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:
SA25 Customers
Customers using the SA25 Aseptic Filling Workcell include ADMA Biologics, Amgen, Emergent BioSolutions, FUJIFILM Diosynth Biotechnologies, Genentech / Roche, Moderna, Patheon, Singota Solutions, WuXi Biologics, and Wildlife Pharmaceuticals.
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).
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.
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.
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.
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 |
Safer injectables for patients
Completely closed gloveless isolator that eliminates operator interventions.
Drug product contact is limited to single-use flow path and inside of container.
Vanrx Dynamic Peristaltic Pump provides 10x less variability vs. conventional peristaltics down to 0.1 mL.
Single-use flow paths prevent cross-contamination and speed changeover.
Uses press-fit closures with integrated stoppers, eliminating quality problems with crimp capping and stopper bowls.
Inert gas capping / plungering for oxygen-sensitive drug products filled into vials, syringes and cartridges.
Servo-driven vacuum plunger insertion for bubble-free syringes and cartridges.
March 18, 2020 - Featured
“The required dosage for many advanced therapies is very low—sometimes 0.5 mL or less. Getting the highest yield from your batch is essential, since each additional dosage treats another patient. Current and future customers will be able to serve their patients better thanks to the new Dynamic Peristaltic Pump,” explains Chris Procyshyn, CEO and co-founder of Vanrx.
Read More
Learn about how Vanrx’s customers are using the SA25
Vanrx's partners in the Matrix Alliance provide nested vials, syringes, cartridges and closures.