When developing or manufacturing sterile medicines, patient safety is paramount. Yet, challenges arise from short shelf lives and urgent clinical need. Some products demand rapid testing and a seamless transition from traditional to rapid methods, all while maintaining full regulatory compliance. 

At Eurofins BioPharma Product Testing (BPT) network of laboratories, we understand the complex demands you face. That’s why we deliver end-to-end sterile product testing services that combine scientific excellence, robust processes, and industry-leading turnaround times. Our expert teams support your compliance with USP, Ph. Eur., and other regulatory standards, ensuring your product is safe, sterile, and ready for market. Our sterility testing encompasses standard and rapid sterility testing, Bacterial Endotoxins testing, and Particulate Matter. We provide the full scope of testing to ensure your product is safe.

Traditional Sterility Testing
Sterility testing is a critical process used to confirm the microbiological safety of sterile medicinal products. Its purpose is to verify that a product is free from viable microorganisms. Testing must be conducted under aseptic conditions, either in an isolator or a sterility testing cabinet, and is performed using one of two validated methods: membrane filtration or direct inoculation. The appropriate method is selected based on the characteristics of the product.

Eurofins BPT offers a range of established sterility testing setups. These support a wide variety of product types, including traditional pharmaceuticals, biopharmaceuticals, cell lines, and genetically modified Advanced Therapy Medicinal Products (ATMPs). Wherever control of sterility is required, we provide accurate, compliant testing backed by deep expertise and global regulatory knowledge.

Our laboratories conduct each test under aseptic conditions in accordance with the latest requirements set by key international and national pharmacopeial standards:

• Ph. Eur. 2.6.1
• USP <71>
• JP 4.06
• ISO 11137

Rapid Sterility Testing
For products with short shelf lives, especially ATMPs, speed is critical. Our rapid sterility testing methods are validated and optimised for faster turnaround times, without compromising reliability. Utilising several validated technologies, such as the BacT/Alert® 3D system, RedOne™ or Celsis®, these testing methods allow you to initiate investigations and corrective actions early in the process. 

Bacterial Endotoxins and Particulate Matter
We also provide testing for bacterial endotoxins and particulate matter. These services are seamlessly integrated into your sterility testing package, helping you meet all quality and safety standards in one streamlined process.