Connect 2 Cleanrooms (C2C), a company that specializes in the expedited design and build of temporary life sciences facilities, constructed a temporary medicines unit on behalf of the National Health Service of Wales (NHS Wales). The facility, constructed for the agency’s Central Intravenous Additive Service (CIVAS), is able to produce up to 2,600 syringes per week to meet the growing demand for COVID-19 solutions.
Jeni Thomas, content and communications leader for C2C, spoke with Outsourcing-Pharma about the project, and how temporary facilities can be useful during times of crisis.
OSP: Could you please share a short description of C2C—who you are, what you do, key capabilities, customer base, and what sets you apart?
JT: C2C designs, builds and validates industry-leading critical environments across the UK and Europe. With a multi-disciplined team, we provide our clients with the most appropriate classified environment for their process.
For activities regulated under GMP, we provide MHRA-compliant manufacturing environments with full qualification. We innovate to overcome technical challenges and provide end-to-end support with integrated consumables, equipment, validation and training services.
OSP: How did C2C come to work with NHS Wales—have you worked with that agency or other government units before?
JT: Connect 2 Cleanrooms has supplied various NHS trusts with consumables for many years, but this project was the first time we had been contracted by them for a facility build.
NHS Wales first explored if it was possible to make the sterile injections on the benchtop and give them a very short shelf life of 12-24 hours. The MHRA advised that it should be done in proper cleanroom facilities, so they started looking at how they could quickly create cleanroom capacity to do this.
They approached C2C and started a discourse around the options. Very quickly, a design developed that then progressed through a procurement process and building started.
OSP: Could you please share NHS Wales's initial goals and directions, and what some of the obstacles you faced in helping that to happen?
JT: Due to the rapidly evolving situation with COVID in the UK, there was a great sense of urgency from NHS Wales which C2C reacted to. To increase the speed of construction for the fast-tracked project, whilst also remaining COVID-secure was a challenge for our site lead, Craig Druce.
Craig was the site manager all the way through the build, right from the start when the lines were drawn on the screed floor to the last day when he handed it over to the client. They had a good working relationship and he knew the build inside out which gave good continuity.
“To shorten the installation schedule, we brought in specialist subcontractors to install the more complex elements of the built-environment, such as the interlocking door and alarm system, at speed,” said Craig.
With multiple teams working on the same build, greater consideration was given to planning the program schedule and on-site organization to ensure teams were kept separate. With cleanrooms, there is as much work to do at ceiling level as there is on the ground level due to the air handling system.
Working on a split level helped teams stay distant and also supported efficient working as teams had their own designated areas to operate in for a set period of time. We used signage and hygiene stations to create a designated build-zone within the NHS facility, restricting access to only those who were essential to the build.
“The forward planning and more detailed program schedule supported a faster and more efficient COVID-secure build,” said Craig. “We’ll continue to spend more time forward planning throughout 2021 and beyond, as the extra time invested at this stage generated efficiency gains. On projects such as this, where time is of the essence, a shortened installation schedule is of great benefit to our clients.”
OSP: Please describe the initial plans for the purpose-built cleanroom facility, as well as lessons and adjustments you might have made along the process.
JT: In normal times there might have been more site attendance during the commissioning process, but everything was able to be completed remotely, mainly by email and the occasional virtual meeting. The process went well, and the client described the documentation as excellent. Any issues detected were corrected promptly.
OSP: Could you please describe the cleanroom you created—size, location, features, etc?
JT: The 80m2 cleanroom features five zones of GMP Grades B, C & D. An UltraTech panel system creates a flush finish to walls and ceilings with a minimum of projecting ledges.
Integrated doors feature an interlocking system to create airlocks that protect the integrity of each zone as staff move through the facility. Safe transfer of materials in and out of the facility is provided through diffusion pathway interlocking transfer hatches, that maintain pressure cascades and airflow management.
C2C’s ECO2 integrated monitoring and control system gives real-time visibility on the cleanroom’s performance by monitoring pressure differentials, temperature, relative humidity, particle counts and other requirements. NHS Wales can record batch ID against datasets and the 21 CFR 11 system meets audit trail requirements for traceability and protection of data.
OSP: What has feedback been from your client?
JT: The modular cleanroom was designed appropriately for the process they are going to follow. The quality of the build is high, the technology involved is state of the art, and it was built and commissioned extremely quickly.
It was a modular build whereas they were used to large air handling plants with ducting. That space-saving technology that operates with redundancy is something they will look at for future builds as it gives the flexibility that if one room in the suite goes down for maintenance, then others can remain operational.
OSP: Is there anything you’d like to add—about this project, your company, upcoming projects you’d like to preview, etc?
JT: Connect 2 Cleanrooms created facilities for a number of rapid diagnostics test manufacturers during 2020 and is the principal contractor on a new cell and gene therapy manufacturing facility for Roslin, CT, which is due for completion in 2021.