The Liquid / Lyo Workcell System can fill pharmaceutical vials, syringes and cartridges, and automatically load and unload a pharmaceutical lyophilizer.

Aseptic filling and lyophilizer loading machine

Flexible aseptic filling and lyophilizer loading and unloading system

The Vanrx Liquid / Lyo Workcell System is a closed gloveless robotic isolator for filling liquids into vials, syringes or cartridges, and then loading / unloading nests into a lyophilizer.

The system combines three separate workcells – the SA25 Aseptic Filling Workcell, the Accumulator, and the Lyophilizer Loader Workcell. Having the Accumulator buffer the two adjoining workcells also allows for cytotoxic products such as antibody drug conjugates to be safely processed.

Customer experience

Vanrx Liquid / Lyo Workcell System

Speed to Market

The delivery lead time for the Liquid / Lyo Workcell System is 9 months. Overall implementation timelines depend on the lead and installation time for a lyophilizer provided by a third party. However customers have been able to begin liquid filling operations and then validate lyophilized drug products at a later date. 

Flexibility

The Liquid / Lyo Workcell System can fill any vials, syringes and cartridges with short changeover time of 45 minutes. During lyophilization cycles, the system can continue to fill and close liquid dosages to increase machine utilization.

Drug product quality

Throughout the filling, lyophilization and closing process, dosages remain within an ISO5 / Grade A environment. The system is gloveless, meaning that it is completely closed, and sources of operator interventions are designed out of the aseptic process. All containers remain within their nest throughout the process, so there is no container tipping or breakage. 

Process capability

The Liquid / Lyo Workcell System includes the new Vanrx Dynamic Peristaltic Pump, which provides 10x less variability vs. conventional peristaltic pumps, down to 0.1mL. Vials and press-fit closures with integrated stoppers are completely closed in the lyophilizer when the shelves compress at the end of the cycle. The result is that there is no unit loss from tipped vials or stoppers sticking to the shelves of the lyo. 

Specifications

Containers

Nested, pre-sterilized vials, syringes and cartridges in tubs (glass or plastic)

Closures

For vials, nested, pre-sterilized press-fit closures with industry standard stoppers. For syringes and cartridges, nested pre-sterilized plungers.

Decontamination system

Built-in vapour phase hydrogen peroxide (VPHP) system

Cleaning system

Automated clean-in-place (CIP) system

Pump type

Vanrx Dynamic Peristaltic Pump

Pump accuracy

10x less variability than conventional peristaltic pumps

In-process control (IPC)

Programmable up to 100% of units

Machine vision

Robotic guidance, container absence / presence

Product contact materials

Fill path only (single- and multi-use)

Interior Classification

Grade A

Exterior Classification

Grade C or D (depending on regulator)

Dimensions

5.6 x 4.5 x 2.4m (18’4” x 14’7” x 7’9”)

Required cleanroom space

56 m2 (602 sq. ft.)

Compressed air

6 bar clean, dry air, <10 CFM

Control system

21 CFR Part 11 compliant

Batch Records

Electronic batch records and Data Historian included

Drug product quality

Safer injectables for patients

  • Optimal aseptic process

    Optimal aseptic process within completely closed gloveless isolator that eliminates operator interventions.

  • Limited hazard pathway

    Drug product contact is limited to single-use flow path and inside of container

  • Limited contamination opportunities

    Drug product remains in Grade A / ISO 5 space for entire production process.

  • The most accurate peristaltic pump

    Vanrx Dynamic Peristaltic Pump provides the best available accuracy and precision.

  • Eliminates particle risk

    Uses press-fit closures with integrated stoppers, eliminating the particle risk and quality problems of crimp capping and stopper bowls.

  • Improved stability

    Inert gas capping / plungering for long-term product stability.

  • Bubble-free insertion

    Servo-driven vacuum plunger insertion for bubble-free syringes and cartridges.

Lyophilizer Loader Workcell

Vanrx Pharmasystems introduces the Dynamic Peristaltic Pump

March 18, 2020 - Featured

Vanrx is introducing the Dynamic Peristaltic Pump, a new pump technology that helps biopharmaceutical companies bring advanced therapies to patients.

Read More

Case Studies

Learn more about how Vanrx’s customers are using Aseptic Filling Workcells

Container / closure options

Vanrx's partners in the Matrix Alliance provide nested vials, syringes, cartridges and closures

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