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Steam Sterilization Principles - ISPE
numerous applications in the pharmaceutical and medical device industries. The focus of this article is saturated steam applications, such as laboratory media sterilization, decon-tamination, and general component sterilization. Terminal sterilization of parenteral liquid products or devices containing liquids may require
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Steam Sterilization Principles - ISPE
www.ispe.gr.jpSuperheated steam, steam containing excessive liquid water, and steam containing excessive boiler additives or contami-nates (such as rust) should be avoided. Superheated steam ... phase or unloading process as seen in Figure 3. Clean, dry compressed air (process air) is …
v7 Risk MaPPセミナーの案内 - ispe.gr.jp
www.ispe.gr.jpRisk MaPP（Risk Based Manufacturer of Pharamaceutical Product）は、 リスクに基づき ①交叉汚染限界値、②洗浄バリデーション限界値、そして
共用施設における異なる医薬 ... - Welcome to ISPE
www.ispe.gr.jpPage 2 / 10 共用施設における異なる医薬品製造時のリスク特定において用いられる健康への影響に基づく 曝露限界の設定に関するガイドライン
IRTベンダー使用IRT用語 ISPE IRT WG推奨 説明 英語（原文） …
www.ispe.gr.jp5 Randomization ランダム化 無作為化 無作為割付 Randomization 無作為化 無作為（ランダム）に目的治療群と対照群に被験者を 割り付けること。臨床試験において、異なる治療法や 他の介入を比較する為に、被験者を無作為に複数の グループに割り付けるプロセス
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www1.eere.energy.govAug 30, 2010 · steam methane reforming (SMR). The main conclusions of the assessment are that the 350-bar compressed storage system has the potential to meet the 2010 and 2015 targets for system gravimetric capacity but will not likely meet any of the system targets for volumetric capacity or cost, given our base case assumptions.