PQ Protocol for Blister Sealing Machine

Dear Friends,

I am a PM for the IOL (IntraOcular Lens) Laboratory and we bought new Blister Selaing machine, am kind of new to write protocol for the machine. So could you please help me to write the PQ Protocol and the steps I should follow.


for blister lines yu must consider, speeds, confirm the seal intergrity by performing leak tests, pin hole detections for alu alu, the temperature settings for the sealing drum and pocket formation should be established in relation to speeds output.camera settings and challenge testings should be done (learning cycles to be done as well).

Hello Joseph Mbita,

According to what you said, If I want to performe a Design of Experiment with all the parameter you said, what would be the measure responses or output (dependent) variables?

I am telling this because I want some help with a problem I have in a package process on a blister machine.

In the packaging process I have the parameter (factors, imputs) like forming temperature, sealing temperature, speed, sealing pressure and forming pressure. The measure response (output) that I have are leak test, yield, etc. My problem is my product is returned back by the customer because the leak test didn’t pass. When I perform the leak test during my process, the test passes.

My question is: what measure response (output), a numerical variable besides leak test do I have to consider?

I consider that I need an output that can be measure in order to perform a design of experiment.

Attentive to your prompt response. Thanks in advance.