FILLING MACHINE ISOLATORS ARE DESIGNED...
to enclose the filling, stoppering and capping operations of a Powder or Liquid Filling Machine while providing an aseptic environment for the process, achieving ISO 5 grade A classification. This isolator allows for the entry of pre-sterilized stoppers and caps through a Rapid Transfer Port (RTP). Powder is also presented into the Isolator via the RTP. Glassware is transferred to the isolator in separate transfer isolators. The Transfer Isolator “docks” to the filling isolator via a RTP and the trays of glassware are manually positioned on the accumulator of the filling machine. The vials are automatically moved by the filling machine through the filling, stoppering and capping stations and exit through a “mouse hole” in the end wall of the isolator. A conveyor carries the vials from the Isolator under an external unidirectional airflow module and into the adjoining packaging room.
CUSTOM DESIGN
We know that not all customer requirements will fall into a standard isolator design.
For that reason we offer custom designed filling isolators to suit individual customer requirements with full third party filling equipment integration.
CLASSIFICATION
within unidirectional airflow system
DECONTAMINATION
Integrated Hydrogen Peroxide system
Design advantages
- Ergonomically designed oval glove ports
- 316L stainless steel construction
- PLC control
- Positive pressure airflow system with HEPA filtration and a self-contained unidirectional airflow system
- Special “mouse hole” protected by unidirectional airflow for exit of filled vials
- Integrated Hydrogen Peroxide decontamination
- Temperature control to maintain the Isolator at ambient temperature with high/low set points.
Available options
- RTP system for sterile liquid entry/ vial introduction /stopper, cap & product introduction
- Automatic negative pressure breach ventilation system (available for potent aseptic filling applications)
- Connection to an external vial washer (separate piece of equipment) on the exit of the isolator
- Air recirculatory within windows
- Clean in place systems
- Safe change filters
- Full validation services available including IQ/OQ protocols.
Customer Support
Our planned maintenance and re-certification package provides a scheduled visit to undertake a full range of testing to industry standards.
Service UK: +44 01484 354 499
Service Americas: +1 608-747-2482
Spare Parts Americas: +1 608-747-2475
Technical Requirements
Full validation services available including IQ/OQ protocols.