Lyo-DCPS has reached pilot scale and will be available for GMP manufacturing in 2013
The Lyo-DCPS will be delivered in standard nests and tubs to comply with the industrial standard for aseptic filling of nested syringes
Arte Corporation, a Japanese manufacturer of glass packaging systems, has developed a new type of dual chamber prefillable syringe for freeze-dried pharmaceuticals with ProJect Pharmaceutics of Germany.
The Lyo-DCPS (lyophilised dual chamber prefillable syringe) will be delivered in standard nests and tubs to comply with the industrial standard for aseptic filling of nested syringes.
Arte Corporation, based in Tokyo, has contributed its manufacturing expertise in prefillable syringes, while ProJect Pharmaceutics, of Martinsried, Germany, added its know-how in developing filling and freeze drying processes and has adapted the Lyo-DCPS design to enable GMP-conformity and efficient manufacturing processes.
The diluent is filled first and can be autoclaved as required by international guidelines. The drug solution is filled into the second chamber and completely sealed on the filling line before entering the freeze drier. Due to its special design, the system opens by itself within the freeze drier enabling lyophilisation of the drug solution in presence of the diluent.
The two firms say the development has reached pilot scale and lyophilisation of first customers’ products in the new device has been performed successfully.
The sterile nested Lyo-DCPS for GMP manufacturing of drug products will be available early in 2013.