Page 2 - 2_Pharmaceutical industry

2. Pharmaceutical industry

2.1. TOC determination in ultrapure water – 2.6. TOC determination according to USP 643 (USP 36-NF 31)
comparison of the various oxidation techniques 2.7. TOC determination according to USP 661.1 –
2.2. TOC determination in cleaning validation – final Rinse Testing of plastic packaging systems and their materials
2.3. TOC determination in cleaning validation – of construction
SWAB Method 2.8. TOC determination according to USP 661.2 –
2.4. TOC determination according to EP 2.2.44 Testing of plastic packaging systems and their materials
2.5. TOC determination in ultra pure water with wet chemical of construction
oxidation

Pharmaceutics is an ancient science that has supported people Many drugs are manufactured in batch mode operation. Prior
with remedies to help alleviate pain and heal illnesses. After to the production of the next batch, materials and working
medication, certain substances are expected to unfold their equipment must be extensively cleaned. In order to verify that
beneficial ef fects – while side effects from interfering sub- the equipment is free from the ‘previous’ drug batch, the TOC
stances and contaminations are undesirable. This is why it is parameter is used for the evaluation of the cleaning process.
important to use the purest possible substances and purified The TOC not only mirrors the presence of drugs, but also re-
equipment and materials in the production of drugs. veals other contaminants such as those from cleaning agents.

To meet this standard, legislators have published Pharmaco- With its TOC analyzers, Shimadzu offers systems that are suit-
poeias. These in clude methods and rules for the manufacture, able for many different TOC analysis issues in the pharmaceuti-
storage, quality and testing of drugs. For drug manufacturers, cal industry. In addition to the lowest detection sensitivity, the
complying with the rules and methods of the Pharmacopoeia is robust analyzers offer the highest precision and accuracy. Just
mandatory. like the analyzers themselves, the operation and evaluation
software complies with all requirements of the FDA and the
TOC determination is also described in the Pharmacopoeia (for Pharmacopoeia.
instance the European Pharmacopoeia = EP). The sum parame-
ter serves as a measure of contamination by organic com- Further information can be found in the individual application
pounds. Not only the method itself is described, but also a test notes (for in stance ‘TOC determination in ultrapure water,
to verify the suitability of a TOC analyzer for the analysis. cleaning validation or in accordance with EP 2.2.44’). In addi-
tion to pharmaceutical applications, there are also application
In addition to ultrapure water required for the manufacture of notes and information on ‘Environmental analysis’, ‘Chemical
drugs, water for injections – water that is directly injected into industry’, ‘TOC special applications’, ‘TOC in daily practice’ and
the bloodstream of the human or animal body – is also tested ‘TOC process analysis.’
for its TOC content. The Pharmacopoeia actually specifies a
maximum TOC limit value for such specific waters.