Zhu Luoyin, Liang Yi
School of International Pharmaceutical Business, China Pharmaceutical University, Nanjing, China.
PeerJ Comput Sci. 2024 Dec 23;10:e2565. doi: 10.7717/peerj-cs.2565. eCollection 2024.
Microbial proliferation presents a significant challenge in membrane-based water for injection (WFI) production, particularly in systems with storage and ambient distribution, commonly refered to as cold WFI production. A comprehensive microbial risk assessment of membrane-based WFI systems was performed by employing Fuzzy-Failure Mode and Effects Analysis (Fuzzy-FMEA) to evaluate the potential microbial risks. Failure modes were identified and prioritized based on the Risk Priority Number (RPN), with appropriate preventive measures recommended to control failure modes that could increase the microbial load and mitigate their impact. Key hazards were identified including fouling of ultrafiltration (UF) membranes, insufficient sealing of heat exchangers, leakage in reverse osmosis (RO) membranes, and ineffective vent filters unable to remove airborn microorganism. Based on Fuzzy-FMEA results, suggestions for optimization were proposed to improve microbial control in membrane-based WFI systems in the pharmaceutical industry.
微生物增殖在基于膜的注射用水（WFI）生产中构成了重大挑战，尤其是在具有储存和常温分配功能的系统中，通常称为冷WFI生产。通过采用模糊失效模式与效应分析（Fuzzy-FMEA）对基于膜的WFI系统进行了全面的微生物风险评估，以评估潜在的微生物风险。根据风险优先数（RPN）确定失效模式并进行优先级排序，并建议采取适当的预防措施来控制可能增加微生物负荷的失效模式并减轻其影响。识别出的关键危害包括超滤（UF）膜污染、热交换器密封不足、反渗透（RO）膜泄漏以及无法去除空气中微生物的排气过滤器失效。基于Fuzzy-FMEA结果，提出了优化建议，以改善制药行业基于膜的WFI系统中的微生物控制。
