Norm

NEN-EN-ISO 13408-4:2011 en

Aseptisch verwerken van producten in de gezondheidszorg - Deel 4: Clean-in-place technologie├źn

79,70

Over deze norm

Status Definitief
Aantal pagina's 14
Gepubliceerd op 01-07-2011
Taal Engels
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.

Details

ICS-code 11.080.01
Nederlandse titel Aseptisch verwerken van producten in de gezondheidszorg - Deel 4: Clean-in-place technologie├źn
Engelse titel Aseptic processing of health care products - Part 4: Clean-in-place technologies
Vervangt
Normatieve verwijzingen
  • 98/79/EG, In vitro diagnostica

Winkelwagen

Subtotaal:

Ga naar winkelwagen