Aseptic test isolator for sterility inspection
Ensure stringent sterility control in your laboratory or production line with an aseptic environment, minimizing contamination risk and maintaining the integrity of sensitive pharmaceutical and biologic products.

Ensures Sterility in Pharmaceutical Operations
The Aseptic Test Isolator from Shinva presents a reliable solution for manufacturers in the pharmaceutical and biotechnology sectors, targeting the sterility challenges in injectable drug production. It features a fully sealed, Grade A isolation chamber that mitigates contamination risks, enhancing sterility testing processes. By using integrated vaporized hydrogen peroxide sterilization, the system achieves a sterilization level of log6, ensuring extensive decontamination. Deploying automatic program control with PID interface, it facilitates precise data analysis, including batch recording and electronic signatures, essential for compliance with GMP standards. The isolator’s modular design promotes seamless integration into existing production lines, while its ergonomic sitting operation provides convenience for laboratory and healthcare settings. Additionally, an online environmental monitoring system ensures continuous, contamination-free processes, further supporting stringent sterility requirements.
Benefits
- Ensures contamination-free processes with a fully sealed Grade A isolation environment.
- Minimizes external interference, reducing false results in sterility testing.
- Achieves rapid sterilization through integrated vaporized hydrogen peroxide, ensuring compliance with regulatory standards.
- Enhances operational efficiency with modular design and ergonomic features.
- Facilitates comprehensive data management for improved quality control and traceability.
- Applications
- Laboratory equipment,Sterility inspection,Pharmaceutical equipment,Biopharmaceuticals,Medical device
- End products
- Sterile injectable drugs,Biologic drug substances,Aseptic packaged pharmaceuticals,Sterile infusion solutions,Aseptic lab samples
- Steps before
- Purification,Sample Collection,Preparation,Filtration
- Steps after
- Sterilization,Packing,Data Analysis,Documentation,Reporting
- Input ingredients
- inspection samples,external environment
- Output ingredients
- sterility inspection control process,data report,historical curve,audit trail,historial alarm
- Market info
- Shinva is known for manufacturing medical equipment, including sterilization and disinfection devices, radiotherapy products, and diagnostic imaging systems, demonstrating expertise in healthcare solutions and a strong reputation for quality in the medical industry.
- Internal operating environment grade
- Grade A
- Automation
- Automatic program control
- PID interface display
- Enabled
- Sterilization system
- Vaporized hydrogen peroxide
- Sterilization effect
- Log6
- Design structure
- Modular (electric cabinet + transfer chamber + operation chamber)
- Environmental monitoring system
- Online,integrated
- Sampling pipeline sterilization
- Online
- Operation design
- Sitting operation
- Automation level
- PLC / PID interface
- Cleaning method
- Integrated vaporized hydrogen peroxide sterilization
- Batch vs. continuous operation
- Batch
- Environmental monitoring
- Online system with independent report generation
- Ergonomics
- Sitting operation design
- Modular design
- Electric cabinet + transfer chamber + operation chamber
- Data management
- Electronic signature,batch record,audit trail
- Density/particle size
- 0.5–2.5 g/cm³ / 50–1000 µm
- Control panel type
- PID interface display
- Discharge method
- Modular design with transfer chamber
- Operation design
- Sitting operation design
- Control panel type
- PID interface display
- Integration possibilities
- Modular design for expansion
- Ergonomics
- Sitting operation design