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October 2019


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Donald English <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Wed, 16 Oct 2019 21:34:08 -0400
text/plain (74 lines)
 Dear all,

I have a question for the group.  I was wondering how people are verifying
cleaning validation for manufacturing equipment that is used for biologic
product manufacturing.  I have heard that there could be problems in using
TOC as a tool in verify cleaning validation of manufacturing equipment for
biologic products.

However, I had found the following references below indicating that there
is no such issue in using TOC for cleaning validation of biologic
manufacturing equipment:


Hernández <>, L., et
al. Biopharmaceutical Facility Cleaning Validation Using the Total Organic
Caron Test, Case studies show TOC is effective for cleaning validation.
BioPharm International, Volume 23, Issue 6, 2010.

 Xin, L et al.  Preliminary study on the application of total organic
carbon (TOC) method in cleaning validation of vaccine manufacturing
enterprises. Chinese Journal of Pharmaceutical Analysis, Volume 36, (8),
2016, 1465-1469.

Mott, A. et al. Methodology for Assessing Product Inactivation During
Cleaning Part II: Setting Acceptance Limits of Biopharmaceutical Product
Carryover for Equipment Cleaning.  Journal of Validation Technology, 2016,
Volume 19 Number 4.

So, I’m a little confused as whether or not that TOC could be used in
verifying the cleaning of biologic manufacturing equipment.  If you had
issues in using TOC for cleaning validation of biologic manufacturing
equipment, could you please let me know what issues were encountered.



Donald J. English Microbiological Quality Consulting LLC

Florham Park, New Jersey 07932

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