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Biotechnologie
Processus sûrs pour la biotechnologie
Pureté maximale, confinement contrôlé et conformité aux BPF pour les principes actifs sensibles et les bioproduits de grande valeur.
Biotechnologie
À usage unique
Asepsie
GMP
Aperçu
Biotechnologie : précision et sécurité comme facteurs de réussite
Dans la production biopharmaceutique, la protection des produits et la sécurité des collaborateurs sont essentielles. De la manipulation des matières premières jusqu’au remplissage final, les systèmes à usage unique dans la biotechnologie exigent le plus grand soin. Les contaminations peuvent rendre des lots entiers inutilisables et engendrer des coûts élevés. Rhein-Plast propose des systèmes de confinement flexibles et conformes aux BPF pour l’industrie pharmaceutique et biotechnologique, qui garantissent un processus entièrement fermé et sûr et s’intègrent parfaitement aux concepts de salles blanches existants.
défis
Exigences critiques dans la production biotechnologique
Protection des produits biologiques sensibles
Les produits biologiques sont souvent sensibles à la contamination et aux influences environnementales. Un transfert aseptique est essentiel pour préserver l’intégrité du produit.
Manipulation de principes actifs hautement puissants (HPAPI)
La manipulation sécurisée des HPAPI nécessite des systèmes fermés pour protéger le personnel contre l’exposition et éviter les contaminations croisées.
Intégration en salle blanche conforme aux BPF
Tous les composants doivent respecter les exigences strictes des bonnes pratiques de fabrication (GMP) et s’intégrer parfaitement dans des systèmes de transfert en salle blanche validés.
NOS SOLUTIONS
Rhein-Plast Containment pour la biotechnologie
Rhein-Plast développe des systèmes à usage unique sur mesure pour la biotechnologie, conçus avec précision pour répondre à vos exigences de procédé. Notre portefeuille comprend des systèmes de remplissage et de vidange de FIBC, des systèmes de transfert fermés tels que le Continuous Liner, ainsi que des solutions Inliner dotées de propriétés barrières spécifiques. Ces systèmes permettent une intégration sûre dans des isolateurs et dans des procédés de salle blanche existants. Nos emballages conformes aux BPF sont fabriqués dans des conditions ISO 5, 7 et 8 afin de garantir une pureté maximale pour la production biopharmaceutique.
avantages
Votre avantage avec Rhein-Plast
Exposition réduite
Nos systèmes fermés minimisent le contact du personnel avec des substances hautement actives.
Rendement maximal du produit
En vous protégeant contre la contamination et les pertes de produit, vous préservez la valeur de vos produits.
Intégration flexible des installations
Nos solutions s’intègrent facilement dans les installations existantes, sans modifications coûteuses.
Validable
Nous fournissons une documentation complète à l’appui de vos processus IQ/OQ/PQ.
Produits
Produits pour la biotechnologie
Demander une solution de confinement biotechnologique
Parlez avec nos experts des exigences de votre solution de confinement biotech et trouvez la solution adaptée.