Clean engineering grade is designed according to the production process requirements of the workshop. The purpose of each workshop in the clean room of the clean engineering is different, and the purifying grade installed is also different. The purifying grade of the clean workshop should be determined according to the applicable situation. Except for the cleanliness level required by customers, such as the cleanliness level of production room, packaging room and laboratory is not the same. It is impossible for all of them to be 100-level cleanliness, nor for all of them to be 10,000-level and 100,000-level cleanliness.
According to past experience, Class 100 clean engineering is suitable for the preparation and filling of sterile drugs which can not be sterilized in the final container, the filtration and filling of injectable drugs with large volume (greater than or equal to 50 ml) sterilized in the final container, the filling and packing of powder injection, the pressing and plugging of sterile preparations, the refining, drying and packing of powder injection raw materials.
The 10,000-grade clean engineering is suitable for the production of sterile and sterile drug dispensing in the final container (no sterile filtration before filling), the dispensing, filtering and filling of large volume injection drug dispensing and small volume injection drug dispensing in the final container, and the dispensing, filtering and filling of eye drops.
The 100,000-grade clean Engineering of workshop is generally applicable to the production of tablets, capsules, pills and other preparations. The raw materials are refined, dried and packed separately. The temperature and humidity of the clean workshop should be in accordance with the production and technological requirements. It is appropriate to control the temperature between 18 ~24 C and the relative humidity between 45%~65%.www.wxrfcleanroom.com