Fungus in Pharmaceutical Cleanrooms: Types, Origins, and Decontamination : Pharmaguideline

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Fungus in Pharmaceutical Cleanrooms: Types, Origins, and Decontamination

The article discusses the different types of fungus that can be found in pharmaceutical manufacturing facilities.
The presence of fungus in pharmaceutical cleanroom areas is considered a critical issue because it denotes a cleanliness issue. Fungus is very difficult to clean because it has spores that are resistant to most of the cleaning agents. In this article, you will find a detailed study on the fungus removal from the cleanroom.

Fungal contamination is very common in pharmaceutical cleanrooms and sometimes may be a cause of product recall. In cleanroom molds are very common those are multicellular and filamentous in mature. These are very small plant-like structures that grow on organic compounds. These are saprophytic in nature, which means they grow on dead organic material. Wooden and other natural materials are very good for their growth. Therefore, these naturally occurring materials are not allowed in clean room areas.

cleanroom fungus
Types of Fungus in Pharmaceutical Cleanrooms

Fungal contamination generally contains molds and yeasts. Aspergillus and Mucor are the common molds found in cleanrooms. Aspergillus niger is developed in cold areas of the cleanroom where moisture is present and cleaning is not done properly like corners and walls.

Yeasts are also found in cleanroom areas. Yeasts are single cellular and grow on protein and carbohydrate-containing materials. It grows in warehouses where starch and sugars are stored. Saccharomyces is the commonly found species in the yeast-contaminated areas.

Origin of Fungus in Pharmaceutical Cleanrooms

Pharmaceutical cleanrooms are highly specialized and controlled environments that protect drugs and other medical products from contamination. In these cleanrooms, fungal growth is a common problem, as fungi naturally grow on surfaces and in the air. Fungi can harbor harmful bacteria, which can lead to product recalls or even patient safety issues.

The climate control systems used to maintain hygiene levels in the cleanroom fail. This can lead to high relative humidity, low air flow, and poor air circulation. The temperature of the room is insufficient to eliminate fungi. Lack of proper cleaning practices (such as using toxic chemicals or nozzles) promotes growth of fungi. Fungi growing on surfaces in your cleanroom create a breeding ground for bacteria on the floor, which leads to cross-contamination between products and waste. Using dirty shoe covers and clothes that have been compromised by fungus growth spread fungal spores onto other surfaces in the cleanroom.
Related: Is Fungal Count Acceptable in Pharmaceutical Classified Area?

Methods to Decontaminate the Pharmaceutical Cleanrooms

There are many methods to decontaminate pharmaceutical cleanrooms. These methods depend on the type of fungus, its origin, and the decontamination strategy. The most common methods for decontaminating a pharmaceutical cleanroom are:

Use detergents and water: This method is used to clean surfaces that are contaminated with fungus. The detergent loosens the fungus from the surface and the water removes the loosened material.

Using ultraviolet radiation: This method is used to kill the fungus and destroy its spores. The ultraviolet radiation destroys fungus cells by denaturing their nucleic acid.

Using biocides: This method is used to kill the fungus and stop its growth. The biocides attach to the cells in the fungus and destroy them.

Using disinfectants: This method is used to kill the fungus and its spores. The disinfectants attach to the cells in the fungus and destroy them.
Related: Mode of Action of Disinfectant Solutions

These methods are used to clean surfaces that are contaminated with fungi. The fungus is loosened from the surface and the water removes it. If the fungus is not removed with water, it can start to grow again.

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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