16 results about "Sterility test" patented technology

The invention provides a whole-process monitoring method and device for a sterile experiment, and belongs to the technical field of sterile monitoring, and the method comprises the steps: carrying out the feature extraction of operation actions of target equipment and target personnel, and obtaining a real-time operation specification which comprises the operation sequence of the target equipment and the operation sequence of the target personnel; based on the deviation between the real-time operation specification and the standard operation specification, the sterile test operation process is evaluated, and the operation sequence of the target equipment and the operation sequence of the target personnel are both provided with the corresponding standard operation specification. According to the sterile experiment whole-process monitoring method and device provided by the invention, the reliability and the success rate of the experiment can be ensured.

The invention relates to the technical field of biological medicines, in particular to a soluble skin-adhering microneedle for delivering an inactivated enterovirus vaccine as well as a preparation method and application of the soluble skin-adhering microneedle. Sodium hyaluronate is adopted as a film forming material to wrap an enterovirus 71 type (EV71)-coxsackie virus A16 (CA16) type bivalent inactivated vaccine antigen, and a needle body layer of the soluble microneedle is formed; the substrate layer is prepared from a pullulan material, so that the microneedle patch with a stable overall structure is formed. The technology provided by the invention is completed in a clean environment, and the vaccine patch which is qualified through sterility detection is obtained. The soluble microneedle disclosed by the invention has good antigen stability under the condition of 2-8 DEG C. In animal experiments, the microneedle is attached to the skin surface of a mouse for skin-adhering immunization, a strong immune response reaction can be induced, good immunogenicity is shown, and a novel, safe and effective vaccine delivery way is provided for prevention and control of the infantile hand-foot-and-mouth disease.

The utility model discloses a VHP sterility test isolator which comprises an installation frame, a plurality of steering wheels arranged at the bottom end of the installation frame, an air circulation box arranged on one side in the installation frame, a power distribution cabinet arranged on the other side in the installation frame, and a transmission mechanism arranged on one side of the top end of the installation frame. An isolation mechanism matched with the transmission mechanism is arranged on the other side of the top end of the mounting frame, a hydrogen peroxide generating device is arranged at the top end of the isolation mechanism, and one side of the hydrogen peroxide generating device is connected with one side of the air circulation box through a U-shaped communicating pipe. The device is scientific and novel in structure, vaporized hydrogen peroxide can quickly cover all the surfaces of the working area by adopting a mode of directly spraying vaporized hydrogen peroxide to the working area, and the vaporized hydrogen peroxide can be more uniformly distributed in the working area by matching with the design of the gas spraying assembly, the gas output assembly and the gas spraying assembly; the disinfection effect is better.

The utility model belongs to the technical field of soil nutrient detection, and particularly relates to a portable sterile test box, which can realize that when a user goes out and carries a test box body to carry out soil detection, clamping blocks on two sides can be held by a hand to extrude each other, and the hand touches a controller in the extrusion process, so that electrons are turned on, and electromagnetic blocks are magnetized; at the moment, the two clamping blocks extrude each other to compress a compression spring, then the compression spring is retracted into a limiting block and is fixed through attraction of an electromagnetic block, so that the self-rebounding rotating shaft is driven to rotate when the shoulder strap is pulled, the shoulder strap is lengthened, the shoulder strap is adjusted to the length suitable for being carried on the shoulder, and after the strap is adjusted, the controller can be touched again to close the electromagnetic block; the clamping blocks are automatically ejected out of the limiting blocks through the elastic force of the compression springs to be clamped with the clamping plates in an abutting mode, so that the self-rebounding rotating shafts cannot automatically rebound, the shoulder straps are limited, and the effects that the test box body can be carried on the shoulders to liberate the two hands when people go out to carry the test box body, and the length of the shoulder straps is freely adjusted are effectively achieved.

The utility model discloses a sterility test sample rack which comprises a supporting assembly and two or more rack bodies, the supporting assembly is used for connecting the two rack bodies in the vertical direction, and each rack body comprises a first clamping part and a second clamping part which are arranged in parallel. When the sample rack is used, an operator can turn over the rack bodies and change the positions of the first clamping part and the second clamping part in the vertical direction according to use requirements, then the supporting assembly is arranged on the first rack body, then the second rack body is placed on the supporting assembly, and the first rack body and the second rack body are stacked in sequence to form the multi-layer sample rack, so that the space utilization rate is increased; according to the utility model, an operator can respectively arrange penicillin bottles or ampoule bottles on different frame bodies, and the plurality of frame bodies are stacked and put into a sterile isolator together, so that the simultaneous sterilization is realized, and the requirement of daily inspection quantity is met. On one hand, the sterile test sample rack can increase the number of samples sterilized at a time, and on the other hand, the requirement for simultaneous sterilization of various samples is met, so that the test efficiency of the samples can be improved.

The invention belongs to the technical field of inspection, particularly relates to a sterility inspection eluent, and provides the following scheme aiming at the problems that the existing sterility inspection eluent does not have environmental protection property and affects the safety: the sterility inspection eluent is prepared from the following components in parts by weight; the raw materials comprise 5 to 10 parts of a protein material, 1.50 to 3.00 parts of a salt extract, 0.50 to 1.50 parts of Tween-80, 0.50 to 2.00 parts of disodium hydrogen phosphate, 0.40 to 1.20 parts of potassium dihydrogen phosphate and the balance of distilled water; the raw materials for preparing the protein material comprise kitchen waste, hydrochloric acid, sodium hydroxide and distilled water, a sterility test eluent is prepared from the protein material, a salt extract, tween-80, disodium hydrogen phosphate, monopotassium phosphate and distilled water, and the prepared material uses a large amount of kitchen waste, so that the environmental pollution can be reduced; the production safety of the sterility test eluent is improved, the corrosivity of the material is low, the safety is high, and the risk can be reduced in the production process of the material.

A rapid sterility test method that reduces inhibition of the nucleic acid amplification reaction of target nucleic acid due to human nucleic acid. The rapid sterility test method can detect the presence of bacterial nucleic acid included in a test sample including human nucleic acid by a nucleic acid amplification method, where an oligoset that is used in the nucleic acid amplification method includes (1) one or more probes selected from the group consisting of a probe group PM1, a probe group PM2, and a probe group PM3 and (2) one or more reverse primer in a primer group RM.

A method of assessing stopper movement in a syringe is provided, the syringe comprising a syringe barrel and a stopper movably disposed within the syringe barrel. The method comprises inoculating a biological particulate through an open proximal end of the syringe barrel such that the biological particulate covers at least a portion of an interface between a proximal face of the stopper and an inner wall of the syringe barrel. A cavity of the syringe contains a fill volume of liquid. Afterwards, the method comprises subjecting the syringe to one or more conditions, extracting the fill volume of liquid from the cavity of the syringe, performing a sterility test on the extracted fill volume of liquid, and determining stopper movement in the syringe based on the sterility test.

The invention belongs to the technical field of levofloxacin hydrochloride injection, and particularly relates to an off-grid vertical-axis wind driven generator with high wind resistance, which comprises the following specific steps: cleaning a beaker, a glass rod, a volumetric flask and a wide-mouth flask with purified water; the preparation method comprises the following steps: firstly, weighing 50.8 g of analytically pure magnesium chloride, adding the analytically pure magnesium chloride into a beaker, then adding a proper amount of purified water, and stirring with a glass rod until the magnesium chloride is completely dissolved; a glass rod is firstly used for drainage. The sterility test qualification rate of the levofloxacin hydrochloride injection is increased from 44.44% to 100%, the quality risk is greatly reduced, the market reputation and customer credibility of the product are enhanced, and powerful support is provided for long-term competitiveness of enterprises. And a detection optimization scheme formed in the attack process provides experience for prevention and solution of subsequent similar problems, and further improvement of a quality management system is promoted.

The utility model provides a high-activity medicine sterility examination isolator which comprises a glove box, a first air inlet device, a second air inlet device, a first air exhaust device, an air return channel and a filtering air outlet channel. A filtering component and a second air exhaust device are sequentially arranged in the filtering air outlet channel. A channel switching mechanism is arranged among the glove box, the air return channel and the filtering air outlet channel, and the communication state among the glove box, the air return channel and the filtering air outlet channel is controlled through the channel switching mechanism; an air return valve is arranged between the filtering air outlet channel and the air return channel and located between the air exhaust fan and the air exhaust valve. According to the utility model, the requirements of two modes of conventional sterility examination and high-activity medicine sterility examination can be met at the same time, and the power of the air inlet device (fan) can be reduced in the high-activity medicine sterility examination mode.

The invention relates to a cartridge for performing a nucleic acid amplification test of sterility on a sample, wherein the cartridge and all components are nucleic acid contamination-free. The cartridge is suitable for processing biological samples, whereas the nucleic acid sterility test detects all clinically relevant bacterial and / or fungal species. Further, the invention relates to a use of said cartridge for performing a nucleic acid amplification test and for detecting at least one fungal and / or at least one bacterial contamination. The invention also relates to a method of producing said cartridge in a nucleic-acid free environment and optionally with DNA-depleted and optionally disinfected components. Further, the invention relates to a kit or a kit of parts comprising at least one nucleic acid contamination-free nucleic acid amplification reagent. The invention also relates to a device comprising said cartridge.

A method for detecting viable cells, such as sterility detection, comprising the steps of: obtaining a sample; pre-treating the sample by maximizing the viability of at least one RNA-based biomarker, wherein the RNA-based biomarker is preferably versatile, rich and short-lived, and a method for preparing the same, wherein the method comprises the steps of: pre-treating the sample by maximizing the viability of at least one RNA-based biomarker, wherein the RNA-based biomarker is preferably versatile, rich and short-lived; processing the sample to facilitate a reagent to contact the RNA-based biomarker; amplifying the at least one nucleic acid sequence of the RNA-based biomarker using an amplification reagent; interacting with an amplification sequence of the RNA-based biomarker to produce a readout signal; and detecting the readout signal and determining the presence of viable cells in the sample. A pharmaceutical regimen for a short-lived drug implements the method for detecting viable cells, the drug being administered to a patient after confirmation of safety within three hours of obtaining the sample from the patient.

The invention belongs to the field of medicine detection, and particularly relates to a sterility test method for a levofloxacin injection. The invention provides a sterility test method for a levofloxacin injection. The inhibition effect of the levofloxacin injection on microorganisms is eliminated by screening conditions such as the concentration of a neutralizing agent in a test solution and a flushing solution, the flushing amount, the flushing times and the like. Under optimal conditions, the sterility test method meets the requirement of the general rule 1101 of the fourth part of Chinese pharmacopoeia on the applicability of the sterility test method, the effectiveness and reliability of sterility test of the levofloxacin injection are improved, a basis is provided for drug detection and antibiotic quality verification, and the application prospect is good.

The invention relates to a high-purity subtilucent 37 peptide reference substance and a production method and application thereof based on biosynthesis industrialization, and belongs to the field of biomedicine.The production method comprises the steps that bacillus subtilis serves as a production strain, and fermentation liquor is obtained through primary seed tank fermentation and seed tank fermentation; carrying out ceramic membrane separation, double-effect concentration, salting-out and tubular centrifugation on the fermentation liquid to obtain a precipitate which is a crude product of the tri17 peptide; the preparation method comprises the following steps: redissolving a crude product of the withered grass tri17 peptide with a 20% ethanol aqueous solution, centrifuging, filtering, dewatering, carrying out ion exchange chromatography, carrying out ultrafiltration concentration, freeze-drying, and subpackaging to obtain a reference substance of the withered grass tri17 peptide; wherein the elution step of hydrophobic chromatography is water-5% ethanol water-50% ethanol water elution. Reversed phase chromatography, ion exchange chromatography and size exclusion chromatography detection results show that the purity of the reference substance is greater than 99.9%, the endotoxin is less than 10 EU / mL, the sterility test and the abnormal toxicity meet the high-purity bulk drug standard, and the reference substance can be used as a crude drug of the triticin.

- 71 - Abstract The invention relates to a cartridge for performing a nucleic acid amplification test of sterility on a sample, wherein the cartridge and all components are nucleic acid contamination-free. The cartridge is suitable for processing biological samples, whereas the nucleic acid sterility test detects all clinically relevant bacterial and / or fungal species. Further, the invention 5 relates to a use of said cartridge for performing a nucleic acid amplification test and for detecting at least one fungal and / or at least one bacterial contamination. The invention also relates to a method of producing said cartridge in a nucleic-acid free environment and optionally with DNA-depleted and optionally disinfected components. Further, the invention relates to a kit or a kit of parts comprising at least one nucleic acid contamination-free 10 nucleic acid amplification reagent. The invention also relates to a device comprising said cartridge.

The invention relates to a cartridge for performing a nucleic acid amplification test of sterility on a sample, wherein the cartridge and all components are nucleic acid contamination-free. The cartridge is suitable for processing biological samples, whereas the nucleic acid sterility test detects all clinically relevant bacterial and / or fungal species. Further, the invention relates to a use of said cartridge for performing a nucleic acid amplification test and for detecting at least one fungal and / or at least one bacterial contamination. The invention also relates to a method of producing said cartridge in a nucleic-acid free environment and optionally with DNA-depleted and / or disinfected components. Further, the invention relates to a kit or a kit of parts comprising at least one nucleic acid contamination-free nucleic acid amplification reagent. The invention also relates to a device comprising said cartridge.