The DWI isolator is a double-walled isolator designed for maximum protection of aseptic or aseptic-toxic processes carried out in a filling line. Its application is oriented to customised systems for filling lines, freeze-drying processes, and any of the aseptic processing systems.
- These isolators can be installed in grade D rooms, according to EU-GMP standards.
- Equipped with a robust ventilation system, different stages of filtration and air treatment can be configured to tightly control pressure, temperature, humidity and particulates inside.
- The interior of the chamber is Grade A (ISO 5), with a laminar airflow with extraordinary homogeneity for perfect process protection.
- The design of the DWI isolator must be done in coordination with the manufacturer of the filler and/or freeze dryer, for a correct final coupling between all of them.
- Different air locks will allow us to solve all the casuistry that we are faced with.
The integrated low-temperature disinfection system using H2O2, developed by LITEK Pharma, enables robust and fast disinfection cycles to be carried out inside the isolator.
Double-walled chamber, made of stainless steel AISI 316L, 3 mm thick, internal polishing Ra<0.6.
Compact ventilation module, for recirculation.
Tempered glass doors with double glazing with inflatable seals.
External electrical panel
Beckhoff HMI industrial PC
Beckhoff 15.6″ touchscreen monitor
SCADA System, and electronic records according to CFR21 Part 11, GAMP5.
Audit Trail, Batch report, bus integration with other equipment: filling lines, freeze dryers, etc…
Integrated VHP disinfection system.
H2O2 monitoring, high and low concentration.
Viable and non-viable particle counting.
RTP (Rapid Transfer Ports) for liquids and solids.
External sliding door, with inflatable seal.
Double HEPA H14 filtration in impulsion.
HEPA H14 filtration in extraction, next to chamber.
Large oval gloves
Internal glove holders
Viable / and non-viable particle monitoring.
Temperature and humidity monitoring
Temperature and humidity control.
- User Manual
- CE Certificate
- Functional Design Specification (FDS)
- Functional Specification (FS)
- Hardware Design Specification (HDS)
- Software Design Specification (SDS)
- Factory Qualification Test (FQT)
- Factory Acceptance Test (FAT)
- Installation Qualification (IQ)
- Operation Qualification (OQ)
- Site Acceptance Test (SAT)
Please do not hesitate to contact us if you require any further information.