Clean Room in injectable / sterile pharmaceutical industry I 24 Interview questions and answers
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Questions covered:
Q. What is clean room ?
Q. What is limit for airborne particle concentration i.e. NVPC in Grade A, B, C and D ?
Q. What is maximum action limits for viable particle contamination ?
Q. Whether sinks and drains are allowed in Grade A and grade B area?
Q. What should be the air velocity in Grade A ?
Q. What are the methods for monitoring of viable and non viable particles ?
Q. What is use of air locks in clean room ?
Q. Where should be the hand washing facility provided in injectable manufacturing facility?
Q. What is the differential pressure requirement for adjacent rooms in clean area ?
Q. Whether view glasses and cameras shall be available in clean rooms ?
Q. What is requirement for Airflow patterns in cleanrooms for injectable dosage forms ?
Q. What are the requirements for door airlocks as per EU GMP Annex-1?
Q. When we should perform Glove integrity test for Gloves used in clean rooms ?
Q. In case of Isolator based facility what should be the background environment ?
Q. Which tests shall be covered in clean room classification ?
Q. What is Gowning Qualification for clean rooms?
Q. What is critical zone in clean rooms?
Q. Whether we need to define alert level and action level for non-viable particle count ?
Q. Which activities shall be performed in Grade A and Grade B ?
Q. Which activities shall be performed in Grade C and Grade D ?
Q. Whether conveyor belt can pass through Grade A to Grade B area?
Q. What is requirement for tubing’s used for NVPC counting ?
Q. Which type of monitoring's are commonly done in clean rooms of pharmaceutical industry ?
Q. Which guidelines are commonly referred for clean room classification in pharmaceutical industry ?
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