ISO-13408-5 Aseptic processing of health care products - Part 5: Sterilization in place

ISO-13408-5 - 1ST EDITION - CURRENT


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ISO 13408-5:2006 specifies the general requirements for 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.

ISO 13408-5:2006 applies to processes where sterilizing agents are delivered to the internal surfaces of equipment that can come in contact with the product.

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11.080.01 (Sterilization and disinfection in general Including sterilization methods, air quality of surgery rooms, etc.)

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Document Number

ISO 13408-5:2006

Revision Level

1ST EDITION

Status

Current

Publication Date

Nov. 15, 2006

Committee Number

ISO/TC 198