SYSTEMS offers turnkey packaging solutions for parenteral medicine as below:
We offer washing, sterilizing, filling, and closing machines for vials to process liquid and powder in sterile conditions. The machines can work either individually or form a complete production line.
All the machines are constructed with cutting edge technology and fitted with various filling units, to suit the product to be treated. Every machine is also specifically designed to guarantee the highest levels of precision, quality and efficiency.
Require less space versus competing filling machines, and can be installed in ISO 8 / Grade C/D space (depending on regulator). Only require one operator.
Can fill a full range of 2R-50R nested vials. Many vial sizes require little or no change parts.
All vial filling machines are standard designs. This means they can be built quickly, which provides a highly scalable production model. Produce clinical supplies on the Microcell and scale to the SA25 for commercialization.
No human intervention necessary during vial filling / capping. No glass-to-glass contact. Automated viable and non-viable environmental monitoring.
Nested vials and press-fit closures provide security for your products. No glass-to-glass contact and no aluminum particles.
High speed Ampoule line, performing the following operations:
All the operations are fully automatic, performed by machines designed according to the latest technology.
Aseptic Filling for Pharmaceutical Syringes.
Pre-filled syringes make it easier for clinicians to administer life-saving drugs. Our Aseptic Filling Workcell is highly accurate and precise in filling and stoppering syringes, including PFS units installed into auto-injectors.
Think bubble-free filling. Our 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.
All filling and closing processes are performed robotically using a recipe-driven control system. This makes production predictable, even when filling and stoppering complex drug products.
Benefits of Aseptic Filling Workcell:
Reduces operating costs vs. competing small-batch fillers by up to 50%. Only one operator required.
Our Machine can fill nested pre-sterilized syringes, vials and cartridges, with fast changeover times between formats of less than one hour.
A standard design provides a scalable model that can expand production quickly, as needed.
No human intervention necessary during syringe filling and stoppering. No glass-to-glass contact. Automated viable and non-viable environmental monitoring.
Nested syringes and stoppers:
Nested syringes and stoppers simplify your process, and reduce both capital and operating expenses.
|Filling||Fully automated, gloveless cGMP filling|
|Handling||Robotic handling of nested syringes and stoppers|
|Throughput||Batch size range of 1,000-25,000 units|
|Syringe sizes||All standard syringe sizes, including in 100 and 160-unit configurations|
|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|
The interior of the gloveless isolator maintains ISO 5 or better particle levels. Machine can be installed in an ISO 8 or Grade C / D room (depending on regulatory area).