The filling line for sale consists of the following components and can be used for liquid and lyophilized final drug product. The line was originally designed to be used with Botulinum Toxin but could be utilizied for filling of other potent compounds. The active API portions of the filling line are protected by an open RABS system to allow for worker protection. The filling line can fill vials from 2R to 6R size with minimal to no modification and could be modified to allow filling up to larger vial formats. The filling line was purchased from IMA Life in 2013 with final install in December 2014. The system has never seen any product and was only commissioned but not validated and never used with Botulinum toxin active product. 

Components

The IMA Life Vega rotary washer used to wash the interior of vials for non-aseptic filling. The washer is capable of speeds up to 250 vials at a 2R vial per minute (VPM). All components in the system are designed to operate at the 250 vpm filling speed. The machine could be adapted for aseptic vial washing.

The air blade dryer is used to internally dry 2R vials post internal washing. Conveyors run between each of the individual components to allow for automated operations.

The Extrema F2000 Filling/stoppering machine allows for 2R vial filling up to 250 vials per minute in its current configuration. The unit is served by (6) Ivek precision surgical pumps for accurate filling to 0.2 mL to 10 mL. The system also automatically stoppered the vials prior to Lyophilization. The automated filling line can be utilized for liquid only filling in its current configuration if Lyophilization is not needed.

(2) IMA Lyophilizer Lyomax 17 sq. M Lyophilizers for use with potent product. EWac Lyo has redundant safety systems for Lyophilization of potent product including toxin/cytotoxins , and ADC

Two independent compact loading systems are used to automatically load and unload vials from the 17 Sq. M. lyophilizers

The ALU400 Capper is utilized to cap the vials post Lyophilization. The system is designed to operate at speeds up to 300 vpm in case the line would be utilized as a liquid filling line only

A Hydra 300 external washer rinse the outside of the vial neck down post lyophilzation to ensure no carry over from the Lyophilization process. This system is designed for operation up to 300 vpm. 

The filling line employs an open RABs (Restricted Area Barrier) system from the Extrema Filler to the Capper to allow use with potent products. This system utilizes negative pressure relative to the room environment to protect workers from the product being filled.