Injectable

Complete Injectable Solutions:

 

SYSTEMS offers turnkey packaging solutions for parenteral medicine as below:

  1. Vial filling line for liquid and powder in sterile condition.
  2. Ampoule filling line
  3. Pre-filled syringe line

 

Vial filling line for Liquid/Powder:

 

 

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.

 

The complete line consist of ….

 

CLEANING/WASHING -> STERILIZING -> FILLING & CLOSING -> BARRIER TECHNOLOGY (LAF/ISOLATOR) -> LABELLING -> MISCELLANEOUS EQUIPMENT.

 

Benefits of our Vial Filling Machines:

 

  • Cost-effective:

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.

  • Flexible filling:

Can fill a full range of 2R-50R nested vials. Many vial sizes require little or no change parts.

  • Standard:

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.

  • Reduced risk:

No human intervention necessary during vial filling / capping. No glass-to-glass contact. Automated viable and non-viable environmental monitoring.

  • Nested containers:

Nested vials and press-fit closures provide security for your products. No glass-to-glass contact and no aluminum particles.

 

Ampoule filling line:

 

 

High speed Ampoule line, performing the following operations:

  • Internal and external washing;
  • Sterilizing (Depyrogenation Tunnel);
  • Filling and sealing.
  • Automatic inspection

All the operations are fully automatic, performed by machines designed according to the latest technology.

 

Pre-filled syringe line:

 

 

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.

 

Accurate:

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.

Repeatable:

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:

 

Cost-effective:

Reduces operating costs vs. competing small-batch fillers by up to 50%. Only one operator required.

Flexible filling:

Our Machine 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 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.

 

Specifications

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
Particle levels  

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).