The SA25 Aseptic Filling Workcell is an aseptic filling machine for pharmaceutical vials, syringes and cartridges within an isolator.

Vial, syringe and cartridge filling machine

Flexible aseptic filling machine for vials, syringes and cartridges

The SA25 Aseptic Filling Workcell is a closed gloveless robotic isolator for filling vials, syringes and cartridges in clinical and commercial volumes.

The SA25 is a standard filling machine that allows users to build capacity faster than the industry norm, using an optimal aseptic process. Once installed, users are agile in switching between different container and closure formats. The closed isolator and removal of human intervention provides safer drug products for patients.

Customers are using the SA25 for the following applications:

  • Aseptic processing of biologics, biosimilars, peptides, mRNA and other modalities;
  • Starting an aseptic filling operation;
  • Increasing uptime/flexibility as a contract manufacturer;
  • Advanced containment for cytotoxic drug products; and
  • Filling gene therapies and other advanced therapeutic medicinal products (ATMPs).

SA25 Customers

Customers using SA25 Aseptic Filling Workcell include Amgen, Emergent BioSolutions, FUJIFILM Diosynth Biotechnologies, Genentech / Roche, Moderna Therapeutics, Patheon, Singota Solutions, WuXi Biologics, and Wildlife Pharmaceuticals.

Customer experience

SA25 Aseptic Filling Workcell

Speed to Market

The delivery lead time for the SA25 is 6 months, and customers have repeatedly reach GMP production within 15 months or less following their purchase order. Compare this against typical timelines for conventional isolated filling systems taking 15 months or longer just to finish a factory acceptance test (FAT).

Flexibility

The SA25 can fill any nested vial, syringe or cartridge format from 0.1 – 50 mL. Customers are filling as many as 15 different drug products into 7 formats, and can finish format changeover in 45 minutes.

Drug product quality

The SA25 is a fully integrated gloveless robotic isolator that removes the need for operator intervention through a redesigned aseptic process. From 40+ media fills on SA25 machines, there have been zero positive units.

Process capability

The SA25 includes the new Vanrx Dynamic Peristaltic Pump, which provides 10x less variability vs conventional peristaltic pumps, for fill volumes down to 0.1mL. The SA25 also supports the highest accuracy plunger placement to +/- 0.2mm and no bubble for pre-filled syringes and cartridges.

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

1.8 x 4.1 x 2.4m (4’9” x 13’8” x 7’9”)

Required cleanroom space

38 m2 (410 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

    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.

  • The most accurate peristaltic pump

    Vanrx Dynamic Peristaltic Pump provides 10x less variability vs. conventional peristaltics down to 0.1 mL.

  • Single-use consumables

    Single-use flow paths prevent cross-contamination and speed changeover.

  • Reduces particle risk

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

  • Product stability

    Inert gas capping / plungering for oxygen-sensitive drug products filled into vials, syringes and cartridges.

  • Bubble-free

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

The SA25 is a closed robotic workcell for aseptic processing.

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 about how Vanrx’s customers are using the SA25

Container / closure options

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

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