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  • 洁净车间包装材料需要提前做哪些准备?
    来源:http://www.jnyhrs.com 浏览: 发布日期:2020-09-04
    洁净车间生产用的物料,原辅料、小瓶、铝盖、胶塞、成品包装纸箱、产品标签等,首先送至各使用岗位所属洁净区域内的拆外包装室内,拆除物料的外包装后再送入岗位使用;在冻干生产工艺过程中需要使用的玻璃器皿,在灭菌前应进行一系列的清洗处理,通常是反复的冲洗和淋洗,通过清洗过程能有效去除器皿表面附着的各种污物杂质。
    Materials for production in clean workshop, such as raw and auxiliary materials, vials, aluminum caps, rubber plugs, finished product packaging cartons, product labels, etc., are first sent to the unpacking room in the clean area of each user post, and then sent to the post for use after the outer packaging of the materials is removed. Glassware that needs to be used in the freeze-drying production process should be cleaned before sterilization. Generally speaking, the glass containers used in the freeze-drying production process should be cleaned before sterilization It is repeated washing and washing, through the cleaning process can effectively remove all kinds of dirt and impurities attached to the surface of utensils.
    一般情况下使用纯化水对器皿表面进行淋洗,以避免对容器污染,更终淋洗应符合对注射用水的要求;小瓶经过洗瓶、蒸馏水和无菌空气冲洗,送入隧道式干热灭菌机内,进行单向高温气流加热或远红外加热的连续干热灭菌,洗涤后的小瓶置于热灭菌设备的入口和灭菌后干热灭菌设备出口处,均应受到级单向流洁净空气保护,干燥灭菌后自动送入灌装室。
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    In general, purified water is used to wash the surface of the vessel to avoid contamination of the container, and the final washing shall meet the requirements for water for injection; the vial is washed by washing bottle, distilled water and sterile air, and sent into the tunnel type dry heat sterilizer for continuous dry heat sterilization by unidirectional high-temperature airflow heating or far-infrared heating. The washed vials are placed at the entrance of the thermal sterilization equipment After sterilization, the outlet of dry heat sterilization equipment should be protected by level unidirectional flow clean air, and it will be automatically sent to the filling room after drying and sterilization.
    玻璃瓶的洗涤效果,洗涤后瓶的清洁度,灭菌后使用前有没有受到再污染,这些质量控制内容主要采用检查洗涤水和瓶清洁度来完成,必要时采用洗涤过程的污染挑战试验来控制。胶塞处理主要原理是采用纯净的、无热原的注射用水,洗涤除去胶塞表面的杂质微粒,并稀释胶塞表面带有热原物质至检验灵敏度以下。
    The washing effect of the glass bottle, the cleanliness of the bottle after washing, and whether it has been re polluted before use after sterilization are mainly controlled by checking the cleanliness of the washing water and bottle. If necessary, the pollution challenge test in the washing process is used to control the quality. The main principle of rubber plug treatment is to use pure and pyrogen free water for injection, wash and remove the impurity particles on the rubber plug surface, and dilute the pyrogen substance on the rubber plug surface to below the detection sensitivity.
    更初胶塞被清洗时逐步将污染物和吸附于胶塞表面的不溶性颗粒清洗下来,随着清洗过程的延续,胶塞表面不断受到摩擦而受损,清洗时间越长,胶塞表面机械损伤越严重,胶塞的清洗方法决定胶塞的损伤速度和程度,应选择一种无损伤的胶塞清洗方法;胶塞在洁净区域内的物料存放室内拆出外包装,清点数量后移至胶塞处理室,用纯化水清洗胶塞的内包装后投入清洗机内,进行漂洗、硅化、漂洗,然后进行灭菌干燥。
    When the rubber plug is initially cleaned, the pollutants and insoluble particles adsorbed on the surface of the rubber plug are gradually cleaned down. As the cleaning process continues, the rubber plug surface is continuously damaged by friction. The longer the cleaning time is, the more serious the mechanical damage on the rubber plug surface. The cleaning method of the rubber plug determines the damage speed and degree of the rubber plug, so a non-destructive cleaning method should be selected Remove the outer package from the material storage room in the clean area, count the quantity and move it to the rubber stopper treatment room. Clean the inner package of the rubber plug with purified water and put it into the cleaning machine for rinsing, silicification, rinsing, and then sterilizing and drying.
    多数的冻干工艺过程中,胶塞的处理工艺含有硅化工序,对胶塞进行硅化,有利于减少灭菌时胶塞粘连与灌装时胶塞传送,要注意不当的硅化可能带来污染,同时在胶塞准备中用的硅油应符合适当的质量控制标准;冻干无菌药品的容器密封系统应能防止微生物侵入,在更终密封产品的检查过程中,应查出任何有损坏或有缺陷的产品,并将其剔除,应有严格的安全措施,防止容器密封性有缺陷并能导致污染的产品投放市场。
    In most of the freeze-drying process, the treatment process of the rubber plug contains silicification process. Silicification of the rubber plug is beneficial to reduce the adhesion of the rubber plug during sterilization and the delivery of the rubber plug during filling. Attention should be paid to the possible pollution caused by improper silicification. At the same time, the silicone oil used in the preparation of the rubber plug should meet the appropriate quality control standards; the container sealing system of freeze-dried sterile drugs should be able to prevent microbial invasion During the inspection of the final sealing products, any damaged or defective products should be found out and removed. Strict safety measures should be taken to prevent the products with defective sealing and pollution from being put into the market.
    设备适应性差、容器及密封件供货缺陷均可导致容器密封系统的完好性发生问题,有些引起产品密封性问题的缺陷若比较难发现,则应尽快设法采取改进措施,防止产生并检出有缺陷的产品。内包装容器的冲洗介质必须是注射用水,纯化水只能用于内包装容器的更初清洗阶段,洗涤用纯化水可以通过对水进行预过滤和采用特殊孔径大小的膜过滤器进行回收,循环利用。胶塞在清洗之后应对其进行灭菌和干燥,此时的灭菌通常采用湿热灭菌,这些步骤可以单独完成,也可以组合在一起连续完成,更好同时一起完成,胶塞应在空气过滤器的过滤空气保护中进行灭菌和干燥。
    Poor adaptability of equipment and defects in the supply of containers and seals can lead to problems in the integrity of container sealing system. If some defects causing sealing problems are difficult to find, improvement measures should be taken as soon as possible to prevent and detect defective products. The final flushing medium of the inner packing container must be water for injection. Purified water can only be used in the initial cleaning stage of the inner packaging container. The purified water for washing can be recycled and recycled by pre filtering the water and using membrane filter with special pore size. After cleaning, the rubber plug should be sterilized and dried. At this time, the sterilization is usually carried out by wet heat sterilization. These steps can be completed separately or combined together, preferably at the same time. The rubber plug should be sterilized and dried in the filtered air protection of the high efficiency air filter.