Visible particles (those greater than approximately 50 microns) in finished products are normally detected through visual inspection of the end-product by trained operators under controlled conditions. There are ongoing efforts to partially or completely automate this process and there is a Visible Particle Interest Group in the Parenteral Drug Association (or PDA).
In the sub-visible range (less than 50 microns), US Pharmacopeia (USP), European Pharmacopeia (EP) and Japanese Pharmacopeia (JP) specify the protocols, equipment and acceptable limits for particulate matter in injectables. The respective web sites and reference documents are www.usp.org Chapter 788, www.pheur.org General Notice 1 Section 2.9.19 and jpdb.nihs.go.jp/jp14e/ Chapter XIV Section 24. Presently there are separate standards however the requirements are being harmonized across all three jurisdictions.
There is one specific document that you need to read, USP <788>. The current version of USP is 30, it is released annually and is combined with the NF (United States Pharmacopoeia & National Formulary). Test 788 refers to particulate matter in injectables (this includes all injectables, SVP & LVP), the first part is that it must be free from all visible particles, these are deemed to be those that are above 100 um, and then set limits are imposed for sub visible particles, 10 & 25 um in size. We have an application note on our website that will point you in the right direction regarding numbers.
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