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.
Sorry for late response. The continuous data to be logged and captured. The excursions are to be evaluated. When data is taken in ft3, then excursions are considered based on cumulative count of last 35 minutes and first in first out concept is used to calculate cumulative data. Also, any count which is excursion in single minute white is more than allowed ft3 limit is also considered as an excursion
Thank you
NICE VIDEO
Important knowledge❤❤❤
Thank You Very Very Much Sir, you defined very well, it really helped me to understand the basics of Pharma HVAC system
Amezing
Nice video sir..
Important and informative video
Nice subjective presentation sir, thanks for your great efforts to educate Pharma world.
Please make more videos, very informative and we like your videos..
Very helpful sir , aaj hi suna
Fantastic explanation. God bless your ilk
Very helpful sir!!
Your explanation Is of great help sir
Very good
Excellent video...
Thanks a lot sir, very nice video❤
Nice
Very nicely explained
Very helpfull, Thank You.
Very nice video Sir
Thanks a Lot
Please also share to your friends and groups
👍
Thank you sir your explanation was on point
Thanks A Lot Dear
Please also share to your friends groups
Too good
Thanks
Welcome
Man gaye guru
Great knoweledge sir hope the same knoweledge we acquire in future
Please share to our other Pharma friends to spread Knowledge
Sir plz make video for facility qualification
New facility me QA ka kaam kab se suru hota h, aur document preparation flow kya rhega, please margdarshan kijiye sir
Sir FDA GUIDLINES SUB PART DETAIL EXPLAINE
Hi
Kindly make video on area classification of clean room and explain each qualification test in sequence
I have Many videos already in my channel for area classification, area validation, HVAC Validation
Sirji kindly give presentation on pharma artwork handling and guidelines associated with artwork
Dry bulb temperature and wet bul temperature kitna hona chahiye?
Sir pls explain how to select sample location in NVPC test of AHU
How to decide the range of DP through magnehelic gauage
Ek sid build candation bhi hota hai
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
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 🙏
Recovery test we need do dynamics and statics explain sir
Static
Sir apne pre filter ke bad kon filter bole the clear bataiye ya screen pe likh diya kijiye
Sterilizing filter or final filter which is 0.3 micron HEPA filter of H14 category
Duct leak limit kitna hai guidelines
Sir what isUp stream & down stream
Pre filter pote size sir and fine filter
Sir kite. Tye ke filetter hepha filete me hote hai
Acph ditel
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
Any specific guidelines on this, plz suggest..
ISO 14644
Sir hvac qualifications and validation both are same
HVAC is qualified
During re qualifications what parameters to be test
Same as initial qualification
How we assure that fresh air is 10% or not, it may be 7% or 8%
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
Dp pressure Kitna Hota hai
10 to 15 pascals between area of two different classifications
Refer USFDA Guidance for Industry September 2004
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
Sir, ACPH test required during initial OQ of AHU ?
Area balancing and air changes per hour are done before we start qualification. During qualification we verify that acceptance criteria is met
During autoclave validation how to use thermocouple give brief knowledge
Steam Sterilization; All You Want to Know #sterilization #aseptic #validation #sterile @PHARMAVEN
th-cam.com/video/Vi-EEjiCAxM/w-d-xo.html
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 👍
😢
During filling ,NVPC count of last 35 min data needs to be check in ft cube? Or only excursion count only to be evaluated?
Sorry for late response. The continuous data to be logged and captured. The excursions are to be evaluated. When data is taken in ft3, then excursions are considered based on cumulative count of last 35 minutes and first in first out concept is used to calculate cumulative data.
Also, any count which is excursion in single minute white is more than allowed ft3 limit is also considered as an excursion
👍