Suez Total Organic Carbon - March 2020 - 6

common process-specific analytical methods
The following process specific (or non-product specific) methods are
commonly used in cleaning applications.

Total Organic Carbon (TOC)

*

Visual inspection

*

Bioburden or endotoxin for detection of biological residuals

*

Ion mobility spectrometry for quick analysis of specific
target compounds

*

pH to detect acidic or basic cleaning agents

*

Infrared methods (NIR/FTIR) used in-situ to identify residues
on surfaces

TOC methods oxidize all organic residues and measure the carbon
dioxide produced.
*

*

Advantages: Sensitive to all aqueous organic compounds
including degradants or unexpected compounds, simple
method development (single method), applicable to all
phases of CV
Challenges: Excellent for identifying a CV process failure
but investigations may require complimentary methods,
compounds must be aqueous

Conductivity
Conductivity is used to detect ionic substances in cleaning rinse
samples, most commonly used to detect traces of acidic or basic
cleaning agents during a final rinse.
*

Advantages: Easy to automate (online), highly sensitive to
ionic residues, simple method development (single method)

*

Challenges: Only applicable to a subset of compounds
(cleaning agents or ionic APIs), for use with rinse
samples only

discussion
It is essential to any cleaning validation program that analytical
methods are selected appropriately for their intended use. Analytical
methods should be able to adequately determine that a validated
cleaning process was completed as designed, thereby minimizing
the risk of product contamination.
In an ideal world, the best analytical method for a given phase
(design, validation, verification) could be chosen. However, in the real
world of cleaning validation, selection of analytical methods may be
limited by practical considerations based on the cleaning process
and the intended use of the method. Therefore, it is more important
for the analytical method to be adequate or suitable rather than the
"perceived" best method for the intended purpose.2

References
1.

for Cleaning Validation. PDA, 2012, https://store.pda.org/

other analytical methods
In addition to product- and process- specific methods commonly
used in cleaning validation programs, other analytical methods for
consideration may include:

6

Technical Report No. 29 (Revised 2012) Points to Consider
tableofcontents/tr2912_toc.pdf

2.

Technical Report No. 49 Points to Consider for Biotechnology
Cleaning Validation. PDA, 2010, https://store.pda.org/
tableofcontents/tr49_toc.pdf

https://store.pda.org/tableofcontents/tr2912_toc.pdf https://store.pda.org/tableofcontents/tr2912_toc.pdf https://store.pda.org/tableofcontents/tr49_toc.pdf https://store.pda.org/tableofcontents/tr49_toc.pdf

Suez Total Organic Carbon - March 2020

Table of Contents for the Digital Edition of Suez Total Organic Carbon - March 2020