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