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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
    Forum Creator gokeeffe's Avatar
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    Default Grade D Laboratory Environment

    Hi Guys

    I was just wondering if anyone knew if to achieve a Grade D laboratory environment if an air lock is required?

    We had our air tested, however we were wondering if that is enough and does it matter how grade D is achieved?

    Any guidance would be greatly appreciated

    Regards
    Graham O'Keeffe
    Director of Operations
    Premier Validation Ltd
    Website: www.premiervalidation.com
    Forum: www.askaboutvalidation.com
    LinkedIn: LinkedIn Profile


  2. #2
    Validation Guru
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    Aug 2007
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    Default

    Quote Originally Posted by gokeeffe View Post
    Hi Guys

    I was just wondering if anyone knew if to achieve a Grade D laboratory environment if an air lock is required?

    We had our air tested, however we were wondering if that is enough and does it matter how grade D is achieved?

    Any guidance would be greatly appreciated

    Regards
    The entry in Grade D area should be through airlocks/ buffer for personnel, equipment and materials.The Grade D area should be maintained to an appropriate cleanliness standard and supplied with air which has passed through filters of an appropriate efficiency. Proper air flow pattern must be designed and complies.

    Thanks
    Shahnawaz Sajid (Ph.D)

  3. #3
    Forum Creator gokeeffe's Avatar
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    Default

    Hi Shahnawaz

    Thanks for the reply, I take it so that without an airlock a laboratory

    cannot achieve a grade D status?

    Regards
    Graham O'Keeffe
    Director of Operations
    Premier Validation Ltd
    Website: www.premiervalidation.com
    Forum: www.askaboutvalidation.com
    LinkedIn: LinkedIn Profile


  4. #4
    Validation Guru
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    Aug 2007
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    Default

    Quote Originally Posted by gokeeffe View Post
    Hi Shahnawaz

    Thanks for the reply, I take it so that without an airlock a laboratory

    cannot achieve a grade D status?

    Regards
    Dear Gokeeffe,
    Most prefebly air lock must be present as a bearrier between two different areas/classes. or clean and unclean zone, if air lock are not present or not designed then at least maximum air changes are required at the entry of Grade D area which may segregate the two areas with positive differientail pressure.

    Thanks
    Shahnawaz Sajid (Ph.D)

  5. #5
    Forum Creator gokeeffe's Avatar
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    Default

    Thank you Sir
    Graham O'Keeffe
    Director of Operations
    Premier Validation Ltd
    Website: www.premiervalidation.com
    Forum: www.askaboutvalidation.com
    LinkedIn: LinkedIn Profile


  6. #6
    Ahsan Khan
    Guest

    Default

    Dear Gokeeffe,

    An air lock must be present at the entrance of a grade D lab which should be bubble type airlock in which air comes out from the air lock in both direction with the pressure differential of 5 - 20 Pa range.

    The filtration efficiency should be minimum F9 according to filter grades EN 779 /EU 9 according to filter grade DIN 24185 part2 .

    Thanks

  7. #7
    Forum Creator gokeeffe's Avatar
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    Default

    Many thanks
    Graham O'Keeffe
    Director of Operations
    Premier Validation Ltd
    Website: www.premiervalidation.com
    Forum: www.askaboutvalidation.com
    LinkedIn: LinkedIn Profile


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