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Purification Case

GMP Pharmaceutical purification case

source:本站    Release time:2017/12/28 14:55:40    Clicks:

The goal of GMP pharmaceutical purification engineering is to design a dust-free workshop for the pharmaceutical factory,which be as a necessary condition for the clean room of pharmaceutical production,it should effectively prevent the drug from being contaminated in the part of designed, operated, maintained, confirmed and tested,to ensure that the drug is produced in the cleanest environment.

The three objectives of the purification control of the pharmaceutical factory are cleanliness,the air lock chamber widely uses the six class standard ,to control the clean room without cross-contamination.CFU refers to the number of live bacteria in a clean room.The project needs to obtain national GMP certification;Only when these three goals are achieved can it be a qualified purification project. The engineering system needs to use the local 5 poles of the on-duty fan, which will be monitored dynamically by the pharmaceutical inspection bureau and used after static acceptance.

When KGW is design the purification workshop,the part that the dust particles may be produced, such as interior decoration, the environment air, the equipment, facilities, containers and tools should be took necessary regulations, moreover ,the  personnel and material which need to enter purification workshop should be divided into people channels and logistics channels.

Under the condition of suitable temperature and humidity, the microorganism can multiply by 21 to 24 times in one day and night. Therefore, purification in the pharmacy workshop is especially important and it becomes more difficult to control.

The main pollution to the pharmaceutical industry is dust, bacteria, virus, heat and allergens.

If the bacteria pollutes the injection, it may cause systemic bacterial infection or local abscess.

In addition to escherichia coli, pseudomonas aeruginosa, staphylococcus aureus, live mites and mite eggs,the fungi and miscellaneous bacteria should also be restricted.

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