Comprehensive service – from one source.

In order to guarantee and document quality, a qualification of
the storage facilities (temperature mapping) was performed at
the company Zur Rose in Frauenfeld. The results of this analysis
were used as the basis for developing of a central monitoring
system to provide continuous recording and monitoring of climatic
conditions.

In the process, Zur Rose profited from the comprehensive service
offered by ELPRO: As a system supplier, in addition to installing and
commissioning the monitoring system, ELPRO was also in a position
to perform the IQ/OQ and carry it out in user training.

The project partner

The Zur Rose Group is a group of companies, located on one site,
which represents the interests of doctors. The group includes a
medical wholesaler specialised in supplying the doctor’s surgery
and the Zur Rose mail-order pharmacy which, in collaboration with
doctors, dispatches competitively priced pharmaceuticals.
Zur Rose has achieved a market leading position within the
pharmaceutical industry as key supplier for doctor’s surgeries. In
addition, with the mail-order pharmacy business Zur Rose has been
able to further increase its efficiency in the healthcare market.

Temperature mapping – recording the spatial
temperature distribution

Recording climatic conditions and analysing temperature distribution
are central aspects of evaluating the quality of storage environments.
Among other things, the following questions are answered
during temperature mapping studies:

• How big are the temperature fluctuations at various locations in
  a large storage room?
• What are temperatures like in winter and how high is the storage
  temperature on a hot summer day?
• Is the climatisation of the room sufficient to guarantee compliance
  with the regulations regarding storing temperature and
  humidity-sensitive commodities?

Using ELPRO know-how

Zur Rose contracted ELPRO to perform temperature mapping in
order to record and analyse the distribution of temperature inside
cold storage cells and storage rooms.

ELPRO provided a comprehensive service, from the initial concept,
evaluation of the results and through to the creation of
documentation observing GLP/GMP compliance. This documentation
was used by Zur Rose, among other things, to provide evidence of
storage quality to SwissMedic, the Swiss Agency for Therapeutic
Products.

The results of the temperature distribution analysis provided the
basis for equipping storage rooms and cold storage cells with an
ELPRO central monitoring system. This system enables continuous
and consistent documentation and monitoring of climatic conditions
including alarm forwarding.

The implemented dataloggers of the ECOLOG-NET family allow
autonomous recording of climate values. The ECOLOG-NET devices
are fully functional and continue logging even when the higherlevel
network fails, thus providing a high level of system safety.

Measuring locations for central monitoring

The results of the temperature mapping procedure are used as the
basis for determining the measuring locations. The ELPRO system
monitors temperature at the following locations:

• Four cold storage cells (2°C to 8°C), each fitted with one temperature
  sensor
• Paternoster (15°C to 25°C), with one temperature sensor
• Storage area 1 and storage area 2 (15°C to 25°C), each fitted with
  two temperature sensors

Online monitoring of climate values

Software component elproLOG MONITOR PLUS provides Zur Rose
with a tool that enables online monitoring of all climatic conditions
that are kept under surveillance. This means that the responsible
personnel are always in a position to get information about the
current measured values and to react immediately if deviations
occur.

Alarming

Zur Rose uses the manifold alarm functions offered by the elproLOG
MONITOR PLUS software, on the one hand, to signal alarms with an
alarm flash and, on the other hand, to forward alarms via the ELPRO
alarm interface on a telephone dial unit. Thus, the responsible personnel
have round-the-clock information about the alarm status.

Installation and commissioning

The scope of services provided by ELPRO also includes professional
installing and commissioning of the system.

Realisation

The whole project involved close collaboration between Zur Rose
and ELPRO. This enabled optimal consideration of the specific
requirements laid down by Zur Rose.

Customer benefits

The cooperation with ELPRO allowed Zur Rose to continue to
concentrate on their key functions. ELPRO’s wide experience in the
field of climate measurement technology in a GMP environment
made a targeted and efficient realisation of the requirements
possible.

Central monitoring system

The ELPRO central monitoring system provides Zur Rose with uninterrupted
storage room monitoring. Easy data access is made
available at a central location and, in the case of deviations, a fully
automatic alarm is triggered and the responsible personnel are informed.

The most important customer benefits at a glance:

• The system has a modular structure making it easy to install
  and extend
• ELPRO offers comprehensive services, from analysis and
  conception to realisation and commissioning
• ELPRO provides comprehensive system documentation and
  conducts employee training courses