Sterility test isolator STISO

Modular isolator technology for accelerated production processes

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Product safety is a top priority when filling pharmaceutical products. A sterility test isolator ensures batch sterility.

The STISO is a modular design, customized to your production needs and speeds-up batch release.

Benefits

Effective material transfer
Stable sterility tests
Protection of product, environment and operating staff
Fast reproducible decontamination
cGMP-compliant design

Applications Plug-and-test isolator STISO

The STISO sterility test isolator is ideal for aseptic (STISO) and aseptic-high-potency (STISOhp) applications, such as:

Sterility tests
Quality controls
Weighing and pre-dissolving highly active substances

Why you can count on STISO

Plug & test Pre-configured system for quick start-up

Optimal operational ergonomics Ergonomically located glove ports

Modular design For flexible applications

Temperature control Inside the work space due to an integrated cooling system

Wireless glove testing system Mechanical, integrated on the side of the housing; pre-installed test software in the HMI

Contamination-free exchange of air recirculation filter Maintenance without any additional protective measures

An employee in front of a sterility test isolator

loading the sterility test isolator from the side

employee working at a sterility test isolator

Discover the STISO

Efficient pre-cycle development and optimal decontamination

Optimizing decontamination processes at an early stage ensures efficient start to production. An internal VPHP simulation identifies H₂O₂ saturation zones, followed by STISO pre-cycle tests to homogenize the distribution. The parameters obtained create the basis for cycle development and validation. Further research into injection rate, temperature and gas distribution, and aeration refine the process. With STISO pre-cycle development, all important parameters are predefined – allowing for reduced on-site support and a faster production start.

Advantages of STISO pre-cycle development

Early optimization of decontamination processes

Identification and homogenization of H₂O₂ distribution

Sound foundation for cycle development and validation

Optimization of injection rate and gas distribution

Reduced on-site support time and faster production start

Accelerated time to market through predefined parameters

Precise environmental monitoring for maximum safety

The STISO’s Environmental Monitoring System (EMS) monitors temperature, humidity, pressure, and particle load in the isolator. It also ensures compliance with regulatory requirements and increases product safety. Sensors, data logs, and central software continuously record and analyze measured values. Alarms are triggered in the event of deviation. Remote monitoring is possible through a user-friendly interface. EMS detects deviations at an early stage, minimizes contamination risks, and stabilizes processes.

Do you have any questions about the sterility test isolator, or would like to discuss your requirements with our experts? We look forward to hearing from you.

Experts for isolator and biodecontamination

OPTIMA pharma containment GmbH

+49 7738 9280-0 Write e-mail

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Experts for isolator and biodecontamination

OPTIMA pharma containment GmbH

+49 7738 9280-0 Write e-mail

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