Upgraded facilities to house containment isolators at the manufacturer’s Chippenham headquarters
TCi construction WORKS engaged as principal contractor with project management specialist, PM Group, to deliver a 12-week programme to strip-out and refurbish an existing c.200m2 production area.
The main function of the refurbishment for the “Containment of Formulation Equipment” was to include modification of the air extract/supply, breaking into the waste water drain and provision of equipment cleaning facilities, along with data connection, M&E upgrades (nitrogen, compressed air, LEV extract ductwork and manifolds) and clean room sika grade 3 decoration throughout including flooring and remedial work to doors and wall penetrations.
Bespoke LED light fittings were specified by the client, as identified in the original works contract so it was necessary to engage with supply chain at the earliest opportunity. Due to ongoing Covid-19 lockdown measures, contact-free supply from operational vendors was arranged successfully.
Site activity commenced in June, despite Covid-19 lockdown with strict procedures in place to ensure the safety of site operatives, client staff and the wider public. Mitigation measures included comprehensive site signage, additional welfare, outlining one-way routes, covid-specific rules and designated areas, dictated by a specific H&S risk assessment. Staff were able to maintain 2m distancing or access appropriate PPE where required, with work managed carefully to avoid overcrowding. Regular safety briefings and feedback monitoring ensured consistent protection as the project progressed. Visitors and subcontractors to site were briefed accordingly through mandatory inductions and site notices.
Works were delivered within a fully contained zone, however, the building remained operational and impact to adjacent rooms sharing engineering systems was inevitable, with staff requiring access at all times. Access was facilitated and managed with disruption kept to an absolute minimum.
Through constant engagement with key relevant parties, including the end users (senior scientists) TCi identified at a critical phase that there was potential for the duct design to prevent the installation of the required machinery. Left unchecked, this would have had catastrophic results, leaving the room in need of major rework before it could become operational. On notification to the client, the specification was changed to accommodate revised equipment specifications, managed via NEC4 (Short Term) Early Warning process, resulting in a 2-week agreed extension to the programme. This swift action and communication saved potential remedial costs and lengthy delays, resulting in a positive outcome for all.
Consistent dialogue with client representatives and the designated project management contractor enabled the project to run safely and within budget, with TCi making significant contributions towards best-possible outcomes and finding solutions to potential challenges as they arose. This was particularly important when negotiating the adjustment to schedule to apply equipment changes so that the absolute minimum disruption to programme and cost implications would be incurred. 14 calendar days were added to the schedule in total.
Completion & Handover
Adhering to revised programme dates, handover and commissioning commenced as agreed, with a one-week test and commission process scheduled prior to equipment installation and comprehensive O&M document.
“Your team have done a fantastic job for us- thankyou” noted one client representative
The team has been commended for its excellent communication and approach to the work throughout.
The facility is dedicated to the development of high potency inhaled drugs targeting conditions such as asthma and COPD. Learn more from Vectura HERE
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