Aseptic workshop injection and bottled infusion production purification

Production and purification of injection and bottled infusion in sterile workshop

Injection in sterile pharmaceutical cleanroom is divided into powder injection and water injection. The products produced by powder injection cannot be subjected to final sterilization treatment, while the products produced by water injection can be divided into those that can be terminally sterilized and those that cannot be terminally sterilized. Consider the difference between large and small capacity; the production process of powder injection includes: washing bottle...

Text label: sterile workshop design, purification engineering company, injection and bottled infusion production purification

Production and purification of injection and bottled infusion in sterile workshop

Injection in sterile workshop is divided into powder injection and water injection. The products produced by powder injection cannot be subjected to final sterilization treatment, while the products produced by water injection can be divided into those that can be terminally sterilized and those that cannot be terminally sterilized. Consider the difference between large and small volumes; the powder injection production process includes: bottle washing, rubber stopper treatment, glass bottle and stopper sterilization, sub-packaging and stoppering, crimping, and packaging; powder injection is not terminally sterilized, so in bottle washing The minimum fine cleaning process must be maintained at 100,000 grades, and it can be higher. The fine cleaning water is purified water or water for injection. The rubber stopper treatment and bottle washing have the same requirements. Except for the base rubber stopper, other rubber stoppers can also be boiled with dilute hydrochloric acid first. Washing; when sterilizing glass bottles and stoppers with a double-door electric oven, the air intake of the electric oven should be filtered with a sub-high efficiency or above, and the cooling after sterilization must have a 100-level environment. A sterilization tunnel; when sub-packaging and plugging, pay attention that the sub-packaging port is the most critical part. The sub-packaging process, especially the sub-packaging port, must be in a 100-level environment. In order to ensure sufficient time for disinfection in the sub-packaging room, no Three shifts should be arranged for production; the compressed air used by the airflow distributor must be treated with degreasing and high-efficiency filters, and the cleanliness of the pharmaceutical cleanroom should be achieved or higher than that of the workshop, and the relative humidity should be lower than 20%.

Note that glass containers should be washed and rinsed in a series of cycles before sterilization, which is important to remove debris. The final washing water should be water for injection, and attention should be paid to drying, sterilization, cooling and cleaning after washing. Storage, if it is stored for more than two days, it should be washed and sterilized again; the inert gas or compressed air that is in direct contact with the liquid must meet a certain clean standard for potting; The final sterilization injection potting requires the highest level of cleanliness; local 100-level measures for potting and sealing can achieve local 100-level measures, such as using a small system to make the local 100-level return air an independent system. It is a commonly used method, which can solve the problem of fan pressure head and air volume mismatch, but the noise may still be large; when the fan is installed in the ceiling static pressure box or in the return air passage, the heat dissipation of the fan should be considered, otherwise It is difficult to ensure that the indoor temperature meets the requirements, and the air supply surface at the top is 300-350mm larger than the surrounding area of u200bu200bthe work area. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for sterile workshops and purification projects.

The production process of bottled infusion includes: weighing, configuration, filtration, bottle washing, filling and sealing, sterilization. In order to reduce the pollution in the production process, the large infusion production equipment should have the ability to automate and continuous; The cleanliness requirements are different in different stages of dilution and dilution. The latter is higher than the former. The concentrated process involves adding activated carbon. At this time, attention should be paid to the problem of dust, and a suction hood should be used in the carbon-added part; the cleanliness of the infusion pharmaceutical cleanroom is focused on The openings that are in direct contact with the drug, in the production lines where the products are exposed to indoor air, such as bottle washing, blowing, bottle transportation, etc.; ensure high cleanliness of the opening of the bottle and ensure thorough cleaning and high cleaning in the cleaning room and bottle drying. Cleanliness is the focus of purification measures in infusion workshops; infusion workshops should pay attention to moisture-proof problems. Moisture will mainly cause the relative humidity of the air to rise, up to 80%-90%, such as rubber stopper cooking and cleaning rooms. The humidity is even higher As a result, it promotes the growth of mold in the enclosure structure, equipment surface, etc., which seriously threatens the quality of the infusion. The method to eliminate steam overflow is isolation and local exclusion; in order to prevent mold growth in the high-efficiency filter of the air supply outlet, a moisture-proof high-efficiency filter should be used. The filter adopts metal plastic frame, aluminum foil dividing plate, and glue-sprayed filter paper. The dilute dispensing workshop is often equipped with a large container of high-temperature liquid at 80 °C, and its outer surface temperature is as high as 50 °C. Due to the high size of the container, its heat dissipation surface area can reach 10m2; for such a large infusion workshop with a large amount of waste heat and excess humidity, the air supply volume must be Check with heat and humidity loads.

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