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1 filter sterilization with pharmaceutical liquids request in the consumption of lyophilized preparations, the application of bacteria can not pass through the dense pore filter material, the filter to remove the microorganisms in the gas or liquid used in the process. It is mainly used for sterilization of heat-labile drug solutions or raw materials.
1.1 The pore size of the liquid air filter is selected. The prepared liquid solution needs to be filtered by a high-efficiency air filter with a proper aperture to remove the total impurities and bacteria of the liquid. The liquid chemical filtration on weekdays is filtered in series using a high efficiency air filter with two or more divergent apertures. In the process of practical consumption, the filter is divided and filtered by a filter with a divergence aperture on a weekday, sometimes decarbonization is required to remove the pyrogen, and the solution is filtered through a microporous high-efficiency air filter with a pore size of 0.22 μm. Sterilization. When filtering the liquid, special attention should be paid to confirming the pore size of the sterilizing air filter and its lack of consumption during the consumption process, that is, the sterilizing air filter membrane should stop the bubble point and implement it after passing the test. Before the operation, the operator first checks the original auxiliary materials, title, batch number, and laboratory declaration, checks the appearance quality, and then weighs the raw materials according to the prescription, then stops the dispensing operation. The solution stops the sterile filtration before filling, and the filtration is finished. After the air filter is discontinued, it is implemented. When the liquid medicine preparation system is applied by filtering while filling, the system should use two sterilization effect filters in series to ensure that an air filter filter is present during the filtration and filling process. Damage does not affect the sterility of the filtrate.
In order to effectively remove living microorganisms from the process and obtain a sterile liquid, the nominal aperture of the high efficiency air filter is 0.22 mm or less. In some cases, it is necessary to consider the use of double sterilization air filters, especially during the filling process of the liquid medicine or before the filling is completed, without the premise that the air filter is not required to be used.
The diameter of the sterilizing membrane used in drug consumption does not exceed 0.22 μm. The medium-effect bag filter shall not adsorb or impregnate the filtered components, and shall not release the material. There shall be no fiber drop, and the asbestos-containing air filter shall be banned. Filters and membranes should be cleaned prior to use and either sterilized or sterilized by high pressure steam. Change the type and batch should first clean the filter, then change the filter.
1.2 filter material air filter equipment on weekdays have filter columns, filters and so on. The filter column is made of diatomaceous earth or fused glass. Most of the filter membranes are made of polymers, such as cellulose acetate, nitrocellulose, acrylic polymer, polyvinyl chloride, nylon, etc., and the filter membrane pore size is 0.22 μm.
1.3 Filtration Efficiency The level of sterility assurance during the filtration process is related to the initial bioburden of the filtered liquid and the logarithmic decrease LRV (LogReductionValue) of the air filter. LRV is a common logarithm of the ratio of the number of microorganisms before filtration to the number of microorganisms after filtration, based on the courtesy of the filtered liquid. which is:
LRV=lgN0-LgN
Where: N0 is the number of microorganisms before the product is sterilized, and N is the number of microorganisms after the product is sterilized.
The LRV is used to disclose the filtration sterilization efficiency of the air filter. For an air filter with a pore size of 0.22 μm, the filtration sterilization efficiency LRV value per 1 cm 2 of the effective filtration area should be not less than 7. Therefore, when filtering and sterilizing, the total amount of pollution of the filtered product should be controlled within the limits of politeness. In order to ensure the filtration sterilization effect, two air filters can be used in series to filter, or the air filter can be used to stop the filtration again before filling.
Extraordinary request for 1.40.22μm sterilizing grade air filter (1) Air filter membrane and structural data, requesting superior compatibility with the finished liquid;
(2) The air filter can prove the size of the pore size and the lack of filter through the bubble point test (FDASterileDrugProductsProducedbyAsepticProcessingSeptember, 2004);
(3) The filter material should be carried out through proper and effective bacteria, that is, the biological properties should be confirmed (microbial interception): request the use of Pseudomonas falciparum under the premise of the consumption of the drug instead of water (strain ATCC19146) , the size of Pseudomonas faecalis: 0.68 μm × 0.31 μm) to verify the microbial retention function (Brevundimonasdiminuta);
(4) The filter material should be able to withstand steam sterilization at 121 °C.
1.5 The basic request for the use of the liquid air filter in the filter sterilization, it is not easy to monitor the critical parameters of the air filter in the whole process (the size and distribution of the membrane pore size, the lack of filter membrane and LRV). Therefore, the filter should be carried out before and after each filter sterilization, that is, the bubble point is carried out or the pressure is maintained or the gas diffusion flow is carried out. Confirm the effectiveness and non-defectiveness of the filter in the sterilization filtration process. Under normal conditions, the use of sterile air filters should not exceed one working day.
2 Control points of the filtration process 2.1 Determination of the amount of bacteria in the pre-filtration solution should be determined before the sterilization filtration (before filling). The preparation of the ingredients or liquids should be strictly controlled to avoid the addition of microbial contamination levels that may occur before the sterilization of the liquid. The addition of endotoxin in the drug solution is related to the serious level of microbial contamination.
The bio-load test for stopping the liquid medicine before the final filtration by the pre-filtering is effective for determining the amount of the solution in the sterilization filtration, but it cannot supply the composition of the endotoxin in the liquid and the contaminated water. Peer-to-peer information status. On weekdays, 0.1 ml of the solution sample that was once filtered can be used, and the amount of endotoxin is determined by the sputum reagent method (LAL). At least 100 ml of the sample before the pre-filtration is stopped and tempered (especially in the case of Gram-negative bacteria). When it exists), then the consumption process is suspended.
2.2 drug liquid bacterial endotoxin control Some patients who also use other drugs (such as infants), or patients with large injection volume or dose, it is easy to present the pyrogen reverberation, weekdays, will be higher than the normal Ankang people by weight The reverberation of the original temperance specification is much more serious. From this type of clinical thinking, the request is to strengthen the control of the consumption process to avoid the occurrence of bacterial endotoxin. In this regard, emphasis should be placed on the regulation of bacterial endotoxin, raw materials, containers, seals, storage time limits, and consumer equipment.
In the filtration process, the clean, single and harmonious storage of the filtration equipment should be able to effectively control the biological load (microbial contamination level) and the bacterial endotoxin contamination level. Filtration equipment should be easy to disassemble, clean, disinfect or sterilize. If there is no proper control measures, the upstream and sputum of the filtration equipment may be contaminated by bacterial endotoxin.
A sterile air filter and moist heat sterilization remove bacterial endotoxin. In general, the bacterial endotoxin on the surface of the device can be inactivated by high temperature or removed by washing. In some online cleanliness, the water and/or cleansing agent of the purity can be used for the rinsing in the rough washing stage, and then the hot water is used for the final rinsing. After the equipment has been cleaned, it should be monotonously handled unless it is sterilized immediately.
In order to effectively control the potential bacterial endotoxin contamination during consumption, it is necessary to define the time limit for each step of the polite aseptic process. The steps to set the time limit control include: preparation of the liquid to sterilization, sterilization filtration, when the product is exposed on the consumer line, when the sterilization equipment, container and seal are registered. The time limit for restraint in the divergent consumption phase should be determined based on the implementation data. The total number of microbial contamination and the level of bacterial endotoxin contamination should be assessed when developing time limits (eg, determining the time limit for the formulation phase).
For the liquid filtration operation of the preparation process, the upper limit of the total length of time spent on the polite product filtration process (zui long time limit) should be delineated to avoid microbial penetration of the sterile air filter. The use of time-limited control also avoids the apparent addition of microbial contamination and bacterial endotoxin contamination upstream of the air filter. The addition of microbial and pyrogen contamination levels will bring helium elements to the sputum. Therefore, it is necessary to determine the time limit for the clarification or removal of the particles and to clarify the basis for setting the specifications.
2.3 Quality Control of Filtration Process The primary quality control measures are: the content of active ingredients in the liquid medicine, the pH of the liquid, the brilliance, the clearance, the weighing of the raw materials, the mutual review, and the accurate recording.
3 The liquid medicine filtration unit sets the liquid medicine through the sterilization filtration, can significantly reduce the concentration of impurities and microorganisms in the ingredient solution, and can maintain the sterility of the consumption flow pipe system.
When the liquid product in the aseptic consumption process proves to be able to filter and sterilize, it should be required to filter the product specific to the product. The compatibility of the sterilization filter and the product formulation should be demonstrated, that is, the compatibility of the air filter media with the drug solution should be considered, and the influence of the operation premise of the difference should be considered. Non-zui final sterilization method for the consumption of sterile drugs, the use of aseptic consumption in the case of side filtration, while filling, also requires the use of two air filters in series to filter, to ensure that the filtration process will never be due to Damage to the filter of the air filter causes filtration failure.
Zui terminally sterilized sterile products may also require special sterilization filtration. Before the final sterilization of zui, there is enough reason to stop the effective bio-load control. The product needs no need for sterilization filtration, and must be unique to the product and consumption process. The basic data to stop the effective evaluation.
Traditionally, the sterilization filtration process is completed by the aseptic tightening air filter press liquid, and the raw material liquid in the ingredient tank or the chemical liquid storage container is pressure-filtered into the receiving container of the liquid medicine by using the pressure of the compressed air in the dosing tank. A sterile air filter is installed between the sterile liquid receiver and the sterile liquid receiver.
When the filtration operation is stopped in a small limited sealing condition, the sealed non-pressure container and the silicone rubber tube can be used to obtain the peristaltic pump device filter press liquid. The container and the tail-to-tail piping system can be cleaned and sterilized when the filtration operation is aborted under the condition of large-scale consumption. For less restrictive operation, the liquid container and filter assembly can be properly cleaned and cleaned, then autoclaved and disinfected, and the sterile assembly is stopped under maintenance of Class 100 unidirectional flow clean air.
Whether the filter for sterilization filtration can be used, whether the air filter is applied in the preparation of the freeze-drying process of the drug, and whether the device of the filter between the containers is reliable or not, should be proved by the method of implementing the air filter. The non-destructive implementation is suspended before filtration, and can also be stopped before sterilization. However, after filtration, it is necessary to stop the non-destructive implementation of the air filter to confirm that the filtration process of the batch of liquid is reliable and that the semi-waste is allowed to be released.
Filtering is not assuming that it is better to be able to abort at the original location of the device (ie, abort online).
Typical sterile indoor filtrate acceptor container structure diagram Click here to view the full news picture 4 freeze-dried liquid solution preparation filter system settings related issues 4.1 the size of the preparation of the majority of semi-lyophilized powder injection preparations are small in quantity, In the selection and matching of the preparation tank, the capacity of the preparation tank and the combined use of the external type should be increased as much as possible. It should also be noted that the relationship between the batch number and the preparation system should be matched according to GMP.
4.2 Most of the settings of the sterilizing air filter, at the end of the thinning system, the equipment is always equipped with a membrane air filter with a pore size of 0.22 μm as a sterilization process equipment. There are two situations in the process: one is that the preparation process is a series of concessions and consumption of the consumption line. That is, the liquid medicine is filtered while being filled; the other is medium and small limitation, and the gap type filter is filled, that is, the liquid medicine is completely filtered and then filled.
(1) The liquid is filtered while filling. Under this condition, the air filter is applied in the preparation of the drug freeze-drying process. Because the Fucheng can filter the air filter in the process, the online test can be stopped at any time to confirm that the filter is not damaged during the operation. . In order to ensure the robustness of the filtrate, two 0.22 μm air filters are used in series in the system. Only two sterile air filters are required to pass the non-defective test before use, and the possibility of damage to the two air filters during the filter filling process is simply not available. Thus, the sterility of the final filtrate of zui can be greatly ensured.
(2) The liquid medicine is completely filtered and then refilled. After the filtration of the drug solution is completed, the 0.22 μm sterile air filter after the application is stopped again, and the liquid is filled. Thus, the system is capable of providing only one 0.22 μm sterile air filter.
4.3 After the preparation of the liquid medicine, the mode of the body is selected. After the ingredients are replenished, the two types of liquids are used to stop the delivery: one is pumped (sanitary), and the other is cleaned or cleaned with inert gas. On weekdays, the water-soluble material can be transported by tightening air. If it is a liquid containing organic solvent or a liquid that is easily oxidized, it should be stopped by inert gas.
4.4 Ingredients Steps The formulation of an antibiotic freeze-dried drug batch is as follows: decarbonization through a titanium rod with a pore size of 10 μm, and then filtering through a pore size of 0.45 μm polysulfone air filter to a thin tank, adding full amount of water for injection Prescribe a polite capacity (constant volume) and then stir for 20 minutes. It is filtered through two series of polysulfone air filters with a pore size of 0.22 μm. The air filter is applied in the preparation of the drug freeze-drying process, and samples are taken from the sampling port of the second-stage air filter to measure the content, pH, brilliance, clarity and the like. After passing the test, it is filtered through a 0.22 μm microporous membrane filter to the filling room, and the content should be within the internal control limit (pH 4.5~5.5).
During the filling process, the prepared solution should be filled within 8 hr. In the whole process of filling the liquid, the liquid volume should be strictly controlled.
4.5 The liquid medicine is delivered after the drug is dispensed. The liquid is recovered on a weekday basis. The two types of suspension are guaranteed to be delivered: one is to be delivered by a stainless steel pump; the other is to be cleaned by a clean and compact air or a clean inert gas. In the general case, the water-soluble material can be compressed air. If there is a solvent liquid or a liquid that is afraid of oxidation, it is advisable to use an inert gas to stop the pressure feed. The liquid medicine after the ingredients should enter the filling process in a sterile, pyrogen-free condition and be filled into a glass bottle or tray. Therefore, a filtration device should be provided in the formulation system. On weekdays, the chemical solution is filtered through the secondary filtration system in the delivery system after decarbonization filtration. The 0.45 μm aperture filter is used in the front stage and the 0.22 μm aperture filter is used in the latter stage. The outer casing and fittings of the air filter should be 316L, and the sealing gasket (sheet) is medical grade PTFE. The smoothness of the air filter is based on each batch of material. The secondary air filter should stop the bubble point detection before use, and each stage should be equipped with hygienic type pressure gauge, sampling valve and drain valve.
Introduction Air filter is applied in the preparation of drug freeze-drying process
In general, drugs need to be lyophilized because of the instability of their solution conditions. Many antibiotics throughout the batching system (including: tanks, bodies, air filters, high efficiency air filters, medium efficiency filters, primary filters, air conditioning filters, bag filters, sanitary pipes, fittings and valves) : Some semi-synthetic penicillins, cephalosporins and erythromycin, doxycycline, chloramphenicol salts are produced by the freeze-drying process. It is possible to estimate the level of contamination of such products during consumption as they are antibiotics. Other types of lyophilized agents, such as hydrocortisone sodium succinate, methylprednisolone sodium succinate and many biological products, have no antimicrobial infusion under solution conditions. In order to minimize the level of microbial contamination of such drugs, the daily requirements are to remove the impurities and bacteria contained in the solution before the liquid is poured into the inner container. Let us discuss the preparation of the air filter in the freeze-drying process of the drug. Application.