What is ISO 13408-7 - Alternative aseptic processes for medical devices and combination products about?
ISO 13408 is a European standard that discusses the aseptic processing of health care products. ISO 13408-7 is the seventh part of the series that outlines requirements and provides guidance on alternative approaches to process simulations for the qualification of the aseptic processing of medical devices.
ISO 13408-7 also provides requirements and guidance on alternative approaches to process simulations for the qualification of the aseptic processing combination products that cannot be terminally sterilized and where the process simulation approach according to ISO 13408-1 cannot be applied.
ISO 13408-7 elaborates how risk assessment can be used during the development of an aseptic process to design a process simulation study for medical devices and combination products in those cases where a straightforward substitution of media for a product during aseptic processing is not feasible or would not simulate the actual aseptic process.
Who is ISO 13408-7 - Alternative aseptic processes for medical devices and combination products for?
ISO 13408-7 on alternative aseptic processes for medical devices and combination products is useful for:
- Manufacturers of healthcare products
- Healthcare product test centres
- Medical laboratories
- Regulatory authorities
Why should you use ISO 13408-7 - Alternative aseptic processes for medical devices and combination products?
Aseptic processing is the handling of sterile products, containers, and/or devices in a controlled environment, in which the air supply, materials, equipment, and personnel are regulated to maintain sterility. Process simulation is an exercise that simulates the manufacturing process or portions of the process to demonstrate the capability of the aseptic process to prevent biological contamination. Risk management is a systematic application of quality management policies, procedures, and practices to the tasks of analyzing, evaluating, controlling, and monitoring risk.
ISO 13408-7 guideline assists you with quality system elements, aseptic process definition, risk management, manufacturing environment, equipment, personnel, manufacture of the product, process simulation, and test for sterility for alternative aseptic processes for medical devices and combination products.
With obedience and compliance to ISO 13408-1, you can use various appropriate alternative processes to process simulations for the qualification of the aseptic processing of medical devices and combination products. In addition, assists you in maintaining sterility for health care products.