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.

General


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.

Technical Specifications


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

Operating Characteristics


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

Material Compatibility


Density/particle size
0.5–2.5 g/cm³ / 50–1000 µm

Physical Characteristics


Control panel type
PID interface display
Discharge method
Modular design with transfer chamber
Operation design
Sitting operation design

Custom Options


Control panel type
PID interface display
Integration possibilities
Modular design for expansion
Ergonomics
Sitting operation design