Clean-room technology is a complicated and rapidly growing industry, and although many working processes rely on clean-rooms, this article is solely concerned with clean-room working in UK hospital pharmacies, and the associated regulations. In UK hospitals, drug preparations such as antibiotics and cytotoxics were traditionally prepared at the bedside until the working party on the addition of drugs to intravenous infusion fluids (the Breckenridge Report, 1974) made this type of preparation unfeasible. Since then, intravenous preparations have been prepared centrally under the control of pharmacy departments. The UK COSHH regulations issued in 1989 and the Consumer Protection Act (1987) also affected the way in which pharmaceuticals were prepared in hospitals, considering the health and welfare of the patients, healthcare workers, and pharmacy workers, as well as the products. Commonly prepared products in hospital pharmacy clean-rooms include cytotoxic drugs, total parenteral nutrition (TPN; a food replacement given to patients who are not able to eat), and central intravenous additive service (CIVAS; fluids with antibiotics or pain relief added). Although TPN is not harmful to the pharmacy worker, the product is administered intravenously and must be prepared under the strictest of conditions; with antibiotic preparations, the staff also need to be protected from the product, as well as the product being protected from staff. With the preparation of cytotoxic drugs which can be used in cancer treatment, there is even greater need to minimise the exposure to staff, and as the patients are often immunocompromised because of their treatment, controlled conditions are even more imperative.

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To achieve the goals recommended by the guidance mentioned above, the use of clean-rooms has become necessary. The cleanliness of these is achieved and maintained by controlling the environment, workforce, products, and processes in the room. Environmental controls can …