NF EN ISO 13408-1

NF EN ISO 13408-1

September 2011
Standard Cancelled

Aseptic processing of health care products - Part 1 : general requirements

ISO 13408-1:2008 specifies the general requirements for, and offers guidance on, processes, programmes and procedures for development, validation and routine control of the manufacturing process for aseptically-processed health care products.ISO 13408-1:2008 includes requirements and guidance relative to the overall topic of aseptic processing. Specific requirements and guidance on various specialized processes and methods related to filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in other parts of ISO 13408.

See more
View the extract
Main informations

Collections

National standards and national normative documents

Publication date

September 2011

Number of pages

64 p.

Reference

NF EN ISO 13408-1

ICS Codes

11.080.01   Sterilization and disinfection in general

Classification index

S98-117-1

Print number

1 - 18/08/2011

International kinship

ISO 13408-1:2008

European kinship

EN ISO 13408-1:2011
Sumary
Aseptic processing of health care products - Part 1 : general requirements

ISO 13408-1:2008 specifies the general requirements for, and offers guidance on, processes, programmes and procedures for development, validation and routine control of the manufacturing process for aseptically-processed health care products.

ISO 13408-1:2008 includes requirements and guidance relative to the overall topic of aseptic processing. Specific requirements and guidance on various specialized processes and methods related to filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in other parts of ISO 13408.

Replaced standards (1)
NF EN 13824
March 2005
Standard Cancelled
Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements

Le présent document spécifie les exigences relatives à la conception et au fonctionnement des installations de traitement aseptique et à la validation et au contrôle de routine des procédés aseptiques en vue de la préparation de dispositifs médicaux liquides stériles. Il ne s'applique pas aux produits pharmaceutiques pour lesquels les exigences relatives aux bonnes pratiques de fabrication appropriées s'appliquent.

Standard replaced by (1)
NF EN ISO 13408-1
January 2016
Standard Cancelled
Aseptic processing of health care products - Part 1 : general requirements

ISO 13408-1:2008 specifies the general requirements for, and offers guidance on, processes, programmes and procedures for development, validation and routine control of the manufacturing process for aseptically-processed health care products. ISO 13408-1:2008 includes requirements and guidance relative to the overall topic of aseptic processing. Specific requirements and guidance on various specialized processes and methods related to filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in other parts of ISO 13408.

Table of contents
  • Avant-propos
    v
  • Introduction
    vi
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    2
  • 4 Éléments du système qualité
    7
  • 4.1 Généralités
    7
  • 4.2 Attribution des responsabilités
    8
  • 4.3 Étalonnage
    8
  • 5 Définition d'un traitement aseptique
    8
  • 5.1 Généralités
    8
  • 5.2 Gestion des risques
    9
  • 6 Environnement de fabrication
    11
  • 6.1 Généralités
    11
  • 6.2 Conception de l'environnement de fabrication
    12
  • 6.3 Plan
    13
  • 6.4 Flux de personnes et de matériaux
    15
  • 6.5 Système de ventilation contrôlée
    16
  • 6.6 Qualification de la chambre stérile
    18
  • 6.7 Installations et équipements
    18
  • 6.8 Programmes de surveillance environnementale et du personnel
    19
  • 7 Équipement
    22
  • 7.1 Qualification
    22
  • 7.2 Maintenance de l'équipement
    24
  • 8 Personnel
    25
  • 8.1 Généralités
    25
  • 8.2 Formation à la qualification APA
    26
  • 8.3 Modes opératoires relatifs à l'habillage
    27
  • 8.4 État de santé général du personnel
    29
  • 9 Fabrication du produit
    29
  • 9.1 Stérilisation et maintien de la stérilité
    29
  • 9.2 Durée du procédé de fabrication
    30
  • 9.3 Modes opératoires relatifs à la fabrication aseptique
    30
  • 9.4 Nettoyage et désinfection des installations
    30
  • 9.5 Nettoyage, désinfection et stérilisation de l'équipement
    32
  • 10 Simulation de procédé
    34
  • 10.1 Généralités
    34
  • 10.2 Sélection et soutien de la culture du milieu
    34
  • 10.3 Modes opératoires relatifs à la simulation
    35
  • 10.4 Incubation et inspection des unités utilisées dans les essais de remplissage simulés
    36
  • 10.5 Qualification opérationnelle initiale
    37
  • 10.6 Requalification opérationnelle périodique
    37
  • 10.7 Répétition de la qualification opérationnelle initiale
    38
  • 10.8 Documentation des simulations de procédé
    38
  • 10.9 Mise au rebut du produit rempli
    39
  • 11 Essai de stérilité
    40
  • 11.1 Généralités
    40
  • 11.2 Enquête sur les unités positives à partir des études de stérilité
    40
  • Annexe A (informative) Exemple de logigramme
    41
  • Annexe B (informative) Éléments types de la définition d'un procédé aseptique
    42
  • Annexe C (informative) Exemples de risques spécifiques
    43
  • Annexe D (informative) Comparaison de la classification des chambres stériles
    44
  • Annexe E (informative) Spécifications relatives à l'eau utilisée dans le procédé
    45
  • Annexe F (informative) Zone de traitement aseptique
    47
  • Bibliographie
    48
ZOOM ON ... the Requirements department
To comply with a standard, you need to quickly understand its issues in order to determine its impact on your activity.

The Requirements department helps you quickly locate within the normative text:
- mandatory clauses to satisfy,
- non-essential but useful clauses to know, such as permissions and recommendations.

The identification of these types of clauses is based on the document “ISO / IEC Directives, Part 2 - Principles and rules of structure and drafting of ISO documents ”as well as on a constantly enriched list of verbal forms.

With Requirements, quickly access the main part of the normative text!

With Requirements, quickly access the main part of the normative text!
What is the Redline format?
The Redline + service - standards comparator allows you to easily and simply identify major changes between the current standard and its last canceled version.

At a glance, you will be able to identify the additions, deletions or modifications to a text, table, figure and formula.
At a glance, you will be able to identify the additions, deletions or modifications to a text, table, figure and formula

The Redlines + service is offered to you on the collection of French standards in force, in French language and in HTML and PDF format.

For an overview of the service, click on View a standard in redline format
Need to identify, monitor and decipher standards?

COBAZ is the simple and effective solution to meet the normative needs related to your activity, in France and abroad.

Available by subscription, CObaz is THE modular solution to compose according to your needs today and tomorrow. Quickly discover CObaz!

Request your free, no-obligation live demo

I discover COBAZ