SAXOCON provides microscopic particle count testing in accordance with Method 2 in USP-NF (788). Testing is conducted in our Class N2 clean workspace according to our internal protocols to guarantee the precise identification and measurement of particles that satisfy ISO standards and are essential for preserving product safety.
Our service covers:
- Preparation and filtration of samples
- Obtain images of the filters with optical microscopy
- Data processing of the images and a particle count of the entire surface of the filter(s
- Delivery of a final report and data evaluation
Final reports are delivered within a maximum of five working days after SAXOCON has received the samples.
USP-NF (788) sets the standards for acceptable particulate matter levels in injectable drug products. Following these standards allows you to ensure your products are free from harmful levels of particulate contamination, which can cause adverse effects when introduced into the bloodstream.
Knowing what is in your drug products is essential to ensuring their safety. Particle contamination from packing, production tools, or delivery devices can occur at any point in the manufacturing process, packaging, or storage. You need to know what particles are present, where they come from, and how to mitigate or eliminate them to get your items to market, keep them there, and avoid last-minute delays.
Read more about our particulate services here.