Purified water disinfection system
Release date: November 27, 2019 11:54:01
In the pharmaceutical purified water equipment system, sterilization and disinfection are two effective methods to rapidly reduce the microbial load of pharmaceutical water. Different disinfection and sterilization methods have different characteristics and advantages, and can achieve different effects.
1、 Sterilization and disinfection concept
The sterilization of pharmaceutical purified water equipment system is a process of chemical or physical methods to eliminate all living microorganisms, including all bacterial propagules, spores, fungi and viruses, so as to achieve complete sterility. Disinfection is the use of physical or chemical methods or the removal of pathogenic microorganisms on the media to achieve harmless.
2、 Comparison of various sterilization methods in pharmaceutical purified water disinfection system
In the pharmaceutical purified water equipment system, pasteurization is mainly used for periodic disinfection of pretreatment units such as activated carbon in purified water system, periodic disinfection of RO reverse osmosis and EDI modules, and periodic disinfection of purified water storage and distribution pipelines, and microbial inhibition during normal operation of water for injection system.
After pasteurization, there are still a small number of harmless or beneficial, heat-resistant bacteria in the purified water equipment system. At the same time, the disinfection operation time is relatively long. Hot water circulation above 80 ℃ is often used for one or two hours to complete pasteurization. The advantage is that the microbial contamination level in the purified water system can be effectively controlled at 50cfu / ml, and the endotoxin level in the purified water equipment system can be controlled at 5Eu / ml.
2. Ultraviolet sterilization
In the pharmaceutical purified water equipment system, ultraviolet sterilization is a common sterilization method, mainly including sterilization, TOC degradation and ozone removal. It can slow down the production rate of new colonies in the water system, and then affect the formation of biofilm, but it is not effective for the formed biofilm, only partially effective for planktonic microorganisms. The time and intensity of ultraviolet radiation determine the efficacy of ultraviolet radiation. When the wavelength is 253.7mm, the best bactericidal effect can be obtained.
Because UV lamp can only inhibit the growth rate of microorganisms, can not quickly and effectively reduce the load of microorganisms in the water, and can only kill 90% of the microbial bacteria in the system, so it can not replace the periodic disinfection or sterilization function of pure steam sterilization of bus disinfection and ozone disinfection.
3. Ozone sterilization
Compared with the ultraviolet sterilization and bus disinfection described above, ozone sterilization destroys the structure of microbial membrane through oxidation, which can kill bacterial propagation and spores, viruses, fungi, etc., and can also destroy botulinum.
In the pharmaceutical purified water equipment system, microorganisms will propagate and breed in purified water tank, various filters, membranes and distribution pipe network systems. Ozone can effectively remove halides in water and degrade biofilm, and there is no residue. At present, it is the best method to continuously remove bacteria and viruses in purified water system and high-purity water system. Ozone sterilization has become the mainstream disinfection method of pharmaceutical purified water at home and abroad.
In addition, ozone can also oxidize and decompose pollutants in water, which has significant effects on deodorization, decolorization, sterilization, phenol, cyanogen, iron, manganese, COD and BOD reduction.
4. Pure steam sterilization
Pure steam sterilization belongs to the category of thermal sterilization, which uses high temperature and high pressure steam for sterilization. It can kill all kinds of microorganisms, including spores of bacteria, spores of fungi or dormant bodies. It has the advantages of no residue, no environmental pollution, no damage to the product surface and easy to control and reproduce, so it is widely used in the sterilization of purified water equipment system, water for injection system and liquid distribution system. It should be noted that in pure steam sterilization, the non condensable gas in the tank must be exhausted, otherwise the sterilization effect will be greatly reduced.
5. Hot water sterilization
Superheated water sterilization also belongs to the category of thermal sterilization. In addition to the advantages of pure steam sterilization, it has the following advantages: industrial steam is used as the heat source, and there is no need to prepare pure steam; the existing dual plate heat exchanger is used to heat up the system to maintain a high temperature of 80 ℃ in the water for injection system, which saves the project and is easy to operate; in the process of sterilization of purified water equipment system, it has the following advantages, It is not necessary to consider the discharge of condensate at the lowest point, and the sterilization dead angle caused by delayed condensate discharge will not occur.
The purified water equipment system adopts the combination of ozone sterilization and ultraviolet sterilization, which can completely kill all kinds of bacteria, fungi and microorganisms in the water, and ensure the quality of purified water. At the same time, in the design, material selection, production and manufacturing process of purified water equipment, bacteria, microorganisms and other factors affecting water quality are fully considered, and meet the requirements of 2010 Pharmacopoeia and GMP standards.