This video will walk you through various ways to establish MACO Value during cleaning validation, how to define swab limit and how one can identify worst case scenario
I have the same question, first you need to determine the worst case product by considering cleanability colors solubility... Then you have to calculate the worst case maco. Please feedback, if you find an answer.
Sir, we are from pharma industry and your video has been really helpful in understanding the concept of cleaning validation. Can u please provide the reference documents or guidelines relevant to the data mentioned in this video as we are facing many queries on this topic during audits!
Sir me and my boss both are fan of you ... U r doing excellent job... Only one poin need to be consider that give reference of guidelines which make complete preparations of interview.😊😊😊
Dear sir , Thank you for giving the valuable information . Here in conversion of µg/dm2 to ppm for swab , swab diluent volume taken as 10 ml .kindly explain how can i fix the volume of swab diluent.
Plz answer 1.What is safety limit for injectable. How we calculate safety factor for specific API. 2. What will be the batch size. Is it total bach size of product or only quantity of API in batch.
Fantastic interpretation Sir thank you.. Have a doubt on safety factor, for ex.how much to consider if the range of 10 to 1000 in case of topical, is it any number between 10 to 1000 suppose I select as 200 as safety factor or the maximum as 1000 how it is taken. Thankyou
From long back am searching for this , now I got information about this , thank you professor
I want to give 1000000 likes for this Crystal clear clarity sir....
Iam Working in Cleaning Validation Department
And it is So Useful
Very nice information and thank you sir
Most welcome
Good presentation. How would the worst case scenario be determined when you have to consider solubility, colour, fragrance, PDE.
God point. White in colour + highly insoluble in water = worst case
@@pharmagrowthhub3083 ooooo
I have the same question, first you need to determine the worst case product by considering cleanability colors solubility...
Then you have to calculate the worst case maco.
Please feedback, if you find an answer.
Very nice way to explain in detail,thank you sir
Sir, we are from pharma industry and your video has been really helpful in understanding the concept of cleaning validation. Can u please provide the reference documents or guidelines relevant to the data mentioned in this video as we are facing many queries on this topic during audits!
Excellent sir, superb explanation......
Very nice sir easily understood how to calculate MACO value
Very interesting and can easily understood, thanks for valuble information thank you sir🙏
This is great presentation on cleaning validation
Very informative, thanks for sharing this 😊
My pleasure 😊
Sir me and my boss both are fan of you ...
U r doing excellent job...
Only one poin need to be consider that give reference of guidelines which make complete preparations of interview.😊😊😊
Nyce
Is 1500 dm2 total surface area of equipment?
Dear sir, please help me in how to development dissolution method for NMC molecule
Dear sir ,
Thank you for giving the valuable information .
Here in conversion of µg/dm2 to ppm for swab , swab diluent volume taken as 10 ml .kindly explain how can i fix the volume of swab diluent.
Very helpful
Very informative session...Tq so much sir..
Thank you for your video.. really helpful
How to calculate Maco of different product manufacture in same vessel by rinse method
Bless you, sir. It is so helpful .
very nice explanation, sir.
Good information sir
Plz answer
1.What is safety limit for injectable. How we calculate safety factor for specific API.
2. What will be the batch size. Is it total bach size of product or only quantity of API in batch.
Thank you
sir, how did you calculate MBS 5 Kg = 50 000 000 mg
Bro
1kg=1000g
5kg=5000g
So 1g=1000mg
5000g = 5000*1000mg=5000000mg
I hope you understood
Fantastic interpretation Sir thank you.. Have a doubt on safety factor, for ex.how much to consider if the range of 10 to 1000 in case of topical, is it any number between 10 to 1000 suppose I select as 200 as safety factor or the maximum as 1000 how it is taken. Thankyou
10 should be take to get wort case of MACO value
Sir how to set the limit for that product whose MACO is less than LOQ AND LOD which guidelines to be followed kindly suggest.
Thank you sir ...
Hiii sir how to define acceptance limit in ppm for cleaning validation
Superb bro
Can i get pdf for reference
Nice
Sir how to calculate safety factor???
Thank you sir 🙏
Very good
Is there any training on cleaning validation by napte bhaskar? If anyone knows kindly share link please
Live workshop on Cleaning validation: us02web.zoom.us/webinar/register/8416507954921/WN_b_S4Wk6rS-ukrLy8CBV9mQ
Thank you sir..........