SHINVA · Injectables
Aseptic Test Isolator
SHINVA aseptic test isolator, designed to provide a Grade A internal environment during sterility testing. The fully sealed equipment ensures effective isolation between operators and inspection samples, reducing external cleanroom requirements and minimizing environmental influence on the process. It eliminates the risk of false negatives and false positives, providing a standardized, smooth and effective sterility inspection control flow.
Key specifications
- Internal environment: Grade A for sterility testing
- Isolation: fully sealed equipment between operators and samples
- Flow control: fluid dynamics software analysis with guaranteed airflow pattern, pressure and velocity
- Automation: automatic program control with PID display
- Traceability: electronic signature, batch record, reports, historical curves, audit trail and alarms
- Sterilization: integrated vaporized hydrogen peroxide sterilization system with log6 efficacy
- Modular design: electrical cabinet + transfer chamber + operation chamber
- Monitoring: online environmental monitoring system with in-situ sterilizable sampling line and independent report generation
- Ergonomics: seated operation according to ergonomic principles
Applications
- Pharmaceutical industry
- Biotechnology industry
- Sterility testing
- Quality control laboratories
- Cleanrooms and controlled environments
- Microbiological inspection
- Validation of aseptic processes
- False positive and negative analysis