@article{oai:niigata-u.repo.nii.ac.jp:00004051, author = {松長, 正見 and 角田, 智良 and 城, 斗志夫 and 伊東, 章 and 渡辺, 敦夫}, issue = {2}, journal = {日本食品工学会誌, 日本食品工学会誌}, month = {Jun}, note = {無菌製造法のクリーンルームは衛生上, 洗浄・殺菌操作が不可欠であり, ウエットな環境になる.無菌環境を維持・管理する方法としてOPCを利用する場合もある.しかし, 通常のOPCは一般環境湿度しか対応できないため, 環境監視は断続的な方法で実施するか, または洗浄終了後に測定環境内の液滴濃度が低下するまで計測を開始できない.そのため実質製造時間が短くなり, 生産性に影響を及ぼす.これらの問題対策として, 微粒子の慣性衝突を応用し, OPC計測に障害を生じる液滴粒子を選択的に分離・除去するOPCシステムを設計・製作し検証を行った.その結果, OPCシステムによる常時連続測定が可能であることが判明した.また, 1.0μm以上の粒径は実際の評価対象粒径にならないことが明らかになった.さらに, 洗浄・殺菌工程でミクロンオーダーの粒子だけでなく, 多量のサブミクロン粒子が発生するという事象も確認された., Washing and sterilizing a clean room is indispensable for aseptic production, which means that the clean room usually has a wet environment. Optical particle counter (OPC) may be used to maintain and control the aseptic environment. However, an ordinary OPC can only work under low environment humidity, and therefore the environment is monitored in an intermittent manner or the environment monitoring does not start until the concentration of liquid particles in the measurement environment decreases after completion of the washing cycle. Because of these limitations, net production time is shortened, affecting the productivity. In an effort to resolve these issues, we developed a new type OPC system. Using the inertia impact of minute particles, we attempted to design, make and test a measuring system that selectively separated and removed liquid particles that would hamper the ability of the OPC. The resulting OPC system proved to be suitable for particle continuous monitoring even in a wet environment. It has also become clear that particles with 1.0 ƒÊm or larger diameters can be precluded from the object of OPC monitoring. Furthermore, it was confirmed that not only micron-size particles, but also sub-micron particles were generated in large quantities during washing and sterilizing processes.}, pages = {121--128}, title = {無菌充填包装環境管理のための光学的微粒子測定法の開発}, volume = {5}, year = {2004} }