Monday, 2 December 2019

Visual inspection of particulate matter

Each final container of all parenteral preparations shall be inspected to the extent possible for the presence of observable foreign and particulate matter.

In relation to this a new article of interest has been issued:

This article highlights the key inspectional focal areas in visual inspection processes to guide the reader to re-assess their procedures and practices for enhancing visual inspection process. Each container of liquid parenteral product is required to be inspected for evidence of visible particles and any containers which are seen to be contaminated must be rejected. In addition, containers are also examined for flaws, cracks, misplaced seals etc. These are material issues which could compromise the integrity of the containers and therefore of the sterility of its contents. For staff tasked with the inspection, the inspector will check whether they can detect different particles (or microbial growth) based on their training and may esquire if frequent eye tests are carried out.

The reference is:

Saghee, M.R., Sandle, T. and Das, P. (2019) Regulatory inspection of sterile facilities – the focal points. Part 1 – Visual inspection of particulate matter, GMP Review, 18 (1): 13-18

Foe details, contact Tim Sandle

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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