Clean Room in injectable classification sterile pharmaceutical industry interview questions answers

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  • เผยแพร่เมื่อ 11 ก.ย. 2024
  • 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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    Keywords to find this video:
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ความคิดเห็น • 6

  • @vijay18panneer
    @vijay18panneer ปีที่แล้ว +1

    Super bro... kindly make for temperature mapping for storage area/ cold chamber from initial qualification to re-qualification and frequency with guidlines reference.

    • @PharmGrow
      @PharmGrow  ปีที่แล้ว

      Sure. I will do it

  • @madanprakash7445
    @madanprakash7445 วันที่ผ่านมา

    I feel the diameter of NVPC tubing is wrongly mentioned as 15 cm instead of 15 mm, please check

  • @virendrajagtap4123
    @virendrajagtap4123 หลายเดือนก่อน +1

    Please give 1 hours seminar on Annexe 1 with complete changes

    • @PharmGrow
      @PharmGrow  หลายเดือนก่อน

      Ok. I will prepare 👍

    • @virendrajagtap4123
      @virendrajagtap4123 หลายเดือนก่อน +1

      @@PharmGrow really thanks