Kümin Daniel, Albert Monika Gsell, Weber Benjamin, Summermatter Kathrin
Lonza, Visp, Switzerland.
Institute for Infectious Diseases, University of Bern, Bern, Switzerland.
Appl Biosaf. 2021 Mar 1;26(1):42-51. doi: 10.1089/apb.21.921099. Epub 2021 Mar 19.
Part 1 of this two-part series describes the use of hydrogen peroxide as a fumigant and compares it with other fumigants on the market. Technical requirements are outlined while considering physical and biological limitations of the system. This second part focuses primarily on the use of process controls to verify and validate hydrogen peroxide fumigations. Finally, a model encompassing the entire fumigation process is presented. Part 2 of the series focuses on the authors' long-time personal experiences in room and filter fumigation using various fumigation systems and is supplemented with relevant literature searches. The reader is introduced to the planning and implementation of fumigation process validations. Biological indicators help users develop safe and efficient processes. Chemical indicators can be used as process controls, while measuring physical parameters will help avoid condensation of hydrogen peroxide. How many biological and chemical indicators and what type should be applied for cycle development are additionally explained. It is important to consider numerous technical requirements when planning to implement hydrogen peroxide fumigation at an institution. Also, considerable thought needs to go into the verification and validation of the fumigation process. Part 1 of this series presents an overview of different fumigation systems based on hydrogen peroxide on the market and their technical requirements. Part 2 focuses on validation and verification of hydrogen peroxide fumigation while considering the entire fumigation process. The two parts together will serve users as a guide to establishing hydrogen peroxide fumigations at their facilities.
这个两部分系列的第一部分描述了过氧化氢作为熏蒸剂的用途,并将其与市场上的其他熏蒸剂进行了比较。在考虑系统的物理和生物学限制的同时概述了技术要求。第二部分主要关注过程控制在验证和确认过氧化氢熏蒸中的应用。最后,给出了一个涵盖整个熏蒸过程的模型。该系列的第二部分重点介绍了作者在使用各种熏蒸系统进行房间和过滤器熏蒸方面的长期个人经验,并辅以相关文献检索。向读者介绍了熏蒸过程验证的规划和实施。生物指示剂有助于用户制定安全高效的流程。化学指示剂可用作过程控制,而测量物理参数将有助于避免过氧化氢的冷凝。此外还解释了在循环开发中应应用多少生物和化学指示剂以及应使用何种类型。在机构计划实施过氧化氢熏蒸时,考虑众多技术要求很重要。同样,对熏蒸过程的验证和确认也需要进行大量思考。本系列的第一部分概述了市场上基于过氧化氢的不同熏蒸系统及其技术要求。第二部分在考虑整个熏蒸过程的同时,重点关注过氧化氢熏蒸的验证和确认。这两部分将共同为用户在其设施中建立过氧化氢熏蒸提供指导。