The division of cleanliness level of clean room needs to be formulated according to the size of the space
A regular purification engineering company will consider the space size when making a plan. If the site is 5,000 square meters, it needs to be a Dongguan dust-free pharmaceutical cleanroom and each workshop has different uses, so the cleanliness level is also different. For example, the cleanliness levels of production rooms, packaging rooms and laboratories are not the same. It is impossible for all of them to be 100-level purification, and not all 10,000-level or 100,000-level purification. Except for the cleanliness level required by the customer, the engineer Also give some advice to customers. The following editor will talk about the classification of cleanliness levels in the medical industry. The following are the cleanliness levels suggested by our company for the different sizes of the dust-free workshops in Dongguan. I hope you can judge and choose a level that meets the standards according to the following suggestions. (1) Class 100 clean room is suitable for: the production of sterile drug formulations that cannot be sterilized in the final container (meaning that no sterile filtration is required before potting) and potting; those that can be sterilized in the final container Filtration and encapsulation of large-volume (≥50ml) injection drugs; sub-packaging and plugging of powder injections; purification, drying and sub-packaging of sterile preparations and powder injection raw materials. (2) Class 10000 clean room is suitable for: the production of sterile pharmaceutical solutions that cannot be sterilized in the final container (referring to no need for sterile filtration before filling); large-volume injections that can be sterilized in the final container Dosing of medicines and dosing, filtration, and filling of small-volume (<50ml) pharmaceuticals for injection; dosing, filtration, and filling of eye drops; dosing and filtration of oral liquids that cannot be autoclaved , filling and sealing; preparation and filling of medicines such as ointments, creams, suspensions, emulsions, etc. that are not sterilized in the final container; refining, drying, and packaging of APIs for injections. (3) Class 100000 clean room is generally applicable to: the production of tablets, capsules, pills and other preparations; the refining, drying and packaging of raw materials. The temperature and humidity of the dust-free workshop in Dongguan should be adapted to its production and process requirements. The temperature should be controlled between 18°C u200bu200band 24°C, and the relative humidity should be controlled between 45% and 65%.
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