Solutions used for injection are tested for particulate material. This involves visual inspection and testing for particles that may be hard to see grossly. The nature of the testing depends on the type and volume of the injectable solution.
Injectable
Code
Volume
Example
small volume
SVI
<= 100 mL
drug vial
large volume
LVI
> 100 mL
saline infusion bags
Tests for particulates:
(1) light obscuration particle count test
(2) microscopic particle count test
An injectable that is filtered during administration does not need to undergo the particulate testing.
Particle sizes counted:
(1) >= 10 µm
(2) >= 25 µm
Normally the light obscuration test is done on most injectable solutions.
The microscopic particle count test is performed if:
(1) the injectable is an emulsion
(2) the injectable fails the light obscuration particle count test
Acceptable Limits Using the Light ObscurationCount Test
Injectable
Number of Particles
>= 10 µm
Number of Particles
>= 25 µm
small volume
< 6,000 per container
< 600 per container
large volume
< 25 per mL
< 3 per mL
Acceptable Limits Using the Microscopic Particle Count Test
Injectable
Number of Particles
>= 10 µm
Number of Particles
>= 25 µm
small volume
< 3,000 per container
< 300 per container
large volume
< 12 per mL
< 2 per mL
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