Filling and closing machines for cartridges.
Compact machine / Filling from 0.1 up to 50 ml. / Output up to 200 upm. / Conforms with cGMP - US FDA.
The equipment we present is a filling and closing machine for processing of glass or plastic cartridges, for injectable products in sterile applications.
Production speed: up to 200 units per minute.
The design has been made for use in sterile areas, in compliance with cGMP and US FDA regulations, and in special accordance with the requirements of the pharmaceutical industry.
This machine can perform the following operations:
- Cartridge infeed to the working area through worm-screw system.
- Positioning of the plunger from the bottom.
- Introduction of mixing balls.
- Gas flushing before or during the filling process.
- Filling station.
- Closing of the cartridge with an aluminum cap with rubber seal.
- Accumulation or transfer of the cartridge to the next machine.
Accurate introduction of the plunger into the cartridge is automatically controlled by the servo motor.
The filling station can be equipped with up to 6 filling pumps. The filling is done in two steps to avoid introduction of air in the cartridge.
In the first step of the filling, 2 systems can be used:
- Peristaltic, with SpeedFill pumps.
- Volumetric, with valveless rotary piston pumps.
In the second step, the cartridge is filled at a slower speed. In order to search an optimal level, we use 3 systems:
- Apparent level, through vacuum system.
- Overfilling and extraction of the exceeding product.
- Level filling through laser sensor, without overfilling.
The closing station is equipped with crimping heads with minimum particles generation during the closing process.
The changeover to a different format can be carried out quickly, easily and without tools, by exchanging complete sets of format parts.
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 different solutions, such as LAF, RABs, or isolators.
Using an isolator or RABs system improves the sterily conditions and offers a better protection of the product and for the user.
Optional equipment:
- Gas flushing before or during the filling process.
- Level filling through laser sensor, without overfilling.
- Automatic rejection of defective cartridges.
- Dosing system for CIP / SIP conditions.
- Data recording software to export the production data.
- Laminar flow unit / RABs / Isolator unit.
- IQ / OQ Validation package.