Innovations in Administration and Injection Systems EXPERIENCED CREATIVE FOCUSED

Transcription

1 Innovations in Administration and Injection Systems EXPERIENCED CREATIVE FOCUSED

2 Meeting Your Drug Administration Challenges Your injectable drug product will be perfectly pure when you ship it, but will the administration experience be perfect? Healthcare workers depend on your drug to treat their patients. Patients depend on your drug to enhance their quality of life. But they deserve more. They deserve administration systems that are easy to use, safe and that promote compliance. Selecting an administration system is an important consideration in drug development. We understand your challenges and can provide you with an administration system that can enhance the safe delivery of your drugs through advanced reconstitution, mixing and transfer technologies. West s 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 you can enhance the administration experience for the patients who depend on your drug, please contact West. We invite you to phone, send an to AdministrationSystems@westpharma.com or visit us online at Mix2Vial MixJect Needle-free Transfer Device Vial Adapters Vial2Bag 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. 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. Ordinary drug withdrawl 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 With West vial adapter

3 Every day, injectable drugs are administered to improve the lives of millions of patients around the world. And every day, West is working by your side to design and manufacture drug packaging and delivery systems that will bring your drugs from concept to the patient more efficiently, reliably and safely. West understands your challenges and helps with solutions every step of the way, with cutting-edge production technologies, an unmatched expertise in global regulatory compliance, and an ever-growing knowledge base of pharmaceutical drug product testing, development, packaging and delivery. Whether you want an end-to-end solution or your focus is on one piece of the process, West is by your side for a healthier world. To learn more about West s innovation in administration and injection systems, call your West account manager or a West technical customer support representative., Option (0) West and the diamond logo and By your side for a healthier world are trademarks or registered trademarks of West Pharmaceutical Services, Inc., in the United States and other jurisdictions. Copyright 2014 West Pharmaceutical Services, Inc. #

4 Mix2Vial Needle-free reconstitution system The Mix2Vial needle-free system enables simple, fast vial-to-vial transfer and mixing for the reconstitution of lyophilized drug products. The reconstituted drug is available for immediate aspiration into the syringe used for injection. Mix2Vial System Attributes Needle-free for safety Consistent volume withdrawal Touch-free packaging maintains sterility Designed for minimal residual volume and overfill Easy to use Rapid transfer Performance Options In-line liquid filter Diluent flow restrictor to prevent foaming The Mix2Vial system is ideal for lyophilized drugs provided with fixed-volume diluent vials. Components are available to work with 13mm, 17mm and 20mm stoppers. The Mix2Vial 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 inquiries to AdministrationSystems@westpharma.com. trademarks of West Pharmaceutical Services, Inc., in the United States and other jurisdictions. Mix2Vial is a registered trademark of Medimop Medical Projects Ltd., a subsidiary of West Pharmaceutical Services, Inc.

5 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 inquiries to AdministrationSystems@westpharma.com. 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.

6 Needle-free Transfer Device Rapid drug transfer and reconstitution The needle-free transfer device (NTD) enables the rapid transfer of a diluent from a vial into a lyophilized vial with vacuum for drug reconstitution as well as manual transfer when no vacuum is present. The NTD can also be used for mixing two liquids using manual transfer. NTD Attributes Works with or without vacuum in the drug vial Provides for consistent volume withdrawl Designed for minimal residual volume and overfill Performance Option In-line liquid filter The needle-free transfer device 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 inquiries to AdministrationSystems@westpharma.com. 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.

7 Vial Adapters Enable needle-free drug transfer and reconstitution Vial adapters are the cost-effective solution for the safe and rapid transfer and reconstitution of drugs between vials and syringes. Our vial adapter spike technology provides a reproducible engineered depth for drug and diluent aspiration, which greatly reduces the end-user variability associated with traditional needle aspirations. That means you can assure the most efficient and cost-effective vial overfill volumes for your drug product. Vial Adapters Reduces exposure to needle-stick injuries Fewer steps, parts and sharps Reduce costly overfill requirements Options Siliconized spike reduces insertion force In-line fluid path filters reduce particle transfer Vented Vial Adapter Dual-channel spike facilitates rapid large-volume withdrawal without pressurizing vial Reduces sprayback potential of toxic materials through pressure equalization The design allows sterile inbound air and proper aspiration PTFE 0.2 micron hydrophobic air filter Swabable Vial Adapter Silicone rubber valve with Luer-compatible connector maintains sterility for repeat vial access Eliminates coring and stopper integrity issues associated with multi-dose rubber stoppers Opens only when connected to/compressed by standard Luer slip or Luer lock syringe Swabable surface to insure sterility Vial adapters are 510(k) cleared by the United States Food and Drug Administration and carry the CE mark. trademarks of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.

8 Vial2Bag Needle-free reconstitution for IV systems The Vial2Bag needle-free system enables safe and convenient reconstitution and transfer of a drug between a vial or syringe and an IV bag or bottle. The needle-free system connects to the IV set port and can be used with all manufacturers bags. The drug vial connects to the Vial2Bag system with a vial adapter. The diluent is transferred from the IV bag to the vial for drug reconstitution. The reconstituted drug is then transferred from the vial back to the bag. The system helps provide transfer of the full dose to the IV bag for administration. Standard luer lock or luer tip syringes can also be connected to the Vial2Bag system for addition or removal of solutions. Vial2Bag System Attributes Fits all standard IV systems Helps ensure optimum drug utilization for point-ofuse preparation Safe, needle-free reconstitution and transfer between a vial or syringe and the IV bag Silicone rubber valve with Luer-compatible connector maintains sterility for repeat vial and syringe access Vial2Bag is ideal for Hospital pharmacy drug preparation Out-patient health care centers Point-of-care drug addition to an IV bag The Vial2Bag 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. 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 inquiries to AdministrationSystems@westpharma.com. trademarks of West Pharmaceutical Services, Inc., in the United States and other jurisdictions. Vial2Bag is a registered trademark of Medimop Medical Projects Ltd., a subsidiary of West Pharmaceutical Services, Inc.

9 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. 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. Ordinary drug withdrawl 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 With West vial adapter Needle and Syringe Vial Adapter Overfill Required % Overfill for 2.0 ml Overfill Required % Overfill for 2.0 ml Patients ml 35.6% ml 7.1% Nurses ml 15.9% ml 8.6% Lab Analysts ml 15.3% 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. 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.