Autoclave / HPHV Steam Sterilizer in pharmaceutical industry l Interview Questions

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  • เผยแพร่เมื่อ 27 พ.ย. 2024

ความคิดเห็น • 72

  • @PharmaHunt
    @PharmaHunt 10 หลายเดือนก่อน +8

    Because drainpoint is coolest point of autoclave and sterilization temprature should achieve till coolest point ,for ensuring that one temprature sensor is placed at drain point.thanks

  • @sanapathisekhar9780
    @sanapathisekhar9780 4 หลายเดือนก่อน +1

    Ans : to ensure Cold spot sterilization.
    Kudo to your piece of work 🤌🏾👌🏿👏🏿👏🏿. #valuable information.

    • @PharmGrow
      @PharmGrow  4 หลายเดือนก่อน

      Thank you so much 👍

  • @sanchalaldeshmukh2673
    @sanchalaldeshmukh2673 ปีที่แล้ว +5

    Please share article on F0 value and log reduction

  • @msd6178
    @msd6178 ปีที่แล้ว +3

    It is very important information... Thank you sir

  • @madanprakash7445
    @madanprakash7445 2 หลายเดือนก่อน +2

    Some answers are incomplete or partly correct.
    In Autoclave BI used are spores of Geobacillus sterothermophilus because it is most temperature resistance organism in spore form

    • @PharmGrow
      @PharmGrow  2 หลายเดือนก่อน

      Thanks for update 👍

  • @AJ-rp9vg
    @AJ-rp9vg ปีที่แล้ว +2

    Many chances to contamination from drain point ,that's why require temperature sensor in drain for assure steam penetration achieve sterilization

  • @lifejourneywitharadhya1314
    @lifejourneywitharadhya1314 หลายเดือนก่อน +1

    In the drain points the sensor is placed due to it is the coldest point of the autoclave hence to ensure the proper temp. Distribution throughout the autoclave we placed the sensor in the drain point.

    • @PharmGrow
      @PharmGrow  12 วันที่ผ่านมา

      Rightly said. Thanks for comment.

  • @vmahendran269
    @vmahendran269 ปีที่แล้ว +2

    In drain point all water condensate drain in the point only so if temperature achieved in drain point all locations will be achieved normally

  • @ganeshgokarakonda6586
    @ganeshgokarakonda6586 2 หลายเดือนก่อน +1

    Drain is the worst case location of the autoclave and also steam condensate water drain through so chances of temperature drop (below 121). Hence selected drain point selcted

    • @PharmGrow
      @PharmGrow  12 วันที่ผ่านมา

      Rightly said. Thanks for commenting.

  • @pulavarthijanakiram9701
    @pulavarthijanakiram9701 4 หลายเดือนก่อน +1

    Drain temperature point cold to
    Condensate temprature to forward stream line n cool water

  • @rajamoulicherala2199
    @rajamoulicherala2199 ปีที่แล้ว +3

    Drain point is cold point in autoclave chamber during sterilization

  • @Heliumvlogs
    @Heliumvlogs ปีที่แล้ว +1

    In a worst condition is drain point to maintain temperature.. So it taken a main control feedback...

  • @RakeshKumar-sx8zm
    @RakeshKumar-sx8zm 3 หลายเดือนก่อน +1

    If post vaccum phase is in running stage, during post vaccum phase gets low due to power interruption.
    Does it consider? Or
    Does it is under deviation?
    Cycle will be considered complete

    • @PharmGrow
      @PharmGrow  3 หลายเดือนก่อน +1

      It is deviation and cycle will be considered complete. Deviation has to be raised for root cause analysis and impact assessment likely drying of load.

    • @RakeshKumar-sx8zm
      @RakeshKumar-sx8zm 3 หลายเดือนก่อน +1

      @@PharmGrow thanks for your information

    • @RakeshKumar-sx8zm
      @RakeshKumar-sx8zm 3 หลายเดือนก่อน +1

      What is maximum length of silicone tube/ braided hose pipe in autoclave? As per FDA norms/ EN285 or other reference?

    • @PharmGrow
      @PharmGrow  3 หลายเดือนก่อน

      I need to check this. I will reply once i confirm

  • @shodhaharshad3043
    @shodhaharshad3043 ปีที่แล้ว +3

    Sir in chemical indicater bacteria present or not ?

    • @PharmGrow
      @PharmGrow  ปีที่แล้ว +2

      Chemical indicators does not have bacteria present. It has chemical which undergoes physical or chemical change after sterilization process.

    • @shodhaharshad3043
      @shodhaharshad3043 ปีที่แล้ว

      @@PharmGrow thanks sir

  • @rajeshpattnaik9480
    @rajeshpattnaik9480 ปีที่แล้ว +1

    Drain sensor is placed due to which all others sensor temperature is being maintained

  • @ahmadrasel6936
    @ahmadrasel6936 ปีที่แล้ว +3

    Is it not required to perform I-Cold test (steam penetration) test everyday, sir??

    • @PharmGrow
      @PharmGrow  ปีที่แล้ว

      Yes. According to AAMI ( Association for the medical instrumentation ) bowie - dick test shall be conducted every day.

  • @Kumar-sb3kd
    @Kumar-sb3kd 4 หลายเดือนก่อน +2

    What is difference between standard cycle and HPHV cycle?

    • @PharmGrow
      @PharmGrow  4 หลายเดือนก่อน +1

      There is no as such concept as standard cycle. Can you please explain for what you claim as standard cycle, so i can answer.

  • @SudharaniReddycherla-cy4yj
    @SudharaniReddycherla-cy4yj ปีที่แล้ว +1

    Sir 60 temperature daggara apali hot watertho appudu hot water off cheyyali reacterki

    • @PharmGrow
      @PharmGrow  ปีที่แล้ว

      Please translate in english.

  • @sureshbabuyadla4049
    @sureshbabuyadla4049 ปีที่แล้ว +1

    Why exposed biological indicators should incubate with in 4 hours. What is the rationale?

    • @PharmGrow
      @PharmGrow  ปีที่แล้ว

      To get accurate and reliable results exposed biological indicators should be incubate within 4 hours.
      Exposed biological indicators should be incubated within 4 hours to detect any surviving spores, assess the effectiveness of the sterilization process, and ensure accurate and reliable results in compliance with industry standards.
      Delay in incubation may allow allow other factors to act like temperature, oxygen etc.
      Hope you get answer. I searched for guideline reference but it was not found. We can follow this as standard industrial practice.

  • @rajarao6563
    @rajarao6563 ปีที่แล้ว +1

    Very nice

  • @jeshalsinhchavda575
    @jeshalsinhchavda575 ปีที่แล้ว +1

    What is audit trail of KTA In QC...??

    • @PharmGrow
      @PharmGrow  ปีที่แล้ว

      It is as commonly referred i.e. sequence of recorded computer events that involves any activity around the operating system,applications or user actions.

  • @pritikagamit6714
    @pritikagamit6714 11 หลายเดือนก่อน +1

    Sir, how can we know that we have achieved 6 log reduction.

    • @PharmGrow
      @PharmGrow  11 หลายเดือนก่อน +2

      The concept of confirming 6 log reduction is very simple. We need not to perform testing for 6 log reduction after each routine / commercial cycle.
      We just need to perform validation of parameters (like temp, time and pressure) for sterilization cycle that it will achieve 6 log reduction. During cycle validation / revalidation only we need to prove with testing that set parameters are adequate to achieve 06 log reduction.
      For more detail info you can see my dedicated video on SAL i.e. sterility assurance level. You can get it in playlist of Injectable processing. Link given below,
      th-cam.com/video/pI4VO-psZPE/w-d-xo.htmlsi=LUTXBirId53AyC9I
      Hope this info will help you.

  • @SaikumarGedam-o4w
    @SaikumarGedam-o4w 8 หลายเดือนก่อน +1

    How many valves in Autoclave machine?

    • @PharmGrow
      @PharmGrow  4 หลายเดือนก่อน

      It is based on make, model qnd design. It is not fix.

  • @msd6178
    @msd6178 ปีที่แล้ว +1

    Can please make a video about visual inspection qualification kit (Knap kit )

    • @PharmGrow
      @PharmGrow  ปีที่แล้ว +1

      Thanks for suggetion. This topic is already in my upcoming video list. You will get it very soon.

    • @msd6178
      @msd6178 ปีที่แล้ว +1

      Thank you sir... Please make it as early as possible....

  • @satishthakur5742
    @satishthakur5742 ปีที่แล้ว +1

    Autoclave ki validation video bnao

    • @PharmGrow
      @PharmGrow  ปีที่แล้ว +2

      Ok. I will prepare video on Autoclave Validation

    • @narasimhajogu3532
      @narasimhajogu3532 4 หลายเดือนก่อน

      Autoclave validation video send me

  • @arun_108
    @arun_108 2 ปีที่แล้ว +4

    What is the reason for considering 6 log? Why not 5 log or 7 log? What is the significance of 6 log?

    • @PharmGrow
      @PharmGrow  2 ปีที่แล้ว +11

      Very good and expected question
      As we know that it is practically impossible to get 100 % assured on the sterilization process that it will Inactivate or kill all microorganisms.
      6 log reduction means reducing microbial population of 1000000 (1 million) to 01 i.e. percent reduction of 99.9999. This is considered as very good % reduction for microbial population and recommended as a sterility assurance level (SAL) for sterilization processes.
      Hence, considering good percent reduction, 6 log reduction is accepted for sterility assurance level. With an overkill approach we can go beyond 6 log reduction i.e. 7, 8 and so on to have additional assurance.
      One more reason to go with 6 log reduction is to meet guideline requirements.
      Guideline reference:
      PDA’s technical report No.01 (revised 2007) recommends for 6 log reduction
      EPA performance standard of Hospital / Healthcare disinfection recommends for 6 log reduction for test organism.
      Hope this will help you.

  • @Manicstreams
    @Manicstreams 4 หลายเดือนก่อน

    What is the impact on pre and post loads if B& D test fails how you will assess it?

    • @PharmGrow
      @PharmGrow  12 วันที่ผ่านมา

      If a Bowie-Dick (B&D) test fails, it indicates inadequate air removal or steam penetration in the sterilizer, potentially compromising the sterility of pre and post loads. Assess the impact by quarantining affected loads, investigating the failure's root cause, and revalidating the sterilizer before use.

  • @pulavarthijanakiram9701
    @pulavarthijanakiram9701 4 หลายเดือนก่อน +1

    Wt is kelvin

    • @PharmGrow
      @PharmGrow  4 หลายเดือนก่อน

      The kelvin (abbreviation K), less commonly called the degree Kelvin (symbol, o K), is the Standard International ( SI ) unit of thermodynamic temperature.

  • @jamalpurnareshjamalpurpark3532
    @jamalpurnareshjamalpurpark3532 3 หลายเดือนก่อน +1

    Cold sopt

    • @PharmGrow
      @PharmGrow  12 วันที่ผ่านมา

      Rightly said. Thanks for comment

  • @darshansinhvaghela8938
    @darshansinhvaghela8938 ปีที่แล้ว +2

    Sir hindi me video banavo na plz

  • @anilshewale9649
    @anilshewale9649 9 หลายเดือนก่อน +1

    Drain point is worst location in autoclave

    • @PharmGrow
      @PharmGrow  9 หลายเดือนก่อน +1

      Nice

  • @ashokbharvad6374
    @ashokbharvad6374 ปีที่แล้ว +1

    Pl answer hindi

  • @PardeepKumar-vd6lq
    @PardeepKumar-vd6lq ปีที่แล้ว +1

    Hindi mai bi nolage da do

    • @PharmGrow
      @PharmGrow  ปีที่แล้ว

      Ok. I will try

  • @ashokbharvad6374
    @ashokbharvad6374 ปีที่แล้ว +1

    Please slow speak

    • @PharmGrow
      @PharmGrow  ปีที่แล้ว

      Ok i will speak slow