Fiona Kerr, Connect 2 Cleanrooms (C2C) project business development manager explains how the company kept agile as part of the response to the COVID-19 lockdown, and assesses the cleanrooms market.
When the COVID-19 pandemic hit UK shores, Connect 2 Cleanrooms (C2C) witnessed first-hand how medtech companies across the land responded with vigour to the challenges it brought. Whether organisations needed to increase their production capacity for COVID-19 test kits, ventilators or intravenous drug delivery, as a cleanroom design & build specialist, C2C has been able to support them in their journey.
After lockdown was first announced C2C received communications from a number of medtech and pharmaceutical clients seeking reassurance that cleanroom validations, consumables supply and in-progress cleanroom design & build projects would still be able to be performed and discharged.
One cleanroom design and build project that was already underway when lockdown came in was for Phoenix DX, formerly LIG Biowise. Phoenix DX is developing a point of care and high throughput diagnostics device that tests for a range of pathogens and delivers results in under 30 minutes. The device development is now being accelerated to market as it can detect COVID-19 and common flu within 14-30 minutes, lab-free.
Acting as principal contractor, C2C designed and built a suite of 10 fully-fitted laboratory zones, including two cleanrooms within Phoenix DX’s Headquarters at Salford Quays in Manchester. The initial design phase was client led, progressing into a collaborative approach that included high tech integration and dynamic changes throughout the process. The build took place during lockdown.
How modern construction techniques create a COVID-safe site
Off-site construction techniques have been implemented by C2C since it began pioneering modular design in 2002. Reducing the amount of time that a contractor spends on site has always been a benefit of these ways of working as it reduces disruption for the client and shortens project lead times. During this period of COVID-19 disruption it brings the added benefits of increasing physical distancing by reducing contact time between contractors and clients.
The art-deco style building where Phoenix DX is based, has a unique diamond shaped floorplan in which the new facility is housed. A 3D scan survey was taken of the site, so C2C’s technical design team was able to produce an optimum layout that maximised on the available space. A 3D scan is a fast and accurate method of surveying that uses lasers to capture enough data for a digital model to be created of the facility. A design team can then use this to remotely verify the accuracy of a proposed design. This also allows organisations to simulate workflow and materials flow, and check maintenance related activities upfront to ensure the layout is fully optimised.
From the verified design, C2C is able to manufacture and prepare its cleanrooms so the on-site ‘construction’ is more of an installation of pre-engineered components and systems, leading to a smoother on-site experience. This improved accuracy of design leads to reducing snagging and re-work.
C2C has prioritised a number of design and build projects for rapid delivery in 2020 and will continue to do so to support the changing healthcare needs of the country and meet the demands of COVID-19 testing.
Market trend for EU GMP Design Principles
It has witnessed the post-lockdown economy to be fairly buoyant within healthcare sectors as companies are investing in their facilities to be competitive. One trend its witnessed is that an increasing number of medical device sector organisations are choosing to incorporate GMP design principles even when there isn’t a current need for EU GMP qualification.
ISO 14644 classified environments are suitable for many applications, but organisations looking for increased scope to diversify, or to future-proof their production facilities against regulatory changes may find themselves limited if they don’t consider EU GMP design principles at facility design stage.
ISO 14644 and EU GMP compliant cleanrooms are designed to achieve particulate control, but EU GMP facilities require an additional layer of compliance for microbial control and extended validation / qualification requirements. They require design features that diminish the risks of viable and non-viable particulates and cross-contamination such as ledge-free envelope systems and monitoring and control systems. EU GMP qualification is achievable retrospectively, but only if the correct choices were made at facility design level.
