What is ISO 13408-4 - Clean-in-place (CIP) technologies about?
ISO 13408 is an international standard that discusses the aseptic processing of health care products. ISO 13408-4 is the fourth part of the multi-part series that outlines the general requirements for clean-in-place (CIP) processes applied to product contact surfaces of 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 13408-4 applies to processes where cleaning agents are delivered to the internal surfaces of equipment designed to be compatible with CIP, that may meet the product.
Note 1: ISO 13408-4 does not apply to processes where equipment is dismantled and cleaned in a washer.
Note 2: ISO 13408-4 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.
Who is ISO 13408-4 - Clean-in-place (CIP) technologies for?
ISO 13408-4 on clean-in-place technologies is useful for:
- Manufacturers of health care products
- Test centres
- Regulatory authorities
Why should you use ISO 13408-4 - Clean-in-place (CIP) technologies?
The clean-in-place process is a method of cleaning the internal surfaces of parts of the equipment or an entire process system without or with minimal disassembly.
Clean-in-place processes allow parts of the equipment or an entire process system to be cleaned without being dismantled, reducing the need for disassembling and connections under clean conditions. For example, tanks, vessels, freeze-dryers piping, and other processing equipment used for manufacture may be cleaned in place.
ISO 13408-4 guideline assists you with quality system elements, management responsibility, design control, measuring instruments, measuring systems, process characterization, equipment characterization, cleaning agent characterization, CIP process, validation, routine monitoring, routine control, and personnel training for clean-in-place technologies. This assist in the successful sterilisation of manufacturing equipment that enhances the efficacy, productivity of the medical devices.
With obedience and compliance to ISO 13408-4, you can meet general requirements for clean-in-place (CIP) processes. In addition, you can reach the desired level of cleanliness using clean-in-place (CIP) processes.
