Sterility
test isolation

A positive sterility test can place an entire batch on hold. But when contamination originates from the testing environment, the result triggers investigations, retesting and release delays without revealing a manufacturing failure.

At the opposite extreme, residual H₂O₂ can inhibit microbial recovery and conceal contamination.

EU GMP Annex 1, FDA cGMP, WHO GMP and the associated pharmacopoeias therefore require sterility testing to be performed under controlled aseptic conditions, because the test environment must neither create contamination nor suppress its detection.

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WE BRING CONTAMINATION-CONTROL PROCESS DISCIPLINE TO STERILITY TESTING ISOLATION, COMBINING AN ISO 5 / EU GMP GRADE A ENVIRONMENT WITH AN INTEGRATED, FEEDBACK-CONTROLLED H₂O₂ BIO-DECONTAMINATION SYSTEM.

The difference is direct process control.

Instead of relying on the quantity of peroxide injected or on estimated chamber conditions, the system measures the H₂O₂ concentration achieved in the vapor phase and governs it through a feedback loop.

The result is stable H₂O₂ concentration within ±15 ppm—even when load patterns change. Measured Bio-decontamination. Protected Test Integrity.

BATCH-RELEASE TESTING FOR STERILE DRUG PRODUCTS

For injectable liquids, freeze-dried drugs, sterile antibiotic powders and other sterile preparations, isolation prevents contamination introduced during testing from being attributed to the manufactured product.

HIGH-THROUGHPUT QUALITY-CONTROL LABORATORIES

Modular chambers, configurable glove ports, custom racks, a dedicated transfer pass-box and an internal trolley support continuous material flow across multiple products and testing procedures.

Which regulatory and pharmacopoeial requirements does the technology address?

The system is designed for sterility testing under EU GMP Annex 1, FDA cGMP and WHO GMP requirements and supports test execution according to USP <71> and Ph. Eur. 2.6.1 within an ISO 5 / EU GMP Grade A environment.

Why perform sterility testing inside an isolator?

The isolator separates the test from operators and the surrounding environment, reducing the risk that contamination introduced during testing generates a false-positive result, an unnecessary investigation or a delayed batch release.

What differentiates Fedegari’s H₂O₂ process?

Fedegari directly measures and controls H₂O₂ concentration in the vapor phase. The feedback loop maintains concentration within ±15 ppm instead of relying only on the programmed quantity of peroxide injected.

How does the system protect against false-negative results?

Residual H₂O₂ can inhibit microbial recovery. A dedicated low-range sensor monitors the aeration phase until the defined residual threshold is reached before testing begins.