GXP

Investigating and Addressing Fungal Contamination in Pharmaceutical Cleanrooms

Introduction

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 (1). 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 (2). 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) (3).

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.

Pharmaceutical Recalls Associated with Fungal Contamination

Fungi in pharmaceutical processing environments can originate from air, water, personnel and the material introduced into different facilities where products are manufactured. Over the years, several fungal issues associated with pharmaceutical cleanrooms, cold rooms and controlled areas have been reported. These have affected sterile and non-sterile medicinal products. Perhaps the most infamous sterile products case was the 2012 New England Compounding Center meningitis outbreak (4). Here the fungi recovered, largely as the result for poor environmental controls and facility design, were Exserohilum rostratumAspergillus fumigatus, and the common cleanroom mold Cladosporium species.

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