How to test whether the 100,000-level purification workshop meets the standard?
The 100,000-level purification pharmaceutical cleanroom has strict requirements for purification, and there are also some related detection methods. Next, Dongguan Keshilai Xiaobian will tell you how to check whether the 100,000-level purification workshop meets the standard. Under normal circumstances, the detection method of sedimentation bacteria is mainly used to detect whether the 100,000-level purification pharmaceutical cleanroom meets the standard, and the specific methods are as follows: When opening the sterile operating table, several sterile petri dishes with an inner diameter of 90 mm need to be poured into the nutrient agar medium that has been melted and cooled to 45 °C, and then placed upside down in an incubator at 30~35 °C for 48 hours to prove sterile backup. use. Place the petri dish covered with nutrient agar medium in the designated area, about 1 meter from the ground, expose it to the air for 30 minutes to collect the settled bacteria, then cover the plate and let it stand in the incubator at 30-35 °C for 48 hours , take out and count. At this time, attention should be paid to the operating state in the 100,000-level purification workshop. Detect the number of settled bacteria, no more than 10 per plate, and prove that it has reached the standard of 100,000-level purification workshop. The sedimentation bacteria method can generally be monitored once a month. Each test should pay attention to data records and test process records. Previous: Matters needing attention when using purification pharmaceutical cleanroom Next: Three design requirements that must be known in a 100,000-level purification workshop
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