2018年，我们翻新了我们的化学品重新包装设施，这使我们能够从制造商那里获得大容器的化学品，并将它们重新包装在较小的容器中用于配制药房。当我们收到这些大容器时，我们会检查它们，并测试其中的化学物质，以确保它们符合我们为药店提供的产品设置的高标准。我们甚至在重新包装后重新测试所有活性药物成分化学批次。当我们收到化学品时，仅仅确保它是高质量是不够的;我们还需要确认它的标签和包装是否正确，并在重新包装后进行二次鉴定测试。这些过程都进入 PCCA标准™，我们承诺超越要求，以确保我们每次都能提供尽可能最好的产品。其中很大一部分是我们的质量控制(QC)部门，其核心是QC实验室，所有关键的测试都在这里进行。自从1996年PCCA搬到我们现在的位置以来，我们有了一个QC实验室，使我们能够始终准确地测试我们从制造商那里收到的化学品，但作为一家公司，我们一直在寻求进步。我们的两个核心价值观-无处不在的创新和不妥协的质量-驱使我们寻找方法来改进我们所创造的，我们所提供的，我们所做的以及我们所做的地方。出于这些原因，我们在2019年夏天翻修了我们的QC实验室。< span style=" font - family:宋体; ">
The project planning began over two years ago, and by early 2019, we had completed the design for the new lab that took into account not just regulations and guidelines, but also optimized efficiency to ensure that our QC lab works for our employees and, ultimately, for compounding pharmacies’ needs. “The lab is designed in a way that provides everyone ample space to work and allows QC analysts and analytical chemists to carry out their work efficiently, helping to ensure the fulfillment of customer orders in an orderly and timely manner,” said Star Boxie, PCCA Director of QC/QA and Regulatory Affairs.
The whole renovation process included several PCCA departments from QC itself to Information Technology and Facilities as well as several outside vendors. Demolition and the subsequent build-out lasted from May to July 2019. In the end, we had expanded our QC lab by 280 ft2 to accommodate new equipment, such as three powder containment hoods ranging from 4 ft to 6 ft, an 8 ft fume hood, an instrument for measuring water activity, pH meters, a Fourier transform infrared spectrometer, labware and personal protective equipment, and additional equipment for working with hazardous chemicals.
“With the additional space and new lab instruments, the QC lab is able to perform more tests to ensure the identification and quality of every product is verified,” said Brooke Lyons, PCCA QA/QC Manager. Blanca Stuhr, PCCA Quality Control Supervisor, added, “The redesign of work space and stations has had a positive impact on safety and productivity due to the improved workflow of the lab.” The new QC lab even takes advantage of the 5S workplace organization system, which helps to decrease the amount of waste while maintaining an efficient, safe and clean work environment.
The results speak for themselves. After more than a year and a half of planning, design and execution, our QC lab is an advanced testing facility that stands as an integral part of The PCCA Standard. This allows us to continue to meet the needs of compounding pharmacies into the foreseeable future.
A version of this article previously appeared in PCCA’s members-only magazine, the Apothagram.