Sub-visible Particle Count
BACKGROUND:
Injections or infusions may be contaminated with mobile and undissolved extraneous particles which may then pose a danger to patients receiving the treatments. To minimize the risk of harm to the patient, pharmacopoeias include methods for the determination of sub-visible particle counts and set limits. At Eurofins | ams, particle counting is carried out using techniques that are compliant with the USP and BP/EP pharmacopoeias for parenteral / injectable solutions, ophthalmic solutions, medical devices and water, these include:
-
Sub-visible particle counting using a light obscuration particle counter
-
Sub-visible particle counting investigation using a light microscope
PRINCIPLE:
Sub-visible particle counting using a light obscuration particle counter
This method is generally the method of choice and is carried out with the aid of a HIAC/ROYCO particle counter. It works on the principle of light blockage, which then automatically determines the size and number of particles present in a sample.
Sub-visible particle counting investigation using a light microscope
The sample undergoing test is filtered and the membrane filter is manually examined under binocular microscope for any particles.
SAMPLE REQUIREMENTS
- Container size >25 ml: 2-10 Containers
- Container size <25 ml: 10 or more containers required to obtain a pooled volume of not less than 40ml.
- Medical devices for infusion: 1-10 devices, as long as the total extracted volume is ≥ 40ml.
