Interview Questions for Pharmaceutical industry related jobs (QA,QC,Production,RA,f&d) for B.pharma /M.pharma (Part 2)

      Interview questions for Technician (engineer) in parenteral injectable plant   
      1.  Which test should to be perform for detect the leakage & penetration of steam in Steam sterilizer/ Autoclave?

Answer: The identification for any leakage & penetration of steam can be tested by the following methods: Chamber Leak Test, Bowie Dick test

     2.      Mention the name of all the utility required to run the steam sterilizer/ Autoclave.

      Answer: Plant Steam for Jacket, Pure Steam for Chamber, Soften Water for Vacuum System, Compressed Air

     3.      How many temperature probes are inside the chamber of steam sterilizer/ Autoclave?

Answer: Five Numbers

     4.      Mention the name of all different zones in Sterilization and Depyrogenation tunnel.

Answer: Dry zone, Hot Zone (Sterilization zone), Cool zone

     5.      Mention the utility requirement for run the Ampoule/Vial washing machine.

Answer: Purified water, WFI, Compressed gas

     6.      Write down the steps of washing cycle in Ampoule/Vial washing machine.
      Answer:

Station1: Initial washing of the Ampoules with Recirculated WFI for internal and external surfaces.

Station2: Drying of washed Ampoules after washing with filtered compressed air for internal surfaces.

Station3: Further washing of the Ampoules with purified water for internal surfaces.

Station4: Drying of washed Ampoules after washing with filtered compressed air for internal surfaces.

Station5: Further washing of the Ampoules with WFI for internal and external surfaces.

Station6: Final drying of internal and external blow-dry with compressed air for internal and external surfaces.

     7.      Why Pre-post nitrogen gassing is required during Ampoule filling operation.

     Answer: To maintain sterility and remove air from the ampoule

      8.      Mention the name of gas required to adjust the flame in Ampoule filling machine.

Answer: LPG & oxygen

      9.      Mention the type of filter used in Lyophilizer

Answer: Hydrophobic or Air filter 0.22 micron

     10.   Mention the all different steps of Lyophilization procedure.

Answer:

Clean In Place

Steam In Place

Leak Rate Test

Shelves Pre-cooling and Loading

Freezing

Primary Drying

Secondary Drying

Back filling If Applicable

Release

Defrosting

Cleaning

    11.  Describe briefly the CIP/SIP procedure in Lyophilizer

    12.  Mention the name of tests require for filter integrity of wet and air vent filter.

Wet filter – FF/BP

Air vent - WIT

    13.  Mention the name of major change part in vial filling and stoppring machine.

     14.  Why “Shelf Uniformity TEST” test perform during validation of lyophilizer

Answer: The purpose of this test is to verify that the temperature across an individual shelf and from shelf to shelf is significant.

     15.  Mention few  “Alarms and Safety interlock” in  Steam sterilizer

     16.  Mention few “Alarms and Safety interlock” in  Vial/Ampoule washing machine

     17.  Mention few “Alarms and Safety interlock” in  Depyrogenation tunnel and filling machine

     18.   Material of construction of Product contact part machine should to be SS304. (True/False)

Answer: False

      19.  After Leak test in steam sterilizer door will open in Unloading side.(True/False)

Answer: False

      20.  Purified water is used for final rinsing in Vial/Ampoule washing machine.(True/False)

Answer: False