Sir thank you very much for your valuable knowledge sharing. Always a pleasure to have your video. Request you to please make a video on "if an injection product is failed to comply with in-process specification which is pertaining to bulk sample, in tests such as pH and Assay and if Finished product specification of same batch is well within acceptance criteria, why can't we release batch without solid identification of root cause for bulk failure as ultimately finished product is sent for administration to pateint.
You are right but in practical sense, the batch was failing in process, if there is no laboratory error or if we cannot have another sample to test once lab error is confirmed, then this batch cannot be released
Hi Sir!! Please make a detailed video on difference between collapsed cake vs improper cake vs melt back defects which are blatant defects identified in Lyophilised visual inspection. I would be a great help if expected explanation from your side is along with pictorials.
Then sir, what is the difference between 'lag time' and 'equilibrium time'. Does equilibrium time related to empty load only, Does it mean difference between reference temperature (i.e.inbuilt reference temperature sensor of autoclave) and data logger sensor Plz correct me if I am wrong, plz guide me.
Equilibration time is for loaded chamber Book on validation by Agalloco has given below explanation about lag time with reference to Dry heat sterilization The heating lag is defined as the difference between the time required for the product to reach the minimum required temperature and the time required for the sterilizer air to reach the minimum required temperature. A heating lag will be magnified during the maximum load of product (i.e., maximum density or mass).
jai ho
Very informative vedio
Thank you so much sir
Nice information sir
Video on Manufacturing and storage tank validation .
Sir please make video on dwell time
Sir thank you very much for your valuable knowledge sharing. Always a pleasure to have your video. Request you to please make a video on "if an injection product is failed to comply with in-process specification which is pertaining to bulk sample, in tests such as pH and Assay and if Finished product specification of same batch is well within acceptance criteria, why can't we release batch without solid identification of root cause for bulk failure as ultimately finished product is sent for administration to pateint.
You are right but in practical sense, the batch was failing in process, if there is no laboratory error or if we cannot have another sample to test once lab error is confirmed, then this batch cannot be released
Hi Sir!! Please make a detailed video on difference between collapsed cake vs improper cake vs melt back defects which are blatant defects identified in Lyophilised visual inspection. I would be a great help if expected explanation from your side is along with pictorials.
Ok I will make
Sir can you make a video about the drying process and why it important
Drying of load in autoclave?
Autoclave me hot point and cold point kya hota hai
Hot spot and cold spot identified based on temperature penetration and distribution studies by placing thermocouples
Sir please tell me the temperature distribution acceptance criteria of probe to probe and within probe
Lag time difference between previous validation cycle and present cycle . Value is higher than the previous validation . What is the answer
Then sir, what is the difference between 'lag time' and 'equilibrium time'.
Does equilibrium time related to empty load only,
Does it mean difference between reference temperature (i.e.inbuilt reference temperature sensor of autoclave) and data logger sensor
Plz correct me if I am wrong, plz guide me.
Equilibration time is for loaded chamber
Book on validation by Agalloco has given below explanation about lag time with reference to Dry heat sterilization
The heating lag is defined
as the difference between the time required for the product to reach the minimum required temperature and the time
required for the sterilizer air to reach the minimum required temperature. A heating lag will be magnified during the maximum load of product (i.e., maximum density or mass).
Sir,
Chamber temperature or drain temperature
For Equilibration time, it is chamber temperature