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Pharmaceutique – engineering

Domaine Pharmaceutique

Travail en salle blanche
  1. Connaissance et respect des procédures d’accès
  2. Respect des BPF (cGMP)
  3. Maintien du niveau de propreté pendant les travaux
  4. Maîtrise des techniques spécifiques : traversées de cloisons, bras morts, niveau de finition, etc

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Soudage Orbital
  1. Travail en atelier blanc des tubes aseptiques jusqu’à Ra 0,2 μm
  2. Des opérateurs de soudage expérimentés
  3. Des procédés de soudage homologués

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Contrôle endoscopique
  1. Contrôleurs internes
  2. Capteur CCD, diamètre 5 mm, 6 mm et 8 mm
  3. Enregistrement photo et vidéo

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Suivi de traçabilité
  1. Chaque accessoire et tube est repéré, identifié par son numéro de coulée et associé à son certificat matière
  2. Chaque soudure est identifiée, reliée au soudeur, au procédé de soudage, aux paramètres de soudage, au coupon témoin et aux contrôles
  3. Nos dossiers sont conformes aux exigences les plus hautes requises par la FDA

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Prestations

  1. Etudes à partir des schémas de process de nos clients ou partenaires
  2. DAO 2D et 3D sur Autocad et Inventor

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  1. Travail en atelier blanc des tubes aseptiques jusqu’à Ra 0,2 μm (recuit brillant, électropolis)
  2. Prise en compte des exigences de finition et de propreté
  3. Soudage orbital
  4. Suivi de traçabilité

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  1. Fabrication des châssis
  2. Assemblage des équipements (pompes, échangeurs, filtres, robinets, U.V., instrumentation…)
  3. Epreuve, qualification et essais en atelie

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  1. Installation des skids
  2. Installation des équipements et charpentes
  3. Montage des tuyauteries
  4. Traitement chimique par circulation
  5. Réception et qualification des installations

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