Connect 2 Cleanrooms (C2C) expedited the design and build of a temporary medicines unit for NHS Wales’ new Central Intravenous Additive Service (CIVAS).
In March during the first COVID-19 surge, 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 big time-consuming activities that take critical care nurses away from the patients is making up intravenous infusions. The Welsh Government decided to create a central manufacturing capacity to make the sterile infusions 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. We fast-tracked a purpose-built cleanroom facility, including GMP qualification from DQ-PQ. It was ready for MHRA inspection in just 6 months.
NHS Wales’ new CIVAS temporary medicines unit can produce up to 2600 syringes per week, which met the forecasted demand during the second winter wave.
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 at the design stage and the same urgency went right the way through the construction phase.”
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 the staff moves 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.
For more information on GMP-compliant cleanrooms, visit www.connect2cleanrooms.com.