Autoclave / HPHV Steam Sterilizer in pharmaceutical industry l Interview Questions
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- Опубліковано 29 лип 2024
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Time stamps
00:00 Overview
00:21 What is principle of autoclave / HPHV steam sterilizer ?
01:00 What are the difference cycles taken in autoclave / HPHV steam sterilizer ?
01:47 What is frequency for Bowie-Dick test ?
02:07 What is use of Bowie -dick test ?
02:35 Which biological indicator is used for autoclave Qualification ?
03:06 Why sterilization is done at 121 degree Celsius for 30 minutes?
03:39 What is overkill approach ?
04:05 What is 6 log reduction ?
04:55 What is Sterility Assurance level / SAL ?
05;25 What are the different phases of autoclave sterilization cycle ?
06:00 What is porous load and non-porous load ?
06:33 What is load pattern ?
06:49 Why moist heat is used for sterilization purpose in autoclave ?
07:1 What happens if air pockets are not effectively removed from autoclave?
07:34 Which materials do you sterilize in autoclave / HPHV steam sterilizer ?
08:02 What are the Steam Quality Tests for steam used for autoclave / HPHV steam sterilizer ?
08:47 What is time based cycle and F0 based cycle ?
09:09 What is D-value is autoclave validation?
09:30 Which guideline should we refer for autoclave / HPHV steam sterilizer ?
10:05 Why one temperature sensor is located at drain point ?
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Questions covered:
Q.1 : What is principle of autoclave / HPHV steam sterilizer ?
Q.2 : What are the difference cycles taken in autoclave / HPHV steam sterilizer ?
Q.3 : What is frequency for Bowie-Dick test ?
Q.4 : What is use of bowie -dick test ?
Q.5 : Which biological indicator is used for autoclave Qualification ?
Q.6: Why sterilization is done at 121 degree Celsius for 30 minutes?
Q.7: What is overkill approach ?
Q.8: What is 6 log reduction ?
Q.9: What is Sterility Assurance level / SAL ?
Q.10: .What are the different phases of autoclave sterilization cycle ?
Q.11 What is porous load and non-porous load ?
Q.12 What is load pattern ?
Q.13 Why moist heat is used for sterilization purpose in autoclave ?
Q.14 What happens if air pockets are not effectively removed from autoclave?
Q.15 Which materials do you sterilize in autoclave / HPHV steam sterilizer ?
Q.16 What are the Steam Quality Tests for steam used for autoclave / HPHV steam sterilizer ?
Q.17 What is time based cycle and F0 based cycle ?
Q.18 What is D-value is autoclave validation?
Q.19 Which guideline should we refer for autoclave / HPHV steam sterilizer ?
Q.20 Why one temperature sensor is located at drain point ?
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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
Drain temperature point cold to
Condensate temprature to forward stream line n cool water
Ans : to ensure Cold spot sterilization.
Kudo to your piece of work 🤌🏾👌🏿👏🏿👏🏿. #valuable information.
Thank you so much 👍
Please share article on F0 value and log reduction
Many chances to contamination from drain point ,that's why require temperature sensor in drain for assure steam penetration achieve sterilization
What is the impact on pre and post loads if B& D test fails how you will assess it?
It is very important information... Thank you sir
Thanks
In drain point all water condensate drain in the point only so if temperature achieved in drain point all locations will be achieved normally
Nice
Drain point is cold point in autoclave chamber during sterilization
Very nice
Thanks 👍
What is the reason for considering 6 log? Why not 5 log or 7 log? What is the significance of 6 log?
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.
Is it not required to perform I-Cold test (steam penetration) test everyday, sir??
Yes. According to AAMI ( Association for the medical instrumentation ) bowie - dick test shall be conducted every day.
What is difference between standard cycle and HPHV cycle?
There is no as such concept as standard cycle. Can you please explain for what you claim as standard cycle, so i can answer.
In a worst condition is drain point to maintain temperature.. So it taken a main control feedback...
Yes
Drain sensor is placed due to which all others sensor temperature is being maintained
Thanks 👍
Sir 60 temperature daggara apali hot watertho appudu hot water off cheyyali reacterki
Please translate in english.
Why exposed biological indicators should incubate with in 4 hours. What is the rationale?
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.
Sir, how can we know that we have achieved 6 log reduction.
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,
ua-cam.com/video/pI4VO-psZPE/v-deo.htmlsi=LUTXBirId53AyC9I
Hope this info will help you.
What is audit trail of KTA In QC...??
It is as commonly referred i.e. sequence of recorded computer events that involves any activity around the operating system,applications or user actions.
Sir in chemical indicater bacteria present or not ?
Chemical indicators does not have bacteria present. It has chemical which undergoes physical or chemical change after sterilization process.
@@PharmGrow thanks sir
Can please make a video about visual inspection qualification kit (Knap kit )
Thanks for suggetion. This topic is already in my upcoming video list. You will get it very soon.
Thank you sir... Please make it as early as possible....
How many valves in Autoclave machine?
It is based on make, model qnd design. It is not fix.
Autoclave ki validation video bnao
Ok. I will prepare video on Autoclave Validation
Autoclave validation video send me
Sir hindi me video banavo na plz
Bai kya faida bolna ka hindi to ati nahi hogi
Wt is kelvin
The kelvin (abbreviation K), less commonly called the degree Kelvin (symbol, o K), is the Standard International ( SI ) unit of thermodynamic temperature.
Pl answer hindi
Ok i will do.
Hindi mai bi nolage da do
Ok. I will try
Drain point is worst location in autoclave
Nice
Please slow speak
Ok i will speak slow