Clean Modules meets latest healthcare needs
Clean Modules, a specialist in modular prefabricated cleanrooms, has constructed a major new free-standing two-storey cleanroom building for the Pharmacy Department at Glan Clwyd Hospital in North Wales.
The MHRA-approved facility has three Grade B (ISO Class 5) aseptic suites, complete with isolators and laminar flow cabinets for cytotoxic and total parenteral nutrition (TPN) preparation. To meet the latest clinical demands, the building also houses one of the first gene therapy cleanrooms designed specifically for this purpose and incorporating a single pass air system to avoid any risk of cross contamination.
The cleanrooms are supported by Grade C (ISO Class 7) preparation areas. These feature specially constructed spray booths adjacent to the transfer hatches to minimise alcohol inhalation in this busy environment.
The building is constructed from 14 pre-fabricated modules, making it one of the largest modular cleanroom facilities in the country. It also contains a non-sterile suite for dry powder and wet ointment preparations. The two-storey design provides the space for cleanroom cleaning equipment, dry product storage and most importantly, a walk in cold store, to replace the previous need for multiple fridges and provide more effective operation and stock handling.
Other features include special access points for equipment removal and to provide emergency access for the cleanroom technicians.
The facility highlights the flexibility of modular construction to cope with demands in the general areas outside the cleanrooms. Consideration has been given to access from the main hospital for both staff and patients using the gene therapy suite. For this reason a lift has been installed together with a disabled toilet.
Clive Sparkes, clinical director IM&T, said: “The modular construction provided us with the best solution to our needs. The flexibility of this design meant we were able to find a suitable space in which to create the exact facility we required. Clean Modules took us through the process step by step, and minimised the disruption to staff, patients and visitors because the major construction went to plan and took only weeks to complete. We are delighted with the results; we have a superb new state-of-the-art unit, which is a comfortable working environment and which came in on budget.”
Clean Modules specialises in the design, construction and project management of cleanroom installations, controlled environments, clean air and conditioning systems. In addition to specialist biotechnology cleanrooms, the company has expertise in pharmaceutical, medical, hospital and mobile containerised applications.
In a separate development, Clean Modules has built a new MHRA-approved sterile pharmaceutical unit for cytotoxic, CIVAS and TPN production. This unit has been designed to help meet the growing demand for home therapy, which allows patients to live at home and make hospital beds available for others.
The unit was designed, with efficient workflow. Prepreparation takes place in a Grade D (ISO Class 7) area, where the removal of outer packaging reduces the operation risk from particle and spore contamination.
A well laid out Grade C (ISO Class 7) Preparation Area services each of three Grade B (ISO Class 5) cleanrooms. Important consideration was given to efficient transfer out for examination and labelling. A direct connecting transfer hatch to an associated QC/QA Laboratory has also been incorporated into the design.
The main production suites comprise a cytotoxic Grade B cleanroom, with two 4-glove port Amercare isolators, for the preparation of Cytotoxic products for cancer treatment. There are also two Grade B cleanrooms, with Laminar Flow (LAF) cabinets for the preparation of parenteral nutrition bags and CIVAS products.
Head of production, Martin Lee, said: “The increasing demand for home medication meant that we had to create a unit, with efficiency and long term capacity in mind. We worked closely with Clean Modules to optimise the facility to achieve these objectives. This optimisation produced some novel features, including some borrowed from the electronics market. Clean Modules also ensured we carefully considered the flow of materials through the cleanrooms and the transfer of equipment, something which is often overlooked.”