Present Status of Recommendations for the Design of Laboratory Facilities

Abstract

The design of laboratory facilities for the hospital preparation of radiopharmaceuticals must achieve two major aims:- (i) to protect the product from microbial contamination from the environment, the operator and other products, and (ii) to protect the operator from radioactivity and pathogenic organism hazards where these may be involved, e.g. the handling of blood and blood products. Various guidelines, recommendations, Codes of Practice, and regulations must be borne in mind during the design stage of laboratory facilities so that the above aims can be achieved. The requirements for facilities for sterile production and radiation protection are similar in many ways, but conflicting requirements do occur. Recommendations on the design of radiochemical laboratories are readily obtainable from Codes of Practice and other guidance, which are interpretations of the regulations laid down under national Radioactive Substances Acts. Similarly Guidelines for Good Manufacturing Practice (GMP) published by national and international bodies, assist in the design of laboratories for the production of sterile products. Radiopharmaceutical preparation presents some difficulties, peculiar to this type of product, and over the years many discussions have tried to resolve, to the satisfaction of all the professional disciplines involved, the design of the facilities to cope with these difficulties. Many publications have given guidance on the design of facilities, but the lack of any official status, particularly in the U.K., has not helped to resolve the arguments. However some guidance notes recently produced by the Department of Health and Social Security (D.H.S.S.) in the U.K. will be invaluable to persons designing laboratories.