Enfarma Vol. 15 Nº. 4

SYX-E Cartridge By-pass

Filling and closing machines for double-chamber cartridges / syringes.

The equipment we present is a filling and closing machine for processing of glass double-chamber cartridges / syringes, with an intermediate by-pass, for injectable products in sterile applications.

Production speed: up to 120 units per minute.

The design has been made in compliance with cGMP and US FDA regulations, and in special accordance with the requirements of the pharmaceutical and biotech industries.

For liquid-liquid cartridges, this machine performs the following operations:

• Cartridge infeed to the working area through worm-screw system.
• Infeed and positioning of the intermediate plunger.
• Filling of the first chamber.
• Sealing with an aluminum cap.
• 180º rotating of the cartridge.
• Filling of the second chamber.
• Infeed and positioning of the bottom plunger.
• Accumulation or transfer of the cartridge to the next machine.

Depending on the product which the first chamber will be filled with, different dosing systems can be applied, such as:

• Vacuum-pressure principle of filling for powders.
• Peristaltic filling with SpeedFill pumps, or volumetric filling with valveless rotary pistons, for liquids.

The second chamber is usually filled with liquid.

The closing station is equipped with electronic crimping heads with minimum particles generation during the closing process.

Feeding of the closures is done automatically by vibrating feeders, made in AISI-316L stainless steel.

In order to work in sterile or clean room conditions, Dara provide Laminar Flow units adapted to any machine. The sterile air generated by LAF units assures continuous and efficient extraction of particles and microorganisms out of the working area.

Isolators allow working out of sterile or clean room conditions but still in accordance with the requirements of the pharmaceutical industry. In this case the sterile area corresponds to the working area of the filling and closing machine.

Optional equipment:

• Output rail for IPC.
• Gas flushing before, during or after the filling process.
• Dosing system for CIP / SIP conditions.
• Automatic rejection of cartridges / syringes with process defects.
• Production data recording software.
• Laminar flow unit / Isolator unit / RABS.
• IQ / OQ Validation package.