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Microbial Solutions
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Rachael Kerr

Filamentous Fungi – Facilities Facing Facts

Real risks affecting real people. Ziva Abraham discusses the reality and importance of preventing mold contamination

Ziva Abraham is the President and Founder of Microrite, Inc., a firm providing consulting and training services focusing on pharmaceuticals, biotechnology, medical devices, and in vitro diagnostics for QA, QC, microbiology, and validation. She received her master’s degree in microbiology with a focus on mycology, and has conducted research on developing microbial insecticides using entomogenous bacteria and fungi. Her presentation, Mold Contamination, Investigation, and Remediation Challenges is now available on demand. 

Rachael: Knowing that mold can be an issue and concern across a diverse variety of industries, what are the biggest risks production facilities face regarding mold contamination and proper mitigation?

Ziva: With the pharmaceutical industry, especially within the aseptic manufacturing arena, mold challenges are under increased scrutiny by regulators, specifically related to mold recovery. The reason for the heightened scrutiny is an extreme rise in mold related infections, as noted by the many warning letters recently issued to compounding pharmacies and sterile manufacturers. Fungicidal claim testing for fungicidal agents is performed using easy-to-kill fungi belonging to the group Deuteromycota.

However, the mold brought into manufacturing facilities travel on cellulous material transported into the production plants. These types of molds are much harder to remediate. With over 40 million manufacturing facilities, there can be many different types of molds infringing on sites and for many different reasons. The natural aging of the facility’s structure, compromised walls and floors, and settling and wear over time can cause cracks and leaks that provide perfect conditions and a good food source, in these conditions mold will grow and proliferate quickly within the infrastructure. In terms of when remediation should occur, it is important to understand the type of mold contamination, and follow up with a thorough investigation to establish the source. Using this information is critical in choosing the best disinfectant and cleaning methodology to address the specific mold present.

A challenge within all industries is tracking molds and establishing good prevention and remediation procedures. Obtaining accurate identifications , of all molds recovered, is required to accurately trend the facility’s microflora and to understand seasonal shifts, new mold types, and predominant mold types. Maintaining trends will prove the facility is operating with awareness and control in planning and performing appropriate and effective cleaning measures that work properly to disinfect and prevent risk of product contamination.

Rachael: When a mold is recovered, even if it’s 1 colony forming unit (CFU), should it be considered an objectionable organism to the FDA regulators and is it recommended to identify all molds to the species level, regardless of the counts?

Ziva: Even when 1 CFU of mold is recovered in an area that is critical Grade A or B, it is necessary to accurately identify the organism to the species level and begin an investigation to determine the exact source. If this mold happens to get into the product it may proliferate. It is impossible to avoid mold in Grade D areas due to foot traffic and wheel-borne traffic. Mold enters the cleanroom through personnel and material airlocks. If contaminants brought in by foot and wheel-borne traffic are not acknowledged and properly removed by having continual controls in place and understanding the points of entry, they will continue to travel with movement and therefore contaminate other areas. To manage point of entry— the original sourceit is important to understand the mold brought into the Grade D areas. This can be done by occasionally identifying the molds present to understand the ingress and take remedial proactive actions. Personnel movement causes soil-borne mold and contaminants to become airborne. These mold spores get deposited on personnel gowns and are carried into more critical areas.

Rachael: Once mold is identified, understanding the toxicity and pathogenicity of the mold type is the next most important step in determining proper cleaning procedures for remediation. What are some steps you commonly recommend to mitigate mold contamination recovered in a cleanroom environment?

Ziva: Mold is a source of different kinds of invasive infections; cutaneous (skin/hair/nails), ocular, nasal, pharyngeal, pulmonary, as well as systemic. Mucormycetes are the most common group of molds thought of when dealing with infectious outbreaks, but there are many other molds that are also as pathogenic and dangerous. We have been experiencing many newly emerging and re-emerging mold infections over the past two decades. Understanding the pathogenicity of the mold is very crucial, dependent upon the mode of administration as well as immune status of the patient. The majority of mold infections currently occur in immunocompromised patients, as they have weakened immune systems and immune response caused by their illness and other drugs they receive.

Beyond understanding pathogenicity, it is important to know that mold does not have a calculated infective dose like bacteria. For example, Escherichia coli (E.coli) has an infection dose described to be 10 CFU. A Shigella infection (shigellosis of the intestines) has a dose of 100 CFU. Mold, on the other hand, occurs on soft tissue mucosa and spreads. For this very reason, 1 mold CFU may infect the patient as severely as multiple CFU’s. Mitigation of mold, even a recovery of 1 CFU, requires an accurate ID and getting to the route of the source.

In other words, a count of 1 CFU of mold is a very serious finding and can become a major mold contamination event, contaminate product and cause patient harm or even death. Understanding the mold biotic factors that aid in proliferation in the cleanroom is crucial for proper mitigation, proper disinfectants and the appropriate cleaning procedure. My suggestion on the very first step is obtaining an accurate identification. Determining the appropriate subsequent steps will then follow.

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