Chilled water/refrigeration and hot water circulation required to maintain temperature and relative humidity. We don’t need to circulate hot and cold air
As per your explanation For viable plate exposer 3 days for static and 3 days for at operation so it's total 6 days exposer. Any guideline for it? Can we exposed only at static for 3 days only. Is there any guideline violation. And only four hours per day or any criteria for exposer duration per day?
3 day static is to ensure that the counts are as per area classification 3 day dynamic ensures that we maintain the classification even in operating conditions as we don’t want excursions in operating conditions
If ACPH not performed during OQ than how can we ensure that AHU is capable to deliver required amount of ACPH before PQ,if not achive during PQ than its lead to deviation.and how can we handle such type of deviation.
Before we go for OQ. Air balancing of area as per design specification has to be done and primary assessment of area in terms of Differential Pressure and air changes. After that one Should go for Qualification
During qualification (any) if any discripancy happened, wht kind of QMS document we should follow, because qualification itself is an GMP life time document, we should adress somewhere it's discripancy, which is the best way to come out this.. Some people will say it is non impacting thing, no production is going on, area is still under qualification, so no need to take any kind of QMS document, just by writing down in outcome/conclusion, we can proceed through further by correcting things and qualify the area... so I am confused, which one correct, as I say above, qualification is itself is an GMP document we should adress any discripancy through QMS Document.
Qualification protocol should have a section called Discrepancy which is similar to handling deviations and incidents. Investigation of any Discrepancy to be carried same as deviation/incident Investigation, and CAPAs to be implemented before going for next step. If one wants proceed for next step with open CAPA, a justification and impact assessment should be provided and approved by Quality unit
One more question sir... Before any qualification, what we should do 1st, eighter URS, or change control, Or in that change control everything we should include and after approval of change control we should go for full scale qualification. Or can we consider URS as a base document for change control. After approval of URS by management, then we can take change control... Which one is more correct?
For existing Facility, for new Equipment, change control to prepare URS should be taken. For Brand New Facility, URS can be prepared directly. But it is better to first prepare basic SOPs for preparing documents and URS and other Qualification documents. Change control will come in picture once Facility is primary established.
Please make more videos, very informative and we like your videos..
Important knowledge❤❤❤
Very helpful sir!!
Thank You Very Very Much Sir, you defined very well, it really helped me to understand the basics of Pharma HVAC system
NICE VIDEO
Excellent video...
Important and informative video
Fantastic explanation. God bless your ilk
Nice subjective presentation sir, thanks for your great efforts to educate Pharma world.
Nice video sir..
Your explanation Is of great help sir
Very good
Thanks a lot sir, very nice video❤
Very helpful sir , aaj hi suna
Amezing
Thank you sir your explanation was on point
Thanks A Lot Dear
Please also share to your friends groups
Very helpfull, Thank You.
Very nicely explained
Very nice video Sir
Thanks a Lot
Please also share to your friends and groups
👍
Man gaye guru
Great knoweledge sir hope the same knoweledge we acquire in future
Please share to our other Pharma friends to spread Knowledge
Too good
Nice
Thanks
Welcome
Hi
Sir plz make video for facility qualification
Kindly make video on area classification of clean room and explain each qualification test in sequence
Sir FDA GUIDLINES SUB PART DETAIL EXPLAINE
New facility me QA ka kaam kab se suru hota h, aur document preparation flow kya rhega, please margdarshan kijiye sir
Ek sid build candation bhi hota hai
Sirji kindly give presentation on pharma artwork handling and guidelines associated with artwork
Recovery test we need do dynamics and statics explain sir
Static
Dry bulb temperature and wet bul temperature kitna hona chahiye?
Sir pls explain how to select sample location in NVPC test of AHU
Sir apne pre filter ke bad kon filter bole the clear bataiye ya screen pe likh diya kijiye
Acph ditel
Do we required any system or utility for cold and hot air circulation?
Chilled water/refrigeration and hot water circulation required to maintain temperature and relative humidity.
We don’t need to circulate hot and cold air
Any specific guidelines on this, plz suggest..
How to decide the range of DP through magnehelic gauage
Sir what isUp stream & down stream
Pre filter pote size sir and fine filter
During re qualifications what parameters to be test
Duct leak limit kitna hai guidelines
Sir kite. Tye ke filetter hepha filete me hote hai
Dp pressure Kitna Hota hai
10 to 15 pascals between area of two different classifications
Refer USFDA Guidance for Industry September 2004
Sir, ACPH test required during initial OQ of AHU ?
if any modifications of existing AHU.
Viable and non viable particle can I monitoring 1day only
No
Three days required
@@PHARMAVEN Respected sir please tell me reason why required three day
AHU modification calls for Requalification which is at least three days
What modification are you going to do?
We are plan to replace EC fan drive, all filters and diffuser
As per your explanation For viable plate exposer 3 days for static and 3 days for at operation so it's total 6 days exposer. Any guideline for it? Can we exposed only at static for 3 days only. Is there any guideline violation. And only four hours per day or any criteria for exposer duration per day?
3 day static is to ensure that the counts are as per area classification
3 day dynamic ensures that we maintain the classification even in operating conditions as we don’t want excursions in operating conditions
You should refer EU ANNEX-1 released in August 2022 available on internet as well as FDA Guidance for Industry September 2004
@@PHARMAVEN thank you 🙏
Sir hvac qualifications and validation both are same
HVAC is qualified
During autoclave validation how to use thermocouple give brief knowledge
Steam Sterilization; All You Want to Know #sterilization #aseptic #validation #sterile @PHARMAVEN
ruclips.net/video/Vi-EEjiCAxM/видео.html
If ACPH not performed during OQ than how can we ensure that AHU is capable to deliver required amount of ACPH before PQ,if not achive during PQ than its lead to deviation.and how can we handle such type of deviation.
Before we go for OQ. Air balancing of area as per design specification has to be done and primary assessment of area in terms of Differential Pressure and air changes.
After that one Should go for Qualification
How we assure that fresh air is 10% or not, it may be 7% or 8%
😢
Can you please make ఆ video on how to establish online నువపీసీ conters in filling room.
Can you mention English word for Telugu word?
@@PHARMAVEN Sorry didnt noticed, its online NVPC counters.
Pouring water on duct ? Strange
During filling ,NVPC count of last 35 min data needs to be check in ft cube? Or only excursion count only to be evaluated?
During qualification (any) if any discripancy happened, wht kind of QMS document we should follow, because qualification itself is an GMP life time document, we should adress somewhere it's discripancy, which is the best way to come out this..
Some people will say it is non impacting thing, no production is going on, area is still under qualification, so no need to take any kind of QMS document, just by writing down in outcome/conclusion, we can proceed through further by correcting things and qualify the area... so I am confused, which one correct, as I say above, qualification is itself is an GMP document we should adress any discripancy through QMS Document.
Qualification protocol should have a section called Discrepancy which is similar to handling deviations and incidents. Investigation of any Discrepancy to be carried same as deviation/incident Investigation, and CAPAs to be implemented before going for next step. If one wants proceed for next step with open CAPA, a justification and impact assessment should be provided and approved by Quality unit
One more question sir...
Before any qualification, what we should do 1st, eighter URS, or change control,
Or in that change control everything we should include and after approval of change control we should go for full scale qualification.
Or can we consider URS as a base document for change control.
After approval of URS by management, then we can take change control...
Which one is more correct?
For existing Facility, for new Equipment, change control to prepare URS should be taken. For Brand New Facility, URS can be prepared directly.
But it is better to first prepare basic SOPs for preparing documents and URS and other Qualification documents. Change control will come in picture once Facility is primary established.
Completely agree with answers 👍
👍