Standard: AAMI 13408-4
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 4: CLEAN-IN-PLACE TECHNOLOGIES
This standard is available for individual purchase.
IHS Standards Expert subscription, simplifies and expedites the process for finding and managing standards by giving you access to standards from over 370 standards developing organizations (SDOs).FEATURES & BENEFITS
- Maximize product development and R&D with direct access to over 1.6 million standards
- Discover new markets: Identify unmet needs and discover next-generation technologies
- Improve quality by leveraging consistent standards to meet customer and market requirements
- Minimize risk: Mitigate liability and better understand compliance regulations
- Boost efficiency: Speed up research, capture and reuse expertise
HOW TO SUBSCRIBE
This part of ISO 13408 specifies 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.
This part of ISO 13408 is applicable to processes where cleaning agents are delivered to the internal surfaces of equipment designed to be compatible with CIP, which may come in contact with the product.
This part of ISO 13408 is not applicable to processes where equipment is dismantled and cleaned in a washer.
This part of ISO 13408 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or compendial requirements that pertain to particular national or regional jurisdictions.
|Organization:||Association for the Advancement of Medical Instrumentation|
|Document Number:||aami 13408-4|
|Most Recent Revision:||YES|
|Document #||Change Type||Update Date||Revision||Status|
|AAMI 13408-4||Change Type: REAF||Update Date: 2005-01-01||Revision: 05||Status: ACTV|
|AAMI 13408-4||Change Type: STCH||Update Date: 2005-01-01||Revision: 05||Status: ACTV|