DIN EN ISO 13408-1:2011-09

The standards of the DIN EN ISO 13408 series have been prepared by ISO/TC 198 "Sterilization of health care products" (secretariat: ANSI, USA). Within the framework of the Unique Acceptance Procedure (UAP), Parts 1 to 6 of the ISO 13408 standard series have been adopted by CEN/TC 204 "Sterilization of medical devices" (secretariat: BSI, United Kingdom) without any modifications to replace DIN EN 13824:2005. On the national level, Working Committee NA 063-01-12 AA "Aseptische Herstellung" ("Aseptic processing") at NAMed is responsible.
The standards of the DIN EN ISO 13408 series apply for the aseptic processing of health care products. The aseptic process definition encompasses all production steps following the sterilization of product and components until the final container or package is sealed. To keep the aseptic process definition clear and workable, the parts of ISO 13408 are focused on the risks to the maintenance of sterility and provide guidance on various specialized processes and methods related to filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems.
DIN EN ISO 13408-1: The standard specifies the general requirements for, and offers guidance on, processes, programmes and procedures for development, validation and routine control of the manufacturing process for aseptically-processed health care products. It contains requirements for risk management regarding the assessment of risks and specifications for acceptance criteria for all elements of the aseptic process definition.
DIN EN ISO 13408-2: The standard contains requirements, and offers guidance on, aseptic processing of health care products by filtration. It also provides guidance to filter users concerning general requirements for set-up, validation and routine operation of a sterilization process. This part of ISO 13408 is not applicable to removal of viruses. DIN EN ISO 13408-3: The standard specifies requirements for, and offers guidance on, equipment, processes, programmes and procedures for the control and validation of lyophilization as an aseptic process. It deals with lyophilization, which is a physical-chemical drying process designed to remove solvents from both aqueous and non-aqueous systems, primarily to achieve product or material stability. It does not address the physical/chemical objectives of a lyophilization process. DIN EN ISO 13408-4: The standard includes requirements and guidance that are to be observed during clean-in-place processes. The purpose of this part of ISO 13408 is to achieve standardization in the field of validation and routine control of clean-in-place processes used in the manufacture of health care products. It specifies 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. It is not applicable to processes where equipment is dismantled and cleaned in a washer.
DIN EN ISO 13408-5: The standard specifies the general requirements of 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. It applies to processes where sterilizing agents are delivered to the internal surfaces of equipment that can come into contact with the product. This part of DIN EN ISO 13408 does not apply to processes where equipment is dismantled and delivered to a sterilizer, and does not specify requirements for development, validation and routine control of a process for inactivating the causative agents of spongiformencephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease.
DIN EN ISO 13408-6: The standard includes the requirements for isolator systems used for aseptic processing and offers guidance on qualification, bio-decontamination, validation, operation and control of isolator systems used for aseptic processing of health care products. This part of ISO 13408 is focused on the use of isolator systems to maintain aseptic conditions; this may include applications for hazardous materials.