FORM: PROJECT CODE:

Code: Document Revision: Controlled Document

Revision Date: Document Status: Page: 1 of 13
Origin Date:

Temperature Mapping Report

Company Name & Site

Warehouse

Start Date: DD Month YYYY

End Date: DD Month YYYY
 FORM: PROJECT CODE:
Code: Document Revision: Controlled Document
Revision Date: Document Status: Page: 2 of 13
Origin Date:

Table of Contents
1 Approvals ...............................................................................................................................................................3

2 Introduction ............................................................................................................................................................4

3 Temperature Mapping Study Overview .................................................................................................................4

4 Data Logger Specification .....................................................................................................................................6

4.1 Temperature Only ..........................................................................................................................................6

5 Data Logger Configuration ....................................................................................................................................6

5.1 Temperature Only ..........................................................................................................................................6

6 Data Logger Certification .......................................................................................................................................7

7 Excursions: ............................................................................................................................................................9

7.1 Excursions - Warehouse ................................................................................................................................9

8 Non-Conformances ...............................................................................................................................................9

9 Recommendations: ..............................................................................................................................................10

10 Regulatory Recommendations ........................................................................................................................11

10.1 MHRA .......................................................................................................................................................11

10.2 EUROPEAN COMMISSION .....................................................................................................................12

11 Attachments .....................................................................................................................................................13
 FORM: PROJECT CODE:
Code: Document Revision: Controlled Document
Revision Date: Document Status: Page: 3 of 13
Origin Date:

1 Approvals

Approval Biomap Ltd:

Name Title

Signature Date

Approval (Company Name):

Name Title

Signature Date
 FORM: PROJECT CODE:
Code: Document Revision: Controlled Document
Revision Date: Document Status: Page: 4 of 13
Origin Date:

2 Introduction
This mapping study documents how conditions change in the stated facility and includes analysis of the results.
The study determines where hot & cold spots appear and indicates recommendations for continuous monitoring.

In regards to the rationale used for the logger placement, there is no set formula for the density and position of the
loggers used. Each mapping exercise requires a site survey to document the perceived risk areas and to ensure
product storage areas are captured. Each environment is treated as having individual requirements and will vary
based upon its configuration and layout so the resulting logger concentration may vary. Detailed floor plans are
provided to illustrate how the loggers were placed during the mapping period.

The study results are presented as an independent document, designed to support your internal Standard
Operating Procedures (SOP’s) and overall regulatory requirements.

3 Temperature Mapping Study Overview

Project Code

Company & Location

Facility Type Warehouse

Season

Load State Approximate stock levels during the mapping term

Data Logger Type MP-IN-D-8-L

Accuracy ±0.3ºC from -10ºC to +70ºC (MP-IN-D-8-L)

Number of Data Loggers Total Data Loggers Used: 76

Warehouse 74 internal, 2 External

Logger Position The attached floor plan indicates the exact position of each logger

Date Mapping Started DD Month YYYY

Date Mapping Ended DD Month YYYY

Required Temperature Range Warehouse: +15°C to +25°C

 FORM: PROJECT CODE:
Code: Document Revision: Controlled Document
Revision Date: Document Status: Page: 5 of 13
Origin Date:

Summary & Findings WAREHOUSE

1. Excursions

 Excursions were recorded in locations ??. Further details can be

seen in Section 7 Excursions.

2. General information

 The Warehouse was under normal use during the mapping exercise.

 The Warehouse was at approximately ??% of capacity during the

mapping exercise (detail provided by client).

Recommendations Full details of the locations that have been recommended for continuous
monitoring are included in Section 9 Recommendations and are also illustrated
on the floor plans within this report.
 FORM: PROJECT CODE:
Code: Document Revision: Controlled Document
Revision Date: Document Status: Page: 6 of 13
Origin Date:

4 Data Logger Specification

4.1 Temperature Only

Data Logger Type Escort iMiniPlus (MP-IN-D-8-L)

Operating Environment -40ºC to +70ºC
Sensor Measurement Range -40ºC to +70ºC
Resolution 0.1
Calibrated Accuracy ±0.3ºC from -10ºC to +70ºC
±0.5ºC from -40ºC to -10ºC
Memory Capacity Maximum 8048 Temperature data points
Memory Type EEPROM Non Volatile
IP Rating IP65 (With DB cap on)

5 Data Logger Configuration

5.1 Temperature Only
Dataloggers were programmed with the following configurations:

Location Warehouse

Recording Interval 10 minutes

Alarm Range +15°C to +25°C

Start Up Delay 4 Hours

Location External Monitors

Recording Interval 10 minutes

Alarm Range Disabled

Start Up Delay 4 Hours

 FORM: PROJECT CODE:
Code: Document Revision: Controlled Document
Revision Date: Document Status: Page: 7 of 13
Origin Date:

6 Data Logger Certification

The following data loggers were used for the mapping project and full calibration certification for each data logger is
included within this report:
Logger Number Serial Number Calibration Certificate Number Calibration Date Calibration Due Date
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
 FORM: PROJECT CODE:
Code: Document Revision: Controlled Document
Revision Date: Document Status: Page: 8 of 13
Origin Date:

Logger Number Serial Number Calibration Certificate Number Calibration Date Calibration Due Date
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
61
62
63
64
65
66
67
68
69
70
71
72
73
74
75
76
 FORM: PROJECT CODE:
Code: Document Revision: Controlled Document
Revision Date: Document Status: Page: 9 of 13
Origin Date:

7 Excursions:
7.1 Excursions - Warehouse
Logger Type of Min/Max
Serial Number
Logger Location
Excursion of Excursion
Total time out of Specification

8 Non-Conformances

NC No. Description Impact of NC

N/A N/A N/A

 FORM: PROJECT CODE:
Code: Document Revision: Controlled Document
Revision Date: Document Status: Page: 10 of 13
Origin Date:

9 Recommendations:
The locations for the positions of Continuous Monitoring Probes (CMPs) are based on the findings of this ENTER
SEASON mapping. All locations that recorded excursions (Hot or Cold spots) would usually be recommended by
default, however in cases with a high number of excursions it may not be feasible to monitor all of these locations.
In this case the extremes in each area/zone have been recommended to provide overall coverage and installation
of a temperature control system may also need to be considered. In addition, if no excursions have been recorded,
the highest and lowest temperatures are also considered in each area/zone.

At the time of the mapping, there were an approximate total of ?? x CMPs in place.

The following locations are recommendations only and aimed at providing consistent coverage of the facility for the
purpose of ongoing monitoring. The excursion locations or locations closest to breaching the target range from
each season are listed:

Logger
Facility Logger Number Comment
Location
WAREHOUSE
WAREHOUSE
WAREHOUSE
WAREHOUSE
WAREHOUSE
 FORM: PROJECT CODE:
Code: Document Revision: Controlled Document
Revision Date: Document Status: Page: 11 of 13
Origin Date:

10 Regulatory Recommendations
10.1 MHRA
Temperature Mapping
17. With rare exception, all warehouses and refrigerators should be temperature mapped prior to use to ascertain
the temperature distribution within the area used for handling medicines. The mapping exercise should be
repeated where conditions significantly vary, such as with seasonal variation, alteration in storage layout and
changes in supply of supplemental heating or cooling. Exceptions to the requirement to temperature map include
where multiple monitoring devices spread thorough a storage area provide continuous and thorough monitoring.
Mapping may also not be required where temperature storage areas are deemed too small to warrant mapping e.g.
of a size to store 2 or 3 totes, in which case temperature monitoring without mapping is adequate.

18. A mapping exercise should consist of a description of the mapping method, including equipment used,
placement of probes, responsibilities, types of information to be recorded and method and responsibility for
analysing the data. The mapping method is commonly presented as a protocol and should be approved before any
data is collected. All persons involved in the exercise should have an appropriate level of experience or training.
The mapping exercise should represent conditions of normal use, and in addition to normal storage areas
temperature measurement points should include high and low locations, storage areas near heat sources such as
skylights and near radiators, cold areas such as returned stock areas near loading lobbies, and within enclosed
areas such as controlled drug stores and cupboards.

19. Mapping data should be traceable to the individual equipment taking the record and be traceable to
temperature recorder calibration status. Interpretation of results should include any deviations from the original
method. If the outcome of the mapping exercise is accepted a summary report including any recommendations for
action should be approved. Such recommendations may include the most suitable placement of temperature
monitoring devices for routine temperature measurement, reassigning an acceptable warehouse temperature
range or the identification of hot spots and cold spots not fit for storage.

20. The same principles apply to mapping of refrigerators and cold rooms as for temperate warehouses.
Temperature data should be collected from areas likely to present areas of risk of temperature extremes such as
near condensers or doors as well as throughout the general storage area in normal use. Where a new piece of
equipment is being mapped the conditions should be representative of use, including buffering to mimic stock
holding and opening of the door. Where manual defrosting is carried out this should be included in the data
collection period.

Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2014 (Orange Guide)
Chapter 9 UK Guidance on Wholesale Distribution Practice
Control and Monitoring of Storage and Transportation Temperatures
 FORM: PROJECT CODE:
Code: Document Revision: Controlled Document
Revision Date: Document Status: Page: 12 of 13
Origin Date:

10.2 EUROPEAN COMMISSION

3.2.1. Temperature and environment control

An initial temperature mapping exercise should be carried out on the storage area before use, under representative
conditions. Temperature monitoring equipment should be located according to the results of the mapping exercise,
ensuring that monitoring devices are positioned in the areas that experience the extremes of fluctuations. The
mapping exercise should be repeated according to the results of a risk assessment exercise of whenever
significant modifications are made to the facility or the temperature controlling equipment. For small premises of a
few square meters which are at room temperature, an assessment of potential risks (e.g. heaters) should be
conducted and temperature monitors placed accordingly.

Official Journal of the European Union

Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human Use (2013/C 68/01)
 FORM: PROJECT CODE:
Code: Document Revision: Controlled Document
Revision Date: Document Status: Page: 13 of 13
Origin Date:

11 Attachments
The following documents are attached to this report:

Attachments Description

1. Floor Floor plans/Schematics of facility or asset mapped showing exact logger locations
Plans/Schematic
s

2. Data Summary A table showing Min, Max, Average, SD & Recorded Range for each location
Report

3. Graphs Graphs showing logger readings for multiple locations

4. Calibration Full 3pt Calibration Certificates provided for each Data Logger utilised in the study
Certificates

5. CD – Mapping A CD containing the mapping data including source logger files and mapping reports
Data