Clean Steam In The Pharmaceutical Industry Essay

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Up to the 1950s close systems in the pharmaceutical industries were disassembled and clean manually. This usually takes a large amount of time for some industries that needed frequent internal cleaning of their processes. The use of clean steam in the biopharmaceutical industries is covered by Good Manufacturing Practices (GMP). These are general rules applicable to pharmaceutical manufacture, they do not provide any specific recommendations regarding steam, but do present the general requirements of facilities, systems, equipment and operation needed to prevent contamination of biopharmaceutical processes and finish product. Cleaning validation is a required activity within the pharmaceutical industry which is defined as a process by which steam is passed through every unit operation, in order to prevent the growth of microbial activity such as bacteria and their spores. FDA regulations states that every biopharmaceutical company must abide by a set rules formed in accordance with new principles promulgated in CH Q7 to Q10 FDA’s cGMP, FDA’s Process validation Guideline, etc. This…show more content…
• The system must be suitably trapped and designed for adequate condensate removal.
• Sufficient air vents should be provide to remove formulation of air pockets, which can lead to cold spots.
• The design of SIP systems which ensures continuous steam through the entire system, narrow restriction should be avoided.
• Most vessel contain dead legs where insufficient heat transfer to sterilise them, in that case the length of dead legs must be minimized. Dead legs are typically limited to three pipe diameters in length.

All isolators can be equipped with spray nozzles to perform CIP or WIP procedures, both being air-free systems. The bottom of the isolators is sloped and equipped with a sanitary drain valve (automated or manual) in order to completely drain the washing

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