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

Ask About Validation

Results 1 to 7 of 7
  1. #1
    Validation Analyst
    Join Date
    Aug 2010
    Location
    Ankleshwar
    Posts
    9

    Question Operator Exposure Level - OEL

    Dear Friends,

    Can anybody come up with a suggestion how to Sample & calculate/measure the OEL (Operator Exposure Level) for highly potent drugs ?

    Say for example Finasteride drug..

    Looking forward to hearing from you all.

    AP

  2. #Ads
    AskaboutValidation ajaya.padhi is offline

    Train your staff in GDP in 60 Minutes!
     

  3. #2

    Default

    Calculation of OEL
    OEL = ((N(L)OAEL) x BW) / (SF x α x V)
    OEL: Occupational exposure limit
    N(L)OAEL: No (lowest) observed adverse effect limit
    BW: Body weight (70kg)
    SF: Safety factor which considers uncertainties data (animal to human
    variability in response, interindividual variability, and so on)
    α: Degree of absorption (100 per cent in the absence of data)
    V: Volume of air inhaled during an eight-hour working day


    There are 2 classifications followed in OEL
    1.Merck Classification
    2.Safe Bridge Classification.

    Regards
    Durga Prasad

  4. #3

    Default OEL level required?

    Can anyone please inform
    what is the OEL level required in Solid dosage plant for hormonal druges and not hormonal drugs?
    What are the agencies involved in giving OEL level certificate to a pharma plant? Is it outside agency or a particular agency can only do this job?

    Sanjiv Desai

  5. #4

    Default

    You take OEL based on what product you manufacture.
    OEL is tested by 3rd party in line with Regulatory guide lines.
    Please enquire this in your place.
    Probably you can enquire Klenzaids for this job in Mumbai.
    Durga Prasad

  6. #5

    Default

    Quote Originally Posted by DURGA PRASAD View Post
    Calculation of OEL
    OEL = ((N(L)OAEL) x BW) / (SF x α x V)
    OEL: Occupational exposure limit
    N(L)OAEL: No (lowest) observed adverse effect limit
    BW: Body weight (70kg)
    SF: Safety factor which considers uncertainties data (animal to human
    variability in response, interindividual variability, and so on)
    α: Degree of absorption (100 per cent in the absence of data)
    V: Volume of air inhaled during an eight-hour working day


    There are 2 classifications followed in OEL
    1.Merck Classification
    2.Safe Bridge Classification.

    Regards
    Durga Prasad
    Actually, there are many different classification systems. Depends on your company's specific engineering controls. With advancements in containment technology, I've seen 4,5, and 6 band systems. I explain this in the video below.


  7. #6

    Default

    Fantastic explanation.
    Thanks a million for your time,posting vedio and explaining very well.
    We shall certianly contact you. Thanks again for sharing your contact details.
    Regards
    Durga Prasad

  8. #7

    Default Control banding in the pharmaceutical industry

    Durga Prasad

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