著者

蒲川 拓治

出版者

一般社団法人日本PDA製薬学会

雑誌

日本PDA学術誌 GMPとバリデーション (ISSN:13444891)

巻号頁・発行日

vol.4, no.2, pp.99-106, 2002 (Released:2006-07-18)

参考文献数

27

---

In the development or validation of sterilization process for terminally sterilized parenteral drugs, biological indicators (BIs) are used to evaluate the effectiveness of sterilization. Accurately determining the heat resistance of BIs (D value) in parenrteral solution is extremely important because the D value varies due to variations in the chemical composition of parenteral solutions. The steam BIER vessel can rigidly control the process variables such as exposure temperature and time and provide reproducible physical test conditions. It is possible to heat the BI suspension in capillary tube or small container with short time for come-up and cool-down by using the steam BIER vessel. Because of this advantage, the steam BIER vessel is useful for determination of the D value in parenteral solution. The steam BIER vessel can solve the problem concerning accuracy and procedures of determining the D value in parenteral solution and contribute to perform the high level sterilization process validation for parenteral drugs.