41results about How to "Improving Sterility Assurance Levels" patented technology

The invention discloses a sterile injection water production technique and a sterile compressed air preparation method. The sterile injection water production technique comprises the following steps: firstly, performing online cleaning CIP (Cleaning in Place) and online SIP (Sterilization in Place) and online drying to all pipelines, a preparation tank and a storage tank used in the production of sterile injection water through distilled water or pure steam, and delivering distilled water into the preparation tank; heating and sterilizing the distilled water, and leading into the storage tank and cooling; and finally, performing sterile filtration to the distilled water through a redundant filtration system, and injecting in a blowing-pouring-sealing three-in-one pouring machine through a sterile pipeline system for sterile pouring and sealing, thus obtaining the product. Through the production technique, the injection water is strictly sterilized before pouring and sealing, heat source content can be effectively controlled, an additive and an antioxidant of a plastic bottle can be prevented from diffusing into the injection water and no impurities of scraps and the like do not exist when terminal high-temperature sterilizing is carried out, therefore, the sterile injection water can provide powerful guarantee for the clinical use safety.

The invention relates to a nelarabine injection, which is characterized by consisting of nelarabine, EDTA or EDTA salt, sodium chloride, and water for injection, wherein the nelarabine accounts for 0.25 to 0.625 percent of the total weight of the injection, the EDTA or the EDTA salt accounts for 0.001 to 0.01 percent of the total weight of the injection, the content of the sodium chloride is 0 orthe dose is used for regulating the osmotic pressure, and the balance is the water for injection. The preparing process comprises the following steps: taking 80 percent of the water for injection, adding raw supplementary materials into the water for injection, stirring the mixture to fully dissolve the raw supplementary materials and mixing the mixture evenly, adjusting the pH value, adding 0.02percent of needle activated carbon into the mixture, keeping the water temperature at 70 DEG C, stirring the mixture for 30 minutes, filtering the mixture to remove the activated carbon when the mixture is hot, cooling the mixture to room temperature, measuring the contents and the pH value of the solution, adding the water for injection with full dose into the solution, mixing the mixture evenly, filtering the mixture through 0.22 mu m of microfiltration membrane until the mixture is clear, packaging the filtrate into infusion bottles after intermediates are measured to be qualified, plugging the bottles, and rolling the mouths of the bottoms to obtain the nelarabine injection after hot pressing sterilization.

The invention discloses a dry-cleaning and sterilizing machine, which comprises a sorting mechanism, a conveying belt, a dry-cleaning device and a sterilizing device; the top of the dry-cleaning machine is provided with an air spray head, and the conveying belt passes materials sequentially through the feeding port end of the conveying belt. After passing through the dry cleaning device and the sterilization device to the point of use of the material; the sterilization device includes an inert gas lamp, a pulse laser generator and reflectors on both sides; Through the space; the high-intensity pulse laser generated by the pulse laser generator irradiates all the light energy to the materials to be processed on the conveyor belt through the reflector. In the present invention, cleaning, pressurization, high-temperature air local dry cleaning and overall purging are used to complete the cleaning of foreign matter on the surface of the article and the pretreatment-cleaning work before sterilization. The surface of the object is sterilized by harmless pulsed laser irradiation. The transmission mechanism is used to realize the continuous feeding of items, and to ensure the effective effect of cleaning and sterilization.

The invention discloses a nano ganciclovir freeze-drying preparation for injection and a preparation method thereof. The nano ganciclovir freeze-drying preparation for injection comprises the following components in parts by weight: 100-400 parts of ganciclovir, 10-50 parts of dextran 40, 5-50 parts of solubilizer, 10-100 parts of nano carrier material and 10-80 parts of freeze-drying skeleton agent. The preparation method comprises the following steps of: sequentially adding dextran 40, solubilizer, ganciclovir, nano carrier material and freeze-drying skeleton agent into water for injection to be dissolved, filtering a solution step by step, and carrying out freeze-drying, thus a freeze-drying preparation is obtained. According to the preparation method, no activated carbon is introduced, thus a risk that damage is done to a human body when activated carbon particles are introduced into the preparation as the activated carbon is used is avoided; besides, pH of the nano ganciclovir freeze-drying preparation for injection is 6-8 and close to that of plasma, and local irritation produced to the human body owning to overhigh alkalinity is avoided.