How to choose the appropriate cleanliness level for the workshop according to the industry
The cleanliness levels of the production room, packaging room and pharma machinery of a factory are not the same. It is impossible for all of them to be class 100, or all class 10,000 or class 100,000. Except for the cleanliness level required by the customer, and even if the customer If there are requirements for cleanliness level, professional purification engineering companies will also give customers some suggestions and opinions. By referring to the applicable space for the cleanliness level below, I hope you can choose a clean workshop that meets the standards. (1) The 100-level clean pharmaceutical cleanroom 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 filling and sealing) and potting; those that can be sterilized in the final container Filtration and filling 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 pharmaceutical cleanroom 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 and sealing); large-volume injections that can be sterilized in the final container Dosing of medicines and dispensing, filtration and encapsulation of small-volume (<50ml) injections; dispensing, filtration and encapsulation of eye drops; dispensing and filtration of oral liquids that cannot be autoclaved , Potting Medicine | Education Network sorting and collection; preparation and potting of ointments, creams, suspensions, emulsions and other medicines that are not sterilized in the final container; refining, drying, and packaging of APIs for injections. (3) Class 100000 clean workshop is generally applicable to: production of tablets, capsules, pills and other preparations; refining, drying and packaging of raw materials. The temperature and humidity of the clean workshop should be adapted to its production and process requirements, the temperature should be controlled at 18℃～24℃, and the relative humidity should be controlled between 45%～65%.
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