'A cleanroom cloned'

Clean Room Construction recently handed over its second aseptic cleanroom facility for Clinovia at Harlow, Essex in the UK. Clinovia is an experienced home healthcare provider, supporting Strategic Health Authorities, Primary Care and NHS Hospital Trusts by providing tailored home healthcare services. Clinovia currently supplies more than 7,000 patients on behalf of 600 NHS trusts. One aspect of Clinovia's service is the provision of aseptically compounded products from two state-of-the-art MHRA licensed facilities in Harlow and Derby. These facilities are supported by Clinovia`s own in-house QA laboratories, which allow Clinovia to closely monitor the working environment, production techniques and staff performance to ensure only the highest quality product reaches its patients. These facilities compound a range of therapies including parenteral nutrition, antibiotics, cytotoxics and desferrioxamine for Clinovia's patients. They also provide directly to hospitals as an outsourced service where there is a need for extra capacity, shut down cover or when the hospitals have no aseptic compounding capability of their own. Clinovia was closely involved through all phases of the design process with particular attention paid to ensuring logical process flows for both workload and personnel, that adequate space was available for all tasks and that differing product types were effectively segregated.

Mutual involvement Robert Webb, production manager for Clinovia, says: "It was important to me to find a construction company that encouraged my involvement in the design, build and commissioning of the facility. I could therefore ensure we achieved a suite which perfectly suited our needs and enabled us to continue providing high quality products to our patients and customers". CRC's Nick Davis, who designed and managed the Harlow facility says: "CRC was pleased when Clinovia asked us to design and build its second major aseptic facility, capitalising on design solutions from the first very successful compounding unit at Derby. The design process, by working closely with Clinovia's production manager, significantly helped us to ensure the particular aseptic production requirements were incorporated into the layout, environments and specialised built-in equipment. The entire project delivery really was enhanced by this enthusiastic client/ contractor interaction and also made the project an interesting and enjoyable experience."

Ensuring compliance A qualification protocol incorporating DQ, IQ and OQ was developed jointly and adopted for the project ensuring that the cleanroom design, construction and commissioning was strictly in accordance with the Clinovia URS (User Requirement Specification) and the 'Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2002'. The DQ, IQ and OQ qualification steps assisted in giving Clinovia a deeper understanding of the construction and operation of the cleanroom systems and has helped them take full 'ownership' of their new facility. The Harlow Compounding Facility has a footprint of 450m2 and utilises two partition systems regularly employed by CRC. For the aseptic rooms (Grade B, C clean areas) a metal stud and plasterboard partition system with a 2mm thick welded vinyl applied to the floors, walls and ceilings, runs over a radius profile at all of the corner junctions. This system provides a robust, hygienic room envelope that is very well suited to aseptic process areas. The void between the wall skins is used to route services to the rooms and allows inbuilt, flush low level returns. All other supporting rooms are constructed using CRC's PIR panel modular wall and ceiling system with coved-up vinyl flooring throughout. The integrated HVAC system maintains the environmental conditions of all rooms and the BMS control system provides monitoring for all environmental criteria and items of plant. An indication panel located at the suite entry measures, calculates and displays room air change rates, room differential pressures, and has an alarm facility to indicate any excursions of these room conditions. A test point is installed in parallel to each Magnehelic gauge, eliminating the need to remove the tubes from the back of the gauge as a micro manometer can be plugged into the test point at the front of the panel to sample the room pressures. By blanking off the pressure port within the room the entire tube run can be pressure tested to prove the integrity of the installation and also simplifies routine range calibration of the Magnehelic gauges. A detail perhaps, but attention to such things delivers a better facility, overall. Construction started December 2003 and was completed, including Clinovia's PQ, by April 2004. Following a successful inspection and licensing by the MHRA, Clinovia is now building up to full production. CRC specialises in partnering with clients such as Clinovia, which can benefit from cleanroom solutions developed alongside satisfying their own clear process needs. Clinovia Derby and Harlow provide ample evidence of how this joint design effort can deliver successful results for any project.