GMP-Worthy Semi- And Fully Automatic Equipment Made By DARA
 
 

Please scroll down to see an excerpt of DARA's manufacturing program of technically advanced and surperiorily designed liquid filling and capping equipment.

For more informations please look up DARA's website

www.dara-pharma.com

   
   
SX-100 Automatic Tabletop-Filler  
Automatic Tabletop filling

Cost effective / Filling from 0.1 to 250 ml. / Format change in 4 minutes / Output up to 2,200 uph.

The machine we present to you is a tabletop filling machine for vials and cylindrical glass containers, plastic or metal, for the automatic processing of
liquids, semi-liquids or powder, in sterile or clean room applications.

Its design has been made in accordance with the regulations of the GMP and US-FDA, in specialaccordance with the requirements of the pharmaceutical, biotech, cosmetic, chemical and similar industries.

The filling station is equipped with a peristaltic pump for liquid products or with a volumetric filling station for semi-liquids or powder products. Filling programs are stored and can be recalled from the control panel. New programs can be createdeasily and quickly by the user.

The changeover to a different size is carried outquickly without tools. The adaptation to different heights of containers is made through digital positioning gauge.The machine is suitable either for batches of clinical trials or an extensive range of production batches.


Optional Equipment:

  • Diving nozzle system.
  • Gravimetric dosing system, through scale.
  • Gas flushing before or after the filling process.
  • Laminar flow unit.
  • Isolator unit.
  • IQ / OQ Validation package
  • Printing.
  • Codification.


Features:

  • Output: up tp 2200 bpm
  • Container Dimensions:
    Dimensions des flacons Ø= max. 54 mm, h=max. 210 mm.
  • Dosing range/Accuracy: 0,1 ÷ 250 ml. / ±0,5%
  • Electrical Requirements:200/400 VAC, 50/60 Hz, max. 500W.
  • Compressed Air: max. 30 l/min. – Clean and dry air at 6 bar.
  • Weight: 75 kg.
  • Materials:AISI-304 stainless steel, product contact parts AISI-316 stainless steel, anodised aluminium and POM.
   
DARA SX140-C  
SX-140-C Tabletop machine for the automatic closing of vials

Cost effective / Format change in 2 minutes / Output up to 1,500 uph. / Conforms with GMP-US FDA.

The machine we present to you is a tabletop closing machine, for vials and cylindrical glass containers, plastic or metal, for the automatic closing of
aluminium closures, such as:

• Aluminium caps / Flip-off caps.
• Pilferproof caps.
• Spray pumps.

It's design has been made in accordance with the regulations of the GMP and US FDA, in special accordance with the requirements of the pharmaceutical, biotech, cosmetic, chemical and similar industries.

The closing station is equipped with a pneumatic crimp head or pilferproof head for aluminium capsPP.

Different types of closures are fed manually. However, this process can be automated through a vibrator feeder. The changeover to a different size is carried out quickly, easily and without tools by exchanging complete sets of size parts. The adaptation to different heights of containers is made through digital positioning gauge.

Optional Equipment

  • Automatic feeder for closures.
  • IQ / OQ Validation package
  • Printing

Specification:

  • Max. Output / uph: 1500
  • Container dimensions:Ø= 75 mm. max h= 210 mm. max
  • Type of closuresAluminium cap ø8/13/20/32 mm.Pilferproof cap ø18/22/28 mm.
  • Electrical supply: 110/240 VAC, 50/60 Hz, 100W. max.
  • Air supply: 20 l/min. max. – Clean and dry air at 6 bar.
  • Max. Weight: 40 kg.
  • Materials:AISI-304 stainless steel, anodised aluminium and POM.

Format range:


.



   
DARA SX140-R  

DARA SX140-R Tabletop machine for the automatic closing of containers with srew caps

Cost effective / Format change in 2 minutes / Output up to 1,500 uph. / Conforms with GMP-US FDA.

The machine we present to you is a tabletop closing machine, for vials and cylindrical glass containers, plastic or metal, for the automatic closing of all closures, such as:

• Press-in closures.
• Screw caps.
• Childproof caps.
• Spray pumps.
• Dosing pumps.
• Dropper inserts.

Its design has been made in accordance with the regulations of the GMP and US-FDA, in special accordance with the requirements of the pharmaceutical, biotech, cosmetic, chemical and similar industries.

The closing station is equipped with a pneumatic screw head or with a servo head for difficult screw closures. Different types of closures are fed manually.

However, this process can be automated through a vibrator feeder. The changeover to a different size is carried out quickly, easily and without tools by exchanging complete sets of size parts. The adaptation to different heights of containers is made through digital positioning gauge.

Optional Equipment

• Automatic feeder for closures.
• High frequency or induction closing.
• IQ / OQ Validation package.
• Printing / Codification.

Specification SX-140-RN, SX-140-RE

  • Max. Output / uph: 1500
  • Container dimensions:Ø= 100 mm. max h= 310 mm. max
  • Type of closures cap ø max. 68mm.
  • Torque :0,2-4 Nm
  • Electrical supply: 110/240 VAC, 50/60 Hz, 100W. max.
  • Air supply: 90 l/min. max. – Clean and dry air at 6 bar.
  • Max. Weight: 40 kg.
  • Materials:AISI-304 stainless steel, anodised aluminium and POM.

Format range:






SX-200-R Tabletop filling and closing machine  
SX-200-R Tabletop filling and closing machine for automatic containers processing.

Filling from 0.1 to 250 ml. / Format change in 5 minutes / Output up to 2,700 uph. / Conforms with GMP-US FDA.

The machine we present to you is a tabletop filling and closing machine, for vials and cylindrical glass containers, plastic or metal, for the automatic processing of liquids, semi-liquids or powder, in sterile or clean room applications.
For production speeds up to 2,700 units per hour. Its design has been made in accordance with the regulations of the GMP and US-FDA, in special accordance with the requirements of the pharmaceutical, biotech, cosmetic, chemical and similar industries. The filling station is equipped with a peristaltic pump for
liquid products or with a volumetric filling station for semiliquids or powder products.

Filling programs are stored and can be recalled from the control panel. Parameters such as the dosing volume and the cycle of the filling process are stored in the data memory. New programs can be created easily and quickly by the user.

Dosing volumes from 0.1 up to 250 ml.The pick & place station places the stoppers and caps onto the container sequentially, using a vacuum system. The closing station is equipped with a pneumatic screw head or with a servo head for difficult screw closures. All closures currently used can be easily handled, such as:

• Press-in closures.
• Screw caps.
• Childproof caps.
• Spray pumps.
• Dosing pumps.
• Dropper inserts.

Feeding of the closures can be carried out automatically by vibrating feeders, made of AISI-316L stainless steel. The changeover to a different size is carried out quickly, easily and without tools, by exchanging complete sets of size parts.

The adaptation to different heights of containers is made through digital positioning gauge. The machine is suitable either for batches of clinical trials or an extensive range of production batches.

Optional Equipment:

  • Diving nozzle system.
  • Gravimetric dosing system, through scale
  • Gas flushing before or after the filling process
  • Data recording software in order to report the
    production data.
  • High frequency or induction closing
  • Laminar flow unit.
  • Isolator unit.
  • IQ / OQ Validation package.
  • Printing / Codification

Specifications:

  • Max. Output: SX-200-R/8 - 2200uph, SX-200-R/16 - 2700 uph
  • Container dims: SX-200-R/8 - Ø= 65 mm. max., h= 210 mm. max., SX-200-R/16 - Ø= 54 mm. max, .h= 210 mm. max.
  • Type of closures: SX-200-R/8 - Cap or stopper, SX-200-R/16 - Cap + stopper
  • Dosing range / accuracy: 0,1 ÷ 250 ml. / ±0,5%
  • Electrical supply: 200/240 VAC – 50/60 Hz – 2 KW. max.
  • Air supply: 180 l/min. max. – Clean and dry air at 6 bar
  • Max. Weight: SX-200-R/8 - 200 kg, SX-200-R/16 - 250 kg
  • Materials: AISI-304 stainless steel, anodised aluminium, POM and contact parts with product in AISI-316L stainless steel.


Format range:


SX-200T Tabletop filling and closing machine  
SX-200-T Tabletop filling and capping machine for automatic vials processing
.

Filling from 0.1 up to 120 ml. / Format change in 5 minutes / Output up to 2,500 uph. / Conforms with GMP-US FDA.

The machine we present to you is a tabletop filling and closing machine, for tubes, vials and cylindrical unstable containers, of glass, plastic or metal, for the automatic processing of liquids, semi-liquids or powder, in sterile or clean room applications.

For production speeds up to 2,500 units per hour. Its design has been made in accordance with the regulations of the GMP and US-FDA, in special accordance with the requirements of the pharmaceutical, biotech, cosmetic, chemical and similar industries.

The filling station is equipped with a peristaltic pump for liquid products or with a volumetric filling station for semiliquids or powder products. Filling programs are stored and can be recalled from the control panel. Parameters such as the dosing volume and the cycle of the filling process are stored in the data memory.

New programs can be created easily and quickly by the user. Dosing volumes from 0.1 up to 120 ml. The pick & place station places the stoppers and caps onto the container sequentially, using a vacuum system. The closing station is equipped with a screw head or with a crimp head, both pneumatic, for aluminium caps.All closures currently used can be easily handled, such as:

• Press-in closures.
• Screw caps.
• Childproof caps.
• Spray pumps / Dosing pumps.
• Dropper inserts.
• Rubber / Lyophilised stoppers.
• Aluminium 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 rubber stoppers to lyophilise, in a sterile room application.
• Positioning of aluminium caps and closing of vials, in a clean room application.

Feeding of the closures can be carried out automatically by vibrating feeders, made of AISI-316L stainless steel. The changeover to a different size is carried out quickly, easily and without tools, by exchanging complete sets of size parts. The adaptation to different heights of containers is made through digital positioning gauge.

The machine is suitable either for batches of clinical trials or an extensive range of production batches.

Optional Equipment:

  • Diving nozzle system.
  • Gravimetric dosing system, through scale.
  • Gas flushing before or after the filling
    process.
  • Data recording software in order to report
    the production data.
  • High frequency or induction closing.
  • Laminar flow unit.
  • Isolator unit.
  • IQ / OQ Validation package
  • Printing.
  • Codification.

Features:

  • Max. Output: 2500 uph
  • Container dimensions Ø= 35 mm, max. h= 175 mm. max.
  • Type of closures Aluminium cap or cap + stopper.
  • Dosing range / accuracy 0,1 ÷ 120 ml. / ±0,5%
  • Electrical supply 200/240 VAC – 50/60 Hz – max 3 KW
  • Air supply 180 l/min. max. - Clean and dry air at 6 barmax.
  • Weight 250 kg.
  • Materials AISI-304 stainless steel, anodised aluminium, POM and contact parts with product in AISI-316L stainless steel.

Format range:


SX-200PP Tabletop filling and closing machine  
Injectables SX-200-PP
Tabletop filling and closing machine for automatic vials processing.

Filling from 0.1 to 250 ml. / Format change in 5 minutes / Output up to 3,000 uph. / Conforms with GMP-US FDA..

The machine we present to you is a tabletop filling and closing machine, for vials and cylindrical glass containers, plastic or metal, for the automatic processing of liquids, semi-liquids or powder, in sterile or clean room applications. For production speeds up to 3,000 units per hour. Its design has been made in accordance with the regulations of the GMP and US-FDA, in special accordance with the requirements of the pharmaceutical, biotech, cosmetic, chemical and similar industries.

The filling station is equipped with aperistaltic pump for liquid products or with a volumetric filling station for semi-liquids or powder products. Filling programs are stored and can be recalled from the control panel. Parameters such as the dosing volume and the cycle of the filling process are stored in the data memory.

New programs can be created easily and quickly by the user. Dosing volumes from 0.1 up to 250 ml.

The pick & place station placesthe rubber stopper onto the vial fully or partially, depending on the application (injection rubber stopper or lyophilised rubber stopper). Stoppers are handled by vacuum.

The closing station is equipped with a pneumatic crimp head, characterised by the minimum generation of particles during the closing process.
All closures currently used can be easily handled, such as:

• Rubber stoppers.
• Lyophilised stoppers.
• Aluminium 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 rubber stoppers to lyophilise, in a sterile
room application.
• Positioning of aluminium caps and closing of vials, in a clean room
application.

Feeding of the closures can be carried out automatically by vibrating feeders, made of AISI-316L stainless steel. The changeover to a different size is carried out quickly, easily and without tools, by exchanging complete sets of size parts. The adaptation to different heights of containers is made through digital positioning gauge.

Vials in filling position, pick & place to handle rubber stoppers by vacuum and closing head.
The machine is suitable either for batches of clinical trials or an extensive range of production batches.

Optional Equipment:

  • Diving nozzle system.
  • Gravimetric dosing system, through scale
  • Gas flushing before or after the filling
    process
  • Data recording software in order to report
    the production data.
  • High frequency or induction closing.
  • Laminar flow unit.
  • Isolator unit.
  • IQ / OQ Validation package.
  • Printing / Codification.

Features:

  • Max. Output : SX-200-PP/8 - 3,000uph, SX-200-PP/16 - 3,000uph
  • Container dimensions: SX-200-PP/8 - max Ø= 65 mm., h= max 210 mm, SX-200-PP/16 - Ø= max 54 mm, h= max. 210 mm.
  • Type of closures: Rubber stopper or aluminium cap
    ø13/20mm.
  • Dosing range / accuracy: 0,1 ÷ 250 ml. / ±0,5%
  • Electrical supply: 200/240 VAC – 50/60 Hz – max 2 KW.
  • Air supply: 90 l/min. max. - Clean and dry air at 6 bar.
  • Max. Weight: SX-200-PP/8 - 200 kg, SX-200-PP/16 - 250 kg.
  • Materials:AISI-304 stainless steel, anodised aluminium, POM and contact parts with product in AISI-316L stainless steel.

Format range:

SVY-P
Filling machine for containers and vials.
 
Beauty SVY-P
Filling machine for containers and vials.

Compact machine / Filling from 0.1 up to 1,050 ml. / Output up to 180 upm. / Conforms with GMP-US FDA.

The machine we present to you is a filling, for vials, glass bottles, plastic and metal containers, for the automatic processing of all liquids, semi-liquids or powder products, in sterile or clean room applications.

For production speeds up to 180 units per minute. Its design has been made in accordance with the regulations of the GMP and US-FDA, and in special accordance with the requirements of the pharmaceutical, biotech, cosmetic, chemical and similar industries.

The standard peristaltic station is equipped with a maximum of 12 peristaltic pumps SpeedFill for liquid products or as a special with a volumetric filling station for semi-liquids or powder products.

Filling programs are memory stored and recalled from the control panel. Parameters such as the dosing volume and the cycle of the filling process are stored in the data memory. New programs can be created easily and quickly by the user. Dosing volume from 0.1 up to 1,050 ml.

In accordance with production parameters, different for each application, as well as the characteristics of the product, five different dosing systems can be used:

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

When required by the product, such as foamy products, the dosing is done by “diving nozzle” system, to fill progressively from the bottom of the container.

Both pharmaceutical companies and regulatory bodies are willing to see the progress in the quality manufacturing process of medicaments. To guarantee the tracing of each dosing batch, we dispose of the XDdose® system. We dose vials in line with a precision micro-scale and doing the dose volume adjustments automatically. The software system integrated in the XDdose® system guarantees that all processing data for each vial weight is stored in a 21CFR part 11 according to the requirements of the pharmaceutical industry.

Using “CIP-SIP” construction elements it is not necessary to remove the product contact parts for cleaning or sterilising. To work in sterile or clean room applications we supply of different units of laminar flow suitable to each machine size. The sterile air generated ensures a permanent, reliable expulsion of particles and micro-organisms from the work area.

Using an isolator, the sterile zone can be confined to the work area of the filling machine alone, enabling to work from the sterile and clean room applications, according to pharmaceutical standards.


Optional Equipment

• Vials cleaning system in line.
• Diving nozzle system.
• Gravimetric dosing system, through microscale.
• Gas flushing before or after the filling process.
• Data recording software in order to report the production data.
• Laminar flow unit.
• Isolator unit.
• IQ / OQ Validation package.

Features:

  • Output: SVY-P/4 - 85 bpm, SVY-P/8 - 135 bpm, SVY-P/12 - 200bpm
  • Container Dimensions: Ø= max 100 mm, h= max 310 mm.
  • Dosing range / accuracy: 0,1 ÷ 1.050 ml. / ±0,5%
  • Electrical supply: 200/240 VAC – 50/60 Hz – 2 KW - 4KW
  • Weight: SVY-P/4 - 420Kg, SVY-P/8 - 620Kg, SVY-P/12 - 820Kg
  • Materials:AISI-304 stainless steel, anodised aluminium, POM and contact parts with product in AISI-316L stainless steel.
SFL Syringe Filling System for Cartridges and Syringes  
Cartridges and Syringes SFL Syringe
Filling and closing machine for syringes.

Compact machine / Dosing of syringes in nests from 0.5 to 20 ml. / Output up to 22,600 uph. / Conforms with cGMP-US FDA.

Ready-to-use disposable syringes offer ease of use, security, hygiene and dosing accuracy for medical injections.

Our line allows a combination of fillingclosing for processing ready-to-use disposable syringes and vials in nests.

Ready-to-use disposable syringes are supplied sterilized and ready to-fill into trays called “Nest”. There is no need for washing and sterilizing the associated components prior to the filling and sealing operation.

The equipment is designed to be used in sterile room applications, in accordance with regulations of the cGMP and USFDA.

Machine sequence of operations:

  • Manual or automatic insertion and manual or automatic removal of “Nest”, depending on the machine model.
  • Dosing through valveless rotary piston pumps or through peristaltic pumps.
  • Automatic infeed and automatic positioning of plunger stoppers / stoppers.

All production parameters are stored in the PLC data memory, through “formats”.Therefore, parameters such as:

  • Dosing volume.
  • Programmable kinematics of the filling process.
  • Positioning depth of the plunger stoppers / stoppers.
  • Vibration amplitude of the component feeders.
  • Output speed.

They are adjusted automatically and are associated to each format of syringe or vial processing.

The formats can be recalled from the control panel, re-establishing automatically the ideal predetermined settings. New programs can be created easily and quickly by the user.

The changeover to a different size is carried out quickly, easily and without tools, by exchanging complete sets of format parts.

To work under sterile room applications we offer different laminar flow units or RABs enclosures adapted to each size of machine. These optionals guarantee to work under ISO 5 Class 100 U.S. Federal Standard 209 E.

The unit can be designed to be installed into an isolator when production requirements recommend its use.


Optional Equipment:

  • Vacuum-assisted dosing, to prevent air from being trapped in the tip of the syringe.
  • CIP / SIP cleaning system.
  • Vacuum-assisted positioning of plunger stoppers, to place plunger stoppers coated with teflon.
  • Gas flushing during filling and/or positioning of plunger stoppers
  • Data recording software to report production-related data, SCADA system.
  • Laminar flow unit / RABs / Isolator.
  • IQ / OQ validation package.