NF ISO 13408-7

November 2012

Standard Cancelled

Aseptic processing of health care products - Part 7 : alternative processes for medical devices and combination products

ISO 13408-7:2012 specifies requirements and provides guidance on alternative approaches to process simulations for the qualification of the aseptic processing of medical devices and combination products that cannot be terminally sterilized and where the process simulation approach according to ISO 13408-1 cannot be applied. ISO 13408-7:2012 describes how risk assessment can be used during the development of an aseptic process to design a process simulation study for medical devices and combination products in those cases where a straightforward substitution of media for product during aseptic processing is not feasible or would not simulate the actual aseptic process.

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Main informations

Collections

National standards and national normative documents

Publication date

November 2012

Number of pages

27 p.

Reference

NF ISO 13408-7

ICS Codes

11.080.01 Sterilization and disinfection in general

Classification index

S98-117-7

Print number

1 - 25/10/2012

International kinship

ISO 13408-7:2012

Sumary

Aseptic processing of health care products - Part 7 : alternative processes for medical devices and combination products

ISO 13408-7:2012 describes how risk assessment can be used during the development of an aseptic process to design a process simulation study for medical devices and combination products in those cases where a straightforward substitution of media for product during aseptic processing is not feasible or would not simulate the actual aseptic process.

Standard replaced by (1)

NF EN ISO 13408-7

November 2015

Standard Current

Aseptic processing of health care products - Part 7 : alternative processes for medical devices and combination products

<p>ISO 13408-7:2012 specifies requirements and provides guidance on alternative approaches to process simulations for the qualification of the aseptic processing of medical devices and combination products that cannot be terminally sterilized and where the process simulation approach according to ISO 13408-1 cannot be applied.</p> <p>ISO 13408-7:2012 describes how risk assessment can be used during the development of an aseptic process to design a process simulation study for medical devices and combination products in those cases where a straightforward substitution of media for product during aseptic processing is not feasible or would not simulate the actual aseptic process.</p>

Table of contents

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Avant-propos
iv
Introduction
v
1 Domaine d'application
1
2 Références normatives
1
3 Termes et définitions
1
4 Éléments du système qualité
2
5 Définition d'un procédé aseptique
2
5.1 Généralités
2
5.2 Gestion des risques
2
6 Environnement de fabrication
3
7 Équipement
3
8 Personnel
3
9 Fabrication du produit
3
10 Simulation de procédé
3
10.1 Généralités
3
10.2 Sélection et soutien de la culture du milieu
3
10.3 Modes opératoires relatifs à la simulation
4
10.4 Incubation et inspection des unités utilisées dans les essais de remplissage simulés
6
10.5 Qualification opérationnelle initiale
6
10.6 Requalification périodique de performance
7
10.7 Répétition de la qualification opérationnelle initiale
7
10.8 Documentation des simulations de procédé
7
10.9 Mise au rebut du produit rempli
8
11 Essai de stérilité
8
11.1 Généralités
8
11.2 Enquête sur les unités positives à partir des études de stérilité
8
Annexe A (informative) Évaluation du risque lié au traitement aseptique . Méthode de gestion du risque pour la qualité
9
Annexe B (informative) Sélection d'échantillons pour détermination de la contamination microbienne.17
Annexe C (informative) Options d'essai pour la simulation de procédé
18
Bibliographie
21

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