Performance of high shear mixer (or rapid mixing granulator

[Duyen]

I’m preparing to perform PQ of high shear mixer machine with placebo. This machine can control the torque force in process. I have no idea how to do PQ of this machine. Please give me recommendations????

 

[William55401]

What are your measures of success? What output (result) are you trying to achieve? It sounds like you have an input (the torque). Tell us more about your measurable outputs and the maturity of the associated measurements of each output.

 

[Bev D]

Usually PQ is performed with the actual product - is there any reason that you are using a placebo? Can the product behave differently in the mixer than the placebo?

In general, PQ characteristics are those that are used for the product release and depending on your requirements may include stability testing.

Given teh use of hte word placebo - are you producing a pharmaceutical? Are you under FDA or USDA regulation?

 

[Duyen]

What are your measures of success? What output (result) are you trying to achieve? It sounds like you have an input (the torque). Tell us more about your measurable outputs and the maturity of the associated measurements of each output.

I'm just preparing PQ protocol for this machine and haven't yet to start IQ, OQ so no output I have. Torque force is one of its function. I think I can use this function to evaluate in PQ.

 

[Duyen]

Usually PQ is performed with the actual product - is there any reason that you are using a placebo? Can the product behave differently in the mixer than the placebo?

In general, PQ characteristics are those that are used for the product release and depending on your requirements may include stability testing.

Given teh use of hte word placebo - are you producing a pharmaceutical? Are you under FDA or USDA regulation?

Because now, I don't have any producing process of product so I decide to do PQ with Placebo. I will do with product in process validation. Do u have any experience for doing it. Can u share with me?