article

The power of rapid methods for fungal ID

By leveraging rapid identification techniques, pharmaceutical facilities can enhance their ability to detect and mitigate fungal contamination, safeguarding product quality and patient safety. Here, Dr Tim Sandle explores key challenges associated with fungal contamination in cleanrooms, discusses conventional and rapid identification methods, as well as the importance of validation.

Fungal contamination in pharmaceutical products represents a potential hazard for two reasons. First, it may cause product spoilage; the metabolic versatility of fungi is such that any formulation ingredient may undergo chemical modification in the presence of a contaminating organism. Spoilage not only affects the therapeutic properties of a product but may also discourage the patient from taking the medication. Second, product contamination represents a health hazard to the patient, although the extent of the hazard will vary from product to product and patient to patient, depending on the types and numbers of organisms present, the route of administration, and the resistance of the patient to infection. Fungal contamination in any sterile product will always present a direct risk of causing patient harm.

Most fungi enter the cleanroom from the external environment and are associated with airborne spores or nearby vegetation

With non-sterile pharmaceuticals, fungi can produce degradative spoilage in products due to their ability to synthesise appropriate enzymes. Pharmaceuticals, cosmetics, foods and other products are so much at risk because fungi are extremely versatile and adaptive in synthesising degradative enzymes. A consequence of degradation is that low-molecular-weight substrates such as sugars, amino acids, organic acids and glycerol are broken down by primary catabolic pathways. The enzymes for these pathways are constitutive in a wide range of fungi.