Qualification opérationnelle périodique du système de vision des thermoformeuses.
Contenu
- Titre
- Qualification opérationnelle périodique du système de vision des thermoformeuses.
- Auteur
- Cotabarren, Guillaume
- Résumé (fr)
-
L'année dernière, dans le cadre de mon cursus en chimie et physique, j'ai effectué un stage de deux mois au sein de l'équipe qualification/validation du laboratoire Renaudin. Ma mission consistait à réaliser la qualification opérationnelle périodique des différentes lignes de thermoformage de l'entreprise.
La qualification opérationnelle vise à vérifier et à apporter la preuve documentée que l'équipement fonctionne conformément à des spécifications écrites préalablement approuvées, sur toute la plage de fonctionnement définie et dans des conditions représentatives ou prévues de l'utilisation réelle. Il est ici question de qualification opérationnelle périodique, car il est nécessaire de vérifier tous les trois ans que les lignes de thermoformage n'ont pas subi d'altération et continuent de fonctionner conformément aux normes établies par l'entreprise ainsi qu'à la réglementation en vigueur imposée par l'agence nationale de sécurité du médicament et des produits de santé. - Abstract
-
Last year, as part of my chemistry and physics degree, I did my internship at Renaudin
Laboratory for two months within the qualification/validation team. My mission was to carry out periodic operational qualification for the different thermoforming lines of the company.
Operational qualification aims at checking and providing documented evidence that
the equipment operates to pre-approved written specifications throughout the specified operating domain under representative or anticipated conditions of actual use. Here we are talking about periodic operational qualification because it is necessary to check every 3 years that the thermoforming lines have not been out of order and continue to operate in accordance with the standards defined by the company and the current regulations imposed by the national safety, drugs and health products agency.
Periodic operational qualification took place in three steps:
⇨ The inventory of photos and Renaudin laboratory products
⇨ The taking of photos
⇨ Operational qualification of the thermoforming lines for the vision system
During my internship, I also had to carry out operational qualifications after "Change
Control" on the thermoforming lines. Qualification depends on the technical intervention that has been carried out beforehand. The qualifications I realized were mostly related to ring coding. The ring coding of a bulb corresponds to the color rings on the top of the bulb, any product has one to three rings (red, blue, green, yellow, orange or purple) for each format. Sometimes the vision system confuses two distinct colors such as orange and red. This is due to the color hue rings which can vary greatly due to the manufacturing process.
I also spent a few days with metrology technicians; this allowed me to discover the
filling of the tubs as well as the control of various parameters such as pressure, temperature or oximetry.
We will first of all present to you the company in which my internship took place,
then, in a second part, we will deal with the mission carried out step by step and we will eventually conclude at that point. - Mot(s)-Clé(s)
- Laboratoire pharmaceutique
- Thermoformage
- Système de vision (qualification opérationnelle)
- Thermoformeuses (qualification opérationnelle)
- Système de vision pour thermoformeuse
- Polychlorure de vinyle (PVC)
- Film plastique
- Conditionnement de médicaments
- Ampoules buvables en verre
- Lignes de thermoformage
- Tutelles
- UPPA-STEE
- Année de soutenance
- 2018
- Responsable(s) pédagogique(s)
- Sedes-Uhalde, Amaia
- Laboratoire Renaudin
- Format
- application/pdf
- Langue
- fre
- Type
- Licence
- Diplôme + année
- Licence 3
- Mention
- Physique - Chimie
- Discipline principale
- Physique - Chimie
- Collections
- Physique - Chimie (L3PC)
Position : 11226 (8 vues)