Please help us improve the quality of example sentences! Edit on Github

大鸨级飞船现作为獾级蓝图II的发明要求。MK II for invention purposes as the BPC requirement.

原料药制造厂通常生产实验式规模或中试规模批次。BPC manufacturing plants often produce laboratory scale or "pilot" batches.

Other words in sentence

一些制造商列出了每一原料药和中间体的具体溶剂。Some manufacturers list the specific solvent for each BPC and intermediate.

典型地，然而，环氧乙烷并不会以粉末的形式渗透到原料药中。Typically, however, ethylene oxide does not penetrate the BPC in this powdered form.

应设计空气处理系统以防止交叉污染。Air handling systems for BPC plants should be designed to prevent cross-contamination.

如果可归还的原料药容器被重新使用，所有先前的标签应移去或磨灭。If returnable BPC containers are re-used, all previous labeling should be removed or defaced.

大鸨级飞船现作为獾级蓝图II的发明要求。Bustards are now associated with the Badger MK II for invention purposes as the BPC requirement.

Other words in sentence

主要的考虑是建筑和设施不应该导致实际的或潜在的原料药的污染。The primary consideration is that the building and facilities should not contribute to an actual or potential contamination of the BPC.

这里未单独讨论的要点应视为适用于原料药的制造操作，使用制剂GMP作为指南。Points not separately discussed here should be viewed as appropriate to BPC manufacturing operations using finished product GMPs for guidance.

由于这个原因，211部分的要求，将会用于审查原料药制造商的指南，如本指南解释。For this reason, the requirements under Part 211 will be used as guidelines for inspection of BPC manufacturers, as interpreted in this document.

主要的潜在的问题区域包括离心机原料药的无菌除去，手动移动托盘和粉碎机，和无能力将干燥器灭菌。Major potential problem areas include aseptic removal of the BPC from the centrifuge, manual transfer to drying trays and mills, and the inability to sterilize the dryer.

如果有失误在生产过程中发现，充分的证明和合理的原理必须给出，表明这些失误不会影响原料药的质量。If any such lapses are found in the production process, adequate evidence and appropriate rationales must be shown that such lapses have not compromised the quality of the BPC.

Other words in sentence

一般说来，原料药就是以购买时的状态被使用，无进一步的提纯或精制。因此，原料药中存在的杂质就会在最后的制剂中存在。In general, BPCs are used as purchased, with no further refining or purification taking place. Consequently, impurities present in the BPC will be present in the finished dosage form.

原料药可能会暴露的区域，尤其那些用于制造非肠胃的原料药的区域，应有和制剂制造使用的相近似的环境。The area where the BPC may be exposed, and especially those used to manufacture parenteral substances, should have environmental quality similar to that used for the manufacture of dosage forms.