The Vanrx Liquid / Lyo Workcell System is a robotic filling and lyophilizer loading line. It can process vials, syringes or cartridges into liquid or freeze-dried drug product formats. This Workcell System can continue to produce liquid dosages during freeze-drying cycles.
The Lyophilizer Loader and Accumulator Workcells complement the SA25 Aseptic Filling Workcell. Dosages remain within a closed, gloveless isolator (ISO 5 / Class A) throughout the production process.
Units start in the SA25 Aseptic Filling Workcell, where they are filled. They are passed robotically through the Accumulator and into the Lyophilizer Loader Workcell for loading into the lyophilizer. The Accumulator acts as a buffer for simultaneous vial, syringe or cartridge production while lyo cycles are underway.
When lyophilization is complete, the shelves of the lyo apply the required pressure to the press-fit closure nests to seal all of the vials on each shelf. They are then removed by robotics in the Lyophilizer Loader Workcell into either the Accumulator or the SA25 Aseptic Filling Workcell.
The Vanrx Workcell System connects to lyophilizers from several major suppliers, and has simple integration requirements.
Vanrx’s ‘full line’ system combines the SA25 Aseptic Filling Workcell, Accumulator and Lyophilizer Loader to attach to the lyophilizer.
All filling and handling operations are performed robotically, combined with pre-sterilized, nested components.For lyo dosages, pre-sterilized vials remain within their nest and exit the lyo fully closed, with no breakage or tipping.
Filling of a second drug product can be performed in parallel with the lyophilization of the first drug. Manufacturers can mix production of liquid and freeze-dried dosages up to 3.2M units annually, into nested vials, syringes and cartridges.
Containers remain in completely closed and isolated Grade A space from filling through to lyophilization. There are no glove ports on the Liquid / Lyo Workcell System, as 95% of the causes of interventions in conventional machines have been designed out of the process.
Gloveless robotic filling, closing and lyophilizer loading and unloading.
30-minute vapour-phase hydrogen peroxide decontamination of the entire line.
Automated viable and non-viable environmental monitoring
Track and report on production activities
Clean the isolator after cytotoxic batches
|Throughput||Batches up 20,000 units / 1.2M freeze-dried units + 2M liquid units annually|
|Fill volume range||0.1 – 50 mL|
|Pump accuracy||±0.5% (±1.0% below 1 mL)|
|Lyophilizer compatibility||Up to 12 square metres in shelf space. Requires slot door (“pizza door”) and matching bolt pattern to lyo|
|In-process control||Programmable up to 100% of units|
|Product contact materials||Fill path assembly only (single- and multi-use)|
|Interior classification||Grade A|
|Exterior Classification||Grade C or D (depending on regulator)|
|Dimensions of combined machines||5.6 x 4.5 x 2.4 m (18’4” x 14’7” x 7’9”)|
|Required cleanroom space||56 m2 (602 sq. ft.)|
|Electrical||240 VAC, <60 A, single-phase (per machine)|
|Compressed air||6 Bar clean dry air, <10 CFM (per machine)|
|Control system||21 CFR Part 11 compliant|
|Non-destructive in-process control (IPC)|
|Automated clean-in-place (CIP)|
|Drug product bag load cell|
|Inert gas filling|
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