CLEANROOMS
Quick and clean 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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uring 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 specialists to cover more beds, 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. 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 facility, including GMP qualification from DQ to PQ. It was ready for inspection in just six months. Paul Spark, Pharmacist at NHS Wales, said: “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: “We brought in specialist subcontractors to install the more complex elements of the builtenvironment, 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. C2C used signage and hygiene stations to create a designated buildzone 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 ... On projects such as this, 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 nonviable particulates, as well as crosscontamination. 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 fit for 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. Complete system operation training ensured a simple client handover and NHS Wales now has a full O and M manual to ensure smooth operations.
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