Ortho MTS Gel Workstation Validation

[simret 20]

Can any of you share your Gel Workstation validation, please?

thank you,

 

[David Saikin 1,452]

What do you need to validate?  Is it a manual station?  Is it a new test system for you? Or just a new workstation?

[Sonya Martinez 44]

Here's our plan from 2010 for the equipment validation.  Hope this helps.  Here's the variances we noted during the validation which you might need:

• The centrifuge will not spin if the drawer is not latched.
• Do not press the START button while the centrifuge drawer is open or the time display will automatically start counting down from 10 minutes.
• The centrifuge time is controlled by a pre-programmed timer that applies power to the motor for 10 minutes.  Time and speed are pre-set at the factory and cannot be changed.
• If the START button is pressed with the centrifuge door open, the timer will automatically start counting down from zero, however, the motor will not start.  Pressing the STOP button will clear the time display.

Validation plan-MTS COMBO.doc

[simret 20]

David, it is the manual station.

thanks,

[simret 20]

Sonya,

Thanks!