Sterilization is of vital importance in the pharmaceutical and medical industries. From direct patient care to lab work, every new surface is at risk of being contaminated with spores, bacteria, viruses, or other microorganisms.
Of all the methods available for sterilization, moist heat in the form of pressurized saturated steam is the most widely used and the most reliable. Steam sterilization is non-toxic, inexpensive, rapid sterilization, spore killing, and rapid heating and penetration of the fabric.
Pharmaceutical Autoclave process:
1. Purification stage: in the purification stage, steam replacement of the air in the autoclave chamber. Both temperature and pressure begin to increase. 2. Sterilization stage: the exhaust remains closed, so that the temperature and pressure rise rapidly to the required value. It is at this stage that the harsh conditions of the autoclave destroy bacteria, spores, and other pathogens. 3. Exhaust stage: Pressure is released from the cabin, but the temperature is still quite high. Caution should be exercised by technicians when removing hot contents from the autoclave.
Autoclave Restrictions: While autoclaves remain a very versatile tool, certain materials and substances are not compatible with autoclaves and can be dangerous if contained under load and entered the sterilization cycle. For example,certain chemicals (such as acids and bases) should not be autoclaved, and materials made from polyethylene, polyurethane or polystyrene should not be autoclaved either. Autoclave technicians must understand the principle of autoclave sterilization in order to avoid potential safety hazards in the process of use.
In the pharmaceutical industry, pulsating vacuum sterilizer can be used tosterilize medicines, produce sanitary materials, dressings, instruments and other products. The equipment can also be used for sterilization, fumigation and drying of medicinal materials. After sterilization, it can be used directly, so as to achieve good sterilization effect and meet the requirements of GMP for drug production.
The pulsating vacuum sterilizer uses saturated steam as the sterilizing medium, eliminates the influence of cold air on temperature by pulsating vacuum exhaust, and finally makes the articles dry by vacuum dehumidification combined with sleeve drying. Three times of pre-vacuum, completely eliminate the cold point in the sterilization room, sterilization is more thorough. In order to ensure faster heating, temperature parameters can be set according to field conditions. The vacuum method is adopted to greatly shorten the drying time. The sterilization chamber is pumped to the negative pressure of the ultimate vacuum of the vacuum pump, and then the sterilizer jacket is dried at 132-134℃ to ensure that the sterilized items are dry and clean, and the items are not wet or hot after being taken out.
Pulse vacuum sterilizer is specially designed for pharmaceutical production units, CSSD and other applications requiring strict quality sterilization. It is widely used in medical departments, drug testing, epidemic prevention, pharmaceutical and other biological engineering industries as well as scientific research institutes.
The cabinet body of pharmaceutical sterilization equipment is horizontal rectangular structure, and the sealing door is optional sliding door and motor door. The PLC based control system with the application of touch screen makes the operation more convenient, can dynamically display the working process and the working process of time, temperature, pressure and other parameters, make the operation more intuitive, users can also according to the need for special configuration of the convenient manual operation. The system also has perfect sterilization data recording and printing functions, high control precision, stable and reliable operation. The equipment has standard GMP verification interface, convenient for users to carry out equipment verification at any time.
Steam is widely used in pharmaceutical processes such as heating, humidification, power drive, drying and other steps. Steam is a good sterilization medium, pure steam has a strong sterilization ability and less impurities, It is especially suitable for all purification processes in the pharmaceutical industry (opening bottles, instruments, petri dishes, textiles, all kinds of aluminum drums and rubber stoppers for antibiotics, bottles and rubber stoppers for freeze-dried powder, etc.) All products are sterilized by pure steam.
The saturated steam of the ordinary pressure steam sterilizer is usually provided by the industrial boiler, and because of the conveying system and other reasons, the steam often contains impurities and in order to reduce the damage to the steam boiler and the presence of a small amount of volatile amines and other substances added in the water, so that in the process of sterilization will be deposited on the sterilized items, This can cause harm to patients with medical instruments and diagnostic supplies of sterile tissue, and containers containing sterile items may re-contaminate sterile items and enter tissue culture media, which is also not conducive to the culture of viruses.
In view of the above reasons, on the basis of pulsating vacuum steam sterilizer, CG pure steam sterilizer is a sterilizer that uses pure steam in the inner layer and ordinary boiler steam in the jacket, which not only achieves the ideal sterilization effect, but also improves the product grade and controls the unnecessary increase in operation cost caused by it.
Pure steam as a sterilization medium than ordinary pressure steam as a sterilization medium sterilization cabinet more health, more clean, more in line with the GMP requirements, more suitable for the pharmaceutical industry sterilization operation, such as direct contact with sterile tissue equipment and sterile articles of the container, packaging materials sterilization.
This series of products are double-layer structure inside and outside, electric door design, the inner layer is pure steam in the working process, the sleeve layer is made of ordinary boiler steam, this kind of sterilization cabinet because of low energy consumption, sterilization effect is better, and easy to dry.
The sterilizer is widely used in medical units for sterilization and leak detection of small injections of ampoule oral liquid. It is a high performance and high intelligence sterilization equipment, which can achieve uniform sterilization in the range of 60-127 degrees and avoid secondary pollution at the same time. The device has a CMP inspection interface, can be at any time in the cabinet temperature control point detection. Adopt touch screen and PLC control.
After the sterilization of the equipment, the leakage is detected by vacuum or vacuum colored water. Poor quality ampoules or ampoules will burst or leak when placed in a certain vacuum degree, so it is easy to detect after vacuum test, and unqualified ampoules can be removed from the production line. Vacuum color water leak detection test is to inject dye water into the sterilization chamber to exceed the level of sterilization items, and then, pressure to force dye into all ampoules, and then discharge the water in the sterilization chamber, the broken ampoules with dye are easy to be detected, to ensure the waste detection rate of 99.9%. The cooling water spray is covered in the whole cabinet with no dead Angle, which can make the ampoule cool evenly. Finally, clean the bottle with purified water to ensure that the outer wall is clean and pollution-free.
The water bath sterilizer is widely used in high and low temperature sterilization of glass bottles, ampoules, plastic bottles, plastic soft bags and other liquids, the temperature is relatively low, the sterilization cycle is relatively long.
The medical autoclave has a series of advantages such as high thermal efficiency, good temperature uniformity, wide range of temperature control and so on. Using high temperature and superhot water as the sterilization medium, through the circulation of the sterilization medium, heat exchange with the sterilization items, to realize the sterilization process such as temperature rise, sterilization, cooling and so on. To ensure uniform rapid rise and fall in the process of heating, uniform sterilization at low temperature can be realized, which eliminates the temperature dead Angle caused by the existence of cold air in steam sterilization, and can avoid the secondary pollution phenomenon due to unclean cooling water in the cooling process after sterilization.
The equipment is equipped with simple operation, flexible and light electric sliding door, automatic in and out of the cabinet system, reduce the labor intensity of workers. This machine adopts the computer to carry on the whole process monitoring, the main control system computer PLC touch screen DPS remote backstage monitoring system, various parameters can be modified, real-time record and print out, greatly improved the reliability and intelligence of the whole machine, so that it can be better suited to the needs of modern enterprise industrial production.
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