Lanze Amanda, Rudner Shara
Belvidere Labs, Highland Park, New Jersey, USA.
Int J Pharm Compd. 2014 Sep-Oct;18(5):397-9.
Although it is common knowledge that all sterile compounding pharmacies must have their equipment and facilities certified and calibrated every six months, it is not as clear what is expected of pharmacists. There is currently a disconnect between the certification companies and the pharmacists. As pharmacists, we look to the certification companies as the experts and rely upon them accordingly. The certification companies look upon the pharmacy to know which testing is required. It is the role of the pharmacist to know which tests are necessary and how they are to be interpreted correctly. The end goal of certification testing is to prove that the standards listed in United States Pharmacopeia Chapter <797> are met. Testing requirements can vary from state to state. A few of the most commonly required sterile certification and calibration tests will be discussed in this article.
虽然众所周知，所有无菌配制药房必须每六个月对其设备和设施进行认证和校准，但对于药剂师的期望却不那么明确。目前，认证公司和药剂师之间存在脱节。作为药剂师，我们将认证公司视为专家并相应地依赖他们。认证公司则指望药房知道需要进行哪些测试。了解哪些测试是必要的以及如何正确解读这些测试是药剂师的职责。认证测试的最终目标是证明符合美国药典第<797>章列出的标准。不同州的测试要求可能会有所不同。本文将讨论一些最常见的无菌认证和校准测试。
