Analytical Environmental Microbiology Services in Resolving Contamination Issues

1. Analytical Environmental Microbiology Services in Resolving Contamination Issues Microbiological contaminations are a real and ever-present danger because microorganisms and contaminants of the same are everywhere—from water to the air, on the skin, and various other surfaces. When contamination occurs particularly in manufacturing environments, product batches end up being wasted and an entire list of other risks follows, not the least of which are potential product recalls and even plant shutdowns. This further results in a great deal of lost time and capital for manufacturing organizations, as well as drug shortages and delays, not to mention the loss of consumer and public confidence. Left unaddressed with the right environmental microbiology services, contamination can even lead to criminal consequences and huge fines. Because there is just too much at stake when it comes to contamination issues, drug makers, along with contract manufacturing industry regulators, and other stakeholders look to environmental monitoring environmental microbiology services to make sure that facilities, production environments, water supply, and in turn, life science products are compliant with the required efficacy and safety standards that cater to public health. In recent years, environmental monitoring has become ever more crucial as manufacturers have faced tough organizations, and related consequences and increased scrutiny because of and in relation to contamination. Today, the Food and Drug Administration (FDA) requires that all pharmaceutical manufacturing companies must have standard operating procedures (SOPs) when it comes to environmental monitoring. These environmental monitoring SOPs form a crucial part of the actual drug release process in order to better ensure public safety against contamination and corruption of drug supplies. To continue production manufacturing companies and license holders need to prove the use of aseptic manufacturing processes and the right environmental microbiology services as part of their cGMP or current good manufacturing processes requirement. The same rules apply to generics producers and contract manufacturing organizations as well. Warning letters are being issued to companies that prove to be lacking adequate systems for environmental monitoring and the proper maintenance of safe and healthy conditions within aseptic processing areas. The same is true for companies that don’t have written environmental monitoring procedures, like sampling frequency, locations, and procedures to signify alert and action levels.