Monday 26 September 2022

What the Eye Can See: Vision Requirements for Personnel Who Inspect Injectable Pharmaceuticals


Regulators require pharmaceutical products that are injected into the human body (which are by inference sterile products) to be free of visible particulates. This is because the presence of visible particulates in injectable products may affect patient safety. There are various controls that need to be built into the manufacturing process to minimize the possibility of particle and particulate formation. These controls will begin with product development and proceed to manufacturing controls. In terms of ‘testing,’ this is based on visual inspection techniques, conducted as part of batch release and for stability samples (and retained samples in the event of a customer complaint). Any identified particulates need to be identified, investigated, and corrected. Following this, a preventative action should be put in place to prevent recurrence.


In some cases, automated inspection methods are used (either completely automated or semi-automated involving personnel inspections); in other cases, all inspections are performed by personnel; and sometimes a combination approach is used. The inspection process falls under the general definition of non-destructive testing. While automated inspection machines can be used, these are not always reliable. Additionally, automated technologies need to be validated to show that they meet or surpass human inspection capabilities.


The focus in this paper is with personnel. This paper looks at the ‘testing’ element – the visual inspection of products by people and considers the nature of eye tests required to ensure that personnel are able to detect particulates that could be spotted by another person with acceptable vision under ideal inspection conditions.


In this article, the focus is with visible particles and particulates, which are any mobile, undissolved matter other than gas bubbles unintentionally present in an injectable medicine.



Sandle, T. (2022) What the Eye Can See: Vision Requirements for Personnel Who Inspect Injectable Pharmaceuticals, Journal of GxP Compliance, 26 (1): DOI:

 Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

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