Monday, 2 July 2018

Investigating and Addressing Fungal Contamination in Pharmaceutical Cleanrooms


There are different types of microorganisms associated with medicinal product recalls, as a review of recall notices indicates. One of the major reasons for recalls, aside from Gram-negative bacteria (which prompt the most common reason for microbiologically related recalls), is fungal contamination. This is primarily in relation to non-sterile pharmaceuticals. Fungal contamination of such products can lead to a reduced shelf life through deactivating the active ingredients or presenting a health hazard to patients. Many of the reasons for fungal contamination are due to deficiencies in facility design, inadequate process controls, or materials issues. It is the facility design and operation issue which is addressed in this article. In relation to this, due to several product recalls associated with fungal contamination (as discussed below), the issue of fungal contamination in cleanrooms has seemingly received more attention from regulators.

Fungal issues associated with pharmaceutical cleanrooms, cold rooms and controlled areas are regularly reported, such as through regulatory surveys on major GMP issues and through issued warning letters. Fungi are a particular concern in cleanrooms because they form spores and, once present in an area, fungal spores are ubiquitous, spread relatively easily, and they can be difficult to remove. Fungi occur as yeasts, filamentous fungi and fungi that can appear in both forms, like Candida albicans (what is called dimorphic fungi).

This paper starts by looking at some of the recalls, in order to put contamination concerns in context, and then focuses on sources of fungal contamination and provides some remediation solutions for addressing upward fugal-related environmental monitoring trends.

On the subject of fungal contamination, Tim Sandle has written a paper for the Journal of GxP Compliance. The reference is:

Sandle, T. (2018) Investigating and Addressing Fungal Contamination in Pharmaceutical Cleanrooms, Journal of GxP Compliance, 22 (1): 1-10

For details, contact Tim Sandle



Posted by Dr. Tim Sandle

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