Connect 2 Cleanrooms (C2C) expedited the design and build of a temporary medicines unit for NHS Wales’ new Central Intravenous Additive Service (CIVAS).
NHS Wales and C2C streamlined sterile manufacturing to increase CCU capacity
The new CIVAS temporary medicines unit can produce up to 2,600 syringes per week, to meet the forecasted demand during the second winter wave.
In March 2020, the UK Government increased Critical Care Unit (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 the nurses who have this specialist training to cover more beds than they would normally do, it explored ways in which CCUs could apply lean principles to generate efficiencies.
One of the main activities that takes critical care nurses away from patients is making up their intravenous drugs. The Welsh Government decided to create a central manufacturing capacity to make the sterile injections for critical care to support CCUs right across Wales.
The MHRA determined that this process would need to be conducted in cleanroom facilities, so NHS Wales partnered with C2C. It fast-tracked a purpose-built cleanroom facility, including GMP qualification from DQ-PQ, which was ready for MHRA inspection in just six months.
Paul Spark, Pharmacist at NHS Wales Shared Services Partnership, 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.”
The 80m squared cleanroom features integrated doors with an interlocking system to create airlocks that protect integrity and staff. The safe transfer of materials in and out of the facility is provided through diffusion pathway interlocking transfer hatches.
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.