Contaminants and Impurities

Even trace contaminants can compromise the safety, performance, and approval of a biomedical device. Identifying and quantifying impurities is essential to maintain product integrity, prevent recalls, and satisfy ISO and FDA standards. Invision Biomedical provides advanced contaminant and impurity analysis to safeguard your devices from hidden risks.

Applications & Methods

Particulate Matter Detection

Sensitive imaging and chemical analysis detect microscopic particles before they reach patients.

Organic and Inorganic Impurity Profiling

Advanced methods identify trace compounds across multiple chemical classes, ensuring materials are pure.

Root Cause Analysis

Testing helps determine contamination sources, from raw materials to manufacturing environments.

Regulatory Compliance Support

Data packages are aligned with ISO and FDA expectations, minimizing regulatory setbacks.

Frequently Asked Questions

What qualifies as a contaminant or impurity?
Any unintended chemical, particulate, or compound present in a device that may impact safety or performance.
Using advanced microscopy, chromatography, and spectrometry techniques to identify compounds at trace levels.

They can cause irritation, toxic reactions, or long-term health risks, making their elimination essential.

Through precise testing, validated methods, and root cause investigations that protect patients and support approvals.

Protect Device Quality with Contaminant Analysis

Our impurity testing ensures your devices meet the highest safety standards and patient expectations.