Q: How many Data logger I should use , is there any guidlines that describe
A: You should perform a temp profile and put data loggers in the critical points that will include the highest and lowest temperatures.
Q: What is the acceptance criteria for the temp/humidity.
A: Written The temp/humidity criteria is related to the stability data although momentarily excursions can be tolerated but they should be justified: this should be addressed when validating the whs and during the stability studies and the climate zone of your country.
Q: Is the acceptaqnce criteria for Min or max or Avg value.
A: RSD is acceptable. Good wareHousing practices???
Q: Where I have to put the Datalogger.see above 1.
[quote=maryacton]
Q: How many Data logger I should use , is there any guidlines that describe.
Q: What is the acceptance criteria for the temp/humidity.
Q: Is the acceptaqnce criteria for Min or max or Avg value.
Q: Where I have to put the Datalogger[/quote]
Question 1: I am not aware of any guidelines for this. I think it depends on the product/warehouse. Is the warehouse constructed of individual chambers or is it just a massive ware house? Sometimes you can justify less data loggers because the volume of air is so large that the temperature changes relatively slow. Also, you need to be cognizant of the different geometric planes (top/middle/bottom) as well spatial placement. I would be certain to map the product locations with multiple monitors.
Question 2 : AC depends on the product. Your warehouse should maintain the temperature in the proper range. Excursions for defrost must be justified. and it could be determined that because of defrost no product can be placed within x meters of the air inlet. also, you should make sure that the warehouse has been designed to meet the products requirements. It is always fun to try to qualify a room for 2-8 when it was designed for 25C.
Question 3 - again that is product based.
Question 4 - where product will be plus all that other stuff I said in 1.
Dear Sir/Madam,
I am not getting the following things
1.How many empty cycles & how many loaded cycles I should take for Dry Heat Sterilization Validation?
2. Which tests I should carry out?
3. If I go with different loading patterns, does it need to take 3 cycles for each pattern?
4. What precautions I should take while validation?
At least three empty cycle runs must be performed for determining the cold spot in the chamber. three loaded cycles (distribution & penetrations) without endotoxin and three loaded cycle (distribution and penetrations) with endotoxin must initiatied.
i couldn’t understand this question plz ellaborate it.
Validation give liberty to select worst case scenario, so first u calculate load mass calculations of ur load and select the worst load case and initiated distribution and penetrations studies on it, if worst case qualify it means all the case should be qualify.
carefully selection of equipment, heaters conditions, reproducible mapping, acturate and calibrated thermocouples, identifying coldest spot,calculating delta H value, 3 log reduction of endtoxin. there are many other things which must be consider during qualification HAS and validating their cycle development.