout the facility with radiused coving to improve cleaning efficiency. A bespoke, stainless steel bump-rail has been installed at al floor edges to protect walls from trollies and machinery during daily operation. 

In each of the three >300m3 independently environmentally controlled clean-parts storage rooms, industrial racking to utilise the full 5m height was installed throughout for the management of bespoke stainless-steel washer racks containing clean equipment. The clean-parts rooms and main washing areas are accessed via high-speed roller environment sealing shutter doors with large, transparent window panels, operated via contact-free proximity sensing pads and automatic sensing for machine entry. A bespoke, 3m high GRP doorset separates the GMP zone from the adjacent maintenance department corridor. 

Machinery installation by the specialist manufacturer was overseen by electrical and mechanical engineers and client representatives to ensure a smooth operation. This level of collaboration was employed to minimise risks and irreversible consequences in operation. After successfully positioning the large equipment, remaining wall cladding and ceilings could be completed, leaving the facility ready for commissioning. Dextra IP65 LED panel lighting delivers 500lux at working height, as-per client specification, operated via motion sensor for energy-saving, with sealed emergency lighting throughout the suite.

The entire build took place within a live working GMP factory environment with constant client engagement via regular inspections and stakeholder meetings to discuss every aspect of the project. An exceptional safety record was once again maintained on site, resulting in a total of 15,079 safe working hours. 

Covid-19 lockdown came into force a few weeks into the construction programme, with the client taking strict measures to reduce contamination, as would be expected within the pharmaceutical industry. Due to the critical nature of the project and excellent containment and separation of workforce, TCi was able to risk assess and continue safely with the programme. Contractors and suppliers also overcame challenges to enable the programme to be maintained with utmost consideration of public and personal safety.

565

Footprint (m2)

1100

GRP Wall Panels (m2)

15079

Safe Working Hours

Completion and handover 

The project followed a phased programme with critical paths and milestones to enable close monitoring and reporting of progress on a regular basis to all stakeholders. Finishing ahead of original schedule, providing ample time for the facility to become operational, the site was handed over following a comprehensive commissioning & qualification process.