Sterile pharmaceutical processes require extremely strict sterilization of pharmaceuticals. Not only are they not required to contain live microorganisms, they also have corresponding regulations regarding the performance and cleanliness of pharmaceutical equipment. In the experimental study of sterile drugs, researchers generally use pressure steam sterilizers for sterilization, sterilization methods used by equipment is also one of the main sterilization methods in the pharmaceutical industry.
I understand that pressure steam sterilizers mainly use heat to promote the death of microorganisms. They are generally designed by using the principle of damp heat to kill microorganisms. According to experts in autoclave presses, the advantage of using a moist heat sterilization method is that steam has a strong bactericidal effect, which can increase the moisture content of bacterial proteins, making them easily solidified by heat, thereby accelerating the death process of microorganisms.
In the past, pressure steam sterilizers were generally bottom vent type sterilizers, and the principle of gravity displacement was mainly used. According to professionals, when steam enters the exhaust sterilizer room from above the sterilizer, cold air is discharged from the top to the bottom. At this time, the sterilization chamber is filled with saturated steam. However, the disadvantages of this type of equipment are also obvious. First, the cold air in the sterilization chamber is difficult to drain completely. Second, the presence of dead space and dead ends can impede the penetration of steam and affect the final sterilization effect.
With the advancement of pharmaceutical equipment technology, pressure steam sterilizers have gradually eliminated low-performance technologies and turned to high-end technologies. Taking a pulsating vacuum sterilizer as an example, the author was informed that most of the pulsating vacuum sterilizers are used in China. The equipment is mainly used for vacuum, steam and vacuum. Specifically, the pulsed vacuum sterilizer exhausts the cold air by several times of evacuation, mixing of steam and cold air, and steam instead of cold air. However, this principle has very low demands on the vacuum pump, but it will increase steam loss.
In order to ensure the sterility of medicines and reduce equipment consumption, some pharmaceutical companies have done relevant research and development and verification, and have achieved practical results. For example, Shandong Medical Devices Co., Ltd., Shaoxing Shangyuxing Star Instrument Equipment Co., Ltd., Zhejiang Shengtai Medical Technology Co., Ltd., etc. They developed technology to re-use heat distribution tests, including no-load heat distribution and full-load heat distribution; performance tests including bioindicator verification, post-sterilization culture medium quality verification, and control of the corresponding verification standards for pressure steam sterilizers The performance is verified to put quality equipment into the market.
It is reported that the pressure steam sterilizer is not only suitable for hospital drug companies, but also has an effective role in the sterilization of the food industry. Some companies have also changed the structure of the inlet steam line on the basis of the original pressure steam sterilizer. This can change the structure of the inlet steam line. The inlet steam line will use two pipes, one leading to the inner chamber and the other It leads to the mezzanine. This will enable the device to have a green and environmentally friendly performance, which will not only reduce costs and reduce the rate of goods, but also reduce the operator's labor intensity, easy to produce saturated steam with related drugs and foods, so as to achieve high-quality sterilization effect.
Of course, when it comes to equipment, it must be avoided that the operator must be reminded to pay attention to the daily maintenance of the equipment. The staff of Shaoxing Shangyu Star Instrument Equipment Co., Ltd. made several suggestions for everyone. First, before using the device every day, the operator should wipe the surface of the sterilizer door and the instrument, clean the impurities in the strainer at the drain port in the sterilizer, and clean the floor of the sterilizer. Second, check whether the components of the equipment are flat and in good condition. If problems arise, it is best not to use pressure sterilizers and repairs should be carried out in time.
Thirdly, formulate a clean plan for the equipment, such as cleaning and sterilizing the sterilized room on a weekly basis; clean the outside of the sterilizing equipment on a quarterly basis to avoid dust accumulation and shorten the service life of the air filter; an annual inspection should also be conducted every year. However, the staff reminded users to avoid contacting components with water during cleaning work. If exposed, wipe immediately with a dry cloth.
The technology of pressure sterilizers is still being replaced. Currently, vacuum sterilizers and pulsating fungicides dominate the market. It is believed that through the R&D and innovation of pressure sterilizers in the enterprise, more intelligent, energy-saving and environmentally friendly products will appear in the market to add a protective film for the production of sterile drugs.