DARA PHARMACEUTICAL PACKAGING

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Daniela Bell
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Pharmaceutical Packaging High Technology, Quality and Service.

We provide to the Pharmaceutical, Biotech and Cosmetic Industries the most advanced technological equipment in the market, contributing, thus,

We offer a high level of innovation and development along with the capability to adapt each project to the specific needs of the customer.

semi-solid products, and powder in sterile conditions. The machines can work either individually or form a complete production line.

international regulations of the sector.

2 Pharmaceutical Packaging High Technology, Quality and Service. Since it was founded in 1996, DARA PHARMACEUTICAL PACKAGING has focused all its effort on Quality, Innovation and Technological Excellence. We provide to the Pharmaceutical, Biotech and Cosmetic Industries the most advanced technological equipment in the market, contributing, thus, to the improvement of well-being and quality of life of people. We offer a high level of innovation and development along with the capability to adapt each project to the specific needs of the customer. We manufacture washing, sterilizing, filling, and closing machines for bottles, vials, cartridges, syringes, and bags to process liquid, semi-solid products, and powder in sterile conditions. The machines can work either individually or form a complete production line. Our philosophy is to offer the best service by adapting our knowledge and research to the needs of our customers and to the most demanding international regulations of the sector. Enthusiasm, motivation, and professionalism of DARA s team along with flexibility, simplicity, and reliability of our manufacturing process are key to the company s present success and future development. DARA s international focus is also crucial to the company and about 90% of our equipment is exported. Our sales team, project management and after sales service operate at an international level, being represented in more than 80 countries.

SX-50 SpeedFill Tabletop peristaltic dosing pump. No cross contamination.

Changeover to a different product in 1 minute. Dropless function.

6 mm. SX-60 Syringe Tabletop machine for automatic closing of syringes.

3 SX-50 SpeedFill Tabletop peristaltic dosing pump. No cross contamination. Filling from 0.1 1,050 ml. Flow up to 6.4 L/min. Accuracy ± 0.5 %. Changeover to a different product in 1 minute. Dropless function. For filling tubes of inner Ø: 0.5 / 0.8 / 1.6 / 3.2 / 4.8 / 6.4 / 8 / 9.6 mm. SX-60 Syringe Tabletop machine for automatic closing of syringes. Vacuum-assisted positioning for rigid plungers. Format change in 4 minutes. Output up to 1,200 uph.

SX-180-OR Filling and closing compact machine for automatic processing of eye drops and nasal sprays. Filling from 0.1 250 ml. Format change in 5 minutes. Output up to 3,600 uph.

Vibrating autonomy hoppers for stoppers and caps. Automatic rejection of defective containers. Data recording software to export the production data. Laminar flow unit.

4 SX-180-OR Filling and closing compact machine for automatic processing of eye drops and nasal sprays. Filling from ml. Format change in 5 minutes. Output up to 3,600 uph. Dosing control through microscale and automatic recalibration of the volume to be dosed. Gas flushing before, during, or after the filling process. Vibrating autonomy hoppers for stoppers and caps. Automatic rejection of defective containers. Data recording software to export the production data. Laminar flow unit. RABs / Isolator unit. Printing / Codification. Max. Output / uph: 3,600 Container dimensions: Ø= 65 mm. max. h= 210 mm. max. Dosing range / accuracy: ml. / ±0.5% Air supply: 200/240 VAC 50/60 Hz 2 KW. max. 180 l/min. max. - Clean and dry air at 6 bar.

SX-210-PP Filling and closing compact machine for automatic processing of vials. Filling from 0.1 250 ml. Format change in 5 minutes.

Gas flushing before, during, or after the filling process. Tangential sealing head. Automatic rejection of defective vials.

Output / uph: 3,600 SX-210-PP/D 6,000 Container dimensions: Ø= 65 mm. max.

5 SX-210-PP Filling and closing compact machine for automatic processing of vials. Filling from ml. Format change in 5 minutes. Output up to 6,000 uph. Dosing control through micro scale and automatic recalibration of the volume to be dosed. Gas flushing before, during, or after the filling process. Tangential sealing head. Automatic rejection of defective vials. Data recording software to export the production data. Laminar flow unit / RABs / Isolator unit. Printing / Codification. SX-210-PP/S Max. Output / uph: 3,600 SX-210-PP/D 6,000 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. Dosing range / accuracy: ml. / ±0.5% Air supply: 200/240 VAC 50/60 Hz 2 KW. max. 90 l/min. max. - Clean and dry air at 6 bar.

SX-300-PP + RABs Filling and closing compact machine for automatic processing of vials. Filling from 0.1 100 ml.

Output / uph: 3,600 SX-300-PP/D 7,000 Container dimensions: Ø= 54 mm. max.

6 SX-300-PP + RABs Filling and closing compact machine for automatic processing of vials. Filling from ml. Output up to 7,000 uph. Filling system 100% weight control with automatic calibration. Gas flushing before, during, or after the filling process. Tangential sealing head. Automatic rejection of defective vials. Data recording software to export the production data. Laminar flow unit / RABs / Isolator unit. SX-300-PP/S Max. Output / uph: 3,600 SX-300-PP/D 7,000 Container dimensions: Ø= 54 mm. max. h= 120 mm. max. Ø= 26 mm. max. h= 80 mm. max. Type of closures: Rubber stopper + aluminium cap ø13/20/30/32 mm. Dosing range / accuracy: ml. / ±0.5% Air supply: 200/240 VAC 50/60 Hz 4 KW. max. 90 l/min. max. - Clean and dry air at 6 bar.

SYX-E-OR Filling and closing machines for automatic processing of eye drops and nasal sprays. Filling from 0.

Dosing control through micro scale and automatic recalibration of the volume to be dosed.

Data recording software to export the production data in compliance with 21CFR part 11.

7 SYX-E-OR Filling and closing machines for automatic processing of eye drops and nasal sprays. Filling from 0.1 1,050 ml. Output up to 150 upm. Dosing control through micro scale and automatic recalibration of the volume to be dosed. Gas flushing before, during, or after the filling process. Data recording software to export the production data in compliance with 21CFR part 11. Laminar flow unit / RABs / Isolator unit. SYX-E-OR/S SYX-E-OR/D Max. Output / uph: 5,200 9,000 Container dimensions: Ø= 80 mm. max. h= 310 mm. max. Ø= 26 mm. max. h= 80 mm. max. Dosing range / accuracy: ml. / ±0.5% (200/400 VAC 50/60 Hz) 3 KW. max. 4 KW. max.

SYX-E-PP + RABs Filling and closing machines for injectable and lyophilised vials. Filling from 0.1 540 ml. Output up to 150 upm.

Automatic rejection of defective vials. Data recording software to export the production data in compliance with 21CFR part 11. Laminar flow unit. RABs / Isolator unit.

8 SYX-E-PP + RABs Filling and closing machines for injectable and lyophilised vials. Filling from ml. Output up to 150 upm. Dosing control through micro scale and automatic recalibration of the volume to be dosed. Gas flushing before, during, or after the filling process. Automatic rejection of defective vials. Data recording software to export the production data in compliance with 21CFR part 11. Laminar flow unit. RABs / Isolator unit. SYX-E-PP/S SYX-E-PP/D Max. Output / uph: 5,200 9,000 Container dimensions: Ø= 80 mm. max. h= 310 mm. max. Ø= 26 mm. max. h= 80 mm. max. Type of closures: Rubber stopper + Aluminium cap ø13/20/30/32 mm. Dosing range / accuracy: ml. / ±0.5% ml. / ±0.5% 200/400 VAC 50/60 Hz 4 KW. max.

SYX-E-C Cartridge Filling and closing machines for cartridges. Filling from 0.1 50 ml. Output up to 200 upm.

Dosing system for CIP / SIP conditions. Automatic rejection of defective cartridges.

SYX-E-C/S SYX-E-C/D SYX-E-C/T SYX-E-C/C Max.

9 SYX-E-C Cartridge Filling and closing machines for cartridges. Filling from ml. Output up to 200 upm. Gas flushing before or during the filling process. Level filling through laser sensor, without overfilling. Dosing system for CIP / SIP conditions. Automatic rejection of defective cartridges. Data recording software to export the production data. Laminar flow unit. RABs / Isolator unit. SYX-E-C/S SYX-E-C/D SYX-E-C/T SYX-E-C/C Max. Output / uph: 4,000 7,200 9,500 12,000 Container dimensions: Ø= 6 25 mm. max. h= 95 mm. max. Type of closures: Plunger + aluminium cap with rubber seal. Dosing range: ml. 200/400 VAC 50/60 Hz 5 KW. max.

SFL Syringe + RABs Filling and closing machines for ready-to-use disposable syringes and vials in nest. Dosing of syringes in nests from 0.5 20 ml.

90 mm. 17.05 mm. 22.05 mm. SFL/S 2 filling positions 5,200 5,200 4,800 3,200 1,800 1,200 Vacuum-assisted filling to prevent air trapped in the luer channel.

Data recording software to export production data, SCADA system. Laminar flow unit. RABs / Isolator unit. SFL/D 5 filling positions Max.

10 SFL Syringe + RABs Filling and closing machines for ready-to-use disposable syringes and vials in nest. Dosing of syringes in nests from ml. Output up to 22,600 uph. Formats 0.5 ml. 1 ml. long. 1-3 ml. 5 ml. 10 ml. 20 ml. Syringes x nest Ø Ext. Syringe 6.85 mm mm mm mm mm mm. SFL/S 2 filling positions 5,200 5,200 4,800 3,200 1,800 1,200 Vacuum-assisted filling to prevent air trapped in the luer channel. Dosing system for CIP / SIP conditions. Vacuum-assisted plunger insertion. Gas flushing during filling and/or positioning of plunger stoppers. Data recording software to export production data, SCADA system. Laminar flow unit. RABs / Isolator unit. SFL/D 5 filling positions Max. Output / uph: 11,400 11,400 9,800 5,600 3,600 2,200 SFL/T 10 filling positions 22,600 22,600 20,000 12,000 6,500 4,000 (200/400 VAC 50/60 Hz) 4 KW. max. 5 KW. max. 6 KW. max.

SFL-R Lab Machines for plunger rod insertion and labelling of syringes.

Turning torque control during the positioning of plunger rods.

Introduction of syringes in a BD Preventis security device. Thermo transfer or inkjet printer.

11 SFL-R Lab Machines for plunger rod insertion and labelling of syringes. Reliable, fast and robust labelling. Output up to 150 upm. Turning torque control during the positioning of plunger rods. Assembling of Backstop finger supports. Introduction of syringes in a BD Preventis security device. Thermo transfer or inkjet printer. Barcode control. Artificial vision control. Data recording software to export the production data. SFL-R Lab/S SFL-R Lab/D Max. Output / uph: 5,200 9,000 Syringe external diameter: (200/400 VAC 50/60 Hz) Ø= mm. 5 KW. max. 6 KW. max.

HSL-Lyo Aseptic Filling High speed filling and closing machines for injectable and lyophilised vials. Filling system 100% weight control with automatic calibration. Filling from 0.1 540 ml.

Gas flushing before, during, or after the filling process. Automatic rejection of defective vials. Data recording software to export the production data in compliance with 21CFR part 11.

12 HSL-Lyo Aseptic Filling High speed filling and closing machines for injectable and lyophilised vials. Filling system 100% weight control with automatic calibration. Filling from ml. Output up to 600 upm. Conforms with cgmp-us FDA. Filling systems through peristaltic or valveless rotary piston pumps. Dosing system for CIP / SIP conditions. Gas flushing before, during, or after the filling process. Automatic rejection of defective vials. Data recording software to export the production data in compliance with 21CFR part 11. Statistical or 100% IPC system through loading cells. Laminar flow unit / RABs / Isolator unit. HSL-Lyo/4 4-Head HSL-Lyo/6 6-Head HSL-Lyo/8 8-Head Max. Output / uph: 12,000 18,000 24,000 Container dimensions: Ø= 90 mm. max. h= 210 mm. max. Type of closures: Injection / lyophilised rubber stoppers ø13/20/30/32 mm. Dosing range / accuracy: ml. / ±0.5% 200/400 VAC 50/60 Hz 8 KW. max.

HSL-Cap High speed vial closing machines. Minimal particle generation during sealing.

Data recording software to export relevant production data.

Laminar flow unit / RABs. HSL-Cap/8 8-Head Max.

13 HSL-Cap High speed vial closing machines. Minimal particle generation during sealing. Output up to 600 upm. Vial infeed table. Inspection through artificial vision. Data recording software to export relevant production data. Aluminium closures printing / codification. Outfeed through double tray. Laminar flow unit / RABs. HSL-Cap/8 8-Head Max. Output / uph: 18,000 HSL-Cap/16 16-Head 36,000 Container dimensions: Ø= 100 mm. max. h= 250 mm. max. Ø= 53 mm. max. h= 150 mm. max. Type of closures: Ø= 40 mm. máx. Ø= 24 mm. máx. (200/400 VAC 50/60 Hz) 3 KW. max. 4 KW. max.

WM + DT Complete lines for aseptic filling. Automatic WM washing units to process vials, cartridges, and syringes. WM washing units are characterized by their flexibility and high performance.

The containers are transported individually, each held with special grippers that ensure delicate and efficient treatment. Output: up to 36,000 uph.

14 WM + DT Complete lines for aseptic filling. Automatic WM washing units to process vials, cartridges, and syringes. WM washing units are characterized by their flexibility and high performance. The vials are always processed in one direction to avoid any possible contamination. The containers are transported individually, each held with special grippers that ensure delicate and efficient treatment. Output: up to 36,000 uph. The washing process of the exterior of the containers is carried out by a set of static nozzles, while vertically moving nozzles wash the containers inside. The design has been made in accordance with the cgmp, GAMP and US-FDA regulations, and in special compliance with the requirements of the pharmaceutical industry. Pre-washing cycle with ultrasound bath. Sterilization of washing unit with steam. Drying cycle with hot air. Siliconization cycle. Production data recording software in accordance with 21CFR part 11.

Output: up to 610 kg/h Each tunnel is divided into 3 chambers: preheating chamber, depyrogenation chamber, and cooling chamber.

15 WM + DT Complete lines for aseptic filling. DT sterilizing tunnels. DARA PHARMACEUTICAL PACKAGING offers a wide range of sterilizing and depyrogenation equipment for continuous processing of glass containers such as vials, cartridges, and syringes. Output: up to 610 kg/h Each tunnel is divided into 3 chambers: preheating chamber, depyrogenation chamber, and cooling chamber. The vials are transported through the tunnel on the conveyor belt made of stainless steel, towards the filling area. The thermal cycle is designed to reduce the pyrogens by 3 or 6 Log. A 3 Log reduction means that the vials have been exposed to a thermal cycle equivalent to 15-minute of exposure at a constant temperature of 250 C. The 6 Log reduction corresponds to a 30-minute cycle. Sterilization cycle of the cooling chamber. Automatic adjustment of the gates between the chambers. Anemometers to measure the airflow s speed. Automatic emptying of tunnel. Production data recording software in accordance with 21CFR part 11.

16 S3 Process Limited East Cartshed Barn, Borough Hill Farm Catton Road, Walton-on-Trent Derbyshire, DE12 8LL, UK Tel.: +44 (0) /03/2014 EN.

DEPYROGENATING TUNNELS

DEPYROGENATING TUNNELS DEPYROGENATING TUNNELS STERILINE ST series laminar flow depyrogenating tunnels have been designed to depyrogenize ampoules, vials and syringes with a continuos process maintaining