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The SA25 Workcell is an gloveless isolator for the automated filling of injectable or lyophilized therapies. The SA25 fills syringes, vials or cartridges. The rapid changeover between formats and the use of nested, pre-sterilized containers increases uptime and supports producing multiple drug products in various container types using the same machine. New products can be developed without the need for additional investment in capital equipment or facility changes.
Faster to Market
The SA25 Aseptic Workcell is ideal for the current pharma market, where there are an increasing number of potent, high-value therapies focused on smaller patient populations. Small molecules, biologics, cell therapies, and cytotoxic products all benefit from the SA25’s tight process control and automation. The SA25 supports technology transfer from clinical trials through post-approval commercial production. This enables pharmaceutical companies to get to market faster by developing production processes earlier in a drug’s life.
The Aseptic Workcell approach has lower facility requirements, is easier to validate and requires fewer operators than conventional filling systems. Operators can be trained more easily because interventions (if any) are done robotically.
The SA25 Workcell is an agile filling system—fast and flexible—and able to fill vials, syringes or cartridges. With an industry leading one-hour product changeover and decontamination time, the same machine can produce many different medicines with less downtime than conventional isolators. Its performance reflects an integrated aseptic process using the most advanced technologies, developed by experts with considerable biologics development and production experience.See the technologies integrated in the SA25 Aseptic Workcell
Facility Savings & Design Repeatability
The SA25 Workcell enables companies to reduce space and operating costs for a filling line and supporting facilities by more than 50% compared to a conventional small batch isolator. This space reduction occurs across all categories, including ISO cleanroom, utilities and material preparation (through the use of pre-sterilized, nested components). No separate vial washing, depyrogenation, or other material preparation equipment is required. As a gloveless system that uses isolated robotics, fewer operators are required. Its standardized design enables facilities to be duplicated globally, or rapid production scale-up by adding workcells.
SA25 Aseptic Workcell Specifications
|Filling||Fully automated, gloveless cGMP filling|
|Handling||Robotic handling of nested containers (vials, syringes or cartridges), stoppers and closures|
|Materials||Single-use fill path and product 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|
|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′)|
Vanrx Lyophilizer Loader for Freeze-Dried Pharmaceuticals
The Vanrx Lyo Loader is an add-on isolated workcell that automates the transfer of partially capped containers into a lyophilizer for freeze-drying. Vanrx’s Lyo Loader can be integrated with lyophilizers from many manufacturers. The custom robotics in the Lyo Loader lift and place the nested vials onto the freeze-dryer shelves. This eliminates problems caused by individual vials falling over, and limits product loss through breakage.
This closed workcell maintains an isolated environment between the SA25 Aseptic Filling Workcell and the Lyophilizer Loader workcell and can be used to perform two functions. The Accumulator can hold finished product transferred from the SA25 , or convey product into the Lyo Loader. This workcell buffers the filling process from the loading process and allows waste materials to be removed through a one-way port.