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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.



View Poll Results: As described in thread "Calculation of ACPH in cleanroom"

Voters
5. You may not vote on this poll

  • Air supplied by FFU can be considered while calculating ACPH.

    2 40.00%

  • Air supplied by FFU can be considered while calculating ACPH within the boundry specified in thread

    3 60.00%

  • It should not be considered as.....(pls specify in reply to quote)

    0 0%
Multiple Choice Poll.
Results 1 to 1 of 1
  1. 05-13-2010, 08:35 AM #1
    Ravi Dhanbhar
    Ravi Dhanbhar is offline
    Validation Analyst
    Join Date
    Mar 2010
    Posts
    34

    Thumbs up Calculation of ACPH in cleanroom

    Case 1: If treated air is supplied to cleanroom by AHU through terminal HEPA filters. Same room is equipped with fan filter units (FFU) too, having suction from room & deliver the filtered air in room itself.
    Case 2: If treated air is supplied to cleanroom by AHU through planum & terminal HEPA filters. Same room is equipped with fan filter units (FFU) too having suction from planum & deliver the filtered air in room itself.
    In my opinion while calculating the ACPH, we should consider the total air delivered in room including terminal HEPA & FFU's HEPA as well, because air supplied in room is filtered (i.e.treated air) in both the cases. An intention to run the HVAC system on specified ACPH is in view to assure recovery of particles resulting in dilution of particulate concentration in cleanroom. In both the cases, considering the fresh air taken by AHU is sufficient for maintaining required oxygen level & pressure balancing.
    I would like to have your opinion pls.

    This thread can also be viewed at:Social Group- PHARMA ENGINEERING (Procedural GEP, Engineering Projects & Technical operations in pharma & biopharma.) Path:Askaboutvalidation > Community > Social Groups > Uncategorized > PHARMA ENGINEERING
    Last edited by Ravi Dhanbhar; 05-13-2010 at 09:48 AM. Reason: To make it more elaborative
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