USP Particulate Testing

Microtest has long familiarity with particulate testing for drugs and medical devices to United States Pharmacopeia (USP) specifications. Testing is performed at our laboratories by experienced regulatory microbiologists.

All procedures take place under certified Class 100 laminar flow hoods. Glassware and filtration apparatuses are rinsed with sterile water for injection before use. Samples can include both raw materials and finished products in original containers. To ensure integrity, we run a negative control with each sample.

Microscopic Method:
Drugs or raw materials are examined microscopically. Our specialists rinse the sample device with deionized water, which is then run through a 0.8 micron filter; the resultant liquid is then examined.

Any particles found are categorized into one of three groups:
• Linear dimension equal to or greater than 10 micrometers
• Linear dimension equal to or greater than 25 micrometers
• Fiber material (length at least 10 times width)

Naturally, our USP particulate testing methodologies are designed to eliminate any additional contamination during sample transport, handling, and testing.

Laser Particle Count Methods
Drugs or raw materials are examined using calibrated particle counters.

Any particles found are categorized into one of two groups:
• Linear dimension equal to or greater than 10 micrometers
• Linear dimension equal to or greater than 25 micrometers

Naturally, our USP particulate testing methodologies are designed to eliminate any additional contamination during sample transport, handling and testing.