ISO 13408-6:2005
Aseptic processing of health care products — Part 6: Isolator systems
Reference number
ISO 13408-6:2005
Edición 1
2005-06
Retirada
ISO 13408-6:2005
39782
Retirada (Edición 1, 2005)

Resumen

ISO 13408-6:2005 specifies the requirements for isolator systems used for aseptic processing and offers guidance on qualification, bio-decontamination, validation, operation and control of isolator systems used for aseptic processing of health care products.

ISO 13408-6:2005 is focused on the use of isolator systems to maintain aseptic conditions; this may include applications for hazardous materials.

ISO 13408-6:2005 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or compendial requirements that pertain in particular to national or regional jurisdictions.

Informaciones generales

  •  : Retirada
     : 2005-06
    : Retirada de la Norma Internacional [95.99]
  •  : 1
     : 17
  • ISO/TC 198
    11.080.01 
  • RSS actualizaciones

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