Please,
Can you tell me information about non specific methods that might be used for routine monitoring of cleaning .How to correlate the results from methods used in the cleaning validation studies with this non specific methods
How can we do this ?, what kind of test to demostrate correlation?…
Can you refer an example…
TOC or UV. The methods would have to validated per ICH Q2 as usual except they are non-specific.
Water is the only recovery solvent you can use since it contains no carbons. Make standard concentrations of the API and the drug product formulation separately. LOQ should be 1 ppm or less.
thank you.
please,explain to me…this standard concentrations and the drug product formulation solutions ,Do I get readings by specific method and unspecific separately? … Please,what kind of statistic test that can be used to conclude that there is a correlation?
thanks a lot
paul
As long as the API and the formulation contain Carbons, TOC will give a numerical answer. It works well with ‘dietary supplements’ but not for HPAPI (~1 ug/dosage). You will end up chases ghosts.
For both the API and formulation dissolve in water (test beforehand) 1/100, 1/250. 1/500, 1/750, 1/1000. This is the beginning of your linearity series.
please think about the following approach:
If the solutions prepared for test accuracy exceeding my limit cleaning,i can read by non-specific method (it pHmetry, ultraviolet, toc, Conductimetry, etc) … I can say to the regulatory body that the non-specific methodology correlates with validated analytical methodology (eg HPLC) … and I can use it in the monitoring practice cleaning?
Many thanks
paul.
Monitoring only (since other molecules can interfere), but you will have to use a more specific method like HPLC.
Ok … sorry … .i don’t understand you very well … I use a method like HPLC for monitoring cleaning ??
I say this because I am accepting what dictate the cleaning validation guide:
PDA tr No. 29
It is essential to correlate the results from methods used in the cleaning validation studies to theresults from other non-specific methods used That Might Be for routine monitoring of cleaning effectiveness.
Specific test methods are required for validation Generally cleaning of dosage form for manufacturing. Non-specific testing methods can be used in the early stages of bulk drug production and for routine monitoring purposes.
please,why do you say that I must use a method like HPLC for monitoring cleaning ??
thank you
paul
TOC is fine for monitoring but a specific method like HPLC should have the final say.
We used TOC to determine detergent residue levels, and we used HPLC to determine API residue levels. TOC works but is easily contaminated and like Boomer Chemist stated, you can end up “chasing ghosts”, or investigating failures, where there really weren’t any failures, just a slighly sloppy sample (cough, sneeze, IPA, skin, etc. can all contaminate your sample).
METHODS unspecific (PDA TR 29) : The test sample pH detect any residue having acid-base character; - Detect any ionic conductivity or inorganic material; And TOC tests detect any organic residue.
The idea we have is to validate the cleaning with specific methods and make routine monitoring method according to the unspecific reference table according pda tr # 29
Please,What do you think about it ? It seems to be a good approach to monitor cleanliness in our manufacturing plant?
regards
paul
EVERYTHING can adjust the pH so it is no good. I would use UV, conductivity (applies to ions only), or TOC (organic only including formulation).
