article

The power of rapid methods for fungal ID

By

10 July 2023

Shares

19

Share this post

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.

 

ACCESS your FREE COPY

 


This report addresses the key factors shaping pharmaceutical formulation, including regulation, QC and analysis.

Access the full report now to discover the techniques, tools and innovations that are transforming pharmaceutical formulation, and learn how to position your organisation for long-term success.

What you’ll discover:

  • Key trends shaping the pharmaceutical formulation sector
  • Innovations leading progress in pharmaceutical formulation and how senior professionals can harness their benefits
  • Considerations and best practices when utilising QbD during formulation of oral solid dosage forms
  • And more!

Don’t miss your chance to access this exclusive report ! Access now – it’s free

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.

Share via