According to the General Requirements for Laboratory Biosafety GB 19489-2008, we established a 100,000 level laboratory in 2023. The laboratory is equipped with an independent ventilation system to maintain negative pressure, and the air flows from the clean area to the contaminated area. The number of microorganisms meets the "Hospital Disinfection and Hygiene Standards" GB 15982-2012. A constant temperature and humidity system is used, and the temperature is strictly controlled at 22±2℃ and the humidity is controlled at 55%±5%.
The laboratory researchers have rich experience and expertise to develop different forms of injectable drugs, which can be extended to Hope's existing production facilities.
① Material residue testing;
② detection of each part of the product and the ratio of composition
① Each product undergoes multiple tests(list key testing instruments if necessary);
② In addition to finished products, manufacturing parts and other various will be controlled
