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 integrated VHP 6-log decontamination.

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Fenggu Sterility Test Isolator FG-ISO-ST

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 an integrated VHP cycle 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. Six glove ports on the main working face and additional ports on the transfer chamber give operators full reach with no blind spots.

Key Features

Grade A / ISO 5 (Class 100) turbulent-flow environment with sustained positive pressure
Integrated VHP or ozone decontamination — 6-log spore-log reduction, validated per USP 1208
Supports both membrane-filtration and direct-inoculation sterility test methods
Main chamber plus independent transfer chamber for sterile material entry (custom sizes available)
SUS316L work platform, 6+4 glove-port layout, chemical-resistant sleeves
Siemens PLC and touchscreen, pressure-loss alarm, data export compliant with FDA 21 CFR Part 11

Technical Parameters

Cleanliness	Class 100 / ISO 5	Chamber pressure	−80 to +80 Pa, adjustable
Filtration	H14 HEPA, supply & exhaust	Rated power	1500 VA (test chamber)
Decontamination	VHP / ozone, 6-log	Material	SUS316L / 15 mm tempered glass
Main chamber	1906 × 1048 × 2200 mm	Transfer chamber	1206 × 1048 × 2200 mm

Chamber dimensions and glove-port layout are configurable to your workflow. Share your test method and throughput for a tailored configuration.

Applications

Sterility Testing Medical Preparation Inspection Cell-Therapy QC Veterinary Drug Control Microbiology Laboratories

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Tell us your sterility test method, pharmacopoeia standard and sample throughput, and our engineers will recommend a configuration.

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Frequently Asked Questions

What is a sterility test isolator used for?

It provides a stable Grade A / ISO 5 environment for pharmacopoeia sterility testing, protecting the sample from false-positive contamination and the operator from the tested product. Applications include sterility testing, cell-therapy QC, veterinary drug control and microbiology laboratories.

How is the isolator decontaminated?

Through an integrated VHP (or ozone) cycle designed for a 6-log reduction, confirmed by biological indicators during validation, so testing begins from a validated aseptic condition.

Does it run positive or negative pressure?

Chamber pressure is adjustable from -80 to +80 Pa, so the same unit can run positive (product protection for sterility testing) or negative (operator protection) as your method requires. Supply and exhaust are H14 HEPA filtered.

What are the chamber dimensions and materials?

Main chamber 1906 x 1048 x 2200 mm and transfer chamber 1206 x 1048 x 2200 mm as standard, in SUS316L with 15 mm tempered-glass viewing panels. Chamber size and glove-port layout are configurable.

Can the configuration be tailored to our test method?

Yes. Glove-port count and position, transfer interface and throughput are configured around your sterility-test method. Share your method and sample throughput for a tailored layout.