Control of production and service provision—Specific requirements 7.5.1.2.1 Cleanliness of product and contamination control The manufacturer shall establish documented requirements for cleanliness of product if— (a) product is cleaned by the manufacturer prior to sterilisation or its use; or (b) product is supplied non-sterile to be subjected to a cleaning process prior to sterilisation or its use; or (c) product is supplied to be used non-sterile and its cleanliness is of significance in use; or (d) process agents are to be removed from product during manufacture. If the product is cleaned in accordance with clause (a) or clause (b) above, the requirements content in clauses (a) and (b) of sub-paragraph 6.4 do not apply prior to the cleaning process.