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Standard

SN EN ISO 13408-4:2011

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Lingua
Servizi

Astratto

ISO 13408-4:2005 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. ISO 13408-4:2005 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. ISO 13408-4:2005 is not applicable to processes where equipment is dismantled and cleaned in a washer. ISO 13408-4:2005 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.

Specifiche dei prodotti

  • Standard da INB
  • Pubblicato:
  • Efficace:
  • Tipo di documento: EN
  • Pagine
  • ICS 11.080.01
  • Publisher SNV
  • Distributor SNV
  • National Committee INB/NK 171

Riferimento legale

Autorità federale svizzera: SWISSMEDIC
Designato ai sensi della legge svizzera:
Riferimento legaleRestrizioni
812.213
Designato ai sensi della legislazione dell'UE:
Riferimento legaleRestrizioni
98/79/EG

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