Sterility Test Isolator
A stable Grade A (ISO 5) environment for pharmacopoeia sterility testing — protecting the sample from false positives and the operator from the tested product, with a reserved VHP generator port for 6-log decontamination.
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Overview
The Fenggu Sterility Test Isolator delivers a stable Grade A (ISO 5) environment for pharmacopoeia sterility testing, protecting both the sample from false positives and the operator from the tested product. A rigid stainless-steel platform combined with a transparent enclosure maintains positive or negative pressure as required, while a VHP cycle, via a reserved generator port, achieves a 6-log sporicidal reduction of the chamber and all exposed surfaces before testing begins. The design supports both membrane-filtration and direct-inoculation methods per pharmacopoeia requirements.
A combined main chamber and transfer chamber allow material to enter without breaking sterility; each can also be operated independently. The standard work chamber has 4 front-mounted gloves, with single- or double-sided configurations and additional transfer-chamber ports available to suit the application.
Key Features
- Grade A / ISO 5 (Class 100) unidirectional (laminar) airflow environment with sustained positive pressure
- Reserved port for a vaporized hydrogen peroxide (VHP) generator, achieving 6-log sporicidal reduction of the chamber air and exposed surfaces (subject to validation)
- Supports both membrane-filtration and direct-inoculation sterility test methods
- Main chamber plus independent transfer chamber for sterile material entry (custom sizes available)
- SUS304 exterior / SUS316L internal chamber, 4 front-mounted gloves standard, CSM chemical-resistant sleeves
- Siemens PLC and touchscreen, pressure-loss alarm
- Electronic data storage and export; software compliant with FDA 21 CFR Part 11; validation per USP <1208>
Technical Parameters
| Cleanliness | Class 100 / ISO 5 / Grade A | Chamber pressure | −80 to 150 Pa, adjustable |
|---|---|---|---|
| Filtration | H14 HEPA, supply & exhaust | Rated power | 4 kW (test chamber) |
| Air velocity | 0.36–0.54 m/s | Material | SUS316L / 15 mm tempered glass |
| Biodecontamination efficacy | ≥6-log reduction (subject to validation) | Max. sterility-test pump flow | 300 mL/min |
| Main (test) chamber | 1900 × 950 × 2400 mm (custom sizes available) | Transfer chamber | 700 × 950 × 2400 mm (custom sizes available) |
Applications
Request a datasheet or quotation
Tell us your sterility test method, pharmacopoeia standard and sample throughput, and our engineers will recommend a configuration.
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