Because there are potentially many different root causes of product contamination by microorganisms, it is imperative that manufacturers perform a manufacturing risk assessment to understand manufacturing failure modes and implement prevention measures.
In addition, any risk assessment approach should be informed by an understanding of the microbial contamination vulnerabilities of the concerned product. For example, some product considerations for manufacturers include, but are not limited to:
- Determine the types of microbes that might survive or thrive in your products. Provide additional controls and testing based on the output of the risk assessment to ensure product quality.
- Ensure that your microbial recovery methods are capable of detecting the types of microbes that may affect product quality.
- Evaluate risk of contamination components, including during component production, storage, or due to the intrinsic risk source materials. Consider all possible sources of microbial contamination, including the following:
- Components or products stored in open bins can be at risk for contamination by spore-forming microbes, such as Bacillus cereus, as well as by Serratia species and other worrisome airborne microbes (see the FDA news release and Morbidity and Mortality Weekly Report, referenced below). Manufacturing areas exposed to windy or poor HVAC conditions may increase the potential for this environmental contamination risk.
- Some materials, especially natural sources, may have high or objectionable intrinsic bioburden.
- Water quality can pose a significant risk, as most antiseptics include water as a key ingredient. Contaminated purified water has been the root cause of multiple recalls of antiseptics, including instances of antiseptics contaminated with Burkholderia (previously Pseudomonas) cepacia, an opportunistic pathogen.
- Unsanitary practices or sources.
- When manufacturing in areas with high humidity, molds can be of special concern.
