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PHARMAVEN
India
Приєднався 11 сер 2012
Pharma Knowledge Sharing Channel
#usfda #pharma #injectables #aseptic #bacteria #sterile #sterilization #Dhavalkumar
Dhavalkumar Surti, UA-cam Channel titled 'PharMaven' for sharing knowledge about Pharmaceutical Industry
GMP Trainer, Pharma Professional, Regulatory Compliance, USFDA Exposure, Motivational Speaker, Life and Philosophy Experience Sharing, Thinker, @dhavalkumar Surti, #USFDA, #GMP, #pharma @Dhavalkumar Surti, #aseptic, #media fill, #how to face audits, #sterilization, #smoke study, #autoclave, #freeze, #drying, #smoke, #incident, #investigation, #gemba, #walk, #SOP, #humanerror, #CAPA, #breakdown #trending
#usfda #pharma #injectables #aseptic #bacteria #sterile #sterilization #Dhavalkumar
Dhavalkumar Surti, UA-cam Channel titled 'PharMaven' for sharing knowledge about Pharmaceutical Industry
GMP Trainer, Pharma Professional, Regulatory Compliance, USFDA Exposure, Motivational Speaker, Life and Philosophy Experience Sharing, Thinker, @dhavalkumar Surti, #USFDA, #GMP, #pharma @Dhavalkumar Surti, #aseptic, #media fill, #how to face audits, #sterilization, #smoke study, #autoclave, #freeze, #drying, #smoke, #incident, #investigation, #gemba, #walk, #SOP, #humanerror, #CAPA, #breakdown #trending
Isolator and VHP cycle Validation #isolator @PHARMAVEN #vhp #validation #pharmaven #vhp #sterile
Isolator and VHP cycle explanation, Validation #isolator #vhp
Переглядів: 865
Відео
Risk Assessment for SIP of Filtration Vessel in Sterile Manufacturing #sterilization #validation
Переглядів 86621 день тому
Risk Assessment for SIP of Filtration Vessel in Sterile Manufacturing #sterilization #validation
In Hindi, Gowning Procedure for Aseptic Area #pharmaven #aseptic #validation #qualification #iso
Переглядів 917Місяць тому
Gowning Procedure for Aseptic Area #pharmaven #aseptic #validation #qualification #iso What is Grade A, B, C, D? What is Area Clarification? हिंदी में, #aseptic #quality @PHARMAVEN #gmp Your Queries 1. What is Grade A 2. What is Grade B 3. What is Clean area 4. What is Aseptic area #pharma #usfda #cleanroom #aseptic #fda #fdaknowledge #sterile हिन्दी में, In Hindi, Importance of Gowning in ...
Gowning Procedure for Aseptic Area @PHARMAVEN #pharmaven #aseptic #validation #qualification #iso
Переглядів 339Місяць тому
Gowning Procedure for Aseptic Area #pharmaven #aseptic #validation #qualification #iso What is Grade A, B, C, D? What is Area Clarification? हिंदी में, #aseptic #quality @PHARMAVEN #gmp Your Queries 1. What is Grade A 2. What is Grade B 3. What is Clean area 4. What is Aseptic area #pharma #usfda #cleanroom #aseptic #fda #fdaknowledge #sterile हिन्दी में, In Hindi, Importance of Gowning in ...
4 Media Fill Failure English #aseptic #asepticprocessing @PHARMAVEN #mediafailure
Переглядів 320Місяць тому
4 Media Fill Failure English #aseptic #asepticprocessing #mediafailure हिंदी में: All About Media Fill in Aseptic Processing #media #aseptic @PHARMAVEN #usfda #sterile All About Media Fill in Aseptic Processing #media #aseptic @PHARMAVEN Media Fill Failure Investigation@Dhavalkumar Surti #media #usfda#gmp#aseptic#failure#pharma#audits Media Fill Failure Investigation@Dhavalkumar Surti #med...
2 Media Fill Failure English @PHARMAVEN #asepticprocessing #validation #media #qualification #iso
Переглядів 166Місяць тому
2 Media Fill Failure English #asepticprocessing #validation #media #qualification #iso हिंदी में: All About Media Fill in Aseptic Processing #media #aseptic @PHARMAVEN #usfda #sterile All About Media Fill in Aseptic Processing #media #aseptic @PHARMAVEN Media Fill Failure Investigation@Dhavalkumar Surti #media #usfda#gmp#aseptic#failure#pharma#audits Media Fill Failure Investigation@Dhaval...
2 Media Fill Failure Investigation English #asepticprocessing #validation #media #qualification
Переглядів 129Місяць тому
All About Media Fill in Aseptic Processing #media #aseptic @PHARMAVEN #usfda #sterile All About Media Fill in Aseptic Processing #media #aseptic @PHARMAVEN Media Fill Failure Investigation@Dhavalkumar Surti #media #usfda#gmp#aseptic#failure#pharma#audits Media Fill Failure Investigation@Dhavalkumar Surti #media #usfda#gmp#aseptic#failure#pharma#audits Please subscribe to my channel Your Queri...
Media Fill Failure Investigation in English @PHARMAVEN #validation #aseptic #qualification #media
Переглядів 362Місяць тому
हिंदी में: All About Media Fill in Aseptic Processing #media #aseptic @PHARMAVEN #usfda #sterile All About Media Fill in Aseptic Processing #media #aseptic @PHARMAVEN Media Fill Failure Investigation@Dhavalkumar Surti #media #usfda#gmp#aseptic#failure#pharma#audits Media Fill Failure Investigation@Dhavalkumar Surti #media #usfda#gmp#aseptic#failure#pharma#audits Please subscribe to my channel...
Freeze Dryer Structure and working principle @PHARMAVEN #freezedrying #validation #qualification
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Freeze Dryer Structure and working principle @PHARMAVEN #freezedrying #validation #qualification
Which Tests to be done for Area Qualification?@PHARMAVEN #validation #qualification #ISO
Переглядів 337Місяць тому
Which Tests to be done for Area Qualification?@PHARMAVEN #validation #qualification #ISO
Clean Room Qualification? @PHARMAVEN #qualification #validation #pharmaven #cleanroom #hvac #gmp
Переглядів 464Місяць тому
Clean Room Qualification? @PHARMAVEN #qualification #validation #pharmaven #cleanroom #hvac #gmp
Can we Release Batch if Bulk is failing but Finish Product is Passing? @PHARMAVEN #pharmaven
Переглядів 1,1 тис.2 місяці тому
Can we Release Batch if Bulk is failing but Finish Product is Passing? @PHARMAVEN #pharmaven
SAL and PNSU @PHARMAVEN #sal #pnsu #sterilization #validation #qualification #pharmaven #sterility
Переглядів 8652 місяці тому
SAL and PNSU @PHARMAVEN #sal #pnsu #sterilization #validation #qualification #pharmaven #sterility
SIP Validation #validation #qualification #pharmaven #sterilization #sip #sterile
Переглядів 1,6 тис.2 місяці тому
SIP Validation #validation #qualification #pharmaven #sterilization #sip #sterile
Equilibration Time in Autoclave @PHARMAVEN #sterilization #validation #qualification #autoclave
Переглядів 1,1 тис.3 місяці тому
Equilibration Time in Autoclave @PHARMAVEN #sterilization #validation #qualification #autoclave
Difference Between Pressure Gauge and Compound Gauge @PHARMAVEN #pharmaven #sterilization #gauge
Переглядів 1 тис.3 місяці тому
Difference Between Pressure Gauge and Compound Gauge @PHARMAVEN #pharmaven #sterilization #gauge
Is Change Control required for SOP Revision when there is no change? #change #pharmaven #pharma
Переглядів 6683 місяці тому
Is Change Control required for SOP Revision when there is no change? #change #pharmaven #pharma
In English, Area Classification vs Guidelines Comparison @PHARMAVEN #validation #qualification
Переглядів 5933 місяці тому
In English, Area Classification vs Guidelines Comparison @PHARMAVEN #validation #qualification
Which Autoclave Load Items to Consider for Biological Indicator Placement? @PHARMAVEN #validation
Переглядів 6413 місяці тому
Which Autoclave Load Items to Consider for Biological Indicator Placement? @PHARMAVEN #validation
Area Classification and particle count limits in Different Guidelines @PHARMAVEN #validation
Переглядів 1,8 тис.3 місяці тому
Area Classification and particle count limits in Different Guidelines @PHARMAVEN #validation
Autoclave Revalidation, All Load Patterns to Validate? @PHARMAVEN #autoclave #sterilization
Переглядів 6834 місяці тому
Autoclave Revalidation, All Load Patterns to Validate? @PHARMAVEN #autoclave #sterilization
Media Fill for Terminal Sterilization Products? #validation #sterilization #media_fill @PHARMAVEN
Переглядів 8704 місяці тому
Media Fill for Terminal Sterilization Products? #validation #sterilization #media_fill @PHARMAVEN
In English, Difference Between Validation and Qualification @PHARMAVEN #validation #qualification
Переглядів 5984 місяці тому
In English, Difference Between Validation and Qualification @PHARMAVEN #validation #qualification
Difference Between Validation and Qualification @PHARMAVEN #validation #qualification #pharmaven
Переглядів 1,1 тис.4 місяці тому
Difference Between Validation and Qualification @PHARMAVEN #validation #qualification #pharmaven
How 0.3 Micron HEPA Filter Removes 0.2 Micron Bacteria? #sterilization #validation @PHARMAVEN
Переглядів 6755 місяців тому
How 0.3 Micron HEPA Filter Removes 0.2 Micron Bacteria? #sterilization #validation @PHARMAVEN
How 0.3 Micron HEPA Filter Removes 0.2 Micron Bacteria? @PHARMAVEN #sterilization #validation
Переглядів 1,7 тис.5 місяців тому
How 0.3 Micron HEPA Filter Removes 0.2 Micron Bacteria? @PHARMAVEN #sterilization #validation
Stability Chamber Qualification @PHARMAVEN #ich #validation #qualification #pharmaven #dhaval
Переглядів 8196 місяців тому
Stability Chamber Qualification @PHARMAVEN #ich #validation #qualification #pharmaven #dhaval
In Hindi, Area Classification, Non-viable Particle Count @PHARMAVEN #pharmaven
Переглядів 2,6 тис.6 місяців тому
In Hindi, Area Classification, Non-viable Particle Count @PHARMAVEN #pharmaven
LAF Qualification Failure Impact Assessment @PHARMAVEN #validation #aseptic #pharmaven
Переглядів 7166 місяців тому
LAF Qualification Failure Impact Assessment @PHARMAVEN #validation #aseptic #pharmaven
Overshoot in Autoclave Validation @PHARMAVEN #pharmaven #validation #sterilization
Переглядів 7746 місяців тому
Overshoot in Autoclave Validation @PHARMAVEN #pharmaven #validation #sterilization
Please make video on different between closed RABS & open RABS
I had a doubt sir, during requalification of HVAC after completion of filter integrity is it nesessary to fogging of the area?, if yes justify me, give any reference sir. Thank you.
Sir ye sb reason nhi hai work-life balance ka Reson ye hai ek to private me chutti ni milti har time bhane bna ke chutti leni pdti hai... Or dusra company 12hrs duty krne ko bolti hai... Ab 12 hrs duty krke kb time milega work life balance ko...
Which guidelines refer terminal sterilization.???
Sir please make video on smoke study
There are two video on my channel on smoke study
Sir eugmp revised grade a plz reply sir
Revised EU Annex-I has limit of 3520 particles per meter cube for 0.5 micron. However, no limit specified for 5 micron particles. Old guideline had limit of 20 particles for 5 micron which is removed in new guidline
@@PHARMAVEN but sir palhe less then 1 likhte the a grade me ab nil lekhtr hai kya
@@PHARMAVEN under laf
what is imr
Bhkwas
How can I improve?
jai ho
Sir ky VHP cycle se puri filling machine me hydrogen jata hai ????
Hydrogen Peroxide gas Jata hai Under isolator, all grade A area
Sir filling rubber stopper load ko strile krne bad fir se VHP cycle chalate hai ??
Yes Before VHP, all materials are sterilized and placed under isolator and then VHP cycle run
Sir please prepare video on isolator working principle
1.filter position 2.sterilisation parameters 3.Drying and cooling parameters 4.wetting time before Sterilisation ... 5.wetting time before integrity
Sir please discuss about spary ball efficiency....
Sir asembly frequency kya honi chahiye dry injection me
Nice explanation sir... Thanks for posting
This vedio need in English
Sir, please prepare video for RABS
Sir,What is the temperature limit of hot and cold spots identification
Sir,What is the difference between isolator and cRABS
cRABS has laminar air flow and grade A environment but it doesn’t have VHP cycle capability cRABS has velocity requirements of 72 to 108 feet per minute Isolator can have lower air velocity
@@PHARMAVEN ,can we maintain same grade surroundings the isolator and cRABS
Voice is not coming properly 😢
Sir what is the leak rate value in sip ... In our company the acceptance limit 0.20 bar that is higher then autoclave why ??
In SIP, usual practice is to set 1 bar pressure and 0.1 bar reduction is allowed after 30 minutes of hold. Unlike autoclave, in SIP, pressure is maintained after SIP throughout before filtration is started hence there is no ingress of non-sterile air in vessel.
Sir please tell me the temperature distribution acceptance criteria of probe to probe and within probe
Sir thank you
Grade C and D me ACPH kyu different hota he?
Grade C aur Grade D ka particle count limit different hai. Grade C me 352000 hota hai dynamic condition me, grade D me dynamic ka koi limit nahi hai Isliye, grede C me ACPH jyada hota hai
Sir 01 question is that We have 10 operators in line but generally it is not possible to involve all 10 operators in assembling activity as it is completed within 3 or max 4 hous then how can we include all operators in assembling intervention. As may be possible that out of 10 operators any 01 can be required in future commercial production
It depends on how many media fill you are taking in a year. For example, if you are taking two media fills in a year, then try to simulate 5 operators in each media fill. Assembling takes around 2 hours so you can divide activities within operators so all 5 can do some activities in assembling. Remember, on the job training is important before operators goes for media fill so if operators are new, they can be trained by taking water trial or only assembling activity can be simulated to train operators. As per guidance, operators should participate in media fills periodically and once in a year participation is acceptable so two media fills per year sufficient to cover 10 operators. Also, each filling line is different and may have different interventions so unless you can compare both line as equal, you have to simulate operators for each line separately
During de gowning we can skip 01 exit change room just a passing way and can de gown in last change room.
Yes you can You can keep first exit change room as buffer before Degowning to control particles coming in corridor This is possible if you have sufficient space to create one buffer room
Good narrative
👍👍
Thanks a lot sir, very nice video❤
Thank you very much Sir
Sir muje ye information chahiye ki auditor kese bana jata hai? Koi exam crack karni padti Jese sabhi agencies hai usfda,mhra,eu,schedule M usme auditor kese bana ja sakta hai?? Pls share information.ho sake to uspe ek video bano with all information. Thanks
Sir isko hindi me bhi bnao
Sir apka name क्या h
Dhaval Surti You can search on Google with this name
@@PHARMAVEN sir आज mera interview tha but validation k bare में jyada bta nhi paya
Kya questions ke answers nahi aye?
Sir in our facility online hydrophilic filter PUPSIT integrity test after sterilization keep on failing so what are the different causes of it ? Please make a video on PUPSIT.
Please check 1st comment
Nice information sir
Sir ak video auto clave ke stip chart ke bhare me banwo syi se explain taki deeply smj aa jaye hr batt
sir aap1 video batch manugacturiing ke bare me video bano pls injectable
Problems and Solutions, Injectables Batch Manufacturing #manufacturing #fda #aseptic #sterile #gmp ua-cam.com/video/6GIiRtcgml0/v-deo.html
Plz sir reply kya chemistry honrs wale kal kam kar sakte hai micro department me
Can you call me on WhatsApp 9426046573
Sir kya micro kon se person kam kar sakte hai life science se course kiya ho ya only micro ya bio wale kya chemistry honrs wale ja micro me kam kar sakte hai
Company may not take you in micro if you have chemistry background
But sir usp melikha hua hai life science jo bhi kiya ho microbiology department me kam kar sakte hai
Usp 2023
Life science to chemistry ka branch hai
With primary gowning feet cover is allowable? Feet cover means ankle type socks or bootie is required.
It will be on factory footwear when you enter first change room
Sir,Sip ka Impact/Risk assessment ka video.
Sir always there is a low voice issue in your video 😢
Sorry for that I will take care in next videos
Very helpfull, Thank You.
Nice information sir ji.I am autoclave Operator.
There are lot of other videos on my channel, aap dekh sakte hai aur friends ko bhi share kar sakte hai
Thank you sir... For your valuable information
We talked in past about classes but slipped out of my mind You can Call me anytime on WhatsApp 9426046573
😊 thank you sir...
You got a new subscriber sir ❤️
Thanks A Lot for Subscribing Prasad I am thankful to you
Thank you for information sir 👍🏻👍🏻👍🏻
Thanks for your valid point sir realy it will helpfull for us sir
Please give training about filling machine validation