What is the GMP clean room

gmp workshop in order to prevent cross contamination, cleaning workshop facilities tools should be cleaned according to the product characteristics, process requirements, air cleanliness level of the different respectively dedicated, garbage into the dust bag out. gmp workshop cleaning must be carried out before going to and from work, after the end of the operation of the production process; cleaning should be carried out in the purification of the workshop air conditioning system operation; cleaning after the end of the work, the purification of air-conditioning system to continue to run until the restoration of the specified clean level. Operation, until the restoration of the specified clean level, the boot running time is generally not shorter than the self-cleaning time of the gmp workshop. The disinfectant used should be replaced regularly to prevent microorganisms from developing resistance. Large objects moved into the workshop, first in the general environment with a vacuum cleaner for initial vacuum purification, and then permitted to enter the purification workshop, clean room vacuum cleaner or wipe method for further processing; in the gmp workshop purification system stops running during the large objects are not allowed to be moved into the purification workshop.

gmp workshop to disinfect sterilization, can use dry heat sterilization, wet heat sterilization, radiation sterilization, gas sterilization, disinfectant sterilization. Now introduce radiation sterilization, mainly applicable to heat-sensitive substances or products sterilization, but must prove that the ray is harmless to the product. Ultraviolet radiation sterilization has a certain bactericidal efficacy, but there are a number of problems in the use of ultraviolet lamp intensity, cleanliness, environmental humidity and distance and many other factors will affect the disinfection effect, in addition to its disinfection effect is not high, is not applicable to the space of personnel activities and airflow flow space, these reasons make ultraviolet disinfection is not accepted by the foreign gmp. Ultraviolet sterilization of exposed objects need long time irradiation, for indoor irradiation, when the sterilization rate is required to reach 99%, the general bacterial irradiation dose is about 10,000-30,000uw.s/cm. a distance of 2m from the ground 15w of ultraviolet lamp, the irradiation intensity is about 8uw/cm, it is necessary to irradiate 1h or so to be irradiated, and within this 1h irradiated place can not be accessed, or else on the person's Skin cells are also damaged, there is an obvious carcinogenic effect.