Sterility Test Isolator 520.03
This isolator provides a high degree of product protection being handled in aseptic conditions. The main task is performed in the working chamber where sterility testing of final products occurs.
POPIS
- Single-chamber isolator for sterility testing
- Chamber with 4 sleeves for work with sterile materials
- Option to decontaminate with H2O2
- “A” class cleanliness according to EU GMP
- “Audit Trail” Compliant
- Leak tightness class 3 according to ISO 10648-2
- Inlet filtration HEPA H14 - “A” Class cleanlinnes
- Laminar flow 0,45 m/s ±20%
- Positive pressure mode
- Jacket material: stainless steel AISI 304
- Chamber material – AISI 316L with a thickness of 3.00 mm
- Polished surface finish, Ra < 0.6 µm
- Colour touchscreen control
- Possible to add airlock chamber and provide sterilization with with H2O2
- Electronic control system for automatic adjustment of basic operating modes managed by Siemens PLC
VÝHODY
- Easy-to-clean inner and outer surfaces
- Sliding trays in Airlock for easy material transfer (applicable with airlock)
- Oval holes with gloves for improved material handling