Sterility Test Isolator

Sterility Test Isolator
Sterility Test Isolator

View Other Series

The BIOMATRIX IsoFACT Sterility Isolator System provides a fully enclosed aseptic environment for pharmaceutical and biotechnology applications. Integrating advanced VHP bio-decontamination, Grade A unidirectional airflow, intelligent pressure control, and real-time monitoring, IsoFACT reduces contamination risks while ensuring reliable sterility assurance and GMP-compliant operation.


The system supports automated sterilization, leak testing, electronic records, audit trails, and process traceability compliant with GMP and FDA 21 CFR Part 11 requirements. IsoFACT is widely used for sterility testing, aseptic processing, pharmaceutical QC laboratories, and other contamination-sensitive applications.


KEY FEATURES

1. Integrated VHP Bio-Decontamination

Advanced aVHP technology delivers rapid and effective bio-decontamination with validated >6-log microbial reduction.

2. Grade A Unidirectional Airflow

H14 HEPA filtration delivers stable Grade A airflow conditions for reliable aseptic protection.

3. Fast Decontamination Cycle

Optimized sterilization and aeration processes enable fast turnaround within 2.5 hours.

4. Low-Temperature Sterilization

Minimal chamber temperature rise during VHP cycles protects temperature-sensitive biological products and sterile materials.

5. Fully Sealed Hard-Wall Chamber

Robust hard-wall structure with inflatable sealing technology ensures excellent containment and low leakage performance.

6. Data Integrity Compliance

Supports electronic records, audit trails, batch management, and FDA 21 CFR Part 11 compliance.

7. Intelligent PLC Control System

Touchscreen HMI with automatic/manual operation, parameter management, and multi-level user access control.


APPLICATIONS

1. Sterility Testing: Designed for pharmaceutical sterility testing under fully aseptic conditions.

2. Aseptic Processing: Suitable for aseptic transfer, filling, and contamination-sensitive operations.

3. Biotechnology: Widely used in biological products, cell therapy, and gene therapy applications.

4. Pharmaceutical QC Laboratories: Provides reliable contamination control for microbiological quality control environments.

5. Research & Development: Ideal for laboratories requiring validated aseptic containment systems.


OPTIONAL CONFIGURATIONS



ModelIsoFACT 2TIsoFACT 3TIsoFACT 4T
Number of Gloves in Main Chamber224
Number of Operators112
Overall Dimensions W x H x D2270*850*24302217*1160*21702417*1160*2170
Main Chamber Internal Dimensions, W x H x D, in mm1200*630*7001595*650*7001795*650*700
Transfer Chamber Internal Dimensions, W x H x D, in mm595*515*700595*515*700595*515*700
Chamber TypeRigid Wall Isolator
Material of ConstructionSUS304SUS316L
Chamber Cleanliness ClassificationDynamic Grade A (As Required)
Power SupplyAC220V±22V
Frequency50Hz±1Hz
Power Consumption3500W
Control SystemSiemens PLC
Hydrogen Peroxide Concentration During Decontamination400-500PPM
Chamber Pressure Control Range-80-80Pa
Leakage Rate≤0.5%vol/h
Noise Level≤75dBA
Main Chamber Supply Air FilterHEPA, H14
Transfer Chamber Supply Air FilterHEPA, H14
Main Chamber Return Air FilterHEPA, H14
Transfer Chamber Return Air FilterHEPA, H14
Illumination300LX
Isolator Airflow PatternLaminar Flow
VHP Decontamination Cycle TimeTransfer Chamber: ≤35 min, Main Chamber: ≤70 min
Chamber Temperature Rise1℃-3℃
Sterilant Solution30% Hydrogen Peroxide Solution
Decontamination EfficiencySLR6
Standard Features21 CFR Part 11 Audit Trail
SCADA Software Architecture
Automatic Leak Testing
Positive Pressure
PAO/DOP Test Port
Compressed Air Dehumidification
Desiccant Dehumidification
Differential Pressure Gauge
Temperature & Humidity Sensor


Request a Quote

If you have any questions or comments, please fill out the form

+86 15806557756

+86-532-87890321