Monday 17 January 2022

Subvisible particle testing: Towards international harmonisation


The compendial text for subvisible particles, an important release test for liquid parenteral solutions and other pharmaceutical products, is being revised with the aim of achieving harmonisation between the European, U.S., and Japanese pharmacopeia. The revision process will include an expansion of scope (in relation to the range of products to be examined). This article looks at subvisible particle testing, considering its importance and key issues, before concluding with a consideration of the intended pharmacopeial revision. Non-visible particles are allowed, the limit values depend on the size and the test method used. Particles smaller than 25┬Ám are considered subvisible.



Tim Sandle has written a new article on this subject in GMP Review.


Sandle, T. (2021) Subvisible particle testing: Towards international harmonisation, GMP Review, 20 (2): 9-12


 Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

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