Connect 2 Cleanrooms expedited the design and build of a temporary medicines unit for NHS Wales’ new Central Intravenous Additive Service (CIVAS).
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In March 2020, during the first COVID-19 surge, the UK Government increased CCU bed numbers by 3-4 times. However, it wasn’t possible to increase the number of critical care nurses overnight. With an urgent requirement for specialist nurses to cover more beds than they would normally, ways in which CCUs could apply lean principles to generate efficiencies were explored.
One of the main activities that takes critical care nurses away from patients is making up their intravenous drugs. The Welsh Government therefore created a central manufacturing capacity to make the sterile injections for critical care to support CCUs. The new CIVAS temporary medicines unit can now produce up to 2,600 syringes per week to meet the forecasted demand.
The MHRA determined that this process would need to be conducted in cleanroom facilities, so NHS Wales partnered with Connect 2 Cleanrooms (C2C) to fast-track a purpose-built cleanroom facility, including GMP qualification from DQ to PQ. It was ready for inspection in just six months.
Paul Spark, Pharmacist at NHS Wales, said: “Connect 2 Cleanrooms recognised the importance of the project and it’s been completed amazingly quickly. The company pulled out all the stops to begin with at design stage and the same urgency went right the way through the construction phase.”
Construction during Covid-19
Increasing the speed and safety of construction was a challenge for C2C’s site lead, Craig Druce, who said: “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.”
With multiple teams working on the same build, greater consideration was given to planning the programme schedule and on-site organisation to ensure teams were kept separate. 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.
C2C used signage and hygiene stations to create a designated build-zone within the NHS facility, restricting access to essential personnel only.
Druce added: “The forward planning and more detailed programme schedule supported a faster and more efficient COVID-secure build. 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.”
GMP Qualification
The GMP manufacturing environment is designed to diminish the risks inherent to sterile manufacturing, such as viable and non-viable particulates, as well as cross-contamination.
Joan Benson, C2C’s Regulatory Governance and Assurance Manager, said: “It is a GMP requirement that manufacturers control the critical aspects of their particular operations through qualification and validation over the lifecycle of the product and process. Our qualification process is therefore not an independent activity, but an integrated application of GMP practices.”
Design Qualification (DQ) documented and verified that the proposed design of the facilities, systems and equipment was suitable for the intended purpose.
Factory Acceptance Tests and Site Acceptance Tests evaluated any bespoke or customised equipment and determined the functionality before and after installation. Installation Qualification (IQ) then documented that the facility and equipment provided what was required.
Operational Qualification (OQ) demonstrated that the cleanroom would consistently perform and maintain the specified conditions, by using a series of challenges such as smoke visualisation testing. For the initial Performance Qualification (PQ), test engineers repeated what had been done at OQ but under load, rather than as built.
Benson concluded: “We provided training on how to operate the complete system during the final client handover and NHS Wales have a full O and M manual to ensure smooth operations in between our ongoing performance qualification visits.”