Definition of clean pipeline in the pharmaceutical factory: The clean pipeline system in the pharmaceutical factory is mainly used for the transportation and distribution of process water, gas, and sterile clean materials, such as water for injection, purified water, pure steam, clean compressed air, etc.
Pharmaceutical factory clean pipeline standards and their types: According to the requirements of GMP standards, the surface of clean pipelines should be smooth, flat, easy to clean or disinfect, corrosion-resistant, and not chemically reacted with drugs or adsorbed drugs, to prevent the growth and pollution of microorganisms, and to guarantee the quality and quality of medicines. At present, this requirement can be well met, and sanitary stainless steel pipes are widely used.
The sterilization of clean pipelines in pharmaceutical factories is roughly divided into two categories.
One is periodic disinfection and sterilization: which generally is the disinfection and sterilization of the storage tanks, process pipelines, and water intakes of the system. Such as pure steam sterilization, pasteurization, peracetic acid, other chemical sterilization, etc.; The second is online sterilization, mainly for the sterilization of transportation, which generally will not affect the use of workshop production. Such as ultraviolet, pasteurization cycle, ozone sterilization, membrane filtration sterilization, etc.
The definition of disinfection and sterilization in the 2002 edition of the Disinfection Technical Specification of the Ministry of Health: Disinfection: kill or remove pathogenic microorganisms on the transmission medium to achieve harmless treatment.
Sterilization: The process of killing or removing all microorganisms from a transmission medium.
From this definition, they are different, so ultraviolet light, pasteurization cycle, and ozone can only be considered disinfection. Superheated water and pure steam sterilization are considered sterilization.
Post time: May-16-2022