11.

A Sanitation Page 1 of 2

11.A Sanitation
Here you will find answers to the following questions:

■ What is sanitation and who is responsible for it?

■ What contamination sources are there?

Sanitation can be understood as the interaction of production hygiene and personnel hygiene.
Often the terms sanitation and production hygiene are used as synonyms. In addition to hygienic
measures in the narrower sense, precautions and measures to prevent cross-contamination,
confusions and cross-mixing are assigned to the term production hygiene. Sanitation measures are
required to carry out pharmaceutical production.

The aim is to achieve and retain a defined cleanliness status. The required cleanliness grade is
prescribed by the production step or dosage form. A cross -plant structure must be developed, which
ultimately leads to the integration of systematic hygiene measures in the production process.

Defined measures are expected (EU GMP Guideline), which stipulate how to deal with the field of
sanitation.

Basis

The organisation of the material and personnel flow is an important criterion for the quality of
sanitation. A logical and consistent workflow organisation leads to reproducible conditions on which
established procedures can be based. The definition and documentation of the material and
personnel flows allow for critical consideration of these areas. Deviations from these flows increase
the risks to an unforeseeable degree. It is disproportionately more difficult to provide for adequate
hygiene measures for material flows that cross over each other, e.g. by limited space, as the risk of
contamination rises sharply. Worst-case considerations, i.e. the absolute simultaneity of
contamination eventualities, are necessary. It is understandable that inadequately defined flows will
bring further risks. This means that before defining the sanitation measures, the in-plant process
structures must be accurately illuminated. The design of new buildings and production rooms should
ideally include this as part of qualification or risk analysis. Knowledge of possible malfunctions in the
normal process means it is possible to take these into consideration when compiling standard
sanitation programmes. Dedicated target/actual analysis of deviations is enabled through the
process descriptions obtained or parts of the job description. (See chapter 3.C Material flow,
personnel flow and layout .)

Figure 11.A-1 Principles of

sanitation

Principles of sanitation

■ Definition of the material flow

■ Definition of the personnel flow
■ Definition of processes

Contamination of products can be both physical particulate and microbial and can take place in
various ways. This encompasses the fields of personnel, including visitors and all those involved in
the production area, surfaces of the production rooms and facilities and bordering rooms in the
wider sense. Likewise, raw materials (including water and packaging), cleansing agents and the

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11.A Sanitation Page 2 of 2

processes themselves, can be a cause for impurities. Contaminants can also enter via the utilities
used (e.g. product contact nitrogen) and the ambient air (see figure 11.A-2).

The combination of all influence factors results in the real actual status of sanitation.

Figure 11.A-2 Sources of

contamination

Sources of contamination

■ Personnel
■ Surfaces (rooms, facilities)
■ Raw materials (including water)
■ Processes
■ Utilities (nitrogen gasing)
■ Ambient air

Responsibilities

The head of production is responsible for sanitation. Monitoring can be co -ordinated and evaluated
by quality assurance in collaboration with quality control. Depending on the cleanliness grade, the
results are added to the evaluation of batches (e.g. for filling under a laminar flow) by quality control.

Summary
The head of production is responsible for ensuring compliance with sanitation. He is supported by
information, e.g. on monitoring data from quality assurance.
Sources of contamination in the production process include personnel, starting materials, utilities,
equipment, rooms and the process itself. This must be specifically controlled during monitoring.

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