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本试验探讨在非最终灭菌大容量注射剂生产的洁净室内,呼吸袋在胶塞转移过程中的应用,以最大限度减少灭菌后的胶塞在转移及使用过程中遭受异物污染的风险,同时考察运用呼吸袋转移胶塞对制品外观可见异物不合格率的影响。分别选取未使用和使用呼吸袋,以及改进呼吸袋使用方式后分装的制品A与制品B,比较不同胶塞转移方式生产的制品中可见异物不合格瓶数。统计结果显示,使用热合封口的呼吸袋较未使用呼吸袋进行胶塞转移分装的制品中可见异物不合格瓶数显著上升。通过注射用水冲洗呼吸袋内表面、并改用不锈钢夹封口后,分装的制品中不合格瓶数较未使用呼吸袋显著降低(P<0.05)。上述结果表明,将洁净胶塞装入注射用水冲洗过的呼吸袋中,利用不锈钢夹封口,再放入带孔的不锈钢盒内高压灭菌,可以实现胶塞转移过程中的隔离保护,降低异物污染的风险,同时不会额外升高制品外观中可见异物的不合格数。
This study explored the use of a breathing bag in the transfer of rubber stoppers in clean rooms where non-final sterilized bulk injections are manufactured to minimize the risk of foreign body contamination during the transfer and use of sterilized rubber stoppers, Investigate the use of breathing bag transfer rubber stopper on the appearance of foreign products can see the impact of the failure rate. Respectively selected unused and the use of breathing bags, as well as to improve the use of breathing bags after the sub-packaged products A and B, compared with different rubber stopper transfer products produced products can be seen substandard bottles. Statistics show that the use of heat sealing breathable bag than the non-use of respiratory bags for plastic bag dispensing products can be seen substandard bottles of unqualified bottles increased significantly. Flushing the inner surface of the respirator bag with water for injection and replacing it with a stainless steel clamp resulted in a significant reduction in the number of unqualified bottles in the dispensed product (P <0.05) as compared with the unused breathable pouch. The above results show that the clean rubber stopper is filled into the respiratory bag washed with water for injection, the stainless steel clip is sealed by the stainless steel clip, and the autoclaved sterilized stainless steel box with the hole is used to achieve the isolation protection during the rubber stopper transfer and reduce the foreign matter The risk of contamination does not increase the number of unacceptable foreign bodies visible in the product appearance.