Modular sterility testing isolator
The ST-IS is a GMP Grade A (ISO 5) modular sterility testing isolator designed to
support safe and controlled quality control operations. Developed for sterility testing
in accordance with pharmacopeial requirements, the system provides a compact and
practical solution for pharmaceutical and biotech environments. A compact
configuration (CST-IS) is also available.
Operation
The ST-IS features a dual-chamber configuration to maintain aseptic conditions
throughout the testing workflow.
Materials are first introduced into the transfer chamber, where an integrated
vaporized hydrogen peroxide (VPHP) cycle performs the biodecontamination
process. Once completed, materials can be safely transferred into the processing
chamber without compromising its aseptic environment.
The working chamber is equipped with an integrated peristaltic pump to support
consistent and controlled sterility testing activities. The modular design allows
adaptation to specific process and laboratory requirements.
Integrated glove integrity testing
The ST-IS series can be equipped with the integrated AGLTS 2 automatic glove leak
testing system. This supports structured glove integrity testing in line with ISO
14644-7 Annex E.5 and Annex 1 requirements.
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