Aseptic Isolation Technology

Aseptic Isolation Technology

Isolation technology is a fast-growing trend among first-class pharmaceutical and Biotechnology companies around the world. Today, the use of isolators has become standard practice for sterility test.

Features
1 Two chambers, Transfer Chamber and Testing Chamber
2 Dual-Gates transmission technology
3 Sterility Test Pump can be integrated in Testing Chamber
4 With sanitization System: Hydrogen Peroxide Vapor System
5 Remote Control System: Pressure control and monitoring, ensures the environment figures can be controlled and traced.
6 Independent air handling system with HEPA filters for each chamber.
7 All system can be custom-made
Specifications Sterility Test Isolator for SCAN RDI General Requirements
Chamber working area in mm 1100x540x750mm ( Isolator inner size ) 600x540x750mm (T chamber inner size) or as per URS.
Construction SS 316L for working chamber
Height adjustment Not automatic Can adjust it by hand
Glove ports 2 ports of isolator and 1 port of transfer chamber)
Sterilization method H202 Fogging technology
Circulation of H202 unidirectional air flow = Turbulent air flow
Decontamination time till reducing less than 1 ppm Automatic and manual for choice. 20 minutes for decontamination and aeration time is approx. 20 min cycle time 3:30 min
Concentration of H202 35% H2O2, supply empty solution bottle for adding H202
VHP Low concentration sensor Included H2O2 Monitoring System – High Level chamber reading
VHP High concentration sensor Included H2O2 Monitoring System – Low Level chamber reading
RH/TEMP Sensor Temperature sensor is provided inside the chamber for Monitoring the chamber temperature
BI indicator provided at additional cost
CI indicator included with package
Glove holder Available
Sample racks Available
Supporting area class C or D
Real Time printer Available
Compressed air line Available
Exhaust through HEPA filter class H14
One IPC for all VHP cycles , NVPC , VPC , Glove integrity Available
H202 impact 6 log reduction on product during sterilization (kill)
Waste collection provision can be provided .additional cost
Cleaning drain Provided
Functional Requirements
Pass box with sterilization Included transfer chamber
Integrated incubator Isolator and sealing well. The device body will be outside of isolator and temperature: 25-30degree.
RTP port Included it to connect with Transfer chamber.
Concentration of H202 monitor Inside Isolator Fully integrated Hydrogen Peroxide Gas generator. H2O2 concentration monitoring sensor available.
Residual allowable limit Less than 1ppm
Wireless Glove integrity tester Included, 1min. can get test result