You are visiting a website that is not intended for your region

The page or information you have requested is intended for an audience outside the United States. By continuing to browse you confirm that you are a non-US resident requesting access to this page or information.

Switch to the US site

This website uses cookies

By continuing to use this website you consent to using cookies. For more information about cookies and how we use them, please see our Privacy Policy.

MODULINE™ COMPACT ISOLATED FILLING LINE

Moduline_1-width460.jpg
Modiline_2-width460.jpg
Moduline_3-width460.jpg

MODULINE™ COMPACT ISOLATED FILLING LINE

Compact modular units with one single isolator design

Overview

A compact solution for aseptic isolated filling lines, the MODULINE™ is a new modular concept developed by Getinge and Dara Pharma.

A fully automated filling station is placed inside a standard isolator of a single design, for processing either vials, bottles, syringes or cartridges, for automatic filling of any liquid or powder in sterile conditions. Depending on the product processed, different module combinations are possible.

Supervision and control are performed via a single HMI with integrated SCADA system, with production parameters and dosing recipes saved in the PLC. Software is GAMP compliant. The isolator is constructed with a single shell surrounding the filling machine frame with a continuous jointless base, for improved cleaning and leaktightness. Standard design and manufacturing result in cost effectiveness and optimized delivery time.

The filling equipment from Dara Pharma is optimally arranged inside the compact isolator chamber. Closures are automatically fed through vibrating feeders with electromechanical tool-less fixation for easy change of format. Particle generation is minimized by the use of tangential rolling heads for the closing process. Bio-decontamination system on board by traditional HPV (hydrogen peroxide vapor, H2O2) or by NO2 ( nitrogen dioxide) for bulk and RTU applications.

The MODULINE™ BioDecontamination module provides in-line sterilization of tubs prior to insertion into the filling line, with innovative technology using NO2 sterilant gas, delivered in situ by Getinge's Biotrace (Noxilizer Inside®) equipment. Total process time, 20 tubs in 20 minutes, provides twice the throughput of HPV (hydrogen peroxide vapor).

Compact modular units with one single isolator design

Easy access through a single front window controlled automatically

Suitable for "Ready To Use" (RTU) materials supplied in tubs

Can also process materials supplied in bulk

Designed to cGMP and FDA regulations

DPTE® transfer system for safe transfer

Technical data

  Vials Bottles Syringes Cartridges
Max. Output/uph. 6000 6000 5200 4800
Container dimensions Ø= 54 mm. max. h= 110 mm. max. Ø= 26 mm. max.
Closures Rubber stopper + aluminium cap Ø13/20 mm
Stopper + screw cap
Plunger
Plunger+aluminium cap
Liquid dosing range 0.1 + 100 ml. / ± 0,5 0.1 + 20 ml. / ± 0,5%
Powder dosing range 2 + 1,500 mg. / ±0.5 + 2%
Electrical supply 400 to 480 VAC, 50/60 Hz, 8KW max.
Max. Weight 2,500 kg.
Materials External materials are AISI-304 stainless steel and glass. Internal materials are high quality polymers and AISI-316L SS.

Accessories

DPTE®-XO Alpha ports are installed on the Moduline™ for efficient transfer of materials both into and out of the filling line without breaking containment. These rapid transfer ports are rotation-free and are opened from the exterior of the isolator for fast efficient loading.

The DPTE® handling system has been developed by Getinge for ergonomic insertion of components from DPTE-BetaBag®. This transport and docking trolley system improves ergonomy for the end-user.

Application areas

Aseptic Filling

Bulk and RTU (Ready To Use)

  • Vials
  • Bottles
  • Syringes
  • Cartridges

Useful for small clinical trials as well as mass production.

Read more about aseptic filling here