ENDOTOXIN
TEST

What is the definition of endotoxins?

Endotoxins are components of Gram-negative bacterial cell walls that are resistant to heat and are a significant concern for the pharmaceutical and medical device industry in terms of safety and quality. These toxins are capable of causing fever and illness when they enter the bloodstream. Therefore, the detection of endotoxins in injectable pharmaceutical products or on medical devices that come into contact with blood is crucial for ensuring safety.

How is the testing conducted?

Austrianova utilizes a quick testing approach called the Charles River Endosafe®-PTS™ system. This method utilizes kinetic chromogenic techniques with specific quantities of LAL (Limulus amoebocyte lysate) reagent, chromogenic substrate, and control endotoxin pre-loaded in a four-channel cartridge. The FDA approved cartridges are extremely sensitive and designed to detect very low levels of endotoxin (as low as 0.005 EU/mL) and the results are reported as Endotoxin Units (EU)/mL. This testing method aligns with the current bacterial endotoxin test outlined in the US Pharmacopeia. Both the British Pharmacopoeia Commission and the European Directorate for the Quality of Medicines and Health Care have confirmed that this test complies with the requirements outlined in the current harmonized test.

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STERILITY
TEST

Austrianova offers fast GMP standard rapid sterility testing at its GMP facility in Thailand that provides interim results within 3 days and official results within 7 days along with a Certificate of Analysis, all completed in less time than traditional compendial methods. By utilizing the BioMerieux BacT/Alert 3D system, we assist in reducing product cycle times and enhancing overall production efficiency through rapid sterility testing.

Why Select Austrianova?

With quicker detection capabilities, we aid clients in minimizing the financial and operational consequences of a contamination incident by promptly initiating investigations and corrective measures.
We support bio/pharmaceutical companies in transitioning from the conventional compendial sterility approach to a fully-validated rapid method. Our Services include a 3-day Certificate of Analysis based on interim test outcomes.
We supply BacT/Alert culture bottles to clients for sampling during manufacturing processes, eliminating the need for secondary transfers and reducing potential sources of microbial contamination.
Our extensive and adaptable team of 4 microbiologists, with over 20 years of experience catering to the bio/pharmaceutical sector, offers vast capacity.

About BacT/Alert 3D Technology

BioMerieux developed the BacT/Alert 3D microbial detection system as a fully automated solution based on their patented colorimetric technology that detects microbial growth by monitoring CO2 production. This system incubates, agitates, and continuously monitors culture bottles for microbial growth using solid-state reflectometers.
This technology offers several benefits, including faster testing timelines with sample results available in less than 7 days compared to the 14-day incubation needed for traditional sterility tests. Moreover, turbidity caused by cellular components of debris in the sample does not affect the system’s results, making it suitable for testing a wide range of products.
The BacT/Alert 3D system accommodates various sample types, sizes, enrichment broths, and volumes, and is widely accepted as an efficient alternative for testing products with short shelf lives. With quicker microbial screening and reduced production cycle times, this method delivers substantial cost savings and efficiencies.

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