The Sterilization of Pharmaceutical Solutions, with Emphasis on the Kinetics of the Bacterial Death Process
MJ Groves - Sterilization of Drugs and Devices, 2018 - taylorfrancis.com
This chapter demonstrates how products can be considered to be free from living
microorganisms. Disease-causing organisms or pathogens are of principal concern when …
microorganisms. Disease-causing organisms or pathogens are of principal concern when …
Determining the capability of a drug product to be terminally sterilized: A case study involving a heat-sensitive, oxygen-sensitive drug product
MR Duncan, P Wang… - Pharmaceutical …, 1998 - Taylor & Francis
ABSTRACT A decision scheme for determining the capability of a finished product dosage
form to be terminally sterilized was presented and followed for a heat-sensitive, oxygen …
form to be terminally sterilized was presented and followed for a heat-sensitive, oxygen …
[引用][C] How does moist heat inactivate microorganisms
J Moldenhauer - Steam Sterilization, A Practitioner's Guide. Bethesda …, 2003 - sterilize.it
Microorganisms are living organisms, and the environment in which they live can positively
and negatively affect them. The environmental stress exerted on the microorganism leads to …
and negatively affect them. The environmental stress exerted on the microorganism leads to …
[引用][C] PRODUCT STABILITY ISSUES
J Moldenhauer - sterilize.it
BACKGROUND Pharmaceutical products may exhibit thermal degradation. When
developing and implementing a sterilization cycle, it is necessary to limit or balance the …
developing and implementing a sterilization cycle, it is necessary to limit or balance the …
[引用][C] CYCLE DEVELOPMENT
MS Korczynski, J Moldenhauer - sterilize.it
Cycle development is the process of determining the physical properties to be met in a
sterilization cycle that will be used to reproducibly and consistently sterilize the product …
sterilization cycle that will be used to reproducibly and consistently sterilize the product …
医薬品の滅菌保証におけるBIER (生物指標抵抗性評価装置) の有用性について─ 注射剤滅菌プロセスのバリデーションへの活用
蒲川拓治 - 日本PDA 学術誌GMP とバリデーション, 2002 - jstage.jst.go.jp
抄録 In the development or validation of sterilization process for terminally sterilized
parenteral drugs, biological indicators (BIs) are used to evaluate the effectiveness of …
parenteral drugs, biological indicators (BIs) are used to evaluate the effectiveness of …