3.

C Material flow, personnel flow and layout

Here you will find answers to the following questions:

 What is the significance of the personnel flow and material flow in production?
 Which principles governing the material flow are applied in pharmaceutical production?
3.C.1 Material flow
Material flow refers to the interlinking of all operations relevant to sourcing, processing and
treatment, as well as the distribution of material goods within specified areas. This specifically
involves: processing, handling, transportation, testing, stopovers and storage. Material flow is the
sequence of individual manufacturing and storage steps, starting with the raw material and ending
with the finished product. In addition to economic considerations, the material flow has a particular
significance in terms of Good Manufacturing Practice.

Figure 3.C-1 Functions and characteristics of material flow

Functions and characteristics of material flow
Functions

 Suitable for preventing the omission of quality-determining manufacturing and control steps
 Prevention of confusion
 Compatibility with other manufacturing procedures in other rooms
Characteristics

 Clear
 Unambiguous
 Crossing-free
 Characterised by short routes
The material flow ultimately represents the manufacturing process in the building which must be
broken down into individual steps and presented in a flow diagram. Each processing step must be
assigned to a machine, and each machine assigned to a room. The rooms in the building must then
be grouped in a manner that reflects the material flow.

There are two main principles governing the material flow that will obviously be influenced by the
building structure as well as the products: these are the horizontal and vertical material flow.

Figure 3.C-2 Illustration showing the principle of vertical material flow

[Pohal, 1999]
The horizontal material flow is determined by the transportation of materials using conventional
methods. Production takes place at one level, or several levels connected by lifts. Transport and
production take place at the same level. The horizontal material flow is widespread in the case of
sterile dosage forms and in solids production.

A vertical material flow, implemented for the first time by Prof. Lhoest, involves the specific use of
gravity for the transportation of products. The production equipment operates at several connected
levels. Transport and production take place at different levels wherever possible. This procedure is
mainly used in solids production (see figure 3.C-2).

In addition to the two main principles of material flow described, an interlinking of facilities is
desirable from the GMP standpoint, particularly for vertical material flows but also for horizontal
material flows. The facilities are joined together using fixed connections such as pipes, tubes, coils,
etc. The product may be transported from one machine to the next via these connecting elements
without having to be transferred to intermediate containers (see figure 3.C-3).

Figure 3.C-3 Illustration showing principle of interlinked material flow

 A comparison of the aforementioned principles of material flow is shown in figure 3.C-4.

Figure 3.C-4 Comparison of principles of material flow [Pohl, 1999]

Comparison of principles of material flow
Advantages Disadvantages
 No connection with other levels  Large hygienic areas
Horizontal
 Clear production sequence  Transport and production not separated
 Simple tried-and-tested  Transportation systems (stackers) often not
transportation systems compatible with GMP
Vertical Transport and production separated
 Technically complex
 Small hygienic areas  Greater need for validation
 High degree of automation  No visual check possible
 Closed systems  Special architectural design required
 Complicated cleaning process
 Flexible transport
Interlinked  Large hygienic areas
 Closed systems to a large extent  Transport and production not separated
 Can be automated  Technically complex
3.C.2 Personnel flow
Many characteristics and functions of material flow also apply to personnel flow. Most importantly,
logical organisation of the personnel flow serves to protect the product in addition to considerations
of economy and labour legislation.

Figure 3.C-5 Functions of the personnel flow

Functions - personnel flow
 Support of zonal concept
 Prevention of cross-contamination
 Product and personnel protection
 Economic efficiency
To optimise the material flow, the appropriate number of persons required to operate, monitor and
maintain the machines and facilities must be determined. The functions of individual persons must
then be described and the routes transferred to the layout. The personnel flow and its
iterative optimisation are assessed together with the layout and material flow based on the
following assumptions:

 Access to pharmaceutical areas only via locks/changing rooms

 Separate routes for pharmaceutical and non-pharmaceutical personnel
 Short routes
3.C.3 Layout
"Layout" refers to the visual representation of machines inside rooms and also the arrangement and
shape of rooms within a building. When finding a suitable layout, personnel and material flow are
also factors to consider in addition to the necessary areas or volumes and room planning. The layout
shows functions that ensure a safe manufacturing process and so when designing the layout it is
recommended that quality assurance is also considered. Figure 3.C-6 shows the information that
can be read off from the layout

Figure 3.C-6 Layout information

Layout information
 Type and size of rooms
 Room layout and arrangement of machines
 Traffic routes (personnel flow and material flow)
 Locks for material and personnel
 Staff rooms (short break areas, toilets)
 Zone classification
.

Summary

Material and personnel flow influence GMP and the economic efficiency of an operation.
Horizontal material flow is predominantly used in the pharmaceutical industry, though examples
of vertical material flow are becoming increasingly common - particularly in the production of
solid dosage forms.

It is recommended that quality assurance is also taken into account when determining the layout.