10/11 March 2020
Ph. Eur. chapter 2.9.20 ("Particulate Contamination: Visible Particles") is currently being revised; a draft is available and has been released for comments. Longer observation periods, if needed e.g. for coloured or turbid product solutions, and higher light intensities (if necessary) will be added. Furthermore, LEDs (light emitting diodes) will be included as a possible light source for particle observation. Hence, not much will change contentwise.
But Working Group 12 decided to develop a new chapter 5.17.2 ("RECOMMENDATIONS ON PARTICULATE CONTAMINATION: VISIBLE PARTICLES") with more details on the visual inspection of injectables. This informational, non-binding chapter is supposed to give an overview and background knowledge on visual inspection and the control of visible particles. Topics such as the classification of particles/defects, the AQL test on batch level, the qualification of manual visual inspection and fully automated visual inspection and other issues will be addressed. With chapter <1790>, the United States Pharmacopoeia (USP) also contains a non-binding, informational chapter. This chapter supplements the binding chapter <790>, which is more detailed than chapter 2.9.20 of the European Pharmacopoeia.
We will keep you updated on further news.