What is ISO 13408-5 - Sterilisation in place for healthcare products about?
ISO 13408 is an international standard that discusses the aseptic processing of health care products. ISO 13408-5 is the fifth part of a multi-part series that outlines the general requirements for sterilisation 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 to ensure the successful sterilisation of manufacturing equipment.
ISO 13408-5 applies to processes where sterilising agents are delivered to the internal surfaces of equipment that can meet the product.
Note 1: ISO 13408-5 does not apply to processes where equipment is dismantled and delivered to a sterilizer.
Note 2: ISO 13408-5 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or compendial requirements that pertain to national or regional jurisdictions.
Note 3: ISO 13408-5 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 countries for the processing of materials potentially contaminated with these agents.
Who is ISO 13408-5 - Sterilisation in place for healthcare products for?
ISO 13408-5 on sterilisation in place for health care products is useful for:
- Manufacturers of health care products
- Test centres
- Regulatory authorities
Why should you use ISO 13408-5 - Sterilisation in place for healthcare products?
Sterilisation in place (SIP) is a method of sterilisation of the internal surfaces of parts of the equipment or an entire process system in situ, without disassembly, using appropriate sterilising agents.
Sterilisation in place is, in most instances, preceded by cleaning in place which is described in ISO 13408-4. While methods of cleaning in place and sterilisation in place differ considerably in technology, the concept of in situ treatment is similar.
ISO 13408-5 guideline assists you with quality system elements, management responsibility, design control, measuring instruments, measuring systems, process characterization, equipment characterization, cleaning agent characterization, SIP process, validation, routine monitoring, routine control, and personnel training for sterilisation in place.
This assists in the successful sterilisation of manufacturing equipment that enhances the efficacy, productivity of the medical devices.
With obedience and compliance to ISO 13408-5, you can meet general requirements for sterilisation in place processes. Additionally, you can reach the desired level of cleanliness using sterilisation in place processes.