Guaranteeing the drug’s preservation until administration
Sylvie Ponlot with support from Jean-Yves Bauer
For a drug to be granted its commercial authorization (Autorisation de Mise sur le Marché or AMM), pharmaceutical companies have to submit a file to the relevant regulatory authorities (the Agence Française de Sécurité Sanitaire des Produits de Santé, the Food & Drug Administration). The latters pay specific attention to the analyses of extractible substances from material in direct contact with the solution. Interaction problems between container and content are monitored with extreme care to ensure the drug’s integrity.
Inerta®, a perfect control on the film’s formulation
To meet drug preservation requirements with utmost precision, Technoflex has developed its own polypropylene-based formulation since 2004: Inerta®.
The Inerta® film is composed of three co-extruded layers:
- an external layer resisting autoclave terminal sterilization
- a middle layer providing great flexibility to the whole film
- an internal layer, in contact with the solution, enabling the bag’s sealing
This highly inert polymer is used to manufacture the flexible conditioning and its related connectors. It is compliant with European and American pharmacopoeia (EP 3.1.3 & EP 3.1.6 / 21 CFR 77.18.10 / USP class VI) and registered at the FDA (DMF #19057) and in Canada (DMF # 2007-070). Moreover, all the extra tests to which Inerta® was submitted – transparency studies, residual volumes, integrity test, permeability measuring,… – support the fast conditioning of molecules in a reliable and already-tested container. Using this unique material significantly increases the end product’s performances.
Thanks to these properties, Technoflex raises quality standards by offering a product range aimed at conditioning solutions with ever-greater sensitivity.