Environmental Monitoring (EM)
This module is designed to support #biomanufacturing #training and describes Environmental Monitoring (EM) and how Environmental Monitoring programs work to keep Aseptic Processing Areas (APA) qualified for manufacturing processes. Regulatory requirements and specific parameters as well as Environmental Monitoring techniques and equipment will also be discussed.
#EnivornmentalMonitoring
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Пікірлер: 25
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 😍
Best explanation 👍
Thanks for sharing
best explanation👍👍
Good Explanation
very informative presentation. Thank you very much.
Muy buen video, gracias por compartir 👍
Very well covered
Thanks for this video
great good. i can go to any EM role and preform like a boss.
In next video ...Pls mam discuss about active sampling and passive sampling unit ... I am realy confused ...how is it ??🙏
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This is perfectly presented. Thanks
@NCBioNetwork
2 жыл бұрын
You're very welcome!
Contact plate 10 seconds/ 55 mm . am I wrong? 10:39
In the table for contact plats (CFU/10 Sc55mm plate ) not (CFU/10 hrs/55mm plate )
Plz , are there a requirment to do thé EM in a non sterile product ??
@khemrajpradhan3529
Жыл бұрын
No
How could became EM in phrma industry??
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.
@jeetadhvaryu5680
3 жыл бұрын
So you mean that we should take sample when that area is operational?
@jimnmag
5 ай бұрын
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.