Particulate Contamination Testing

The FDA requires that intravenous and infusion medical device manufacturers provide data regarding particulates in or on their devices and evaluate how they may affect patients. When a medical device is deployed or exposed to a patient, it may release particles that lodge in the vascular capillary system.

How harmful the particles are depends on their size, shape, composition, and where and to what degree they cause an occlusion. Possible sources of particulate contamination include the manufacturing process, the environment, the product packaging or the device itself.

SAXOCON has the tools and laboratory setup to provide you with comprehensive data to document whether your device is within acceptable particulate limits, including:

• Class N2 clean workspaces
• Filtration units
• Optical microscopes for analysing filters
• Automated particle count capabilities.

Why choose us?

SAXOCON analytical services for particulate contamination testing give you access to:

• Extensive expertise in fast particle counts according to UPS guidelines
• A multidisciplinary team of highly skilled scientists and experts
• We are ISO 13485-certified and work with GLP-based standards

Delivery

SAXOCON generates, compiles, and delivers reports according to the latest UPS guidelines within days after receipt of the samples.

This service helps you comply with the following standards and guidelines: