Regulations have been put in place by the MHRAFDA/BAPW to ensure warehouses storing

pharmaceutical products are "Mapped" and "Monitored". The purpose of mapping is to identify Hot
Spots, to know how the internal temperature is effected by climatic changes and to better manage
the storage of your product. This should be conducted once in the Summer and once in the Winter.

We suggest that, initially, a temperature map is conducted either:

By yourselves, using low cost, high spec loggers, either hired or purchased
By a complete temperature map carried out by Wessex Power

The Authorities require that readings of minimum and maximum are recorded at least hourly. This
can be carried out manually. However, with electronic dataloggers, a full picture can be produced
without the need to remember to take the readings. Downloaded information can automatically
calculate min/max values, averages, means, MKT, as well as standard deviation.
If needed, a product life versus temperature calculation could be performed in
the software.

This mapping exercise ensures compliance as well as enabling

proper use of the warehouse and a fuller understanding of
products effected by temperatures.

If you have warehouses, cold stores, fridges, freezers,

stability cabinets etc, where temperature sensitive
pharmaceutical products are stored, you will need to map
these areas.

Datalogger Specification

Temperature Start Time: Programmable start time and date

Range: -40C to +80C up to 6 months in advance; or
external pushbutton
Temperature
Resolution: 0.1C Data Format: Date and time stamped C,

Calibrated Calibration: Digital calibration through software

Accuracy: 0.5C (0 to +50C) with certificate traceable to na-
tional standard

Humidity Sensor: Semiconductor Dimensions: 36mm x 56mm x 16mm

Humidity Range: 5% to 95%H User Replaceable

Battery: 1 years typical life

Humidity Temperature Programmable high and low limits;

Resolution: 0.1%rH Alarm: When logged data reaches or
exceeds either limit, red LED blinks
every 3 seconds
Calibrated
Accuracy: 3.0%rH (2%rH typical at 25C) Software: Windows 95/98/NT/ME/2000/XP
based software

Accuracy Range: 10% to 80%rH, +10C to +40C

 So. What can I find out from a Temperature Survey?
A temperature mapping survey of a space can reveal a great deal of information about the dynamics and
performance of your installation. This is just the information you need to confirm proper operation of the
system or to identify and resolve suspected shortcomings in the performance.

A survey will plainly reveal: stratification of the air, hot and cold-spots, anomalies in the chilling/heating
system, power outages, the effects of door-openings, effects of introducing goods, presence of personnel,
time-to recovery of set temperature, and much more.

The report provided contains all the data shown as multi-trace coloured graphs for the entire area plus
sectional breakdowns to point up differences by location, level etc. Where unexpected behaviour is seen, a
sectional graph will be produced to give a zoomed-in view allowing closer scrutiny of the data. Examination
of the multi trace graphs will reveal the movement of change in temperatures in the volume so indicating
air-movements

Derived values of Max, Min and Average are shown for each location in bar-graphs to help point up any
zoning either by level or plan-location. This will show you if you have a patchy, uneven distribution of
temperatures.
Wa r e ho use M a i n - M i n M a x & A v e r a g e s

28

26

24

22

20 Loc at i on M i ni mum

18 Loc at i on A ver ages

16 Loc at i on M axi mum

14

Warehouse
12 Main - Comparison w ith Outside Temperature

10
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23
30

25

20

15 High Aver age

Low Aver age

10 Out side

0 Top Racking

-5 18

16
C-19
14
C-20
C-21
12
C-22
C-23
10
C-24
C-26
8
C-27
6

4
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Also Available

WESSEX POWER TECHNOLOGY LTD

189 Ashley Road, Parkstone, Poole, Dorset, BH14 9DL
Tel: +44 (0)1202 723000 | Fax: +44 (0)1202 723400
Email: SgtTemp@wessexpower.co.uk | www.wessexpower.co.uk