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- aseptic processing areas 无菌操作室(区)
- We believe that industry and regulatory communities currently find themselves caught on the horns of a dilemma regarding aseptic processing. 我们相信,现在制药公司和药证机构发现他们对于“无菌工艺”处于进退两难之间。
- Using the process areas of the CMMI are not like using a cookbook. 使用CMMI过程域不同于使用烹调书。
- This condition, however, is not now and never has been possible to prove in aseptic processing. 这一条件,从古至今,在无菌工艺中都无法被证明。
- Experienced in some of the Fiber Mill process areas. 具有纤维制造过程某些领域的相关经验。
- Currently, a majority of parenterals and other products labeled sterile are manufactured using aseptic processing(8). 现在,很多标签上写着“无菌“的注射用药品和其他的产品是用无菌工艺生产的。
- Familiar and experienced in Fiber mill Process areas. 熟悉纤维制造过程并具有相关经验.
- Promote, sell and provide technical support on spare parts, key components of liquid food aseptic processing lines. 对无菌加工设备的主要部件,及备品备件做宣传,销售,和技术支持。
- Currently, a majority of parenterals and other products labeled sterile are manufactured using aseptic processing (8). 现在,很多标签上写着“无菌“的注射用药品和其他的产品是用无菌工艺生产的。
- Are toilet room doors self-closing, and do not open to processing areas? 厕所门是否自动关闭?其门不能朝向车间。
- The intent of this review is similar to that of its1988 predecessor: to identify and discuss the current capabilities of aseptic processing technology. 本文的目的与1988年的立场书相似:明确并讨论当前无菌工艺技术的能力。
- Time Delay Estimation (TDE) is a popular issue in signal processing areas. 时间延迟估计(TDE)是信号处理领域里一个十分活跃的研究课题。
- This article reviews current industry practices and regulatory expectations for the aseptic processing of sterile drugs. 本文回顾了目前制药业无菌药物的无菌工艺所使用的方法、及药政机构对此的期望。
- The improvements to aseptic processing operations described in the1988 position paper were characterized in the opening section of that document as" evolutionary. 在1988年的立场书中,无菌工艺操作的改良在开头部分被描述为“渐进式的”。
- Aseptic processing requires the careful application of microbiological contamination control principles to exclude infectious organisms from sterile products. 无菌工艺要求仔细地实施微生物污染控制措施,以防止致病菌进入无菌产品。
- Process volution: Key process areas are not processes. 过程进化:关键过程域并不是过程。
- The intent of this review is similar to that of its 1988 predecessor: to identify and discuss the current capabilities of aseptic processing technology. 本文的目的与1988年的立场书相似:明确并讨论当前无菌工艺技术的能力。
- Any manipulation of sterile BPCs post-sterilization must be performed as an aseptic process, including the utilization of Class 100 air and other aseptic controls. 其它的无菌原料药的操作,批准后无菌操作必须进行作为无菌工艺,包括100等级空气和其它无菌控制的使用。
- Good: All pesticides and dispersal equipment are stored in a locked room/ cage away from processing areas and in an organized manner. 好:所有杀虫剂和喷洒用具整齐地存放在远离加工区的上锁的房间/子内。
- Packaging biologics may involve aseptic processes, restricted access barrier systems, and/or isolators, not to mention sophisticated materials. 生物制剂包装可能涉及无菌加工过程,限制进入屏障系统,和/或隔离,更不用提先进的材料。
