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 OQ Protocol and the steps I should follow.
Thanks,
Danny
Dear Danida,
I have worked previously with Blister packing machine (IQ/OQ). Some of the test cases that i remenbered: Start/Stop verification, Alarm/Interlock verification, Data recovery verification for its computer, Blister defects verification (small/big tablet/capsule, wrong position, broken tablet/capsule, different color tablet/capsule). this may help…
Regards,
Anil
Dear All,
I want to learn which type of tests do you execute in OQ generally. For example shall we write how we can operate the machine step by step like operatig manuel?
Plain and simple: OQ tests need to be based on verifying requirements! (And don’t forget that a good source of requirements would be from risk controls identified in a risk analysis; e.g., an FMEA.) To attempt anything otherwise turns into guesswork.
Hello Yodon,
Can I use OQ to create a operational window? I mean to optimize the parameter?
Attentive to your prompt respond. Thanks in advance.
Regards,
[quote=Henry]Hello Yodon,
Can I use OQ to create a operational window? I mean to optimize the parameter?
Attentive to your prompt respond. Thanks in advance.
Regards,[/quote]
Yes, it’s quite common for OQ to define the range for operating parameters.
Dear Yondon,
What type of study can I perform to define the range for operating parameters?
Attentive to your comments.
Yes, that’s where the challenge is.
The general process would be to determine what the range is that results in good product and then do statistically-significant testing at the range end.
To determine the operational range, you may need to do some experimental testing (outside the scope of the validation).
Since the title of this thread mentions blister sealing machine, I presume there are at least 2 variables in play: heat (if thermal) or frequency (if ultrasonic) and dwell time. Introducing multiple variables like that increases the complexity of the testing (and determining the parameter ranges).
It would be difficult in a forum like this to provide details more specific for your problem. Hopefully that gets you going a bit.
[quote=yodon]Yes, that’s where the challenge is.
The general process would be to determine what the range is that results in good product and then do statistically-significant testing at the range end.
To determine the operational range, you may need to do some experimental testing (outside the scope of the validation).
Since the title of this thread mentions blister sealing machine, I presume there are at least 2 variables in play: heat (if thermal) or frequency (if ultrasonic) and dwell time. Introducing multiple variables like that increases the complexity of the testing (and determining the parameter ranges).
It would be difficult in a forum like this to provide details more specific for your problem. Hopefully that gets you going a bit.[/quote]
Hello Yodon,
The dwell time would be an input variable or an output variable in a design of experiment?
How can I measure dwell time?
What would be the parameters that affect the measure responses or output (dependent) variables?
Attentive to your comment.