Contamination control in pharmaceutical clean rooms is driven by various technologies and disciplines like engineering and science. And it is surrounded by a large body of domestic and international regulations. It requires up-to-date information on microbiological contamination in sterile manufacturing, microbiological media fills and environmental monitoring, control in aqueous-bases, non-sterile pharmaceuticals, rapid testing methods, and clean room contamination control.
To control contamination effectively, routes and sources of contamination must first be identified, then controlled.
This is a huge topic and this article focuses on identifying the sources of contamination and ways to address them.
Sources of cleanroom contamination include:
After identifying a hazard, its relative importance must be assessed. Then comes assessing the necessity and method for controlling it.
Methods that can be used to control the routes and ways that contamination spread are as varied as the contamination possibilities themselves. They include:
Pharmaceutical cleanrooms are highly regulated environments that require meticulous levels of compliance with various regulations and codes. Particle levels are tested and addressed, as is the presence of microorganisms.
In the United States, advanced technologies are now combined to address air and surface contamination and control in pharmaceutical cleanrooms. This is done using environmental monitoring methods that rely on advanced monitoring systems to control and identify non-viable particle counts, the presence of microorganisms, temperature, humidity, and pressure.
To ensure that your pharmaceutical cleanroom is fully compliant with the regulations and as efficient as possible through the use of appropriate technology, get in touch with our experts at Blue Thunder Technologies today.
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