What is ISO 13408-1 - Aseptic processing of healthcare products about?
ISO 13408 is a European standard that discusses the aseptic processing of healthcare products.
ISO 13408-1 is the first part of a multi-part series that outlines the general requirements for and offers guidance on, processes, programs, and procedures for development, validation, and routine control of the manufacturing process for aseptically processed health care products to ensure proper smooth flow of manufacturing process for aseptically processed health care products.
ISO 13408-1 includes requirements and guidance relative to the overall topic of aseptic processing. Specific requirements and guidance on various specialised processes and methods related to filtration, lyophilization, clean-in-place (CIP) technologies, sterilization in place (SIP), and isolator systems are given in other parts of ISO 13408.
Note: ISO 13408-1 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or pharmacopoeial requirements that pertain to national or regional jurisdictions.
Who is ISO 13408-1 - Aseptic processing of healthcare products for?
ISO 13408-1 on general requirements for aseptic processing of healthcare products is useful for:
- Manufacturers of healthcare products
- Healthcare product test centres
- Medical laboratories
- Regulatory authorities
Why should you use ISO 13408-1 - Aseptic processing of healthcare products?
Health care products that are labelled “sterile” are prepared using appropriate and validated methods under stringent control as part of a quality management system. 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.
ISO 13408-1 guideline assists you with quality system elements, aseptic process definition, manufacturing environment, equipment, roles for personnel authorised, general employee health, manufacture of the product, process simulation, and test for sterility for general requirements for aseptic processing of healthcare products.
With obedience and compliance to ISO 13408-1, you can improve the aseptic processing of healthcare products and manufacture a standardised product of high quality and assist you in meeting the general requirements for aseptic processing of healthcare products.
In addition, assists you in maintaining the sterility of health care products.