Autoclave / HPHV Steam Sterilizer in pharmaceutical industry l Interview Questions

[@PharmaHunt]

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

[@sanchalaldeshmukh2673]

Please share article on F0 value and log reduction

[@msd6178]

It is very important information... Thank you sir

[@PharmGrow]

Thanks

[@AJ-rp9vg]

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

[@lifejourneywitharadhya1314]

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]

Rightly said. Thanks for comment.

[@rajamoulicherala2199]

Drain point is cold point in autoclave chamber during sterilization

[@vmahendran269]

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

[@PharmGrow]

Nice

[@sanapathisekhar9780]

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

[@PharmGrow]

Thank you so much 👍

[@pulavarthijanakiram9701]

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

[@madanprakash7445]

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]

Thanks for update 👍

[@ganeshgokarakonda6586]

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]

Rightly said. Thanks for commenting.

[@alvinostime-lapse3038]

Can I mixed standard cycle instrument to 18minutes cycle instrument

[@chemistryclass13]

Why secondary filter flushing in cumartiol batch valid reson?

[@RakeshKumar-sx8zm]

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]

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]

@@PharmGrow thanks for your information

[@RakeshKumar-sx8zm]

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

[@PharmGrow]

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

[@Kumar-sb3kd]

What is difference between standard cycle and HPHV cycle?

[@PharmGrow]

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

[@subhashchandra-ep6gn]

New load to be designs how ? Please make a video

[@PharmGrow]

Thanks for suggesting. I will definitely work on it 👍

[@shodhaharshad3043]

Sir in chemical indicater bacteria present or not ?

[@PharmGrow]

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

[@shodhaharshad3043]

@@PharmGrow thanks sir

[@Heliumvlogs]

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

[@PharmGrow]

Yes

[@ahmadrasel6936]

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

[@PharmGrow]

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

[@rajarao6563]

Very nice

[@PharmGrow]

Thanks 👍

[@rajeshpattnaik9480]

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

[@PharmGrow]

Thanks 👍

[@SudharaniReddycherla-cy4yj]

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

[@PharmGrow]

Please translate in english.

[@pritikagamit6714]

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

[@PharmGrow]

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, kzbin.info/www/bejne/pnqXh4JjpdiNhqcsi=LUTXBirId53AyC9I Hope this info will help you.

[@msd6178]

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

[@PharmGrow]

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

[@msd6178]

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

[@sureshbabuyadla4049]

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

[@PharmGrow]

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.

[@satishthakur5742]

Autoclave ki validation video bnao

[@PharmGrow]

Ok. I will prepare video on Autoclave Validation

[@narasimhajogu3532]

Autoclave validation video send me

[@SaikumarGedam-o4w]

How many valves in Autoclave machine?

[@PharmGrow]

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

[@jeshalsinhchavda575]

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

[@PharmGrow]

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

[@Manicstreams]

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

[@PharmGrow]

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.

[@arun_108]

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

[@PharmGrow]

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.

[@jamalpurnareshjamalpurpark3532]

Cold sopt

[@PharmGrow]

Rightly said. Thanks for comment

[@pulavarthijanakiram9701]

Wt is kelvin

[@PharmGrow]

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

[@anilshewale9649]

Drain point is worst location in autoclave

[@PharmGrow]

Nice

[@darshansinhvaghela8938]

Sir hindi me video banavo na plz

[@PardeepKumar-vd6lq]

Bai kya faida bolna ka hindi to ati nahi hogi

[@ashokbharvad6374]

Pl answer hindi

[@PharmGrow]

Ok i will do.

[@PardeepKumar-vd6lq]

Hindi mai bi nolage da do

[@PharmGrow]

Ok. I will try

[@ashokbharvad6374]

Please slow speak

[@PharmGrow]

Ok i will speak slow