There is worldwide concern with regard to the adverse effects of drug usage. However, contaminants can gain entry into a drug manufacturing process stream from several sources such as personnel, poor facility design, incoming ventilation air, machinery and other equipment for production, etc. In this validation study, we aimed to determine the impact and evaluate the contamination control in the preparation areas of the rapid transfer port (RTP) chamber during the pharmaceutical manufacturing processes. The RTP chamber is normally tested for airflow velocity, particle counts, pressure decay of leakage, and sterility. The air flow balance of the RTP chamber is affected by the airflow quantity and the height above the platform. It is relatively easy to evaluate the RTP chamber′s leakage by the pressure decay, where the system is charged with the air, closed, and the decay of pressure is measured by the time period. We conducted the determination of a vaporized H 2 O 2 of a sufficient concentration to complete decontamination. The performance of the RTP chamber will improve safety and can be completely tested at an ISO Class 5 environment.
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机译:关于药物使用的不利影响,世界范围内存在关注。但是,污染物可能会从人员,设备设计不良,通风空气进入,机械和其他生产设备等多种来源进入药物生产过程。在此验证研究中,我们旨在确定影响并评估在药品制造过程中,对快速传输端口(RTP)腔室准备区域中的污染进行控制。通常对RTP室进行气流速度,颗粒计数,泄漏压力衰减和无菌性测试。 RTP腔室的气流平衡受气流量和平台上方的高度影响。通过压力衰减来评估RTP腔室的泄漏相对容易,其中系统充满空气,处于关闭状态,并且按时间段测量压力衰减。我们进行了足够浓度的汽化H 2 O 2的测定,以完成去污。 RTP腔室的性能将提高安全性,并且可以在ISO 5级环境中进行全面测试。
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