Product Vialing (Aseptic Filling)

GBI maintains a Class 100 filling suite that provides customized, economical, and compliant filling of client products.   This operation is a semi-automated process that utilizes a programmable pump and manual fill nozzle manipulation to accomplish the fill.  Fill checks are performed at predetermined intervals and this semi-automated process has consistently met all standards for acceptable fill volume variation.  Our semi-automated process provides improved yields as compared to fully automated systems . Vials are manually stoppered immediately after filling by a second operator before removal from the fill room for sealing and fill checks.  All fill operations are continuously observed and environmentally monitored by Quality personnel.  Sealing and fill checks performed outside of the fill room are also monitored by Quality.

Specialized filling for difficult materials such as Aluminum Hydroxide adsorbed proteins is also available.  The techniques for keeping these materials in suspension during filling operations have been developed and successfully used for multiple clients.

The fill operation is fully validated for fills up to 2000 vials and for fill volumes of 0.6 to 10.0mLs per vial.  The validation includes fill operator sterile gowning, environmental control, and aseptic fill of all vials.  The fill validation is repeated yearly.

• Sterile Product Filling
• Sterile Custom Liquid Filling