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AAMI 13408-4
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AAMI 13408-4 2005 Edition, January 1, 2005 Aseptic processing of health care products - Part 4: Clean-in-place technologies
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Description / Abstract:
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.
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.