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Farmespaña Industrial 65

Farmespaña Industrial 65

Press release
01 de March de 2015

SX-300-PP

Filling and closing compact machine for automatic processing of vials.

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

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

Production speed: up to 7,200 units per hour.

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

When using “CIP-SIP” construction elements, it is not necessary to remove the product contact parts for cleaning or sterilizing.

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 100 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.

The closing station is equipped with a pneumatic crimping head. Optionally, the closing process can be done with a tangential rolling head, characterised by the minimum generation of particles during the closing process.

All closures currently used can be easily handled, such as:

  • Rubber stoppers.
  • Aluminium caps / Flip-off caps.

For products that require freeze-drying, the following processes can be carried out in two separate machines:

  • Filling and half-stoppering for freeze-drying.
  • Positioning of aluminium caps and closing of vials.

In order to work in sterile or clean room applications, Dara provide different 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:

  • Dosing control through micro scale and automatic recalibration of the volume to be dosed.
  • Gas flushing before, during, or after the filling process.
  • Tangential rolling head.
  • Automatic rejection of defective vials.
  • Data recording software to export the production data in compliance with 21CFR part 11.
  • Outfeed through double tray.
  • Laminar flow unit.
  • RABs / Isolator unit.
  • IQ / OQ Validation package.
  • Printing / Codification.
Farmespaña Industrial 65