Vanrx Liquid / Lyo Workcell System performs filling, closing and lyophilizer loading for liquid or freeze-dried pharmaceutical dosages in vials, syringes or cartridges.

Flexibility for multi-product manufacturing

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.

Liquid / Lyo Workcell System Benefits

Flexibly produce either liquid or lyophilized dosages

Compatible

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.

Secure handling

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.

Flexible

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.

Superior Aseptic Assurance

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.

Key Features

  • Fully automated

    Gloveless robotic filling, closing and lyophilizer loading and unloading.

  • Integrated decontamination

    30-minute vapour-phase hydrogen peroxide decontamination of the entire line.

  • Environmental monitoring

    Automated viable and non-viable environmental monitoring

  • Data historian

    Track and report on production activities

  • Automated clean-in-place

    Clean the isolator after cytotoxic batches

The Vanrx Lyophilizer Loader Workcell robotically loads and unloads pharmaceutical vials from a lyophilizer. Automates the process of loading and unloading, while keeping product in a Class A / ISO 5 environment.

Vanrx Liquid / Lyo Workcell System Specifications

Specifications

Throughput Batches up 20,000 units / 1.2M freeze-dried units + 2M liquid units annually
Pump Type Peristaltic
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

 

Options

Non-destructive in-process control (IPC)
Automated clean-in-place (CIP)
Drug product bag load cell
Inert gas filling

 

Workcell System Process

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.

Pharmaceutical industry transitioning to press-fit vial closures

September 5, 2018 - Blog, Featured, Innovation

Press-fit closures for pharmaceutical vials provide a number of benefits for container-closure integrity, manufacturing and marketing differentiation. This blog reviews the benefits of these closures in replacing aluminum crimp caps.

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