UNLIMITED FREE
ACCESS TO THE WORLD'S BEST IDEAS

SUBMIT
Already a GlobalSpec user? Log in.

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

Customize Your GlobalSpec Experience

Select Your Free Newsletters

Industry Newsletters

Select Your Free Product Alerts

Finish!
Privacy Policy

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

CEN - EN ISO 13408-1

Aseptic processing of health care products - Part 1: General requirements

inactive
Organization: CEN
Publication Date: 1 June 2011
Status: inactive
Page Count: 60
ICS Code (Sterilization and disinfection in general): 11.080.01
scope:

This part of ISO 13408 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.

This part of ISO 13408 includes requirements and guidance relative to the overall topic of aseptic processing. Specific requirements and guidance on various specialized 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 This part of ISO 13408 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or pharmacopoeial requirements that pertain in particular national or regional jurisdictions.

Document History

EN ISO 13408-1
June 1, 2015
Aseptic processing of health care products - Part 1: General requirements
This p art of I SO 13408 specifies t he general r equirements for, a nd offers g uidance on, processes, programmes and procedures for development, validation and routine control of the manufacturing...
EN ISO 13408-1
June 1, 2011
Aseptic processing of health care products - Part 1: General requirements
This part of ISO 13408 specifies the general requirements for, and offers guidance on, processes, programmes and procedures for development, validation and routine control of the manufacturing...
EN ISO 13408-1
June 1, 2011
Aseptic processing of health care products - Part 1: General requirements
This part of ISO 13408 specifies the general requirements for, and offers guidance on, processes, programmes and procedures for development, validation and routine control of the manufacturing...

References

This document references:
ISO 14971 - Medical devices - Application of risk management to medical devices
Published by ISO on December 1, 2019
This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process...
This document references:
ISO 14698-1 - Cleanrooms and associated controlled environments - Biocontamination control - Part 1: General principles and methods
Published by ISO on September 1, 2003
This part of ISO 14698 establishes the principles and basic methodology of a formal system of biocontamination control (Formal System) for assessing and controlling biocontamination when cleanroom...
This document references:
14644-4 - Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up
Published by ISO on November 1, 2022
This document specifies the process for creating a cleanroom from requirements through to its design, construction and start-up. It applies to new, refurbished and modified cleanroom installations....
This document references:
EN 1822-1 - High efficiency air filters (EPA, HEPA and ULPA) - Part 1: Classification, performance testing, marking
Published by CEN on April 1, 2019
This document applies to high efficiency particulate and ultra-low penetration air filters (EPA, HEPA and ULPA) used in the field of ventilation and air conditioning and for technical processes, e.g....
This document references:
AAMI ST67 - Sterilization of health care products—Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled “sterile”
Published by AAMI on January 1, 2019
Inclusions This standard specifies requirements and provides guidance on selecting approaches to establish assurance of sterility for a health care product labelled as “sterile.” Approaches to...
View Less
View All
Advertisement