Jenke Dennis
Technology Resources Division, Baxter Healthcare Corporation, Round Lake, IL.
PDA J Pharm Sci Technol. 2012 Jan-Feb;66(1):63-77. doi: 10.5731/pdajpst.2012.00742.
An emerging trend in the biotechnology industry is the utilization of plastic components in manufacturing systems for the production of an active pharmaceutical ingredient (API) or a finished drug product (FDP). If the API, the FDP, or any solution used to generate them (for example, process streams such as media, buffers, and the like) come in contact with a plastic at any time during the manufacturing process, there is the potential that substances leached from the plastic may accumulate in the API or FDP, affecting safety and/or efficacy. In this article the author develops a terminology that addresses process streams associated with the manufacturing process. Additionally, the article outlines the safety assessment process for manufacturing systems, specifically addressing the topics of risk management and the role of compendial testing. Finally, the proper use of vendor-supplied extractables information is considered.
Manufacturing suites used to produce biopharmaceuticals can include components that are made out of plastics. Thus it is possible that substances could leach out of the plastics and into manufacturing solutions, and it is further possible that such leachables could accumulate in the pharmaceutical product. In this article, the author develops a terminology that addresses process streams associated with the manufacturing process. Additionally, the author proposes a process by which the impact on product safety of such leached substances can be assessed.
生物技术行业中一个新兴趋势是在用于生产活性药物成分（API）或成品药物（FDP）的制造系统中使用塑料部件。如果API、FDP或用于生产它们的任何溶液（例如，培养基、缓冲液等工艺流）在制造过程中的任何时候与塑料接触，那么从塑料中浸出的物质有可能在API或FDP中积累，从而影响安全性和/或有效性。在本文中，作者制定了一套术语，用于描述与制造过程相关的工艺流。此外，本文概述了制造系统的安全评估过程，特别讨论了风险管理主题和药典测试的作用。最后，考虑了供应商提供的可提取物信息的正确使用方法。
用于生产生物制药的制造车间可能包括由塑料制成的部件。因此，物质有可能从塑料中浸出并进入制造溶液，并且这种可浸出物进一步有可能在药品中积累。在本文中，作者制定了一套术语，用于描述与制造过程相关的工艺流。此外，作者提出了一个可以评估此类浸出物质对产品安全性影响的流程。
