09:57 "cfu ...is a presumed single bacterium, yeast, fungal spore..." etc. This is incorrect. A cfu is that which gives rise to a single colony after prescribed incubation temperatures and duration. It may be a single cell, single spore, single endospore etc. However, it also may be a clump of cells, spores, etc.
Class D lab. If EM "operational" monitoring is always far below class B (iso6) even though being D. And EM at "rest" is even lower. What is the use of doing EM at rest if EM operational is 100X less than allowed.. Can you do EM operational instead of EM at rest if you have 4 years of data. Can we define an EM plan that incorporates the EM operational = EM rest. Seems so wasteful to do EM at rest.
The monitoring plan is driven by your risk assessment. Your question about eliminating the EM at rest would depend on whether or not it's supported by your Risk Management Department. This, I would think, is dependent upon your product, activities, and the impact of contamination. Ultimately, it will also depend on what regulatory auditors will or will not support.
One of the best presentations ever heard. Congratulations. Very clear and helpful.
Excellent brief description about the EM.
Best piece of work 😍😍 there is nothing on youtube like you did keep going 😍
Excellent information
best explanation👍👍
very informative presentation. Thank you very much.
Best explanation 👍
09:57 "cfu ...is a presumed single bacterium, yeast, fungal spore..." etc. This is incorrect. A cfu is that which gives rise to a single colony after prescribed incubation temperatures and duration. It may be a single cell, single spore, single endospore etc. However, it also may be a clump of cells, spores, etc.
Good Explanation
great good. i can go to any EM role and preform like a boss.
Muy buen video, gracias por compartir 👍
Thanks for this video
Very well covered
In next video ...Pls mam discuss about active sampling and passive sampling unit ... I am realy confused ...how is it ??🙏
Contact plate 10 seconds/ 55 mm . am I wrong? 10:39
Thanks for sharing
This is perfectly presented. Thanks
You're very welcome!
Plz , are there a requirment to do thé EM in a non sterile product ??
No
Take steps to make your eyes safer. I Recommend Softgle Comfort
How could became EM in phrma industry??
In the table for contact plats (CFU/10 Sc55mm plate ) not (CFU/10 hrs/55mm plate )
Class D lab. If EM "operational" monitoring is always far below class B (iso6) even though being D. And EM at "rest" is even lower. What is the use of doing EM at rest if EM operational is 100X less than allowed.. Can you do EM operational instead of EM at rest if you have 4 years of data. Can we define an EM plan that incorporates the EM operational = EM rest. Seems so wasteful to do EM at rest.
So you mean that we should take sample when that area is operational?
The monitoring plan is driven by your risk assessment. Your question about eliminating the EM at rest would depend on whether or not it's supported by your Risk Management Department. This, I would think, is dependent upon your product, activities, and the impact of contamination. Ultimately, it will also depend on what regulatory auditors will or will not support.