Depyrogenation tunnel in pharmaceutical industry l Interview questions
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4. OSD - Tablet Manufacturing in Pharmaceutical industry : [ Ссылка ]
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Questions covered:
Q.1 : What is endotoxin and why depyrogentaion is important ?
Q.2 : Why we do Depyrogenation of glasswares like vials, ampoules and glass bottles?
Q.3 : How does depyrogenation tunnel works ?
Q.4 : What are the different zones in the Depyrogenation tunnel ?
Q.5: What are the significance of various zones for depyrogenation tunnel ?
Q.6 : Which zone has maximum zone pressure / chamber pressure ?
Q.7 : What are the qualification tests for depyrogenation tunnel ?
Q.8 : What is basic requirement of maintaining pressure zones in Depyrogenation tunnel ?
Q.9 : Why we check non-viable particle count in Depyrogenation tunnel?
Q.10 : Why we check conveyor speed of Depyrogenation tunnel and what is acceptance criteria?
Q.11 : Whether it is necessary to use all available container configuration or sizes during initial qualification ?
Q.12 : What is recommended Depyrogenation tunnel temperature ?
Q.13 : Which indicator is used for Depyrogenation tunnel efficiency check?
Q.14: Which guidelines are referred for Depyrogenation tunnel?
Q.15: What is purpose of performing filter system leakage test for Depyrogenation tunnel ?
Q.16: What is acceptance criteria for air velocity test for Depyrogenation tunnel ?
Q.17 What is acceptance criteria for empty chamber heat distribution ?
Q.18 What should be the periodic qualification frequency for Depyrogenation tunnel ?
Q.19 What should be the action plan in case of Depyrogenation tunnel breakdown ?
Q.20 What are the performance qualification run requirement for Depyrogenation tunnel ?
Q.21 Can filtration process remove pyrogens ?
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Keywords to find this video:
depyrogenation tunnel,Depyrogenation tunnel working principle,Autoclave / HPHV steam sterilizer,Media fill or Aseptic process,Filter integrity testing in pharmaceutical industry,Depyrogenation tunnel temperature,qualification tests for depyrogenation tunnel
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