- 361
- 743 799
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
Filter Pre and Post Integrity in Product Filtration #filter #integrity #validation @pharmaven
Pre and Post Integrity in Product Filtration #filter #integrity #bubble #validation
PUPSIT
What is PUPSIT as per EU ANNEX-1? #pharmaven #validation #qualification #sterile #eugmp
कैसे 0.2 micron फिल्टर बैक्टीरिया को फिल्टर करता है? @PHARMAVEN #aseptic #filteration #bacteria
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 channel
#pharma #usfda #aseptic #gmp
Your Queries
1. What is Sterilizing Filtration?
2. What is filtration?
3. What is Injectables?
4. What is filtration?
5. What is aseptic processing?
#pharma
injectables in pharma,
injectables interview questions, injectables in pharmaceuticals, injectables contraceptive, injectables training, injectables before and after, injectable in angular, injectable manufacturing process, injectable plant, injectable production process
PUPSIT
What is PUPSIT as per EU ANNEX-1? #pharmaven #validation #qualification #sterile #eugmp
कैसे 0.2 micron फिल्टर बैक्टीरिया को फिल्टर करता है? @PHARMAVEN #aseptic #filteration #bacteria
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 channel
#pharma #usfda #aseptic #gmp
Your Queries
1. What is Sterilizing Filtration?
2. What is filtration?
3. What is Injectables?
4. What is filtration?
5. What is aseptic processing?
#pharma
injectables in pharma,
injectables interview questions, injectables in pharmaceuticals, injectables contraceptive, injectables training, injectables before and after, injectable in angular, injectable manufacturing process, injectable plant, injectable production process
มุมมอง: 722
วีดีโอ
Bubble Point Integrity Testing @PHARMAVEN #filter #integrity #sterilization #validation #sterility
มุมมอง 1.4K14 วันที่ผ่านมา
Bubble Point Integrity Testing #filter #integrity #sterilization #validation #sterility Pre and Post Integrity in Product Filtration #filter #integrity #bubble #validation PUPSIT What is PUPSIT as per EU ANNEX-1? #pharmaven #validation #qualification #sterile #eugmp कैसे 0.2 micron फिल्टर बैक्टीरिया को फिल्टर करता है? @PHARMAVEN #aseptic #filteration #bacteria Filter Validation, Bac...
Terminal Sterilization Cycle Development @PHARMAVEN #sterilization #validation #qualification
มุมมอง 54814 วันที่ผ่านมา
Terminal Sterilization Cycle Development #sterilization #validation #qualification 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 Clea...
Glass Particles in Injectable Products @PHARMAVEN #visualinspection #injectables #particles
มุมมอง 761หลายเดือนก่อน
Glass Particles in Injectable Products #visualinspection #injectables #particles Visual Inspection in Injectables, #usfda #visual #inspection #particles @Dhavalkumar Surti #injection Please subscribe to my channel Your Queries 1. Visual Inspection in Injectables 2. Visual Inspection 3. Particulates in Injectables 4. Particulates 5. USFDA 6. Injection inspection 7. Inspection 8. Particle siz...
What is Population 1 and 2 in Media Fill? #validation #aseptic #pharmaven #sterile
มุมมอง 409หลายเดือนก่อน
What is Population 1 and 2 in Media Fill? #validation #aseptic #pharmaven #sterile
Why some products are Terminal Sterilized & some are Aseptic Preparation? @PHARMAVEN
มุมมอง 572หลายเดือนก่อน
Why some products are Terminal Sterilized & some are Aseptic Preparation? @PHARMAVEN
Media Fill Batch Sizes & Acceptance Criteria @PHARMAVEN #validation #qualification #media
มุมมอง 763หลายเดือนก่อน
Media Fill Batch Sizes & Acceptance Criteria @PHARMAVEN #validation #qualification #media
Smoke Study Related 483s and Warning Letters @PHARMAVEN #smoke #validation #qualification
มุมมอง 952หลายเดือนก่อน
Smoke Study Related 483s and Warning Letters @PHARMAVEN #smoke #validation #qualification
Change Room Classification for Classified Area@PHARMAVEN #pharmaven #validation #aseptic
มุมมอง 535หลายเดือนก่อน
Change Room Classification for Classified Area@PHARMAVEN #pharmaven #validation #aseptic
CIP Spray Ball Coverage Test @PHARMAVEN #validation #qualification #cleaning #cip
มุมมอง 324หลายเดือนก่อน
CIP Spray Ball Coverage Test @PHARMAVEN #validation #qualification #cleaning #cip
What is Working Height in Grade A (ISO5)? @PHARMAVEN #pharmaven #qualification #validation #iso
มุมมอง 253หลายเดือนก่อน
What is Working Height in Grade A (ISO5)? @PHARMAVEN #pharmaven #qualification #validation #iso
Yield Calculation in Injectable Batch and Deviation Investigation @PHARMAVEN #validation
มุมมอง 320หลายเดือนก่อน
Yield Calculation in Injectable Batch and Deviation Investigation @PHARMAVEN #validation
Media Fill for Terminal Sterilization Required or Not? @PHARMAVEN #validation #validation
มุมมอง 325หลายเดือนก่อน
Media Fill for Terminal Sterilization Required or Not? @PHARMAVEN #validation #validation
Equilibration Time in Autoclave Validation @PHARMAVEN #validation #qualification #autoclave
มุมมอง 416หลายเดือนก่อน
Equilibration Time in Autoclave Validation @PHARMAVEN #validation #qualification #autoclave
Isolator and VHP cycle explanation, #validation #isolator #vhp @PHARMAVEN #qualification #gmp
มุมมอง 5672 หลายเดือนก่อน
Isolator and VHP cycle explanation, #validation #isolator #vhp @PHARMAVEN #qualification #gmp
In Hindi, Media Fill Video Recording, required or not? #validation #aseptic #sterile #media
มุมมอง 3072 หลายเดือนก่อน
In Hindi, Media Fill Video Recording, required or not? #validation #aseptic #sterile #media
Media Fill Video Recording, required or not?@PHARMAVEN #validation #aseptic #sterile #media
มุมมอง 5502 หลายเดือนก่อน
Media Fill Video Recording, required or not?@PHARMAVEN #validation #aseptic #sterile #media
What is Working Height in Grade A Operation? @PHARMAVEN #validation #qualification
มุมมอง 6682 หลายเดือนก่อน
What is Working Height in Grade A Operation? @PHARMAVEN #validation #qualification
What is Population 1 and 2 in Media Fill? @PHARMAVEN #validation #aseptic #pharmaven #sterile
มุมมอง 7202 หลายเดือนก่อน
What is Population 1 and 2 in Media Fill? @PHARMAVEN #validation #aseptic #pharmaven #sterile
In English,What is First Air in Grade A? #validation #aseptic #qualification @PHARMAVEN #pharmaven
มุมมอง 2552 หลายเดือนก่อน
In English,What is First Air in Grade A? #validation #aseptic #qualification @PHARMAVEN #pharmaven
What is First Air in Grade A? #validation #qualification @PHARMAVEN #pharmaven #pharma #hvac
มุมมอง 5292 หลายเดือนก่อน
What is First Air in Grade A? #validation #qualification @PHARMAVEN #pharmaven #pharma #hvac
In English, Why Three Process Validation Batches? @PHARMAVEN #validation #qualification #pharmaven
มุมมอง 3622 หลายเดือนก่อน
In English, Why Three Process Validation Batches? @PHARMAVEN #validation #qualification #pharmaven
Why Three Process Validation Batches? @PHARMAVEN #validation #qualification #pharmaven #pharma
มุมมอง 9652 หลายเดือนก่อน
Why Three Process Validation Batches? @PHARMAVEN #validation #qualification #pharmaven #pharma
CIP Cleaning in Place validation @PHARMAVEN #pharmaven #qualification #validation #riboflavin
มุมมอง 9472 หลายเดือนก่อน
CIP Cleaning in Place validation @PHARMAVEN #pharmaven #qualification #validation #riboflavin
CIP Cycle Spray Ball Coverage and its Importance @PHARMAVEN #cip #validation #pharmaven #cleaning
มุมมอง 7863 หลายเดือนก่อน
CIP Cycle Spray Ball Coverage and its Importance @PHARMAVEN #cip #validation #pharmaven #cleaning
In Hindi, PUPSIT As per EU ANNEX-1, Pre Use Post Sterilization Integrity Testing @PHARMAVEN
มุมมอง 1.4K3 หลายเดือนก่อน
In Hindi, PUPSIT As per EU ANNEX-1, Pre Use Post Sterilization Integrity Testing @PHARMAVEN
Yield Calculation and Deviation Investigation @PHARMAVEN #pharmaven #yield #asepticprocessing
มุมมอง 8603 หลายเดือนก่อน
Yield Calculation and Deviation Investigation @PHARMAVEN #pharmaven #yield #asepticprocessing
What is Change Room Classification for Grade C B Areas @PHARMAVEN #pharmaven #qualification
มุมมอง 8303 หลายเดือนก่อน
What is Change Room Classification for Grade C B Areas @PHARMAVEN #pharmaven #qualification
What is PUPSIT as per EU ANNEX-1? #pharmaven #validation #qualification #sterile #eugmp
มุมมอง 1.3K3 หลายเดือนก่อน
What is PUPSIT as per EU ANNEX-1? #pharmaven #validation #qualification #sterile #eugmp
What is Difference between oRABS and cRABS? @PHARMAVEN #pharmaven #hvac #validation #sterile
มุมมอง 1.8K3 หลายเดือนก่อน
What is Difference between oRABS and cRABS? @PHARMAVEN #pharmaven #hvac #validation #sterile
Microbiology all test validation
Sir please yokogawa Graph ke bare me btaiye
Thank you so much sir
Sir if filter is hydrophilic than why air bubbles is pass through other side of the filter?
Water Intrusion test is performed for hydrophobic filters If bubble point used then. IPA+water mixture is used
Hello sir please make video on water system
Thanks sir 🙏
Thanks for the information
Hello sir , what media is used to perform the media fill , and is it done after cleaning and after the media fill can start manufacturing the batch soon after or needs another cleaning.. thanks sir
Tryptic Soy Broth is most commonly used media for media fills Cleaning after media fill should be extensive cleaning and may be done for two times followed by sterilization cycles for vessels and filling machine as you do for batch
@ thanks for your reply sir , I have an another doubt , is cleaning required even before performing the media run ? thanks
Yes You need to do cleaning before starting media fill same as per cleaning you do before your batch
@ thanks a million sir , much appreciate it
I need GMP training
Do you provide GMP TRAINING
Yes I can do on Saturday or Sunday
Online
Please give me your number or mail than i contact you sir
Very helpful Sir...
Why 6 log reduction is not required in tunnel?
In tunnel, we are doing 3 log endotoxins reduction which is much higher against 6 log microbial reduction
@@PHARMAVEN Thank you sir
That good
please help about warehouse main doors for pharmatical factors
Sir ye memren solutions kaha milsakte hai india main
Very useful information sir thank you so much
Very nice 👍 sir
Thank you do much sir❤
If Brivindomonas is 0.2 microns why we are going for 0.30microns filter
For product filtering, we use 0.2 micron filters. 0.3 is for HEPA for air filtration and we have allowed limit of microbial count specific to grade B, C and D.
Dp pressure Kitna Hota hai
10 to 15 pascals between area of two different classifications
Refer USFDA Guidance for Industry September 2004
Awesome explanation Dawal sir..
Sir please confirm, Leak test vial integral or non integral?
Vial failing in leak test will be non integral
What is the idle time for pre and post integrity
Your question is not clear Can you WhatsApp more details on 9426046573
Sir mere plastic product manufacturing unit hai sir mere product pharma company main supply krte hu company is asking for clean rooom envviorment classification area ap muje help kr sakte hu kaise hum iska setup kare
Please call on WhatsApp on 9426046573
Excellent sir Thank u so much sir
PUPSET ke jarurat hai kya. Agar avoid karane ke liye kya karana padega Sirji
Refer EU ANNEX 1 It also have instructions to justify if you cannot do it
Helpful❤😊
Most informative Vedeo
Excellent explained in a simple way to understand 👍
What an amazing explanation Sir. Thank you.
Thanks Please also share the videos to your PHARMA friends to spread knowledge
Very informative sir Please give detail information about CPP. CQA, CPK and APQR
Sir
Thank you
You're welcome
Hi Sir.. as we know that the boiling point of water is 100 deg. and water become evaporate. Then how water circulates in TS at 121 deg.
Superheated water sterilizer has air over pressure to maintain pressure. Also in terminal sterilization, the product inside container boils and creates sterilization temperature and pressure within container. To prevent container from bursting due to pressure, air over pressure is required. Heat from superheated water used to boils the content and achieves sterilization temperature inside container
Nice information sir 👌👌
Thank you sir always be with us❤
Sir,I impressed for your fundamental teaching. I want to know what's the guidline for autoclave qualification and validation.
Sir plz explain forward flow integrity test
Dear sir please make video on WIT.
WATER INTRUSION TEST
For Hydrophobic filters
Concept clear thanks
thank you so much sir for Insightful explanation❤
Absolutely brilliant explantaion Dhaval Sir, thank you so much.
Wonderful explanation sir Share some more videos about filter integrity test methods
Thank you sir
Hlo Sir ,any guidelines for media fill vials acceptance criteria
Guidance for Industry September 2004 Google it
Sir, Thanks for making videos related to Qualifications and challenges in pharma industry.I have watched almost all you videos. In the video for HVAC qualification... You have mentioned Filter integrity, Air velocity //ACPH, temp, Dp, RH, Recovery, VPC,NVPC static and dynamic... Does Air flow pattern test is Required during HVAC qualification ?Pls confirm.
Yes Air flow from higher classification area to lower classification area by opening door As well as Air coming down from HEPA filter, air getting sucked in return riser we need smoke study
Good information sir
Great information
What is the standard time limit of VHP cycle for qualification of Idolator