What are objectionable microorganisms and why do they matter? An objectionable microorganism is any microorganism that can cause illness, or which will degrade a product and thus cause it to be less effective. This is specifically in relation to the product's intended use and for products that are not required to be sterile. Obviously, sterile products have their own guidelines and must meet their own requirements. Any bacteria that are prone to proliferation would clearly be a concern, since their proliferation could quite easily adversely impact the intended performance of a given product.
Perhaps one of the most popular and commonly known objectionable microorganisms is Escherichia coli (or E. coli), which tends to make the news whenever an outbreak occurs. Escherichia coli clearly falls into the category of causing illness, and so its inclusion is well deserved. However, there's a laundry list of objectionable microorganisms, each with its own behavior and associated concerns. Have you ever wondered why we have biological safety cabinets, and why they're so important? Well, now you know. They serve a valuable purpose.
The U.S. Food and Drug Administration (FDA) has guidelines and recommendations, specifically in relation to objectionable microorganisms. The FDA requires appropriate written procedures, which are intended to prevent contamination by objectionable microorganisms. These procedures are designed to avoid contamination of drug products that are not required to be sterile. Additionally, the FDA requires laboratory testing for each batch of any drug that's required to be free of objectionable microorganisms. Of course, objectionable microorganisms are one of the main reasons that cleanroom decontamination
is so incredibly important. Certain regulations and standards have to be met.
This is where professional decontamination services come into play. Whether it's decontamination of your biological safety cabinet, incubators, or any other safety equipment, you'll need people that are familiar with contaminants and biological hazards. Perhaps you need a biological safety cabinet to be certified, or you require biological and chemical surface decontamination, whether that's for your facility, equipment, or even your ductwork. Whether it's bacterial spores, mold, or any other viable decontamination, meeting standards is non-optional. If you want to pass inspection and meet certification requirements, it has to be done.
Particle counters, pressure gauges, temperature controls, and humidity controls will all play roles in keeping control of and avoiding objectionable microorganisms. Monitoring will also be important. You'll need to administer testing for both airborne and surface organisms. If monitoring and testing reveal any issues, you'll need to have expert assessments, evaluations, and analysis. Caution when dealing with objectionable microorganisms isn't just recommended, it's demanded. Public health and safety are at risk, but so too is the health and safety of staff members. Professionally speaking, you're obligated to defend the safety of your products and prove that they are free of objectionable microorganisms. However, the professionals you employ and the public also require those assurances.