Page 38 - Shimadzu Journal vol.9 Issue2

Initially, TOC analyzers were mainly used for ensuring the Extractables and leachables from plastic materials: A TOC
water quality of environmental waters, industrial effluents, and analyzer compliant with standards for substances extracted from
so on, but later, as TOC performance improved, the scope of ap- plastic materials in pharmaceutical packaging (USP 661) can be
plications expanded. Now they are also used for quality control used to easily check for extracted substances with high sensitivity.
of purified and ultrapure water, for ensuring compliance with Pharmaceutical packing materials interact with pharmaceuti-
public drinking water quality standards, for controlling/evaluat- cals. Substances that can be transferred from packaging materials
ing pharmaceutical manufacturing processes, and for researching to pharmaceuticals under normal storage conditions are referred to
carbon-neutrality. Thus they serve a vital role in various fields im- as “leachables,” whereas components that form under more severe
portant for people and the Earth. storage conditions are referred to as “extractables.” Due to the in-
crease in biopharmaceuticals, there has been growing interest in
Applications for Biopharmaceuticals extractables and leachables in recent years. Because most biop-
At pharmaceutical manufacturing sites, in- harmaceuticals are injectable drugs, there is a high risk of biop-
gredients and rinse water must be controlled harmaceuticals interacting with packaging materials. Furthermore,
based on pharmacopoeia requirements in re- to reduce biopharmaceutical manufacturing costs, momentum is
spective countries. The following describes also increasing for using continuous production methods. The use
an application of using TOC analysis for Takahide Hiramatsu of plastic materials in single-use production equipment also adds
Pharmaceutical
biopharmaceutical manufacturing. Application Specialist the risk of leachables being introduced from such equipment.
Shimadzu TOC analyzers can be used as a physicochemical testing
Culture tank cleaning validation: Using an online TOC ana- parameter for extractables.
lyzer to validate the culture tank cleaning process can shorten the
validation time and reduce human errors.
TOC – Determination according to USP 661.1
Biopharmaceutical production lines include a large number of
Testing of Plastic Packaging Systems and their
culture tanks. Inadequate cleaning of culture tanks can prevent the Materials of Construction
culturing process from progressing as expected, which can some-
TOC – Determination according to USP 661.2
times waste an entire tank of ingredients. However, using an offline
Testing of Plastic Packaging Systems and their
TOC analyzer to check the cleaning status of culture tanks requires Materials of Construction
people to sample the rinse water and measure the samples in a lab-
oratory, which is time-consuming and expensive. In contrast, using
an online TOC analyzer can reduce waiting times by periodically Looking forward to the future of TOC
measuring automatically sampled rinse water and successively Ever since Shimadzu released its first TOC analyzer in 1972,
sending that data to a host computer. Shimadzu has been constantly improving TOC analyzer accuracy,
sensitivity, functionality, the product line, and options. Today, as
Cleaning Validation System for the leading TOC analyzer company, Shimadzu now has the largest
Biopharmaceutical Cell Culture Tanks Using global market share. In the future as well, Shimadzu remains com-
On-Line TOC Analyzer
mitted to “Realizing Our Wishes for the Well-being of Mankind
and the Earth” by continuing to develop additional systems.

Image: Environmental TOC Development Team

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