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09:43 Mar 27, 2018 |
English to Russian translations [PRO] Medical - Medical: Pharmaceuticals | |||||||
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| Selected response from: Vladyslav Golovaty Ukraine Local time: 03:49 | ||||||
Grading comment
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Summary of answers provided | ||||
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3 +2 | проверка герметичности с помощью дыма |
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3 +1 | визуализации потока при помощи дыма |
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Summary of reference entries provided | |||
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smoke visual, проверка герметичности с помощью дыма Explanation: Если я правильно понял, речь идет о проверке целостности упаковки (точнее, контейнера, закрытого крышкой). CCI = Container Closure Integrity |
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8 mins confidence: peer agreement (net): +1
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2 hrs |
Reference Reference information: https://www.fda.gov/downloads/ICECI/ComplianceManuals/Compli... Evaluate the airflow pattern (smoke studies) conducted under dynamic conditions to verify the unidirectional airflow and air turbulence within the critical area where sterilized drug product, containers, and closures are exposed to environmental conditions. Air flow pattern evaluations (smoke studies) under dynamic conditions are performed to visualize and demonstrate unidirectional air flow within a designated area/room The smoke studies may also reveal air turbulences and air eddies that could be a vector assisting the dissemination of microbial and/or non-viable contamination within critical manufacturing areas. |
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