Train Your Staff on Good Documentation Practices in 60 Minutes!

20% Discount With Coupon Code LAGMP-002





Results 1 to 7 of 7
  1. #1
    Banned
    Join Date
    Jun 2011
    Location
    NJ
    Posts
    11

    Thumbs up Cleanroom ISO 7 Cleaning Requirements

    I was looking into the ISO14644 Part 5 (2004) document, and it almost seems to suggest that Vacuuming the room is a requirement rather than a recommendation.
    Can anyone here with cleanroom cleaning experience tell me whether vacuuming is a requirement?
    The outfit I'm working to get into compliance is an ISO 7 (10,000) room.

    Thanks!

  2. #Ads
    AskaboutValidation donovan99 is offline

     

  3. #2
    Validation Guru
    Join Date
    Oct 2010
    Location
    Copenhagen,Denmark
    Posts
    1,798

    Default

    Its really expensive to vaccum the entire room.
    You can really observe a vaccuming effect when you have tight & leak proof fittings. Once the AHU'S are shut down it has that vaccuming effect and try to suck air from the crevices and leaks.
    This shows how concern are the regulators regarding the tightness or integrity of such rooms.The ducts, doors and other covings-joints in panels are all tested for smoke test and tested for leaks.
    Durga Prasad

  4. #3
    Banned
    Join Date
    Jun 2011
    Location
    NJ
    Posts
    11

    Default

    Oh - sorry I should have been more specific. I meant "vacuum cleaning" as stated in ISO ISO14644 Part 5 on Page 34 where it says "Vacuum cleaning can be used in gross and intermediate cleaning operations as a basic first step to cleaning both general and critical areas. Vacuum cleaning is a prerequisite, not an alternative, to mopping or wet wiping. Vacuum cleaning is effective in removing larger particles and other debris such as glass fragments. Vacuum cleaning should be performed in deliberate, unidirectional strokes to minimize air turbulence at the floor level and at operator height."

    But after I read it a couple of times, this means that if you are going to vacuum-clean the room, you still have to mop!
    Hence, the requirement is to mop, not to vacuum.

  5. #4
    Validation Guru
    Join Date
    Oct 2010
    Location
    Copenhagen,Denmark
    Posts
    1,798

    Default

    Vaccum clean all fixtures that are being installed in Clean room.
    After installtion vaccum clean all panels, coners, floor, covings, under equipments etc.
    Then spray the required cleaning agent and mop floors, covings, roofs, panels, walls, mirrors etc.
    Then repeat this process.
    The vaccum cleaner should be a heavy duty one which has maximum capacity for dust collection.You should always open such bags in a designated area , clean the collection bag or replace it with new bag and place it properly.
    Durga Prasad

  6. #5
    Validation Analyst
    Join Date
    Jul 2010
    Location
    Zimbabwe
    Posts
    12

    Default

    I was wondering does the vacuum cleaner require qualification if yes, what is the rational?
    Witness Tongoona
    Validation Engineer
    Varichem Pharmaceuticals Pvt Ltd
    Zimbabwe

  7. #6
    Validation Analyst
    Join Date
    Aug 2012
    Posts
    1

    Default

    will you post the guideline of iso14644-5 for reference

  8. #7
    Validation Guru
    Join Date
    Oct 2010
    Location
    Copenhagen,Denmark
    Posts
    1,798

    Default

    Sorry. We have no right to post here or in any other known registered forums across the globe.
    ISO guidelines are to be purchased by Individuals or Companies.
    There is a legal clause attached for transmitting such guidelines.
    Durga Prasad

Tags for this Thread

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
  •  
Privacy | Terms © 2006 - 2014 askaboutvalidation. All Rights Reserved