Infusion agent sterile workshop
Infusion agent sterile workshop
The quality requirements for infusions are basically the same as those for injections. The inspection items include visible foreign bodies, sterility, pyrogens, insoluble particles, pH, content determination and safety tests. Specifications, the additive is preferably the specification for injection; lose...
Text label: sterile workshop for infusion agents, design and decoration of sterile workshop, sterile workshop for infusion agents
Infusion agent sterile workshop
The quality requirements for infusions are basically the same as those for injections. The inspection items include visible foreign bodies, sterility, pyrogens, insoluble particles, pH, content determination and safety tests. Specifications, additives are preferably injection specifications; infusion containers can be divided into glass bottles, plastic bottles, plastic bags. The glass bottle is made of hard neutral glass, which has the advantages of transparency, compatibility, good water and gas resistance, wide material source and low price, but it also has poor mouth sealing, direct contact between the rubber stopper and the liquid medicine, easy to use. Falling off and being fragile are not conducive to transportation; plastic bottles are represented by polystyrene plastic bottles, and their performance characteristics are mainly good stability, good mouth sealing, no shedding, light weight, strong impact resistance, and infusion products. In the production process, the probability of contamination is reduced, energy is saved, and disposable use is both hygienic and convenient. The disadvantages are poor transparency and high air permeability; bottled containers have a common weakness, and infusion products can form an air loop during use. , the outside air enters the bottle body to form internal pressure to make the medicine drop out, which greatly increases the secondary pollution of the infusion process, so the plastic infusion bag packaging came into being, and the plastic bag infusion can rely on its own tension during use. Drop out, no need to form an air loop, which greatly reduces the probability of secondary pollution.
The raw and auxiliary materials for infusion must be of high quality and non-polluting, meet the specifications and standards for injection, and the preparation equipment meets the requirements and regulations of GMP. At present, high-quality stainless steel interlayer liquid dispensing tanks and stainless steel quick Install pipeline pressure filtration transportation liquid dispensing system. The preparation methods include concentrated preparation method and thin preparation method. When preparing, the name, quality and specification of raw and auxiliary materials must be strictly checked. After preparation, the quality of semi-finished products should be checked; when preparing infusion , needle-use activated carbon is often added, and the usual amount is 0.01%-0.3% of the total solution. When used, it is generally heated and boiled, cooled to 60-70 ° C and then filtered, or it can be filtered while hot; filter device and filter method for infusion Basically the same as the injection, the filtration mostly adopts the pressure filtration method, and the effect is better; the filter material is generally pre-filtered and decarbonized with a ceramic or titanium filter rod or a plate-and-frame filter press, and the fine filtration adopts a microporous filter membrane, which is commonly used. The pore size of the filter membrane is 0.45-0.8μm. During prefiltration, a layer of carbon should be adsorbed on the filter rod, and at the beginning of filtration, back filtration is repeated until the clarity of the filtrate is qualified; the viscosity of the solution will affect the filtration rate, and the greater the viscosity , the slower the filtration rate, so the infusion with high viscosity can be filtered at a higher temperature. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for sterile workshops and clean workshops.
Potting consists of four continuous operations: perfusion, membrane isolation, rubber plug and aluminum cover. Infusion potting should strictly control the cleanliness of the clean room modular, and local level A purification should be adopted to prevent bacterial dust pollution. After completion, it should be inspected bottle by bottle, and those that are not tightly tied should be removed; the infusion should be sterilized immediately after potting, and the time interval from dispensing to sterilization should generally not exceed 4H to reduce microbial contamination. To ensure that the product is sterile and pyrogen-free, the infusion sterilizer adopts the autoclave sterilization method at 121°C for 15 minutes; the temperature should be gradually increased at the beginning of infusion sterilization, and generally preheat for 20-30 minutes to reach the predetermined temperature; , The cooling rate and time can be controlled automatically and with high precision according to a predetermined program, and the sterilization status can be automatically recorded and displayed.
SUZHOU PHARMA MACHINERY CO.,LTD. thinks that that firms can avoid the artificial choice between quantitative and qualitative risk management, allowing both to play important roles in surfacing and assessing risks.
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