DANSK DSF/FPREN ISO 13408-5 PDF

1.1 This part of ISO 13408 specifies the general requirements for sterilization in place (SIP) applied to product contact surfaces of the equipment used in the manufacture of sterile health care products by aseptic processing and offers guidance on qualification, validation, operation and control. NOTE SIP can be achieved by using steam or other gaseous or liquid sterilizing agents. Specific guidance on steam sterilization in place, which is the most common method used, is given in Annex A. 1.2 This part of ISO 13408 applies to processes where sterilizing agents are delivered to the internal surfaces of equipment that can come in contact with the product. 1.3 This part of ISO 13408 does not apply to processes where equipment is dismantled and delivered to a sterilizer. 1.4 This part of ISO 13408 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or compendial requirements that pertain in particular national or regional jurisdictions. 1.5 This part of ISO 13408 does not specify requirements for development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents. NOTE See also ISO 22442-1, ISO 22442-2 and ISO 22442-3.