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Choosing and Using Clean-in-Place and Sterilize-in-

Place Systems
Dec 17, 2014
By Pharmaceutical Technology Editors
Equipment and Processing Report
Issue 12

Sterilize-in-place (SIP) and clean-in-place (CIP) systems can be used in various

pharmaceutical manufacturing operations to automate cleaning and
sterilization. Pharmaceutical Technology spoke with Klaus H. Schreiber, marketing and
sales for Pharmatec, a Bosch Packaging Technology Company, and Klaus Ullherr,
product manager at Bosch Packaging Technology, about the key considerations for
choosing and using such systems in aseptic filling.
PharmTech: What are the key considerations for using/installing CIP/SIP systems in an
aseptic filling process?
Schreiber (Bosch): An SIP system is usually combined with a CIP system to ensure the final
and automatic sterilization of modules or a complete system before the next batch is
produced. In general, SIP systems reduce the handling of parts or modules to be sterilized.
SIP may be required if the production exceeds a certain size, weight, and level of complexity.
The automated SIP process with validated parameters ensures a reproducible result and at the
same time monitors and records critical process parameters, which is a must in industrial
pharmaceutical production.
Aseptic handling is always critical at the interfaces between different systems or whenever
human interference is required. Potential contamination by humans, as well as faulty
operations or non-compliance with standard operating procedures in aseptic processing, is
considered a risk. Automated processes (like CIP and SIP) can significantly reduce the need
for, and thus impact of, human interference and ensure sterility. When highly potent or toxic
ingredients or APIs are handled, CIP systems help protect both the operators and also the
environment from exposure. Prior to disposal, any liquid waste will be chemically and
thermally inactivated.

Ullherr (Bosch): When it comes to the actual aseptic filling process, the benefits of a
CIP/SIP system primarily depend on the level of production. From a pharmaceutical point of
view, it makes more sense to sterilize filling paths when they are already installed rather than
to install them after sterilization. The latter has to be carried out manually and is more prone
to human errors. Using a CIP/SIP system removes the operator as a cause for possible
contamination. Aseptic handling is reduced and the system does not have to be dismounted.
The use of CIP/SIP systems is recommended for the production of large batches and toxic
products since the initial investment for implementing CIP/SIP systems is comparatively
high. Such systems need space, and the process can require a considerable amount of time.
For smaller batches, the installation of CIP/SIP systems is not efficient, as downtimes might
be too long. Contract manufacturers are also less likely to use CIP/SIP systems since a large
number of different products and formats require higher validation efforts.

As an alternative, single-use, pre-validated, preassembled and pre-sterilized parts, including

hoses, product bags, filling needles, and tubing, can eliminate the loss of capacity resulting
from lengthy cleaning validation as well as the risk of contamination between batch runs.
They also reduce the amount of cleaning media and energy. Eventually, each customer’s
decision depends on the following factors: economic evaluation, anticipated risks, and
established processes.

PharmTech: SMB, a Bosch Packaging Technology Company, recently introduced a

patented energy-recovery concept for hot-water shower sterilizers, which is described
in Pharmaceutical Technology's Equipment & Processing Report.

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