- 287
- 503 278
PHARMAVEN
India
เข้าร่วมเมื่อ 11 ส.ค. 2012
Pharma Knowledge Sharing Channel
#usfda #pharma #injectables #aseptic #bacteria #sterile #sterilization #Dhavalkumar
Dhavalkumar Surti, TH-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, TH-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
Can we Release Batch if Bulk is failing but Finish Product is Passing? @PHARMAVEN #pharmaven
Can we Release Batch if Bulk is failing but Finish Product is Passing? #pharmaven
มุมมอง: 928
วีดีโอ
SAL and PNSU @PHARMAVEN #sal #pnsu #sterilization #validation #qualification #pharmaven #sterility
มุมมอง 764หลายเดือนก่อน
SAL and PNSU #sal #pnsu #sterilization #validation #qualification #pharmaven #sterility
SIP Validation #validation #qualification #pharmaven #sterilization #sip #sterile
มุมมอง 919หลายเดือนก่อน
SIP Validation #validation #qualification #pharmaven #sterilization #sip #sterile Filter Validation, Bacterial Retention Test, Brief Understanding @PHARMAVEN #filter #bacterial How 0.2 Micron Filter retains Bacteria? @PHARMAVEN #filter #bacterial #usfda #aseptic #sterile Sterilizing Filtration in Aseptic Processing @PHARMAVEN #sterile #filtration #aseptic #usfda #gmp Please subscribe to my...
Equilibration Time in Autoclave @PHARMAVEN #sterilization #validation #qualification #autoclave
มุมมอง 872หลายเดือนก่อน
Why Air Removal is Required in Autoclave? How to calculate F0 Value? What is Overkill Cycle in Steam Sterilization? #autoclavevalidation #Validation #Validationinpharma #sterilization #autoclave #aseptic #usfda #steam #bacteria #bacterial #filter #pharmaknowlege #sterility #qualityassurance #quality #sterile #gmp
Difference Between Pressure Gauge and Compound Gauge @PHARMAVEN #pharmaven #sterilization #gauge
มุมมอง 830หลายเดือนก่อน
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
มุมมอง 598หลายเดือนก่อน
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
มุมมอง 517หลายเดือนก่อน
In English, Area Classification vs Guidelines Comparison @PHARMAVEN #validation #qualification
Which Autoclave Load Items to Consider for Biological Indicator Placement? @PHARMAVEN #validation
มุมมอง 589หลายเดือนก่อน
Which Autoclave Load Items to Consider for Biological Indicator Placement? @PHARMAVEN #validation
Area Classification and particle count limits in Different Guidelines @PHARMAVEN #validation
มุมมอง 1.1Kหลายเดือนก่อน
Area Classification and particle count limits in Different Guidelines @PHARMAVEN #validation
Autoclave Revalidation, All Load Patterns to Validate? @PHARMAVEN #autoclave #sterilization
มุมมอง 6372 หลายเดือนก่อน
Autoclave Revalidation, All Load Patterns to Validate? @PHARMAVEN #autoclave #sterilization
Media Fill for Terminal Sterilization Products? #validation #sterilization #media_fill @PHARMAVEN
มุมมอง 8142 หลายเดือนก่อน
Media Fill for Terminal Sterilization Products? #validation #sterilization #media_fill @PHARMAVEN
In English, Difference Between Validation and Qualification @PHARMAVEN #validation #qualification
มุมมอง 5252 หลายเดือนก่อน
In English, Difference Between Validation and Qualification @PHARMAVEN #validation #qualification
Difference Between Validation and Qualification @PHARMAVEN #validation #qualification #pharmaven
มุมมอง 9573 หลายเดือนก่อน
Difference Between Validation and Qualification @PHARMAVEN #validation #qualification #pharmaven
How 0.3 Micron HEPA Filter Removes 0.2 Micron Bacteria? #sterilization #validation @PHARMAVEN
มุมมอง 6273 หลายเดือนก่อน
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
มุมมอง 1.5K3 หลายเดือนก่อน
How 0.3 Micron HEPA Filter Removes 0.2 Micron Bacteria? @PHARMAVEN #sterilization #validation
Stability Chamber Qualification @PHARMAVEN #ich #validation #qualification #pharmaven #dhaval
มุมมอง 7094 หลายเดือนก่อน
Stability Chamber Qualification @PHARMAVEN #ich #validation #qualification #pharmaven #dhaval
In Hindi, Area Classification, Non-viable Particle Count @PHARMAVEN #pharmaven
มุมมอง 2.1K4 หลายเดือนก่อน
In Hindi, Area Classification, Non-viable Particle Count @PHARMAVEN #pharmaven
LAF Qualification Failure Impact Assessment @PHARMAVEN #validation #aseptic #pharmaven
มุมมอง 6414 หลายเดือนก่อน
LAF Qualification Failure Impact Assessment @PHARMAVEN #validation #aseptic #pharmaven
Overshoot in Autoclave Validation @PHARMAVEN #pharmaven #validation #sterilization
มุมมอง 7094 หลายเดือนก่อน
Overshoot in Autoclave Validation @PHARMAVEN #pharmaven #validation #sterilization
Change Control in Pharma, Tool for FDA and Regulatory Compliance @PHARMAVEN #pharma
มุมมอง 1.7K5 หลายเดือนก่อน
Change Control in Pharma, Tool for FDA and Regulatory Compliance @PHARMAVEN #pharma
Riboflavin Coverage Test in CIP? #riboflavin #pharma @PHARMAVEN #cleaning #validation
มุมมอง 9455 หลายเดือนก่อน
Riboflavin Coverage Test in CIP? #riboflavin #pharma @PHARMAVEN #cleaning #validation
Media Fill Manufacturing Process #mediafill #aseptic #sterilization #validation @PHARMAVEN
มุมมอง 1.8K6 หลายเดือนก่อน
Media Fill Manufacturing Process #mediafill #aseptic #sterilization #validation @PHARMAVEN
Depyrogenation Tunnnel, Smoke Study and Air Velocity #validation #pharma @pharmaven #tunnel
มุมมอง 2.3K7 หลายเดือนก่อน
Depyrogenation Tunnnel, Smoke Study and Air Velocity #validation #pharma @pharmaven #tunnel
SOP Questions and Answers? #sop #validation @PHARMAVEN #pharma #aseptic #gmp #Questions
มุมมอง 5067 หลายเดือนก่อน
SOP Questions and Answers? #sop #validation @PHARMAVEN #pharma #aseptic #gmp #Questions
AHU Qualification, HVAC Qualification #validation #ahu #hvac @PHARMAVEN #aseptic
มุมมอง 14K8 หลายเดือนก่อน
AHU Qualification, HVAC Qualification #validation #ahu #hvac @PHARMAVEN #aseptic
Autoclave Cycle Development #autoclave @PHARMAVEN #validation #pharma #sterilization #aseptic
มุมมอง 3.7K8 หลายเดือนก่อน
Autoclave Cycle Development #autoclave @PHARMAVEN #validation #pharma #sterilization #aseptic
In Hindi, Autoclave Validation #Validation #autoclave #Sterilization @PHARMAVEN #aseptic #pharma
มุมมอง 5K9 หลายเดือนก่อน
In Hindi, Autoclave Validation #Validation #autoclave #Sterilization @PHARMAVEN #aseptic #pharma
In Hindi, CIP Cycle, Development, Validation Cleaning Agents #validation #pharmaceutical @PHARMAVEN
มุมมอง 6K9 หลายเดือนก่อน
In Hindi, CIP Cycle, Development, Validation Cleaning Agents #validation #pharmaceutical @PHARMAVEN
Autoclave Validation, #Sterilization @PHARMAVEN #validation #aseptic #pharmaven
มุมมอง 2.3K9 หลายเดือนก่อน
Autoclave Validation, #Sterilization @PHARMAVEN #validation #aseptic #pharmaven
In Hindi, Grade A, HEPA Filter #qualification Aseptic Area @PHARMAVEN #aseptic #area #sterile #fda
มุมมอง 3.1K10 หลายเดือนก่อน
In Hindi, Grade A, HEPA Filter #qualification Aseptic Area @PHARMAVEN #aseptic #area #sterile #fda
Thank you sir
Thank you
Very good sir
Thank you
Tq so much for information sir❤
😊🎉
Informative
Thank you for all the information and your efforts, really appreciate it 👍
Sir in vessel line there is formation of condensed due to which temperature not reaching 121 so why this condenset is forming in lines what is the reason?
I will make video on this Can you share vessel size , steam trap is there or not, vessel line diameter, length of line, how sensor is placed? Give as much of information available with you as you can
Thanks for information
Very informative video sir........
Sir please define lag time definition.
Thank you sir..tme khub j saras information share Karo cho ak dum concept vadi❤
Kindly make video on area classification of clean room and explain each qualification test in sequence
Sir what isUp stream & down stream
What is temprature band in sip cycle? We have it 0.5 °C in mv (SIP).
The video is helpful but if you add more points like VLT Limit and bowie dick time limit it will be more helpful
What if take the measurements in cubic feet ? Will the sampling time be reduced?
Good imformation give u Sir👍👍
Sir please make a video on Lyophilization
Nice Hindi me hi bnaya karo video Sir
Set 10 Micron and 5 Micron ka efficiency kaise check Karenge
Sir efficiency kaise check kar sakta hai hepa filter ko
Should we perform Recovery test In DPB?
Very nicely explained
Thank you sir ji 🙏💐
Welcome
Nice video
Hlw sir Sir ek question h app video bnaiye is topic p Rubber stopper k liye BET test kaise lgaye iska procedure kya rhega
Nice information sir, And please make a vedio on contamination control strategy (CCS) as per EU
Very nice sir..... Please can you make video on F0 value in details means which value we need to calculate and how? Difference between terminal sterilization and autoclave?
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.
Legend ❤❤❤
Sir please make video on dwell time
Hi sir if Inprocess is not available, however FP results are passing then how to investigate to release a batch.
Sir your every short reals are very informative. It always refresh the concept. Thank you sir. Great work.
Try to explain in English sir.
Sir autoclave criteria kya he...?
Very nice 👍
English version helps to us and your channel
Hi I am very Grateful that You are part of my Channel I will make video in English
Nice sir
Very nice sir
Very simply explained & superb video
Sir Media fill matrix video required
Sirji kindly give presentation on pharma artwork handling and guidelines associated with artwork
Sir in one of the probable root cause you mentioned presence of water droplets on sampler - If this is the case, wouldn't it be considered as inadequate sterilization cycle?
We are talking of in process bulk sample where sample containers are required to be cleaned for chemical analysis and if bottle not dried properly then can lead to problems in assay For bio burden, we need sterile containers
Sir can we Take Duplicate samples (additional sample) for all inprocess sampling of bulk ( I. e: Asaay & Sterility)
Yes if you want to have backup samples, it should be part of protocol and batch record.
In pharma we can do anything.. Until justify... But never do testing for compliance the results nevertheless can do for compliance for actually what happened.
How to decide the range of DP through magnehelic gauage
One month me kitne bar change control le sakte hai iska koi criteria bhi hai kya
No criteria You can all required change control no matter what
Sir....First of all inprocess results should be considered as reference purpose only and should not not be apply specification critera The reason behind not Considering the result is due to in process means incomplete process and further reaction shall happen to make the perfect product. Even FDA guiidelines never speak about in process oos results it says finished product results only as finished the manufacturing In those cases we need to take incident and understand the issue to avoid recurrence