Download MixJect - West Pharmaceutical Services

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