Jump to content

  • Quick Navigation
Photo
- - - - -

TOC method for cleaning validation


  • You cannot start a new topic
  • Please log in to reply
1 reply to this topic

#1 MDG

MDG

    Grade - MIFSQN

  • IFSQN Member
  • 76 posts
  • 4 thanks
1
Neutral

  • India
    India
  • Gender:Male
  • Location:India

Posted 27 July 2017 - 09:53 AM

Hello,

 

Guidance require for the usability of the Total organic method in dairy /food industries . As per the US FDA same is valid in pharmaceutical industry.

 

Thank you,


  • 0

#2 rtanit

rtanit

    Grade - Active

  • IFSQN Active
  • 3 posts
  • 2 thanks
0
Neutral

  • Canada
    Canada

Posted 11 August 2017 - 03:55 PM

I would suggest doing a swab and rinse water study. Validate your limits of detection using known standards of what ever you are cleaning. 3 replicates. 

 

Then figure out how effective your cleaning methods are and set a tolerance for "clean". Once you start testing rinse water samples/swab samples of clean equipment, anything over that tolerance would have to be re-cleaned.


  • 0

Thanked by 1 Member:



0 user(s) are reading this topic

0 members, 0 guests, 0 anonymous users