Refurbishment of an existing storage facility (circa 800m2) to provide a mixture of ISO 7, Class C and D clean room space
Design stage (PCSA)
Working with the client and design team, TCi engaged in an extensive design process from RIBA stage 3 under a JCT Design & Build contract. To meet user requirements within the existing structure, the complex M&E/HVAC system would demand intricate planning to make efficient use of space, with equal emphasis on the logistical arrangement of material and personnel airlocks to maintain adequate access. Approaching the task, the project team worked carefully to incorporate value engineering at each stage, managing process and material mapping to integrate with the coordinated building model.
Construction
A steel sub-structure was constructed to support the air-handling and management systems above ground-floor cleanroom space, incorporating a loading bay and heavy-load bridge to allow substantial air-handling equipment to be installed above the hygienic, walk-on ceiling.
Project delivery benefitted from an integrated supply-chain, providing manufacturer-installed hygienic partitioning and ceilings, synchronised airlock door systems, solid-surface furnishings and a complex MEP package to meet client ATEX rating requirements.
Coordinated site teams were managed across a phased programme to maximise concurrent working capacity and ensure an efficient programme. Shut-downs and notice periods for relocation of client staff and production facilities were scheduled throughout the programme to minimise disruption.
Completion & handover
The resulting facility features a fully integrated Building Management System (BMS) and operational GMP ISO 7 cleanroom space, complete with ATEX (explosive atmospheres) rated HVAC, data, lighting and power terminals, personnel and goods airlocks as well as innovative, cleanroom breakout panels for fire escape integrated within the cleanroom wall system.
Practical completion and handover was successfully achieved thanks to an ongoing, comprehensive snagging process using a mobile app platform to record notifications for immediate attention throughout the project.
Installation and Operational Qualification (IQ/OQ) of the facilities and associated utilities were generated and executed by TCi’s in house experienced Quality team in accordance with the client User Requirement Specification (URS), Design Qualification (DQ) and Validation Master Plan (VMP) and commissioning of all controls and functions was undertaken ahead of the client’s machinery installation programme, generating a full documentation package for the client.
The success of this project has been reliant upon excellent stakeholder awareness by both client and contractor, working hand-in-hand to operate a resilient model, overcoming challenges as they arise and harnessing expertise to create a state-of-the-art pharmaceutical development facility.
TCi’s collaborative and inclusive approach, from early design stages through to completion, has been crucial to this project’s success. The support we have received throughout has helped to overcome difficulties and deliver an advanced facility that perfectly addresses end-user needs requirements with fully FDA & MHRA compliant qualification documentation. By actively seeking improvements and solutions at every level, managing stakeholder relationships and navigating complex supply-chain challenges, the whole team at TCi has been committed to the delivery of much-needed cleanroom space that will enable us continue to increase our capability and capacity for innovation & manufacturing.
Tim Smithers – Programme Director, Vectura Ltd
About Vectura
Vectura is a provider of innovative inhaled drug delivery services that enable partners to bring their medicines to patients. With differentiated proprietary technology and pharmaceutical development expertise, Vectura is one of the few companies globally with the device, formulation and development capabilities to deliver a broad range of complex inhaled therapies.
Vectura has eleven key inhaled and eleven non-inhaled products marketed by partners with global royalty streams, and a diverse partnered portfolio of drugs in clinical development. Our partners include Hikma, Novartis, Sandoz (a division of Novartis AG), Mundipharma, Kyorin, GSK, Bayer, Chiesi, Almirall, and Tianjin KingYork.
For further information, please visit Vectura’s website at www.vectura.com