Description
Sterility testing isolator
MATERIALS:
- Stainless Steel AISI 316L and glass
- PMMA (Polymethylmethacrylate with Stainless Steel AISI 316L working base)
- Soft wall (PVC Flexible Chambers with Stainless Steel AISI 316L working base)
CONFIGURATION:
- 2 Gloves
- 2 Gloves and one Airlock
- 3 Gloves
- 3 Gloves and one Airlock
- 4 Gloves
- 4 Gloves and one Airlock
- 4 Gloves and two Airlocks
- Half Suit
- Customized configurations
AIRLOCK FOR FAST DECONTAMINATION AND MATERIAL TRANSFER:
- Possibility to install one or two lateral transfer airlock
- Fast decontamination cycle
- Sliding trolley with Basket and hooks
BIODECONTAMINATION SYSTEM:
- Integrated H2O2 (Vapour Hydrogen Peroxide 35%) biodecontamination system
- H2O2 HPV
- H2O2 35% - 1 Liter bottles with safety system for operator safety
AUTOMATION:
- PLC Siemens or other brands on request
- HMI - PANEL PC Windows based
- GAMP 5 - CFR 21 Part 11 compliant
GENERAL TECHNICAL SPECIFICATIONS :
- Ventilation System ETF (Engineered Turbulent Airflow)
- UDAF (Unidirectional Airflow)
- Filtration by HEPA filters H14 or ULPA U15
- Regulated pressure positive or negative
- RTP Rapid Transfer Port for waste management (solid and or liquid)
- Microbial Air Sampler integration as option for environmental monitoring
- Particle Counter integration for environmental
- Sterility pump integrated (mechanical and electrical integration)
- H2O2 sensors for the concentration measurement inside the isolator during the process
- H2O2 sensor for the concentration measurement in the room (operator safety)
- GLT Glove Leak Tester – Integrate or with dedicated software interface