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Normas DIN – AENOR
DIN EN ISO 13408-3:2011-01

DIN EN ISO 13408-3:2011-01

Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006); German Version FprEN ISO 13408-3:2010 / Note: Date of issue 2011-01-17

Traitement aseptique des produits de santé - Partie 3: Lyophilisation (ISO 13408-3:2006); Version allemande FprEN ISO 13408-3:2010 / Attention: Date de parution 2011-01-17

Aseptische Herstellung von Produkten für die Gesundheitsfürsorge - Teil 3: Gefriertrocknung (ISO 13408-3:2006); Deutsche Fassung FprEN ISO 13408-3:2010 / Achtung: Erscheinungsdatum 2011-01-17

Fecha Anulación:
2011-09 /Withdrawn
Equivalencias internacionales:

FprEN ISO 13408-3 (2010-12)

ISO 13408-3 (2006-09)

Relación con otras normas DIN:

Reemplazada por: DIN EN ISO 13408-3:2011-09

Resumen:
This part of ISO 13408 specifies requirements for, and offers guidance on, equipment, processes, programs and procedures for the control and validation of lyophilization as an aseptic process. It does not address the physical/chemical objectives of a lyophilization process.
Keywords:
Aseptic, Clean rooms, Cleaning, Containers, Definitions, Freeze-drying, Guide books, Health services, Insulators, Maintenance, Medical devices, Medical equipment, Medical products, Medical sciences, Medical technology, Occupational medicine, Personnel, Processing, Public health protection, Quality assurance, Quality management, Specification (approval), Sterile, Sterility, Sterilization (hygiene), Surveillance (approval), Validation
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