Media fill or Aseptic process simulation in Pharmaceutical industry l Interview Questions

Media fill or Aseptic process simulation in Pharmaceutical industry l Interview Questions
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Questions covered:

Q.1 :What is Media fill ?
Q.2: What is frequency for media fill ?
Q.3: What is purpose of media fill? Or Why media fill is done ?
Q.4: What are the important guidelines used for media fill ?
Q.5: Which media is used for aseptic process simulation ?
Q.6: Why SCDM is used as media in media fill ?
Q.7: Which processes should be covered during media fill ?
Q.8: What is intervention and what are the types of interventions ?
Q.9: What is Population 1 and Population 2 ?
Q.10: For which dosage forms media fill is applicable ?
Q.11: What are the pre-requisites for media fill?
Q.12: What should be the start point and end point of media fill consideration?
Q.13: What should be the duration of media fill ?
Q.14: What is incubation period for media fill vials / bottles ?
Q.15: Why nitrogen is not used in aseptic process simulation ?
Q.16: Media fill is required for terminally sterilized vials or not?
Q.17: What should be the filling speed consideration during media fill?
Q.18: What should be the fill volume consideration during media fill?
Q.19: What should be the leak testing consideration during media fill?
Q.20: How visual inspection of media filled units is done prior to incubation?
Q.21: What are the growth promotion test requirements for media fill units?
Q.22: What should be the acceptance criteria for media fill ?
Q.23: How container closure integrity is performed for media fill units ?
Q.24: Can we abort media fill run ?
Q.25: What are the requirements for media fill recording and review ?
Q.26: What is the destruction procedure for media fill units ?
Q.27: Can we justify the Pass media fill batch with Grade A EM excursion for Batch release?
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Key words to find this video:
media fill trials,media fill guidelines,media run,media simulation,sterile process validation,validation of aseptic processing,media fill,media trials,media fill study,media fill simulation,media fill interventions,aseptic process simulation,aseptic process validation

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