Hello Guest! Log In or Register now. Lost Password? Click Here to Reset

Ask About Validation

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.



Results 1 to 2 of 2
  1. #1
    Validation Analyst
    Join Date
    Feb 2008
    Posts
    6

    Question Samling Room Qualification

    Dear all,

    In one of the site sampling rooms an issue regarding air flow requirements from the Hepa filter.

    The room has 2 zones (a b), zone A is under the Hepa filter. in addition a 50cm Plastic sheets are been used around - marking the zone A area.
    The Enterance to the room is also guarded with a long plastic sheets (to the floor).

    can you please tell me the purpose of the plastic sheets and whether the length has a meaning ? ( i am considering shorthen the sheets)

    Please advise,

    Regards.

  2. #2
    Validation Expert
    Join Date
    Jan 2008
    Location
    South Africa
    Posts
    74

    Default

    Firstly, what are both areas classed as? When you mention " under the HEPA filter" I take it that you mean UDAF. Should they both be of the same class then I would assume that the 'plastic sheets' are used to,
    1) differentiate between area A and B- a sort of divide,
    2) as a barrier to exclude disturbances to that airflow.
    Maybe you could elaborate on the whole sampling system such as are there airlocks, change over rooms, interlocking doors that prevent the possibility of cross contamination/contamination etc.
    Hope that this is of some help.

Bookmarks

Posting Permissions

  • You may not post new threads
  • You may not post replies
  • You may not post attachments
  • You may not edit your posts
  •  

Get In Touch with AskaboutValidation

© 2006 - 2012 askaboutvalidation. All Rights Reserved
Single Sign On provided by vBSSO