The SA25 Aseptic Filling Workcell is a pharmaceutical cartridge filling machine capable of batches up to 25,000 units.

Cartridge filling machine for 1.5 / 1.8 / 3 / 5 mL cartridges

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.

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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).

How We Got To Now: Aseptic Filling for Pharmaceutical Cartridges

March 13, 2018 - Blog, Featured

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.

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