Precise Cartridge Filling

Pharmaceutical companies are moving to auto-injector devices for drug delivery. Vanrx's SA25 Aseptic Filling Workcell is highly accurate and precise in filling and stoppering cartridges, enabling the auto-injector to function properly. The SA25 will produce batches up to 25,000 units.

Accurate

 

Think bubble-free filling. Today’s medical devices require high precision in fill volume, air gap, and physical stopper placement. Vanrx’s SA25 Aseptic Filling Workcell delivers extremely accurate stopper placement and bubble-free filling. This is achieved through servo-driven mechanical placement with precise vacuum control and inert gas backfill.

Repeatable

 

All filling and closing processes are performed robotically using a recipe-driven control system. The SA25 is a completely closed gloveless isolator. It removes the need for human interventions, and can run at extremely low particle counts, drastically reducing the risk of contamination in the drug product.

Cost-effective

 

Building cartridge filling capacity used to be expensive, custom and time-consuming. The combination of the compact SA25 and ready-to-use cartridges and stoppers provides a 65% reduction in the facility footprint versus conventional systems. Validated capacity can be achieved in 15 months or less because of a standard machine design.

Benefits of the SA25 Aseptic Filling Workcell

  • Cost-effective

    Reduces operating costs vs. competing small-batch fillers by more than 50%. Only one operator required.

  • Flexible filling

    The SA25 can fill nested pre-sterilized syringes, vials and cartridges, with fast changeover times between formats of less than one hour.

  • Standard

    A standard design provides a scalable model that can expand production quickly, as needed.

  • Reduced risk

    No human intervention necessary during cartridge filling and stoppering. No glass-to-glass contact. Automated viable and non-viable environmental monitoring.

  • Nested cartridges and stoppers

    Nested cartridges and stoppers simplify your process, and reduce both capital and operating expenses.

Vanrx pharmaceutical cartridge filling systems for auto-injectors and other drug delivery devices.

Specifications

Filling

Fully automated, gloveless cGMP filling

Handling

Robotic handling of nested cartridges and stoppers

Throughput

Batch size range of 1,000-25,000 units

Cartridge sizes

All standard cartridge sizes, including 1.5, 1.8, 3.0 and 5.0 mL

Materials

Single-use fill path and product contact materials

Interior

Full 316L stainless steel interior and robotics

Decontamination

Vapor-phase hydrogen peroxide, Clean-in-Place (CIP)

Environmental Monitoring

Automated viable and non-viable environmental monitoring

Control System

21 CFR Part 11 compliant

Dimensions

1.5m wide x 4.2m long x 2.4m high (4.9′ x 13.8′ x 7.9′)

Particle levels

The interior gloveless isolator can maintain ISO 5 or better particle levels. Machine can be installed in an ISO 8 or Grade C / D room (depending on regulatory area).

Blog: How We Got to Now - Aseptic Filling for Pharmaceutical Cartridges

The PBS documentary How We Got To Now highlights the unintended, evolutionary consequences of inventions. In this blog, we are going to chart the path to the auto-injector for biologics, and therefore, the need for new aseptic filling methods for pharmaceutical cartridges.

Continue reading

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