19 results about "Sterility assurance level" patented technology

The invention provides a diphenhydramine hydrochloride injection and a preparation method thereof. According to the preparation method, the diphenhydramine hydrochloride injection with stable pH value, stable chemical property and sterility assurance level SAL less than or equal to 10 <-6 > can be obtained by controlling the material of a liquid medicine pipeline and the water resistance of a medium borosilicate glass ampoule. The diphenhydramine hydrochloride injection does not contain preservatives and cannot generate safety risks.

The invention relates to the technical field of terminal sterilization and filtration in a radiopharmaceutical preparation process, in particular to a filter membrane sterilization and filtration device and system. Comprising the steps that a state sensing module collects liquid medicine radioactive activity data and filter membrane structure strain data and generates real-time data flow; the twinborn modeling module constructs a filter membrane digital twinborn body, and outputs an accumulated radiation damage prediction result through data assimilation; the prediction decision module generates a filtering parameter optimization sequence by using a deep reinforcement learning agent; the control execution module adjusts the flow velocity of the liquid medicine through fuzzy self-adaptive PID control and feed-forward compensation; and the verification feedback module performs an integrity test and transmits data back to the twin modeling module to realize model parameter correction. All the modules form a closed-loop control system through a high-speed data bus, so that the damage of radiation to a filter membrane material is effectively inhibited, and the integrity and the sterile guarantee level of a membrane structure in the filtering process are maintained.

The invention provides an electron beam sterilization method of an implant, which is characterized in that the implant is irradiated by using a high-energy electron beam, the irradiation mode is at least twice, the irradiation dose of each time is not more than 20kGy, and the absorbed dose of the implant after irradiation is not less than 16kGy and not more than 50kGy. The method provided by the invention can ensure that the sterility level SAL is less than 10 <-6 >, can ensure that the drug quality of the implant is not affected, and can ensure that no new impurities are generated in the sterilization process.

Provided is a dry hydrogel-forming article which contains a crosslinked body of a vinyl alcohol polymer and an alcohol solvent, and which is characterized in that the content of the alcohol solvent is 0.01-15 mass% inclusive and the content of water is 0-70 mass% inclusive, based on the amount of the dry hydrogel-forming article. The dry hydrogel-forming article has a sterility assurance level SAL of 1 * 10 <-6 > or less and an aggregation degree of 10% or less.

There is disclosed an acellular dermal matrix (ADM) graft stored as a packaged ADM graft pocket product prepared by a process that includes providing a portion of ADM tissue having a thickness between 1 mm and 2 mm. The process includes scoring the portion of the ADM tissue into a pre-defined shape to form the domed shape ADM graft. The process includes verifying the thickness of the domed shape ADM graft; shaping the domed shape ADM graft to form an ADM graft pocket configured to receive a breast implant. The process includes packaging the ADM graft pocket to form a packaged ADM graft pocket. The process includes irradiating the packaged ADM graft pocket to a sterility assurance level of a desired level to form the packaged ADM graft pocket product. Other embodiments are also disclosed.

The invention provides a sterilization method for a product containing a marine organism extract, which adopts a moist heat sterilization process, the moist heat sterilization process is carried out by adopting a staged pressure pulse synergistic mode, the sterilization temperature is 120-130 DEG C, and the sterilization time is 9-15 minutes; the product contains sodium alginate, trehalose and other raw materials, an intermediate is prepared through a specific preparation technology, and the intermediate is filled, sealed and sterilized. A bacillus stearothermophilus biological indicator verifies that the sterility guarantee level of a sterilized product is less than or equal to 10 <-6 >, indexes such as pH and heavy metals meet standards, and sodium alginate is stable and is not obviously degraded; the method disclosed by the invention avoids the problems of pungent smell and component degradation of irradiation sterilization, improves the production efficiency and reduces the energy consumption compared with the traditional moist heat sterilization, gives consideration to the sterile effect and the product performance stability, and is suitable for skin care products containing marine organism extracts.

The invention relates to the technical field of progesterone preparation composition production, in particular to a progesterone preparation composition and a preparation method thereof.The progesterone preparation composition comprises progesterone and further comprises a first compound and a second compound, and the mass ratio of the progesterone to the first compound to the second compound is 84.4: 90: 108. A progesterone preparation composition is formed after progesterone raw materials are prepared and synthesized, then the progesterone preparation composition is subjected to impurity removal, purification, filling and sterilization to complete the production process, the progesterone injection belongs to high-viscosity liquid at the temperature of 20 DEG C to 60 DEG C, the standard filling amount of the progesterone injection with the specification of 0.8 ml: 20 mg is 0.94 ml, the standard filling amount of the progesterone injection with the specification of 1 m: 25 mg is 1.15 ml, and the progesterone injection with the specification of 1 m: 25 mg is 1.15 ml. The standard volume of the progesterone injection with the specification of 1ml: 10mg is 1.15 ml, and gt is designed in the development process of the progesterone injection; according to the dry heat sterilization process at the temperature of 170 DEG C / 60 minutes, the sterilization condition meets the excessive killing condition, no-load and full-load performance confirmation is also carried out on the performance of dry heat sterilization equipment, and it can be considered that the expected sterility guarantee level SALlt can be achieved; and 10 to 6 parts.

The invention belongs to the field of pharmaceutical preparations, and particularly relates to a diphenhydramine hydrochloride composition and a preparation method thereof. According to the diphenhydramine hydrochloride injection disclosed by the invention, the pH of the diphenhydramine hydrochloride solution is adjusted by adopting carbon dioxide, and terminal sterilization is performed on the diphenhydramine hydrochloride solution, so that the sterile guarantee level of the diphenhydramine hydrochloride injection is improved, and the clinical use safety is greatly improved.

Plant cultivation device (100) comprising a foam body (1) for holding a seed and / or seedling during at least one growth stage, which foam body is made of soft material with a Shore A hardness according to ISO 868:2003 of less than 80 on average according to ISO 291:2008, wherein the foam body (1) is sterilizable at least to a sterility assurance level of SAL 10-5, sterilized by chemical sterilization, preferably by hydrogen peroxide, ozone, perchloroacetic acid, ethylene oxide, ethanol and / or isopropanol, and / or by physical sterilization, in particular by eBeam and / or gamma radiation.

The invention discloses a methyhaaltrexone bromide injection tolerant to terminal sterilization and a preparation method thereof, and belongs to the technical field of preparation of pharmaceutical preparations. According to the method, a terminal sterilization production process is adopted, and the sterility probability can be theoretically smaller than or equal to 10 <-6 > and far exceeds the sterility probability in the prior art. Therefore, through the preparation method, the sterility assurance level of the preparation can be improved, so that the clinical use safety is ensured, the production cost and the environmental control risk can be reduced, and the supervision requirements are met. And the potential safety hazard that the highest sterile level cannot be ensured when the medicines on the market are subjected to a filtering and sterilizing process is solved. In the preparation process of the injection finished product, specified impurity limits are clearly defined, known impurities do not exceed 0.15%, unknown impurities do not exceed 0.1%, total impurities do not exceed 1.0%, the product quality of the preparation is controllable after the preparation is accelerated for 6 months and 24 months, and clinical test data prove that the injection is safe and effective.

A system may determine an application condition of sterilant to achieve a sterility assurance level (SAL) for an article. The system may determine a hypothesized sterilant resistance (ΘHS) that indicates a probability of a micro-organism expressing growth once exposed to a unit of sterilant; determine, based, at least in part, on the hypothesized sterilant resistance, an estimated number of samples that include a micro-organism expressing growth once exposed to the unit of sterilant; determine an observed number of samples that include a micro-organism expressing growth subsequent to exposure to the unit of sterilant; iteratively determine, based on one or more iterations, at least one first correction based on the observed number and the estimated number, and apply convergence criteria to determine whether to perform a next iteration; and determine the application condition of the sterilant, based on the first correction. Other aspects are also described and claimed.

The invention relates to the field of medical beauty materials, in particular to injectable cross-linked recombinant collagen gel for medical beauty and a preparation method of the injectable cross-linked recombinant collagen gel. Mixing the recombinant collagen with glutamine transaminase, and carrying out cross-linking reaction to form gel; carrying out dialysis on gel formed by crosslinking in normal saline at the temperature of 2-8 DEG C for 12-24 hours so as to remove free glutamine transaminase; diluting the dialyzed gel to a target concentration; and filling the diluted gel, and carrying out terminal moist heat sterilization under the conditions that the temperature is 121 DEG C and the standard sterilization time is greater than or equal to 12 minutes, so that the gel is homogenized. According to the technical scheme, through specific crosslinking and subsequent process treatment, the obtained gel can tolerate terminal moist heat sterilization conditions that the temperature is 121 DEG C and the F0 is greater than or equal to 12 minutes. Therefore, an expensive and high-risk sterile filling process can be abandoned in production, but a terminal sterilization process with more consistent batch sterility guarantee level is adopted, so that the production cost and the quality risk are remarkably reduced.

A system may determine an application condition of sterilant to achieve a sterility assurance level (SAL) for an article. The system may determine a hypothesized sterilant resistance (ϴHS) that indicates a probability of a micro-organism expressing growth once exposed to a unit of sterilant; determine, based, at least in part, on the hypothesized sterilant resistance, an estimated number of samples that include a micro-organism expressing growth once exposed to the unit of sterilant; determine an observed number of samples that include a micro-organism expressing growth subsequent to exposure to the unit of sterilant; iteratively determine, based on one or more iterations, at least one first correction based on the observed number and the estimated number, and apply convergence criteria to determine whether to perform a next iteration; and determine the application condition of the sterilant, based on the first correction. Other aspects are also described and claimed.

The application relates to a preparation method of a final sterilization process of triamcinolone acetonide injection, which comprises the following steps: (1) mixing auxiliary materials with triamcinolone acetonide raw materials to prepare triamcinolone acetonide injection intermediate products, wherein the volume mode particle size distribution of the triamcinolone acetonide raw materials in the triamcinolone acetonide injection intermediate products meets the following conditions: D(0.9)=13.5-24.0 mu m, D(0.5)=6.0-8.0 mu m, and D(0.1)=1.1-1.4 mu m, and the viscosity of the triamcinolone acetonide injection intermediate products is 30.0-50.0 mPa.s; (2) filling and sealing the triamcinolone acetonide injection intermediate products to obtain triamcinolone acetonide injection pre-sterilization intermediate products; and (3) performing final sterilization on the triamcinolone acetonide injection pre-sterilization intermediate products, wherein the triamcinolone acetonide injection after the final sterilization meets the following conditions: the volume mode particle size distribution is D(0.9)=14.0-26.0 mu m, D(0.5)=6.0-9.0 mu m, and D(0.1)=1.1-1.6 mu m; and the viscosity is 9.0-16.0 mPa.s. The triamcinolone acetonide injection obtained according to the application meets the quality attributes of a reference preparation, and the sterile guarantee level is improved.

The present invention belongs to the field of medicine and provides an aprepitant micelle injection and a preparation method thereof. The aprepitant micelle injection is composed of an active ingredient aprepitant, a phospholipid, bile acid or a salt thereof, a nano-micelle stabilizer, a pH regulator and water for injection. The above scheme selects a phospholipid and bile acid micelle system with good physiological compatibility and good safety for solubilization, thereby significantly improving the solubility of aprepitant; the combined use of the nano-micelle stabilizer can significantly improve the stability of the preparation; avoids the use of a large amount of soybean oil for solubilization, thereby reducing the risk of lipid metabolism; does not contain ethanol to avoid ethanol allergic reactions, thereby improving the safety of clinical medication; adopts a hot press sterilization method, thereby improving the sterility assurance level; the process is simple, easy to scale up for production, similar to the production process of ordinary injections, does not require special equipment such as a high-pressure homogenizer and a dedicated fat emulsion production line, and can significantly reduce production costs.

A Plant cultivation device (100) comprising a foam body (1) for holding a seed and / or seedling during at least one growth stage made of soft material with a Shore A hardness according to ISO 868:2003, of less than 80 in average at ISO 291:2008, wherein said foam body (1) is sterilizable to at least a sterility assurance level of SAL 10-5 sterilized by chemical sterilization, preferably by hydrogen peroxide, ozone, perchloric acetic acid, ethylene oxide, ethanol and / or isopropanol, and / or by physical sterilization, especially by eBeam and / or gamma radiation.

A plant cultivation device (100) comprising a foam body (1) for holding seeds and / or seedlings during at least one growth phase, made of a soft material having a Shore A hardness according to ISO 868:2003 of less than 80 on average under ISO 291:2008, wherein the foam body (1) is sterilizable to a sterility assurance level of at least SAL 10-5 by chemical sterilization, preferably by hydrogen peroxide, ozone, peracetic acid, ethylene oxide, ethanol and / or isopropyl alcohol, and / or by physical sterilization, in particular by electron beam and / or gamma radiation.

There is provided an isolator that is capable of improving work efficiency by shortening a sterilization time, and that is capable of securing a sterility assurance level. An isolator, in which a circulation fan above a work room supplies clean air to the work room via a HEPA filter, includes: the work room; a front door provided in a front surface of the work room; a glove provided in the front door; and an air supply unit that causes an air supply HEPA filter to clean air taken in from an air supply airtight damper, and that causes an air supply fan to supply the clean air into the isolator, when work is performed. When a sterilization gas is removed, the air supply unit is configured such that the air supply fan circulates the air inside the isolator through a sterilization gas-removing catalyst.

The application belongs to the technical field of pharmaceutical preparations, and particularly relates to a kind of injection containing bilastine and a preparation method thereof.The application protects a kind of injection of bilastine, which is mainly composed of bilastine, an osmotic pressure regulator, a pH regulator and water for injection;the concentration of the active ingredient bilastine is 0.1 mg / ml-10 mg / ml, the osmotic pressure regulator is sodium chloride, which has a concentration of 0.7%-1.5% w / v in the solution;the pH regulator is phosphoric acid or sodium hydroxide, and the pH value of the injection is 3.0-9.0.The bilastine injection prepared by the application has a faster effect than commercially available tablets, is suitable for acute urticaria patients, is sterilized by an overkill method, has a high level of sterility assurance, high formulation safety, good stability, few impurities and a simple preparation process.