ISO 14644-1 is the international standard that defines cleanroom classifications, and it sets particle count limits for different cleanliness classes, including ISO 8 (Grade D). Commonly, acceptable limits for microbial contamination in Grade D cleanrooms could be in the range of 1 CFU/m³ (Colony Forming Units per cubic meter) for air and 5 CFU/contact plate for surfaces. To comply with these requirements, we should perform surface monitoring during initial and periodic requalification of area. We can have routine surface monitoring during batch processing for Grade D, It will be safer approach. However, based on the control measures like cleaning, sanitization, pressure differential, data trending etc. we can keep it limited to area qualification and requalification frequency. Based on formal risk assessment and adding historical data we can minimize or negate surface monitoring in Grade D area. Hope this answer will help you.
Here is some supporing information for 4 hours settle plate exposure 1. Statistical significance : 4 hour exposure provides sufficient sample size for analysis. 2. It gives representative sample from area from which we can conclude. 3. It is practically possible to change plates after 4 hours. Considering aseptic area, interventions needs to be minimized. 4. Guidelines support : Many guidelines including USFDA recommond for 4 hour exposure. 5. Now over the years of practice exposing plates for 4 hours become set or established procedure providing consistent results. Hope this will anser your question.
Media plates are exposed in the main area's of activity and positioned such that they capture the maximum amount of particle.large particle tend to settle faster on the plate due the gravitational force smaller particle however take some time in settling.time for media plates expose is 4 hr this time has been determined as the best time according to mathematical calculation of the rate of settling of micro organism per/hrs...
If Non-viable particles are non-living particles that cannot reproduce or metabolize, why is it that you mention in Q.5 that during a non-viable particle count we are looking for bacteria? You copy pasted this answer from a common internet source without providing the context of why we might even be looking for bacteria/ viable particles in the first place in a NVPC. Please also cite your work when you post information publicly.
Non viable particle count control is important as they can be carrier for bacteria. Answer is simple. I check thrice before posting publically. Thanks for your less technical and more emotional comment.
@@PharmGrow I know the answer, and the answer you posted in this thread is true to an extent but still does not explain why we measure 0.5u- 5.0u particles for NVPC. Just because you have a channel and are posting scientific information publicly doesn't mean you don't cite your copy pasted answers on YT. It is the basics of sharing information and giving credit to the author where it is due. **Answer to q5 on your slide literally shows word-to-word copied from google, I have screenshots of where you might have copied it from. You could have done a better job explaining the reason to that question for anyone else wondering, those that don't know OR are new to the industry and looking to get more information or are LITERALLY interviewing for a job within EM, which is quite literally why you even have this channel, to GIVE INFORMATION. Instead of ridiculing on my comments, please do better!
@@soujanyamamidi2308 i take it positively. I said it is unnacessorily extended not unnecessory comment. Your suggetion will really help me to improve. Thanks.
Dear sir
Is surface test mandatory for Grade D (iso 8) area or non sterile area,
If yes, then what should be the frequency
With reference?
ISO 14644-1 is the international standard that defines cleanroom classifications, and it sets particle count limits for different cleanliness classes, including ISO 8 (Grade D). Commonly, acceptable limits for microbial contamination in Grade D cleanrooms could be in the range of 1 CFU/m³ (Colony Forming Units per cubic meter) for air and 5 CFU/contact plate for surfaces. To comply with these requirements, we should perform surface monitoring during initial and periodic requalification of area.
We can have routine surface monitoring during batch processing for Grade D, It will be safer approach. However, based on the control measures like cleaning, sanitization, pressure differential, data trending etc. we can keep it limited to area qualification and requalification frequency. Based on formal risk assessment and adding historical data we can minimize or negate surface monitoring in Grade D area.
Hope this answer will help you.
Good
Thanks
You should mention wrong full form of RODAC plate
Ok. I will correct.
RODAC full form is Wrong
Replicate organism detacting and counting
What is the reason for 4 hours to settle plate keep in the aseptic area
Why only 4 hours
Here is some supporing information for 4 hours settle plate exposure
1. Statistical significance : 4 hour exposure provides sufficient sample size for analysis.
2. It gives representative sample from area from which we can conclude.
3. It is practically possible to change plates after 4 hours. Considering aseptic area, interventions needs to be minimized.
4. Guidelines support : Many guidelines including USFDA recommond for 4 hour exposure.
5. Now over the years of practice exposing plates for 4 hours become set or established procedure providing consistent results.
Hope this will anser your question.
@@PharmGrow Yes, thank you
Media plates are exposed in the main area's of activity and positioned such that they capture the maximum amount of particle.large particle tend to settle faster on the plate due the gravitational force smaller particle however take some time in settling.time for media plates expose is 4 hr this time has been determined as the best time according to mathematical calculation of the rate of settling of micro organism per/hrs...
Ohhh. So nicely written. Thanks for comment. Agreed.
If Non-viable particles are non-living particles that cannot reproduce or metabolize, why is it that you mention in Q.5 that during a non-viable particle count we are looking for bacteria? You copy pasted this answer from a common internet source without providing the context of why we might even be looking for bacteria/ viable particles in the first place in a NVPC. Please also cite your work when you post information publicly.
Non viable particle count control is important as they can be carrier for bacteria. Answer is simple. I check thrice before posting publically. Thanks for your less technical and more emotional comment.
@@PharmGrow I know the answer, and the answer you posted in this thread is true to an extent but still does not explain why we measure 0.5u- 5.0u particles for NVPC.
Just because you have a channel and are posting scientific information publicly doesn't mean you don't cite your copy pasted answers on YT. It is the basics of sharing information and giving credit to the author where it is due.
**Answer to q5 on your slide literally shows word-to-word copied from google, I have screenshots of where you might have copied it from.
You could have done a better job explaining the reason to that question for anyone else wondering, those that don't know OR are new to the industry and looking to get more information or are LITERALLY interviewing for a job within EM, which is quite literally why you even have this channel, to GIVE INFORMATION. Instead of ridiculing on my comments, please do better!
I got your average suggetion through unnecessarily extended comment. I will do better.
@@PharmGrow Lol 🤣, it is an unnecessary comment and an average suggestion to you because you cannot take constructive feedback. Good Luck!
@@soujanyamamidi2308 i take it positively. I said it is unnacessorily extended not unnecessory comment. Your suggetion will really help me to improve. Thanks.