Enfarma Vol. 16 No. 4. Filling and closing pharmaceutical Equipment

SFL/S Syringe + RABS

Filling and closing machines for ready-to-use disposable syringes, vials and cartridges in nest.

Ready-to-use disposable syringes provide security, hygiene and dosing accuracy for medical injections.

Our  Filling and closing pharmaceutical Equipment allow a combination of filling-closing for processing ready-to-use disposable syringes, vials, and cartridges in nests.

Syringes are supplied in “Nests”, already sterilized and ready to fill.

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.

The operations to be carried out on the machine are:

• Manual or automatic  positioning of the “Nest”, depending on the model of the machine.
• Dosing through valveless rotary piston pumps or through peristaltic pumps.
• Automatic infeed and positioning of plungers or stoppers.

All production parameters can be saved in the PLC  through different recipes. The parameters are:

• Dosing volume.
• Kinematics of the filling process.
• Insertion depth of plungers / stoppers.
• Adjustment of the component feeders.
• Output.

These parameters are automatically regulated and associated to each format of syringe, vial, or cartridge. The recipes can be loaded from the HMI, re-establishing automatically the parameters for a new format. New recipes can be easily created and edited.

The changeover to a different format is carried out quickly, easily and without tools, by exchanging complete sets of format parts.

In order to work in sterile or clean room applications, Dara provide different pharmaceutical equipment solutions, such as LAF, RABS, or isolators. The generated sterile air ensures a permanent and reliable expulsion of particles and microorganisms from the working area.

Using an isolator or RABS system improves the sterily conditions and offers a better protection of the product and for the user, according to pharmaceutical standards.

Optional equipment:

• Vacuum-assisted filling to prevent air trapped in the luer channel.
• Dosing system for CIP / SIP conditions.
• Vacuum plunger insertion.
• Gas flushing during filling and/or positioning of plungers.
• Data recording software to export production related data, SCADA system.
• Laminar flow unit.
• RABS / Isolator unit. 
• IQ / OQ validation package.