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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 article discusses the different types of fungus that can be found in pharmaceutical manufacturing facilities. It goes over how these microorganisms grow and spread, explaining how fungicide use impacts the prevalence of certain types of fungus. The article also covers the importance of implementing a plan for cleaning up any contaminated surfaces before they become a source for further contamination.

What is Fungus?

A fungus is a group of living organisms that form colonies, which can be single cells or large groups. Fungus is classified according to the type of their reproductive structure: hyphae (fibrous threads), yeasts (a single-celled organism that grows and reproduces by budding off new cells), or molds (flat, branching, single-celled organisms). Fungus is ubiquitous in nature, occurring on land, in water, and even in the air.

The fungus can cause a wide variety of diseases and infections, including athlete’s foot (tinea pedis), ringworm (tinea corporis), fungal pneumonia (pneumocystis carinii) and Aspergillus fumigatus infection. While many fungi can be eliminated by standard decontamination procedures, others may require special consideration.

Decontamination strategies for fungus depend on the species of fungus involved and the severity of the infection. Standard decontamination procedures such as steam cleaning and high humidity may be effective for most fungi. However, some particularly virulent fungi, such as Aspergillus fumigatus, require extensive decontamination measures.

cleanroom fungus
Types of Fungus in Pharmaceutical Cleanrooms

Cleanrooms are often extremely clean and sterile environments, which can be challenging for fungi to thrive in. However, there are a variety of fungus that can live and grow in cleanrooms, and some are necessary for the proper function of the environment.

Fungus is a diverse group of organisms, and their presence in cleanrooms can be dependent on the type of environment they need to survive. There are three main types of fungus found in cleanrooms: saprophytic, mycetophilic, and heterotrophic.

Saprophytic fungus is a generalist that feeds on other organisms or dead material in the environment. They are common in cleanrooms due to the high levels of organic material and bacteria present. Saprophytic fungus can be removed using standard decontamination procedures.

Mycetophilic fungi prefer moist environments with good airflow, and they typically grow on surfaces like wood or paper. Mycetophilic fungi can be removed using standard decontamination procedures, but they can be difficult to detect.
Related: Typical Microbiology Concerns in an FDA Inspection

Heterotrophic fungi do not consume nutrients, but they can often cause infections in humans and other animals. They are commonly associated with copper, aluminum, and steel surfaces inside cleanrooms.

These surfaces are usually found at the exit of a cleanroom and near machinery that produces dust or fumes. Heterotrophic fungi can be removed using standard decontamination procedures. Most of these fungi are known for their ability to damage the skin and cause disease when present in high concentrations. Cleaning with chemicals is not an effective long-term solution to controlling fungal growth in cleanrooms because the chemicals will kill spores, not active fungus.

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 pharmaguideline.com, 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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