Sterilization by superheated water
Sterilization by means of superheated water at high temperature and high pressure is a very mature thermal sterilization method in the pharmaceutical industry.
Like pure steam sterilization, superheated water sterilization belongs to the field of thermal sterilization. Both of them have the same working principle and sterilizing effect, both of them use wet heat to destroy the important components and enzyme system in microorganisms, which can make all microorganisms dead. Usually the temperature is maintained at 121℃ for 30min, and it is divided into four stages: water injection, heating, sterilization and cooling.
The difference is that superheated water sterilization utilizes high temperature and high pressure superheated water, while pure steam sterilization utilizes high temperature and high pressure steam. The two also differ in application. Currently, superheated water sterilization is mainly used in the storage and circulation system of water for injection, while pure steam sterilization is widely used in the purified water system, water for injection system, and liquid dispensing system.
Process
The procedure for sterilizing the Water for Injection Storage and Distribution System (WIDS) with superheated water is divided into four main stages:
(1) Water injection stage: inject a certain volume of water for injection into the tank, generally at a level of 30%~40%;
(2) Heating Stage: Start the circulation system and heat the water for injection in the storage and distribution system from 80°C to 121°C using a double-plate tube heat exchanger;
(3) Sterilization stage: Maintain the temperature at 121℃ for 30 minutes and make sure that the temperature of the tank, the temperature of the return water network and the sterilization temperature of the respirator all reach 121℃ before starting the timer;
(4) Cooling stage: Start the cooling water control program, the circulating water for injection will be cooled down to the set temperature at a predetermined rate.
Compared with pure steam sterilization, superheated water sterilization has the following advantages:
(1) No need to consume pure steam: industrial steam is used as the heat source, and there is no need to prepare pure steam separately.
(2) No need to consider condensate discharge: In the sterilization process, there is no need to consider the discharge of condensate at the lowest point, high-pressure superheated water circulates through the entire system, and there will not be a dead zone caused by condensate discharge failure.
(3) Easy to control the modulation of heating and cooling: the use of injection water system already maintains a high temperature of 80 ℃ circulating double plate tube heat exchanger for system heating, saving project investment and very convenient operation.
(4) When the system uses more points or the cold point adopts fully automatic sub-loop design, the advantage of superheated water disinfection is more obvious;
(5) When sterilizing superheated water, the gas phase in the tank of water for injection is high-pressure saturated pure steam, which can effectively realize the online sterilization of the respirator of the tank of water for injection.
FOW superheated water sterilizer is suitable for:
1. Sterilization of non-intestinal solutions, non-deformable liquids in sealed containers (e.g., glass vials) and liquids or bottles in heat-sensitive sealed containers (e.g., plastic bags)
2. Terminal sterilization of pre-filled injectors (PFS)
Extended appreciation:Verification of the process of rotating superheated water spray sterilizer cabinets
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