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Multiformat-line-for-aseptic-packaging

Flexibility: The Key to Success

The continuous evolution and development of new inactivated, attenuated, or viral vector-based vaccines, as well as their dispensing methods, make adaptation to a versatile aseptic packaging system essential. Dara Pharma has evolved in this direction, integrating complete lines, Turn-Key Solutions, which make the vaccine packaging process more profitable.

Multiformat

Great versatility with different types of packaging —vials, cartridges, and syringes—, and quick format changeover.

Bulk & RTU

For formats supplied in bulk and RTU (Ready-to-use).

Multiproduct

Dosing of liquid and powder products, as well as integration with a freeze drying process.

Further details

Multiformat line for aseptic packaging

  • Washing and sterilization of bulk vials
  • Debagging, delidding and denesting in RTU formats
  • Filling and closing of vials, syringes, and cartridges for liquid and powder injectables
  • Freeze drying and closing of vials for freeze dried injectables
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2
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7
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1
Bulk vial infeed
2
Washing
3
Depyrogenation
1
Debagging for RTU formats
2
Delidding
3
Denester
4
Filling and closing
5
Loading and unloading systems
6
Freeze drying
7
Closing
8
External washing

Bulk processing

The line has a washing machine and a sterilization and depyrogenation tunnel for bulk supply.

Cleaning

WM / RWM

Maximum efficiency and high flexibility to process as many formats as possible: vials, bottles, or cartridges.

Sterilization & Depyrogenation

DT

Maximum flexibility and adaptability, low consumption, and easy maintenance thanks to its modular design.

Linear washing unit

for vials

WM

  • Multiformat machines
  • Quick format changeover
  • Output up to 36,000 uph
Optional equipment
  • Pre-washing cycle with ultrasound bath.
  • Steam sterilization of pipes.
  • Drying-in-place of pipes.
  • Siliconizing cycle.
  • Automatic rejection of defective containers and extraction for sampling.
  • SCADA software to process data acquisition in accordance with FDA 21CFR Part 11.
  • IQ / OQ Validation package.

Rotary washing machine

for vials and cartridges

RWM

  • Multiformat machines
  • Quick format changeover
  • Output up to 24,000 uph
Optional equipment
  • Pre-washing cycle with ultrasound bath.
  • Steam sterilization of pipes.
  • Drying-in-place of pipes.
  • Siliconizing cycle.
  • Automatic rejection of defective containers and extraction for sampling.
  • SCADA software to process data acquisition in accordance with FDA 21CFR Part 11.
  • IQ / OQ Validation package.

Sterilization and depyrogenation tunnel

 

DT

  • Continuous process
  • Automatic format control and adjustment
  • Output up to 610 kg/h
Optional equipment
  • Differential pressure control.
  • Clean room sealed door.
  • Automatic tunnel discharge.
  • Cooling chamber sterilization.
  • Automatic adjustment of chambers doors opening.
  • Air speed monitoring.
  • SCADA software to process data acquisition in accordance with FDA 21CFR Part 11.
  • IQ / OQ validation package.
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RTU processing (Ready-to-use)

Debagging, delidding and denesting are available for supply in nest and tray.

Debbaging

DB

Deliding

DL

Denesting

DN

Automatic debagging

 

DB/A

  • Automatic opening of the bag
  • Automatic transfer of the tub to a downstream machine through an automatic sliding door
  • Output up to 225 tubs/h
Optional equipment
  • SCADA software to process data acquisition in accordance with FDA 21CFR Part 11.
  • GAMP complying software.
  • Laminar air flow / RABS.
  • IQ / OQ Validation package.

Automatic delidding

 

DL/A

  • Tub pre-heating to avoid particle generation during Tyvek lid removal
  • Inner liner removal through vacuum
  • Output up to 225 tubs/h
Optional equipment
  • SCADA software to process data acquisition in accordance with FDA 21CFR Part 11.
  • GAMP complying software.
  • Laminar air flow / RABS / Isolator.
  • IQ / OQ Validation package.

Automatic denester

 

DN/A

  • Compact machine
  • Quick format changeover
  • Output up to 24,000 uph
Optional equipment
  • SCADA software to process data acquisition in accordance with FDA 21CFR Part 11.
  • “No glass-to-glass contact” denester.
  • Monitoring and particle counting.
  • Laminar air flow / RABS / Isolator.
  • IQ / OQ Validation package.
More information

Filling

Dara Pharma's filling solutions have revolutionized the aseptic packaging machinery sector thanks to their versatility and flexibility. With our solutions, it is possible to process liquid, semi-solid and powder products in the same equipment.

Peristaltic
dosing
Volumetric
dosing
Time-pressure
dosing

Liquid

Pressure-vacuum
dosing

Powder

Closing

Closing is the operation that guarantees the seal of the container. Dara Pharma's closing machines control and measure the parameters required in this process, such as torque, crimp pressure, closing height, and any visual control – guaranteeing that the products are closed in a satisfactory way.

Multiformat filling and closing machine

 

VSC

  • Filling from 0.1 - 100 ml
  • 100% IPC
  • Output up to 24,000 uph
Optional equipment
  • Washing unit and sterilization tunnel for vials and cartridges supplied in bulk.
  • Denesting unit for RTU (Ready-to-use) formats.
  • Weight dosing control for 100% of processed elements.
  • Gas flushing before, during or after the filling process.
  • Dosing system for CIP / SIP conditions.
  • Automatic rejection of defective containers.
  • SCADA software to process data acquisition in accordance with FDA 21CFR Part 11.
  • Monitoring and particle counting.
  • Laminar air flow / RABS / Isolator.
  • IQ / OQ Validation package.
Find out more

Freeze drying

Lyophilization is a drying process that removes solvent by sublimation and not boiling like other drying processes. Sublimation is a product changing from a solid to a gas without passing through an intermediate liquid phase. As a result, the product with much more powerful active ingredients and nearly immediate reconstitution time is obtained.

Extends
shelf life

Extends the shelf life of the product.

Easy
reconstitution

The rehydration process is instantaneous.

Maximization
of properties

Maintains the qualitative properties of the product.

Freeze drying

Loading system + Freeze dryer

Automatic loading and unloading systems

for vials

VLS (Vial Loading System)

  • Output up to 24,000 uph

NLS (Nest Loading System)

  • Output up to 115 nest/h

GMP Freeze Dryers

LyoCompact

  • From 2 to 6 m² of shelf area
  • Condenser capacity up to 80 kg
  • Output for 2R up to 28,000 vials
More information

LyoCool

  • From 7 to 15 m² of shelf area
  • Condenser capacity up to 250 kg
  • Output for 2R up to 65,000 vials
More information

LyoPro

  • From 16 to 45 m² of shelf area
  • Condenser capacity up to 800 kg
  • Output for 2R up to 200,000 vials
More information

LyoPharm

  • From 2 to 45 m² of shelf area
  • Condenser capacity up to 800 kg
  • Output for 2R up to 200,000 vials
More information
Optional equipment

External closing and washing
of freeze dried vials

Closing

HSL-CAP

External washing

EWM

High speed vial closing machines

 

HSL-CAP/8

  • Compact machine
  • Minimal particle generation during crimping
  • Output up to 36,000 uph
Optional equipment
  • Washing unit and sterilization tunnel for vials supplied in bulk.
  • Automatic rejection of defective vials.
  • SCADA software to process data acquisition in accordance with FDA 21CFR Part 11.
  • Laminar air flow / RABS / Isolator.
  • IQ / OQ Validation package.
Lavadora externa

External washing unit

 

EWM

  • Output up to 24,000 uph
  • For 1 to 500 ml vials
More information

Advantages of full line integration

1

Mechanical integration between machines

Design, manufacture, and adjustment of the transfer systems for the correct integration of all the machines of the line.

2

Software architecture and single control

A control system is configured for the entire line, so that all the machines operate under the same software and data acquisition system.

3

Complete service and maintenance

The complete maintenance plan for the entire line ensures that all machines will operate optimally and efficiently in the long term.

Contact
Dara Pharma

We have a team of specialists waiting to answer all your questions and inquiries. Feel free to contact us through this form and we will get in touch with you.