SX-210-PPFilling and closing compact machine for automatic processing of vials.

Filling from 0.1 ÷ 250 ml. / Changeover in 5 minutes / Output up to 6,000 uph. / Conforms with cGMP-US FDA.

P h a r m a c e u t i c a l P a c k a g i n g

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 theregulations of the cGMP and US FDA, in specialaccordance with the requirements of the pharmaceutical,biotech, cosmetic, chemical and similar industries.

Production speed: up to 6,000 unitsper hour.

The filling station is equipped with aperistaltic pump, valveless rotarypiston pump, or powder doser.

All production parameters can besaved in the PLC, through differentrecipes. The parameters are:

• Dosing volume.

• Programmable kinematics of thefilling system.

• Adjustment of the automaticfeeders.

• Output .

New recipes can be easily createdand edited.

Dosing volumes from 0.1 up to 250 ml.

SX-210-PP

P h a r m a c e u t i c a l P a c k a g i n g

Transport system of vials adapted to laminar flow conditions.

Vials in filling position, pick & place to handle rubber stoppers by vacuum and closing head.

Filling and closing compact machine for automatic processing of vials.

The pick & place station placesthe rubber stopper onto the vialfully or partially, depending on theapplication (injection rubberstopper or lyophilized rubberstopper). Stoppers are handled byvacuum.

The closing station is equippedwith a pneumatic crimping head,characterised by the minimumgeneration of particles during theclosing process.

All closures currently used can beeasily 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.

Feeding of the closures can be carried out automatically by vibrating

feeders, made of AISI-316L stainless steel.

The changeover to a different format is carried out quickly, easily and

without tools, by exchanging complete sets of format parts. The

adaptation to different containers heights is made through digital

positioning gauge.

The closing station is equipped with a pneumatic crimping head, characterised by the minimum generationof particles during the closing process.

Allen Bradley or Siemens HMI and PLC.

Automatic rejection of defective vials.

This equipment is suitable for clinical trialsor medium production batches.

Optional equipment:

• Dosing control through micro scale andautomatic recalibration of the volume tobe dosed.

• Gas flushing before, during, or after thefilling process.

• Tangential rolling head.

• Automatic rejection of defective vials.

• Data recording software to export theproduction data.

• Laminar flow unit / RABs / Isolator unit.

• IQ / OQ Validation package.

• Printing / Codification.

Filling from 0.1 ÷ 250 ml. / Changeover in 5 minutes / Output up to 6,000 uph. / Conforms with cGMP-US FDA.

Pol. Ind. Coll de la Manya • Galileo Galilei, 5-1908403 Granollers (BARCELONA) • SPAINTel. +34 938 718 784 • Fax +34 938 718 375info@dara-pharma.com • www.dara-pharma.com

Subject to technical modifications.

Please note that the illustrations may vary from the standard versionin some details.

Your official representative:

P h a r m a c e u t i c a l P a c k a g i n g

Max. Output / uph: 6,0003,600

Dosing range / accuracy: 0.1 ÷ 250 ml. / ±0.5%

Electrical supply: 200/240 VAC – 50/60 Hz – 2 KW. max.

Air supply: 90 l/min. max. – Clean and dry air at 6 bar.

Max. Weight: 460 kg.420 kg.

Container dimensions: Ø= 65 mm. max.h= 210 mm. max.

Ø= 25 mm. max.h= 60 mm. max.

Type of closures: Rubber stopper + aluminium cap ø13/20/30/32 mm.

Materials:

Format range:

1250 mm.

1600 mm.

1300

mm

. 920

mm

.

1900

mm

.

Control panel.

tray.Outfeed

Filling station.Rotary infeed table.

Infeed tray.

Stoppers infeed.

Caps infeed.

Closing station.

900

±50

mm

.

Dimensions:

AISI-304 stainless steel, anodised aluminium, POM and contact parts with product in AISI-316L stainless steel.

h

Ø

SX-210-PP/S SX-210-PP/D

P h a r m a c e u t i c a l P a c k a g i n g

SX-210-PP