If we need sterilized other material (eg.forceps) which is part of maximum load but not identified as a worst case material, than we put both material (required item + worst material identify)during run of minimum load or only put required material(forceps) and start minimum run.
In such case, you need to put all load items validated as minimum load and the item (forceps). You must put what was validated as minimum load for every such case
Thanks Dhaval bhai for such an informative video Can you suggest which pharmacopeia to refer for defining validation tempelate in a regulated environment?
Any Pharmacopeia will not have templates for validation. Regulatory guidance and 21 CFR Rules provides rules and guidance to follow. Documentation templates we have to make of our own. There are various sites which provide templates, you can choose suitable one and can also modify to suite your requirements
Steam follows easy path. In Maximum Load, There is no escape for steam due to load and forced penetrate load. In minimum load, steam has lot of empty space to escape hence can be a problem for penetration
@@PHARMAVEN I think Mini load have more surface area for steam working in comparison of maximum load more side of material has been covered by each other. More surface area. more active side, more action.
My question is Can we take only maximum load during annual validation as a worst case scenario. Because we have validate minimum load during PQ for thrice and continued the practice for annual validation till date. so on the basis of substantial data of minimum load we can take only maximum loads as a worst case scenario.however our autoclave is about 12years old so we have enough data for minimum load pattern which r found satisfactory. Kindly send your feedback.
Based on risk assessment and data analysis, you can eliminate some of minimum loads I recommend that the load Pattern for product which are filed to agency should be done, other loads such as garments, sanitization load etc can be eliminated
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Jaberjust
Nice information sir thank you sir
Sir the way u explain is very fantastic.... Thank u sir
Thank u so much sir
Very helpfull
Nice information sir
Great knowledge sir.
What is Minimum Load and Maximum Load in Autoclave? Why Required? @PHARMAVEN #aseptic #sterile
Very nice! Please also state the importance of the number of pulsating vacuum applications being included in the validation protocol.
Nice explanation...
Can we consider empty chamber load as minimum load ?
I was searching for this question and you answered perfectly.
06:30
Keep posting thanks.
Many Thanks For Your Appreciation, Please also share to your Friends and Groups and Juniors to Spread Knowledge
What is Fix Load in Autoclave? #autoclave #sterilization #validation #ich #dhaval
Validation me kitne cycle calate hai kitna uspe sir pa video bnaaye
Ap validation sterilization autocalve paer video banaiye
If we need sterilized other material (eg.forceps) which is part of maximum load but not identified as a worst case material, than we put both material (required item + worst material identify)during run of minimum load or only put required material(forceps) and start minimum run.
In such case, you need to put all load items validated as minimum load and the item (forceps).
You must put what was validated as minimum load for every such case
@@PHARMAVEN thanku sir
Welcome Pushkar
Sir plz make a video on Hot VLT and Cold VLT
I want to difference between in both in detail
Thanks Dhaval bhai for such an informative video
Can you suggest which pharmacopeia to refer for defining validation tempelate in a regulated environment?
Any Pharmacopeia will not have templates for validation. Regulatory guidance and 21 CFR Rules provides rules and guidance to follow. Documentation templates we have to make of our own. There are various sites which provide templates, you can choose suitable one and can also modify to suite your requirements
Ye hospital se relatevie video banaye hai ya pharam comapny mu use hone Wale autocalve validation 37 ye kya hai kis guidelines me hai
If you validate the max load. It means there is no panitration problem. How can panitration problen in comes in minimum load.
Steam follows easy path. In Maximum Load, There is no escape for steam due to load and forced penetrate load. In minimum load, steam has lot of empty space to escape hence can be a problem for penetration
@@PHARMAVEN I think Mini load have more surface area for steam working in comparison of maximum load more side of material has been covered by each other. More surface area. more active side, more action.
Try to explain in English sir.
My question is Can we take only maximum load during annual validation as a worst case scenario.
Because we have validate minimum load during PQ for thrice and continued the practice for annual validation till date. so on the basis of substantial data of minimum load we can take only maximum loads as a worst case scenario.however our autoclave is about 12years old so we have enough data for minimum load pattern which r found satisfactory.
Kindly send your feedback.
Based on risk assessment and data analysis, you can eliminate some of minimum loads
I recommend that the load Pattern for product which are filed to agency should be done, other loads such as garments, sanitization load etc can be eliminated
Thank u sir
But sir when max load successfully completed then why MIN load require while already done MAX load
In my video. Refer section at minute 6:30