BLOCK Technology

Sterility Test Isolator

Sterility Test Isolator

Description

• Single-chamber isolator for sterility testing
• Chamber with 4 sleeves for work with sterile materials
• Possible to add airlock chamber and provide sterilization with with H2O2
• Leak tightness class 3 according to ISO 10648-2
• “A” class cleanliness according to EU GMP
• “Audit Trail” Compliant
• Option to decontaminate with H2O2
• Electronic control system for automatic adjustment of basic operating modes managed by Siemens PLC
• Colour touchscreen control
• Jacket material: stainless steel AISI 304
• Chamber material – AISI 316L with a thickness of 3.00 mm
• Polished surface finish, Ra < 0.6 µm
• Inlet filtration HEPA H14 - “A” Class cleanlinnes
• 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
• Laminar flow 0,45 m/s ±20%
• Positive pressure mode

Parts

1. Visual and acoustic alarm
2. HMI panel
3. Working chamber
4. Main switch
5. F5 Pre-filter
6. Front window
7. Clamp for connection of a ball valve or waste piping
8. Equipped with a connection for a RTP (rapid transfer port)
9. Equipped with a connection for an airlock
10. Panel for a connection to an external H2O2 generator (Puriter)
11. Service panel
12. Sensors for monitoring safe window closure

Display

HMI Panel

This isolator control system is operated with a Siemens color touch screen. The Simatic control system from Siemens together with a foot operated switch creates an intuitive and user-friendly experience. The screen displays the actual parameters of the environment and monitors emergency statuses. The system includes remote access for customer service support. As required, it is possible to implement connection to an additional device for production data storage and export.

Overview of Functions

• User login and automatic log-off countdown timer
• Illumination control icons
• Chamber interior physical values measurement display
• Device Operation modes menu, Alarms and Settings menu