Page 5 - 2_Pharmaceutical industry

Sum parameter – Total Organic Carbon
TOC determination in cleaning validation
– final rinse
SCA-130-202
The highest purity and most careful handling
of substances and active ingredients is an
important requirement in the manufacture of
pharmaceuticals. An effective removal of
production residues in pharmaceutical plants
is an essential precondition. A well-cleaned
pharmaceutical production system prevents
contamination and, consequently, the
adulteration of the produced drug. This is
particularly important in the production of
active ingredients in batch processes, as the
system is used for different products and
contamination of the next product must be
prevented.
■ Cleaning methods: Clean in Place
CIP cleaning (clean in place) is performed
automatically and without disassembly of the
production system. The production system
must, therefore, have a CIP design. This
includes the use of rinsing heads, no dead
volumes, collection tank and recycling
possibilities for the detergents.
Because time and temperature, as well as the
use of cleaning agents and solvents are
optimized, CIP cleaning is highly effective.
Moreover, automatic cleaning allows a
standardized and, therefore, an easily
validated procedure.
■ Sampling and analysis
In case of CIP cleaning, the rinsing liquid of
the final rinse solution is sampled and
analyzed. This is a very simple, easily
automatable and fast method. When water is
used as a solvent, TOC analysis is suitable
for subsequent analysis.
■ TOC-Analysis
TOC analysis is applied for the determination
of the total organic carbon content as a sum
parameter. The carbon content of the sample
is oxidized to CO 2 and detected by an NDIR
detector. Analysis of final rinse samples is,
therefore, fast and simple (analysis time:
approx. 4 min). The determined TOC value
reflects any contamination by starting
materials, products, byproducts or cleaning
agents, as long as they contain carbon.
■ Shimadzu TOC Series
With its TOC-L series, Shimadzu offers a
highly suitable tool for cleaning validation.
The modular design simplifies the analysis –
no matter whether one wants to measure final
rinse samples or swab samples.