(2003; 148 pages)
4. Premises and equipment
4.1 As a general principle, buildings must be located, designed, constructed, adapted and maintained to suit the operations to be carried out within them. Laboratories for the handling of radioactive materials must be specially designed to take into consideration aspects of radiation protection in addition to cleanliness and sterility. Interior surfaces (walls, floors and ceilings) should be smooth, impervious and free from cracks; they should not shed matter and should permit easy cleaning and decontamination. Drains should be avoided wherever possible and, unless essential, should be excluded from aseptic areas.
4.2 Specific disposal systems should be mandatory for radioactive effluents. These systems should be effectively and carefully maintained to prevent contamination and exposure of personnel to the radioactive waste both within and outside the facility.
4.3 Sinks should be excluded from aseptic areas. Any sink installed in other clean areas should be of suitable material and be regularly sanitized. Adequate precautions should be taken to avoid contamination of the drainage system with radioactive effluents.
4.4 Lighting, heating, ventilation and, if necessary, air-conditioning should be designed to maintain a satisfactory temperature and relative humidity to ensure the comfort of personnel working in protective clothing. Buildings should be in a good state of repair. The condition of the buildings should be reviewed regularly and repairs carried out when and where necessary. Special care should be exercised to ensure that building repair or maintenance operations do not compromise products. Premises should provide sufficient space for the operations to be carried out, allowing an efficient flow of work and effective communication and supervision. All buildings and rooms should be clean, sanitary and free from radioactive contamination.
4.5 Ventilation of radiopharmaceutical production facilities should meet the requirement to prevent the contamination of products and the exposure of working personnel to radioactivity. Suitable pressure and airflow patterns should be maintained by appropriate isolation/enveloping methods. Air handling systems for both radioactive and non-radioactive areas should be fitted with alarms so that the working personnel in the laboratory are warned of any failure of these systems.
4.6 Dedicated facilities and equipment should be used for the manufacture of any radiopharmaceutical product derived from human blood or plasma. Autoclaves used in production areas for radiopharmaceuticals may be placed behind a lead shield to minimize the radiation exposure of the operators. Such autoclaves should be checked for contamination immediately after use to minimize the possibility of cross-contamination by radioactivity of the products in the next autoclave cycles.
4.7 All containers of radiopharmaceutical substances, regardless of the stage of manufacture, should be identified by securely attached labels. Cross-contamination should be prevented by the adoption of some or all of the following measures:
- processing and filling in segregated areas;
- avoiding the manufacture of different products at the same time, unless they are effectively segregated;
- containing material transfer by means of airlocks, air extraction, changing clothes and careful washing and decontamination of equipment;
- protecting against the risks of contamination caused by recirculation of untreated air, or by accidental re-entry of extracted air;
- using “closed systems” of manufacture;
- taking care to prevent aerosol formation;
- using sterilized containers.
4.8 Positive pressure areas should be used to process sterile products. In general, any radioactivity should be handled within specifically designed areas maintained under negative pressures. The production of sterile radioactive products should therefore be carried out under negative pressure surrounded by a positive pressure zone ensuring that appropriate air quality requirements are met.
4.9 Separate air-handling units should be used for radioactive and non-radioactive areas. Air from operations involving radioactivity should be exhausted through appropriate filters that are regularly checked for performance.
4.10 Pipework, valves and vent filters should be properly designed to facilitate validated cleaning and decontamination.