Restore Health Consulting, LLC, Laguna Beach, California.
Int J Pharm Compd. 2022 Sep-Oct;26(5):411-418.
Compounded sterile preparations are required to be at the very least sterile. If not, the parenteral administration of such a preparation can cause serious patient harm, even death. Therefore, cleanroom contamination control strategies must be employed to protect the final preparation and the patient. This article is part one of a two-part series describing a holistic and multi-faceted approach to implementing basic cleanroom contamination control strategies at sterile compounding facilities so that safer pharmaceutical compounds are produced. This segment uncovers where cleanroom contamination comes from, the costs and implications associated with cleanroom contamination, and focuses on the various facility controls required to prevent the ingress of contaminants and cross-contamination. The second part concentrates on personnel and processes that support the same initiative.
复方无菌制剂必须达到无菌要求。否则,给患者注射这样的制剂会严重危害患者健康,甚至导致死亡。因此,必须采用洁净室污染控制策略来保护最终制剂和患者。本文是两部分系列文章的第一部分,介绍了在无菌制剂配制场所实施基本洁净室污染控制策略的整体和多方面方法,以生产更安全的药物化合物。本文首先介绍了洁净室污染的来源、与洁净室污染相关的成本和影响,并重点介绍了防止污染物进入和交叉污染所需的各种设施控制措施。第二部分则侧重于支持同一计划的人员和流程。