Design and construction
Article 17
1. Equipment for manufacturing operations of active substances or intermediates thereof shall meet the following conditions: (a) be of appropriate design and adequate size, and suitably located and qualified for its intended use; (b) be cleaned, sanitised, where appropriate and maintained; (c) be constructed so that contact surfaces do not alter the quality of the products beyond the established specifications for the active substance; (d) be used within its qualified operating range. 2. Major equipment and permanently installed processing lines used during the production of active substances or intermediates thereof shall be appropriately identified. 3. Substances required for the operation of equipment used in manufacturing operations, such as lubricants, heating fluids or coolants, shall not come into contact with the active substances or intermediates thereof. Deviations from this requirement shall be evaluated to check whether there are no detrimental effects to the fitness for purpose of the active substances or intermediates thereof. Wherever possible, food grade lubricants and oils shall be used during the operation of equipment used in manufacturing operations. 4. Closed or contained equipment shall be used when appropriate. Where open equipment is used, or equipment is opened, appropriate precautions shall be taken to minimise the risk of contamination. 5. The manufacturer shall ensure that up-to-date drawings are kept for equipment used in manufacturing operations and critical installations such as instrumentation and utility systems.