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Vetter has ready-to-submit documentation for this service in Common Technical Document (CTD) formats for the US, Europe and Japan.
Vetter, a contract development and manufacturing organization, announced that it is offering filling services for sterile water for injection syringes with five years stability data. The CMO’s stability data and bracketing concept allows a longer shelf life for drugs and high flexibility while defining the filling volume. Vetter has ready-to-submit documentation for this service in Common Technical Document (CTD) formats for the US, Europe and Japan. Validation and stability data according to standard guidelines, such as the US Pharmacopeia, the European Pharmacopoeia and ICH, are also available.
The number of drugs that are sensitive to environmental influences is increasing. The formulations are often freeze dried to prolong shelf life and therefore require reconstitution in a suitable solvent before administration. Vetter filling service for syringes with sterile water for injection provides the solution for safe and simple reconstitution. The system contains the exact amount of solvent required by the customer to produce the required dosage, which helps assure that patients receive the exact amount of substance needed.
Vetter’s filling service for sterile water for injection syringes is available in 1.5 ml formats with a volume of 0.5 ml to 1.3 ml, as well as a 3 ml format with a volume of 1.4 ml to 3.0 ml. The syringe features Vetter’s V-OVS tamper-evident closure, which is designed to give a prefilled syringe system effective protection features. Vetter’s filling service comes with five years stability data and can manufacture batches of up to 140,000 pieces.