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Sterility suitability testing: why it matters for reliable sterility test results
Sterility testing is a critical quality control requirement for products that must remain sterile during their intended use, including pharmaceuticals, medical devices and other healthcare products.
Sterility testing is a critical quality control requirement for products that must remain sterile during their intended use, including pharmaceuticals, medical devices and other healthcare products. To meet sterility testing requirements and support reliable contamination detection, it is essential to verify that the sterility test method is suitable for the specific product being tested.
At ALS, we perform sterility suitability testing in accordance with Ph. Eur. 2.6.1, USP <71>, and for medical devices, SS-EN ISO 11737-2, helping clients meet applicable international standards and regulatory requirements.
Why sterility suitability testing matters
Sterility methods depend on microorganisms being able to grow in the selected culture media if contamination is present. Some products may inhibit microbial growth because of formulation components, antimicrobial properties or design-related factors, creating a risk that contamination will not be detected.
Sterility suitability testing confirms that the test method and culture media can recover microorganisms in the presence of the product. This reduces the risk of false negative results and supports confident decisions in method validation, routine sterility testing and batch release.
How our Sollentuna team works with you
We work collaboratively to align sterility suitability testing with your product type, timelines and regulatory pathway.
Understanding your product and intended sterility method
We review your product, intended test approach, such as direct inoculation or membrane filtration, and assess potential inhibition risks.
Defining the suitability plan
We define challenge organisms, acceptance criteria and the testing strategy in line with the relevant standards and your objectives.
Laboratory execution
Testing is performed in our GMP-compliant laboratory in Sollentuna, Sweden, with transparent communication throughout the project.
Reporting and next steps
You receive a comprehensive report with clear conclusions on method suitability and recommendations if adjustments are needed.
What we test and how we handle challenging products
What is a sterility suitability test?
A sterility suitability test, often referred to as a Bacteriostasis/Fungistasis (B/F) test, confirms that the test method does not inhibit microbial growth in the culture media used during sterility testing.
The study typically involves inoculating the product with controlled, low levels of challenge microorganisms, including bacteria, yeast and/or fungi, and evaluating:
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Bacteriostasis: the sample does not inhibit bacterial growth
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Fungistasis: the sample does not inhibit fungal growth.
Handling complex or inhibitory products
For products with antimicrobial properties, challenging matrices or complex medical device designs, ALS supports appropriate adjustments and reagents in line with the relevant standard and method. This helps demonstrate reliable microbial recovery and suitable method performance.
Quality, sustainability and a lifecycle mindset
ALS supports robust sterility method performance from early suitability work through routine testing. By confirming method suitability early in development, we help customers reduce rework, shorten investigation timelines and strengthen long-term testing readiness while maintaining data integrity and compliance.
Partner with ALS
Whether you need Bacteriostasis/Fungistasis testing for pharmaceuticals or medical devices, sterility validation support, or tailored protocols for complex products, ALS provides reliable and regulatory-aligned sterility suitability testing.
Method development and validation: a clear path to reliable analytical results
At ALS, we provide reliable analytical methods across the full lifecycle for pharmaceutical, biotech and chemical industries, supporting your quality, compliance and decision-making journey through expert development, validation and transfer.
Microbiological suitability testing for bioburden: the foundation for reliable results
At ALS, we provide microbiological suitability testing to support reliable detection of viable microorganisms in complex or antimicrobial products, confirming methods are fit for purpose and compliant with global pharmacopoeial standards.
Endotoxin suitability testing: the foundation for reliable bacterial endotoxin test results
At ALS we support accurate endotoxin results with suitability testing. We verify bacterial endotoxin test performance for complex products, supporting regulatory compliance, reliable recovery, and GMP-quality data.