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Writing & Executing a Software Validation Protocol: Plain and Simple

Writing & Executing a Software Validation Protocol: Plain and Simple


This quick and easy guide describes methods and approaches for writing a validation protocol that can help ensure a thorough validation effort. It also provides some tips and tricks on executing the protocol and documenting the results.

While this book was written primarily for those new to validation projects and the effort required gathering sufficient evidence to support validation claims , experienced folks will likely find nuggets to help improve their efforts.



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  1. #1
    Validation Analyst
    Join Date
    May 2008
    Posts
    39

    Default Calibration of a Tablet Press

    I was hoping to get some insight about how others calibrate a tablet press.

    Besides hiring a company and paying them to do it, I was looking for in-house methods.

    For newer machines I would set the set speed to an RPM and use a calibrated tach to measure the RPMs. I would do a low RPM and a high RPM. Would I need to also count the output during both low and high speed test?

    For older machines I'm not 100% sure. If there is no dial setting and it's a crank, how would I go about comparing a set speed veruses an actual?

    Is this a good start or am I off base? Any insight provided would be wonderful.

  2. #2
    Validation Guru
    Join Date
    Oct 2010
    Location
    Kalundborg,Denmark
    Posts
    1,698

    Default

    Do you have a place where you have put a Tachometer and measure
    Durga Prasad
    Internal Consultant,Aseptic Process-NNE Pharmaplan
    www.nnepharmaplan.com
    Denmark

  3. #3
    Validation Analyst
    Join Date
    May 2008
    Posts
    39

    Default

    Quote Originally Posted by DURGA PRASAD View Post
    Do you have a place where you have put a Tachometer and measure
    It comes with reflective tape. So we would place that on the machine and the tach has a vision sensor that uses the tape to determine RPMs.

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