Depyrogenation Tunnel Working principle & validation

Depyrogenation Tunnel Working principle & validation #sterilization #usfda #aseptic ‎@PHARMAVEN
Your Queries
1. What is Depyrogenation
2. How to qualify Tunnel
3. Hot Air Sterilization
3. Dry Heat Sterilization
4. Depyrogenation
5. Tunnel Qualification
#sterilization #sterile #heat #dhaval #usfda #aseptic
‪@PHARMAVEN‬
Why Air Removal is Required in Autoclave?
How to calculate F0 Value?
What is Overkill Cycle in Steam Sterilization?
#sterilization
#autoclave
#aseptic
#usfda
#steam
#bacteria
#bacterial
#filter
#pharmaknowlege
#sterility
#qualityassurance
#quality
#sterile
#gmp
@PHARMAVEN

[@PHARMAVEN]

Excellent video on simple explanation about Depyrogenation Tunnel working principle, how to select container size and how to qualify tunnel for different container sizes

[@upendrakushwaha8122]

Also explain Endotoxin challenge test during Tunnel validation

[@1985sourabhm]

Sir my heatly gratitude for the very good initiative.
Please make video on cool zone sterilization also and how to place the sensor.
Sir, should we keep Fh as the acceptance criteria, if yes then how much Fh is desirable or 3 log reduction of endotoxin is sufficient.

[@kichootv]

Depyrogenation Tunnel Working principle & validation

[@uday4640]

Dear Sir,
Please clarify following Points.
1.I have 10mL moulded and 10mL tubular vials with the same dimension.
Can I Qualify only for 10mL Moulded vials? by considering worst case.
2.5mL moulded vials having 13mm Neck and 5mL tubular having 20mm neck.which one i should selected and Qualified?
3.2mL moulded and tubular vial having 13mm neck then which one is should consider worst case for Qualification?or both the vials should be Qualified?
4.when my vials having Type-1 and Type-3 with the same dimensions... Qualification should be performed for both the vials or worst case I can consider as a type-3 and recommended same parameters for type-1 vials?
Thanks/Uday

[@PHARMAVEN]

10 ml Molded
5 ml 13 mm neck (less air penetration in vial with small neck)
2 ml Molded
You can take approach as 2 ml minimum, 10 ml Max, three runs each
5 ml as one run verification

[@tinoandtini]

Depyrogenation Tunnel Working principle & validation

[@balambpk]

Why dwell time is 3mins sir.. can you explain sir???

[@SandeepSingh-td7yq]

Thank you

[@arpitpandya8231]

Easy explanation with thorough understanding. Thank you sir.

[@manikantasiva337]

Very understandable and useful sir thank you

[@RAVI-sv9co]

Sir thank you so much🙏
Can you please explain FH value

[@PHARMAVEN]

FH value is same as F0 value
Only difference is F0 value is for moist heat sterilization and FH value is for Dry heat sterilization

[@nidhigarg3857]

Simple and knowledgeable video. One suggestion to jnclude the references of different guidelines used in industry. This will be helpful for viewers.

[@PHARMAVEN]

Ok
I will do

[@ravendrakumar2646]

Please provide the video of vial filling and sealing m/c

[@ap14spt]

What should be the cooling zone pressure wrt Filling room .
Kindly suggest

[@PHARMAVEN]

Filling Room should be positive to cool zone

[@ap14spt]

Thanks for sharing!
My queries:.
Is smoke study applicable for Tunnel ?
If online flow Measurement then do we need to check Flow Measurement at 5 points
Similarly about Filter integrity of Tunnel
How is the industry practice?
As all of above is not easy to perform.
Kindly suggest or make vedio on this

[@michaelscofield1577]

Very well explained, thank you

[@PankajSingh-wu9zp]

Kindly provide guideline references if possible

[@rajpalsingh6245]

Sir please make a video for sip, cip

[@ArunYadav-qp8re]

Dear sir plz confirm that can we understand the dwell time and fd value is same tunnel validation?

[@dreams7763]

Very helpful sir

[@dreams7763]

🙏🙏

[@harishthakur5124]

Exllent sir

[@gopalbhambhariya8854]

Dear sir please. Send all videos in Hindi language

[@thefactsshow5674]

Great 👍👍👍