The United States Pharmacopeia (USP) invites interested parties to suggest changes and amendments to US Pharmacopeia chapters by publishing so-called Stimuli Articles in the Pharmacopeial Forum (PF). The recently published article suggests an additional testing of parenteral products. This testing is supposed to be conducted after the 100% control in the process and to substantiate the required "essentially free" of visible particles.
This article starts with a critical view on the risk emanating from single visible particles in parenterals. Despite 15 Billion injections per year, the article states, no cases of sanitary impairment are noted demonstrably caused through single visible particles. In addition to the very interesting historical development of the testing for particles in American medicinal products the article picks up the old discussion what "essentially free" of visible particles exactly means. This quite elusive specification originated from the desire for particle free medicinal products and the fact that the required 0 particles cannot be fulfilled with the available technologies and packaging materials.
Based on the Federal Standard 142a from 1962 respectively 1970, according to which parenterals were tested for decades for the American government respectively military, the authors suggest an additional testing as an amendment to the general chapter <1> of USP "Injections" which is supposed to be conducted as a release testing in addition to the still required 100% testing during the process. According to the authors, sampling is to be made according to ANSI/ASQ Z1.4*, and testing for visible particles has to be conducted without magnification at a defined illumination in front of a white and black background and an acceptance criterium according to AQL 0,65. Essentially free of visible particles is fulfilled, if the number of samples not containing visible particles is smaller than the defined number.
The complete article can be found here.
Dr. Rober Eicher
On behalf of the European Compliance Academy (ECA)
*ANSI/ASQ Z1.4.-2003 Sampling Procedures and Tables for Inspection by Attributes. American Society for Quality