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Transcript
MixJect Integrated transfer device for drug reconstitution and injection The MixJect® system enables the safe, rapid and easy preparation of lyophilized drugs. The system is a single unit for reconstituting a powder drug with a diluent prefilled syringe. Upon reconstitution, the drug is available for immediate injection with a pre-attached needle. MixJect System Attributes • Preassembled with a client-specified standard or safety needle • Fits standard vials, syringes, needles and Luer lock connections • Compatible with popular auto-injector devices • Designed for minimal residual volume and overfill MixJect is ideal for Lyophilized drugs supplied with prefilled diluent syringes • Depot injections • Self administration of drugs for chronic illness • The MixJect system is 510(k) cleared by the United States Food and Drug Administration and carries the CE mark. Innovations in Safety and Administration Systems West’s administration systems enhance the safe delivery of drugs through advanced reconstitution, mixing and transfer technologies. The systems are easy to use, help promote safety and compliance and use your existing formulation, manufacturing process and primary packaging. West has extensive experience helping our customers around the world navigate local regulatory requirements to facilitate registration. To find out how West’s innovative systems can add value to your drug product or application, please contact your local West account representative. You may also send email inquiries to [email protected]. North America 1-800-345-9800 option 8 South America +55 11 4055 6061 Europe +49 (0) 2403-7960 Asia Pacific +65 6862 3400 www.WestPharma.com • www.WestReconstitution.com West Pharmaceutical Services, Inc. • 530 Herman O. West Drive • Exton, PA 19341 West and the diamond logo and By your side for a healthier world™ are registered trademarks or trademarks of West Pharmaceutical Services, Inc., in the United States and other jurisdictions. MixJect® is a registered trademark of Medimop Medical Projects Ltd., a subsidiary of West Pharmaceutical Services, Inc. Copyright © 2014 West Pharmaceutical Services, Inc. #7250 • 0214 Dosing Accuracy Needle-Free Vial Adapters Reduce Drug Overfill Drug overfill is a costly practice that is based upon the variability in drug withdrawal technique when using a needle. Typical overfill volumes in use today vary from 10% to 30% of label claim. Ordinary drug withdrawl With West vial adapter The West reconstitution and transfer systems with fluid openings on the side of the plastic spike allows for greater consistency in drug withdrawal and reduced overfill requirements. This lowers your cost per vial and increases the number of doses per lot. For example, reducing the overfill by 20% provides enough drug for one additional vial for each five vials filled. Study Shows Consistent Delivered Volume A West study showed greater consistency in drug withdrawal using a vial adapter compared to a syringe and needle. The study groups consisted of 10 nurses and 10 hemophilia patients, neither having previously used vial adapters. A control group consisted of four experienced lab analysts experienced with using vial adapters. Needle and Syringe Versus Vial Adapter for 2 mL Solution Withdrawal Needle and Syringe Vial Adapter Overfill Required % Overfill for 2.0 mL Overfill Required % Overfill for 2.0 mL Patients 0.711 mL 35.6% 0.142 mL 7.1% Nurses 0.318 mL 15.9% 0.172 mL 8.6% Lab Analysts 0.306 mL 15.3% 0.0750 mL 3.8% The data clearly show more consistent fluid withdrawal with the vial adapter across all groups of users. Reducing the Need for Costly Overfill of Drug Vials For drug companies, evaluation of vial overfill using vial adapters should be initiated early in formulation development. The result can lead to lower API costs and increased amounts of commercially available drug product. North America 1-800-345-9800 option 8 South America +55 11 4055 6061 Europe +49 (0) 2403-7960 Asia Pacific +65 6862 3400 www.WestPharma.com • www.WestReconstitution.com West Pharmaceutical Services, Inc. • 530 Herman O. West Drive • Exton, PA 19341 West and the diamond logo and By your side for a healthier world™ are registered trademarks or trademarks of West Pharmaceutical Services, Inc., in the United States and other jurisdictions. Vial adapters are 510(k) cleared by the United States Food and Drug Administration and carry the CE mark. Copyright © 2014 West Pharmaceutical Services, Inc. #7250 • 0214