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Sum parameters – Total Organic Carbon
Cleaning validation in the food and consuma-
bles industries
No. SCA-130-407
Many everyday necessities, such as different ■ IFS Food
types of food, personal care products or cos- Cleaning of production plants is also ad-
metics, are produced in a discontinuous pro- dressed by the IFS Food standard. Chapter
cess. As soon as one batch is completed and 4.10 ‘Cleaning and disinfection’ describes the
sent to further processing or filling, the pro- required validation of the effectiveness of
duction equipment and machines are being cleaning measures in accordance with a
cleaned. The successful cleaning of the pro- specified sampling plan using suitable meth-
duction equipment is mandatory, before the ods.
production of the next batch can be started.
■ Suitable methods
Cleaning validation is a method that has been
used in the pharmaceutical industry for dec-
ades since pharmaceutical products are often
manufactured in batch processes. After a
batch of an active ingredient is sent to further
processing, the production equipment is be-
ing cleaned so that the next batch can be
produced. The actual cleaning process is
very strictly specified and is subsequently
analytically validated, whereby a sample from
the production equipment is analyzed for
Numerous trade chains offer so-called private specific parameters. As long as none of the
labels which are produced in contract manu- limit values is exceeded, the production
facturing. It happens that a private label man- equipment is considered to be clean and can
ufacturer works for several trade chains and be used again. This process is called clean-
manufactures different products or manages ing validation.
different mixtures and formulas using the
same production systems. In this case, it ■ Parameters
must be ensured that the production systems TOC (Total Organic Carbon) has become an
are cleaned prior to manufacturing the next established parameter for cleaning validation
product. and offers many advantages over single sub-
stance analysis:
The ‘International Featured Standards’ (IFS)
define quality standards to ensure that the TOC determination is fast and straightfor-
products requested by the customer company ward. It can be carried out within a few
comply with all the required specifications. minutes. It does not requires lengthy sample
Several documents set the standards for preparation. Furthermore, TOC analysis not
quality assurance, such as ‘IFS Food‘ or the only detects a single substance but a multi-
‘IFS HPC‘ (Household and Personal Care) tude of components and is, therefore, prod-
standard for the production of household or uct-independent and highly flexible, provided
personal care products. that the product contains organic compounds.
