MODULINE™ COMPACT ISOLATED FILLING LINE
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
|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
|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.|
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.
API Processing Isolators
High-quality 316L stainless steel construction
Aseptic Filling Line Isolators
The originator and manufacturer of the DPTE® system
The originator and manufacturer of the DPTE system
Mechanical interface to prevent incorrect manipulation
Glove Leak Testers (GLT)
Fast and simple to perform
Flexible-wall and rigid-wall options
Isocyt Freja Isolators
Provides seperation of process from the environment and operator