Enfarma Vol 14 Nº 1, SX-210-Lyo Filling and closing vials compact machine 

SX-210-Lyo

Filling and closing compact machine for automatic processing of injectable and lyofilized vials.

The machine we present is a compact filling and closing equipment for automatic processing of vials and bottles in glass, plastic, or metal, for liquid, semisolid, and powder products, in sterile areas or clean rooms­­­.

Production speed: up to 3,600-6,000 units per hour.

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 vial filling station is equipped with a peristaltic pump, valveless rotary piston pump, or powder doser.

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

• Dosing volume.
• Programmable kinematics of the filling system.
• Adjustment of the automatic feeders.
• Output­­­­.

New recipes can be easily created and edited.

Dosing volumes from 0.1 up to 250 ml.

The pick & place station places the rubber stopper onto the vial fully or partially, depending on the application (injection rubber stopper or lyophilized rubber stopper).

Stoppers are handled by vacuum.

Infeed of each kind of rubber stopper is made automatically through vibrator feeders, made of AISI-316L stainless steel.

The changeover to a different format is carried out easily, quickly and without tools, by exchanging complete sets of format parts. The adaptation to different heights of containers is made station by station through digital positioning gauges.

This equipment for filling and clossing vials is suitable for clinical trials or medium production batches.

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:

• Gravimetric dosing system, through scale.
• Gas flushing before, during, or after the filling process.
• Automatic rejection of defective vials.
• Data recording software in order to export the production data.
• Laminar flow unit / RABS.
• Isolator unit.
• IQ / OQ Validation package.