Particle Counting in Injectable Solutions

Liquid formulations, historically known as parenteral solutions, are now described as injectable solutions or injectables. They include opthalmics, ointments, I.V., vaccines, and others. Injectable solutions are packed as Large Volume Injectable (LVI) solutions, Small Volume Injectable (SVI) solutions, and dry powders requiring reconstitution as either LVI or SVI but most commonly as SVI.

USP, EP and JP have strict requirements for parenteral sterility. Requirements laid out by US (USP), European (EP), and Japanese (JP) Pharmacopoeia standards that demand that injectable solutions are effectively monitored for microcontamination, specifically nonsoluble particulates. It is important to have control over the limits of these non-soluble particles as they can prove to be deleterious to human health and also gauge how many particles can be deemed to be a safe limit.

In this paper we review counting particle specifications based on the type of injectable solution as well as the apparatus and methodologies you can use to demonstrate compliance.