Due to the unique needs and requirements found within the biomedical, life science, medical device, and pharmaceutical industries, modular cleanroom manufacturers have developed systems exclusively for these markets.
design, which we will now explain through an example. Typically, low moisture medicinal products such as tablets or capsules are dry and dusty, therefore more likely to be a significant cross-contamination risk. If the “clean” area pressure differential was positive to the corridor, the powder would escape out of the room and enter the corridor, and is likely then to be transferred into the next door cleanroom. Thankfully, most dry formulations do not readily support microbial growth, so as a general rule, tablets and powders are made in “clean corridor” facilities, as opportunistic microorganisms floating in the corridor don’t find environments in which to thrive. This means that the rooms are negatively pressurised to the corridor.
“The Aseptic Core” discusses scientific and regulatory aspects of aseptic processing with an emphasis on aseptic formulation and filling. This column has been developed to provide practical advice to professionals involved in the qualification of aseptic processes and the myriad support processes involved.
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