Department of Chemical System Engineering, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8656, Japan.
Airex Co., Ltd., 14-31 Tsubaki-cho, Nakamura-ku, Nagoya-shi, Aichi 453-0015, Japan.
J Pharm Sci. 2020 Sep;109(9):2767-2773. doi: 10.1016/j.xphs.2020.05.024. Epub 2020 Jun 3.
As part of manufacturing a sterile drug product, we quantified the impact of HO sorption by polymers on the duration of aeration in pharmaceutical decontamination. Five polymers, which are typically used as materials/parts in sterile isolators, were investigated: polyethylene, polyvinyl chloride, Silicone, polyoxymethylene (POM), and chlorosulfonated polyethylene. Experiments were performed to estimate the storage capacity and diffusion coefficients of HO in the polymer. Considering these key properties of sorption/desorption, mathematical models were developed to simulate the duration of aeration to achieve the target HO concentration, which is the indicator to minimize. The models were used to create a map-out of the duration given the properties of the polymers, including the five polymers. In the simulated setup, POM and Silicone were found to require prolonged aeration. Thus, when using these polymers in the isolator, the size/amount should be carefully investigated. Another practical finding was that the superiority of the polymers changed depending on the target HO concentration. This result motivates an early incorporation of the product information in the isolator design, to achieve a rapid decontamination/aeration cycle.
在无菌药品生产过程中，我们量化了聚合物对药物中 HO 吸附对制药消毒中通气时间的影响。研究了五种通常用作无菌隔离器材料/部件的聚合物：聚乙烯、聚氯乙烯、硅酮、聚甲醛（POM）和氯化聚乙烯。进行了实验来估计聚合物中 HO 的储存能力和扩散系数。考虑到吸附/解吸的这些关键特性，开发了数学模型来模拟实现目标 HO 浓度所需的通气时间，这是需要最小化的指标。这些模型用于根据聚合物的特性（包括这五种聚合物）创建通气时间图。在模拟设置中，发现 POM 和硅酮需要延长通气时间。因此，在隔离器中使用这些聚合物时，应仔细研究其尺寸/数量。另一个实际发现是，聚合物的优势取决于目标 HO 浓度。这一结果促使在隔离器设计中尽早纳入产品信息，以实现快速消毒/通气循环。
