In pharmaceutical and healthcare product manufacturing facilities, the presence of fungus in the processing regions is typically viewed as a sign of a control failure, such as one with air handling or with the transfer of materials into the production area.
This article will specify the primary source and steps to prevent fungal Contamination in Pharmaceutical Cleanroom System.
How does Fungus find its way into the Cleanroom?
Contamination control is made more difficult by the physical properties of fungal spores, which range in size from 1 to 50 µm and can infiltrate environments through a number of methods.
Primary source of mold/microbial contamination includes:
Airborne spores can enter through windows or ducting and pipes – openings that also allow moisture, either liquid or vapor, to enter. This increases the relative humidity (RH) of the air, and high RH is a major contributor to contamination.
Once established in the cleanroom environment, fungal spores grow quickly and aggressively, making eradication difficult. There is a variety of information available on how to eliminate mold, but prevention is far superior to cure. In reality, this entails defining materials and components that will resist the growth of mold, fungus, and other microbiological species while still delivering the chemical stability, durability, purity, and fire resistance required of cleanroom materials.
From HVAC Systems to Sterilization Techniques: The Best Strategies for Preventing Fungus Contamination in Cleanrooms:
- Monitor the delivery of products into the cleanroom, making sure they are dry and multiple wrapped. For example, before entering the cleanroom, make sure to remove the top layer and perform a disinfection procedure.
- Making sure the HEPA filter is operating as intended is important since the inside surface of the cleanroom is one of the main sources of fungus.
- Maintaining proper airflow inside the cleanroom is important because the architecture of the cleanroom, particularly the capacity to keep particles suspended and the quantity of air exchanges, can affect whether the fungus spores settle onto new surfaces.
- Maintaining areas in dry state is crucial as it prevents fungal growth.
- Effective gowning of the operators
- Procedures for cleaning and disinfection must be in place in order to prevent people and mobile equipment from bringing fungus into buildings.
- Cleanroom Structures should be made of non-porous materials to prevent fungus growth by preventing water absorption.
Conclusion:
Fungal contamination in pharmaceutical cleanrooms can have significant consequences, including reduced product quality and safety, delays in production, and financial loss.
Pharmaceutical companies must take proactive measures to prevent fungal contamination, including proper cleanroom design and maintenance, regular cleaning and disinfection, personnel training, and environmental monitoring. By implementing these measures, pharmaceutical companies can reduce the risk of fungal contamination and ensure the production of safe and high-quality products.