Aseptic Fill and Finish

GBI maintains an ISO5 filling suite that provides customized, economical, and compliant liquid filling of client products under cGMP and non-GMP conditions. In fact, for over 20 years we’ve been manufacturing material and performing Fill and Finish services for a large, multi-national company that they use to test a commercial product.

Our fill operation is fully validated for batch fills up to 2,000 vials and volumes of 0.5mL to 10.0mL per vial.  We can also accommodate fill volumes to meet your needs. We feature:

• A semi-automated process utilizing a programmable pump and manual fill nozzle, providing improved yields for small lot sizes.
• Vial stoppering immediately after filling by a second operator before removal from the fill room.
• Fill checks performed at predetermined intervals. This semi-automated process has consistently met all standards for acceptable fill volumes.
• All fill operations continuously observed and environmentally monitored by Quality personnel.
• Sealing and fill checks performed outside the fill room are monitored by Quality.

Lyophilization capabilities
We have a lyophilizer that is perfect for small- to mid-scale runs:

• We can accommodate a wide range of vial sizes and configurations
• We provide lyophilization services for both GMP and non-GMP projects
• Since 2000, we have successfully performed lyophilization services for a multinational company to supply GMP material to test a commercially available product.