Filling and closing machines for dual chamber cartridges and syringes.
Compact machine / Dosing of liquid-liquid or powder-liquid / Output up to 120 upm. / Complies with cGMP - US FDA.
The equipment we present is a filling and closing machine for processing of glass dual chamber cartridges and 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.
- Crimping with an aluminium 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 downstream machine.
Depending on the product to be filled in the first chamber, different dosing systems can be applied, such as:
- Vacuum-pressure principle 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, ensuring minimal particle generation during the closing process.
Feeding of closures is done automatically by vibrating feeders, made of AISI-316L stainless steel.
In order to work in sterile or clean room conditions, DARA Pharma provide tailored Laminar Flow units adapted to each machine. The sterile air generated by LAF units assures continuous and efficient extraction of particles and microorganisms from 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 is reduced to the working area of the filling and closing machine.
- 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 acquisition software.
- Laminar flow unit / Isolator unit / RABs.
- IQ / OQ Validation package.