Farmespaña Industrial 57. Filling and closing machines for injectables.

SYX-E-PP + RABS

Filling and closing machines for injectables.

The equipment we present is a 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.

Production speed: up to 150 units per minute.

The design of the SYX-E-PP + RABS 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.

Filling from 0.1 ÷ 540 ml.

The filling station can be equipped with a maximum of 6 peristaltic pumps, valveless rotary piston pumps, or powder dosers.
In accordance with the product characteristics, there are different dosing systems:

• Peristaltic.
• Volumetric, with valveless rotary piston pumps.
• Time-pressure.
• Flow meter.
• Vacuum assisted.
• Auger spendle.

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

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

The closing station is equipped with a closing head of three forming rollers. Optionally, the closing process can be done with a tangential forming roller 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 / Pilferproof caps / Flip-off caps.

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

• Filling and pre-positioning of lyophilized rubber stoppers, in a sterile room application.
• Positioning of aluminium caps and closing of vials, in a clean room application.

The changeover to a different format is 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 of AISI-316L stainless steel.

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.