L
Learning Bob
Hello,
I'm trying to determine sample size for my OQ run for heated sealed packages. I plan on running 3 different experiments to find my center of the process window and what my outer limits are. I plan on performing Peel testing and Dye penetration testing. I don't know if I need 30 samples for each experiment, 500 samples for each experiment and so on? Also the dye penetration testing will be pass/fail (attribute data) and peel testing to be measured in lbs (variable data).
I hear a lot about minimum sample size can be 30??
This is for a new heat seal machine and for a new FDA product as well that will go through ETO sterilization.
Also, any help for sample sizes for a PQ would be appreciated.
Thanks
I'm trying to determine sample size for my OQ run for heated sealed packages. I plan on running 3 different experiments to find my center of the process window and what my outer limits are. I plan on performing Peel testing and Dye penetration testing. I don't know if I need 30 samples for each experiment, 500 samples for each experiment and so on? Also the dye penetration testing will be pass/fail (attribute data) and peel testing to be measured in lbs (variable data).
I hear a lot about minimum sample size can be 30??
This is for a new heat seal machine and for a new FDA product as well that will go through ETO sterilization.
Also, any help for sample sizes for a PQ would be appreciated.
Thanks