Particle analysis
(visible & invisible).
For the identification and root cause analysis of particles in sterile products.
Do you want to ensure that your sterile products are free of harmful particles—and understand the causes of potential contamination at the same time? Checking for visible and sub-visible particles is a key part of quality assurance and is strictly monitored by regulatory authorities such as the EMA and FDA. Even the smallest deviations can pose risks to patient safety and product approval.
Our particle analyses not only provide you with evidence of whether foreign particles are present—we also identify their chemical composition and origin. This allows us to create security for your production and transparency for your regulatory dossiers.
Our methods at a glance:
- ATR-FT-IR microscopy – high-precision identification of visible and sub-visible particles, including chemical material determination. This allows both organic and inorganic residues to be clearly characterized.
- Root cause analysis – we not only determine which particles are present, but also identify their origin: from packaging materials and process disruptions to environmental influences. This information is crucial for preventing contamination in the long term and ensuring that processes comply with regulations.
On request, we can also provide additional support with method development and validation. This ensures that your testing strategy meets the requirements of the relevant pharmacopoeias and is recognized during audits and inspections.
Your advantage: With CUP Contract Labs, you receive reliable, GMP-compliant particle analyses—for safe products and regulatory compliance.
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CUP Contract Labs is our key vendor for radiopharmaceutical analyses.
