Rapid Sterility Testing and Microbial Detection
Release sterile products in days rather than weeks, and run the sterility test in a closed, controlled system that reduces false results. Available across the UAE, Saudi Arabia and Egypt.
Why the conventional sterility test holds products back
The compendial sterility test (USP <71>, Ph. Eur. 2.6.1) incubates the sample in two culture media for 14 days before a result can be read. Every batch of a sterile product waits in quarantine for that time, which ties up inventory and delays the response when a problem does occur.
For products with a short shelf life the wait is more than an inconvenience. Cell therapies, for example, may need to reach the patient before a 14-day result exists, so release has to rely on other controls while the sterility result follows later.
The test also depends on how cleanly it is performed. Contamination introduced while the sample is filtered or transferred can produce a false positive, which triggers an investigation and a retest and can lead to a good batch being rejected.
How rapid methods and closed systems solve it
Arab Lab addresses the problem from two sides: a faster way to detect contamination, and a more controlled way to run the test.
Rapid detection uses ATP bioluminescence. Living microorganisms contain adenosine triphosphate (ATP); reagents isolate the microbial ATP and a luminometer measures the light produced, in Relative Light Units. On Promicol’s PRENOVA® platform, the Promilite M1 and M4 readers cut turnaround from the conventional 14 days to approximately 2 days. For T-cell therapies, the PRENOVA® TCT3 assay differentiates human from microbial ATP and shortens release to 2–3 days.
Test control comes from a closed sterility test system run inside an aseptic isolator. Tailin’s test pump and testing canisters keep the sample sealed from the environment, and its isolators, VHPS decontamination systems and glove leak testers maintain the aseptic conditions around the test. The system is designed to minimise false positive and false negative results.
An alternative microbiological method replaces the compendial test only after it has been validated for the product, following guidance such as USP <1223> and Ph. Eur. 5.1.6. Arab Lab’s Life Science team can discuss how an evaluation would fit your current method.
ATP bioluminescence readers
Promilite M1 and M4 on the PRENOVA® platform, and the NOVILITE luminometer for the TCT3 assay.
Cell therapy release
PRENOVA® TCT3 separates human from microbial ATP for T-cell therapy release in 2–3 days.
Closed sterility testing
Test pump and sealed canisters, so the sample never meets the room environment.
Aseptic isolators
Isolators with VHPS decontamination and glove leak testing to protect the test.
Partner technology
Two partners cover the two halves of the problem: Promicol for speed, Tailin for control.
Frequently asked questions
How long does a conventional sterility test take?
The compendial test in USP <71> and Ph. Eur. 2.6.1 requires 14 days of incubation before the result is read.
How does ATP bioluminescence detect contamination?
Microorganisms contain ATP. Reagents isolate the microbial ATP and a luminometer measures the light it produces, in Relative Light Units, so contamination is detected without waiting for visible growth.
Do regulators accept rapid sterility tests?
Regulators accept alternative microbiological methods once they are validated against the compendial method for the product. For licensed products, changing the release test is normally handled as a change to the marketing authorisation.
Why run sterility tests in an isolator?
An isolator separates the test from the room and the operator. Combined with a closed test system, it reduces the environmental contamination that causes false positive results.
Can rapid methods be used for cell therapies?
Yes. Promicol’s PRENOVA® TCT3 assay differentiates human from microbial ATP, shortening sterility-test release to 2–3 days for T-cell therapies.
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