In residential facilities finding mold is a sign of a larger problem; issues with building materials, structural flaws, water leaks, environmental instigators, to name just a few. In the pharmaceutical industry, discovering mold can lead to the discovery other system or facility issues and must be dealt with in a professional and expedient manner.

Not only is mold a cleanliness issue and health hazard for those employed at a pharmaceutical facility, but it can also pose dangerous threats to the quality and cleanliness of the product. In recent years, mold has been linked to patient fungal infections as well as deaths. Therefore, it is crucial for the pharmaceutical industry to make mold prevention and disinfection a top priority.

Determining a Mold Infestation
When dealing with a possible mold infestation it is important to determine if the culprit is in fact mold and then determine the brevity and scope of the infestation.

Per Pharmtech.com, “a facility infection is indicated by the ongoing and consistent presence of mold.”
Determining if a facility has a mold infestation can be done by targeting and referencing the current mold spore count. Per Baxter, if the┬átotal spore count meets or is below 1200, the facility is in the safe and clean range of exposure, but if the spore count meets or exceeds 1300, the environment can be classified as “moldy”.

It is important to keep in mind that these ranges change with the types of tested molds. The above numbers reference total overall spore count, yet testing can be done for various individual molds such as Aspergillus or Penicillium, two of the most common molds.

Disinfection

Once a mold infestation has been accurately determined, remediation and disinfection procedures must take place immediately.

Unfortunately, when dealing with a mold infestation caused by water leakage into the building structure, disinfection has been proven ineffective and the mold will generally reappear within one to two weeks. In these circumstances, the most efficient way to remove and prevent mold is to demolish and rebuild with mold resistant materials.
Other mold infestations include more contained effected locations, such as laboratory equipment. While this type of infestation is a sign of active mold growth, it can generally be rectified by removal and deep cleansing of all effected materials.

Prevention

Initially it is important to acknowledge that a zero mold tolerance is impossible.
Mold is curated via environmental factors (there are certain molds that simply live in the air and on human skin and are unavoidable), but can also be spurred by human error such as inappropriately maintained air filtering systems, excessive and unattended moisture, and general uncleanliness.

Knowing these factors, it is pertinent that pharmaceutical firms institute proper procedure within and without their facility. For example, some firms put into place procedure for workers to move in and out of certain areas of the facility that require a high-level of cleanliness and air-quality control.

Some simple prevention tips include avoiding spillage and maintaining dry conditions in all parts of the pharmaceutical facility. Putting into place proper cleaning procedures for all types of spillage as well as procedures for moisture control will aid prevention of high levels of mold growth.

For more information on mold infestations, feel free to reference the below provided links:
Determining Facility Mold Infection
OSHA: Preventing Mold-Related Problems in the Indoor Workplace (pdf)
Understanding, Preventing, and Remediating Mold in Cleanrooms
Diagnosing Facility Mold Infection

PharmEng Technology is a reliable and fully capable compliance firm for the biotechnology and pharmaceutical industries available for advisement through this process. For more information or to speak directly with a representative please feel free to contact us.