De Cuong Tham Dinh Nhiet Do Kho

Temperature Mapping Study

Document Reference TEM281707080702 Project Code

Created - 26-07-10 10:21:44

Created : 26-07-10 10:21:44 Document Status : Approved Page 1

DEMO VERSIONDocument Revision 1

Atlas Technology Limited

Printed By Roger BlackReport Tool Version 1.1.0.1

Report Start

Report End

29-06-10

06-07-10

Storage Facility Temperature Mapping Study

Temperature Controlled Cabinet

17:04:24

17:01:40

Warehouse 1A All Zones

Atlas Technology Limited - www.atlastechnology.co.uk



Created - 26-07-10 10:21:44

Created : 26-07-10 10:21:44 Document Status : Approved Page 2


Atlas Technology Limited

Printed By

SignatureDate.............................................. ..............................................................

Roger BlackReport Tool Version 1.1.0.1

Report Start

Report End

29-06-10

06-07-10

Date.............................................

Signature..............................................................

Author

Approved

Storage Facility Temperature Mapping Study

Temperature Controlled Cabinet

17:04:24

17:01:40

26-07-10

26-07-10

Warehouse 1A All Zones

Atlas Technology Limited - www.atlastechnology.co.uk Page 2



Created - 26-07-10 10:21:44


1 Introduction .................................................................................................. 4

2 Temperature Mapping Study Protocol ..................................................... 4

3 Data Logger Specification ........................................................................ 5

4 Data Logger Configuration ........................................................................ 5

5 Data Logger Certification .......................................................................... 6

6 Mapping Report .......................................................................................... 6

7 Deliverables ................................................................................................ 6

Table of Contents

8 Recommendations Report

9 Excursions Report

10 Statistical Report

11 Multigraphs

12 Floor Plans / Placement Plans

13 Logger Configuration Report

14 Validation Report

15 Lost Loggers Report

16 Report Authorisation




Created - 26-07-10 10:21:44


Project Code DEMO VERSIONAsset Type

Temperature Range

Duration

Mapping Type

Number of Loggers

Logging Interval (minutes)Logger Positions

Blood Bank / Fridge / Temperature controlled cabinet

These values will be used as the Upper & Lower acceptance limits for the final mapping report

Days

Temperature

The number and placement of the loggers is detailed in the Floor plans / Placement plans section of this report

Minutes

Individual Loggers will be numbered. The floor plan(s) will indicate the locations of each monitor. An External Logger should be placed outside of the facility out of direct sunlight to record the external temperatures du

RGAReturned Goods Authorisation Number

Other Information When shipping the loggers back to Atlas Technology you must ensure that sufficient insurance is included to cover replacement cost of the loggers.

Lost loggers will be charged at the current replacement cost of 70.00 per logger.

Loggers are assumed to be lost if they are not delivered within 30 days of shipping.

Temp Tale 4Logger Type

DEMO VERSIONRGA

1 Introduction

7

6

High LimitLow Limit

35 Degrees Centigrade10 Degrees Centigrade

2 Temperature Mapping Study Protocol

This Temperature Mapping Service is designed to determine the temperature profile of facilities where temperature sensitive products are held - Clean rooms, Cold rooms, Warehousing, Fridges, Freezers and Blood Banks.

This temperature mapping protocol incorporates the guidelines provided by the Irish Medicines Board in their draft document "Control & Monitoring of Storage and Transportation Temperature Conditions




Created - 26-07-10 10:21:44


Temperature Sensor Measurement Range -30C to +70C

Temperature Sensor Accuracy Range

Memory Capacity

Memory Type

Location

Logging Interval (minutes)Alarm Range

(1.1C from -30C to -18C)

Maximum 1920 Temperature data points

Non-volatile EEPROM

Blood Bank / Refrigerator / Temperature Controlled Cabinet

(0.5C from -18C to +50C)(1C from +50C to +70C)

3 Data Logger Specification

4 Data Logger ConfigurationTempTale4 monitors are configured as follows following specifications:

The TT4 monitors will be supplied with numbered labels on the front of each unit. These numbers correspond to the locations where the monitors are placed in the facility.

The loggers are started and placed at the designated mapping locations as indicated by the label number on the front of each unit which corresponds with the floor plan.

After the specified period, remove and download loggers. The file name of each logger will specify the monitor label number and the serial number of the logger.

Low Limit 10 Degrees CentigradeHigh Limit 35 Degrees Centigrade

6 Minutes




Created - 26-07-10 10:21:44


Section

BPF2_ProjectCode

8

Attachment Description

9

101112

Multi Graphs

Overview of any findings or conclusions derived from the mapping excercise along with recommendations for continuous monitoring if required.

Excursions Report

Recommendations Report

Statistical Data Report

Logger Configuration

Graphs showing logger historical readings.

Plans indicating logger placement locations used for the mapping

A table showing the logger configurations used for the excercise

Floor Plans

13

A table showing Min, Max, Average, SD, and MKT for each location.

5 Data Logger Certification

6 Mapping Report

The Report will include Validation Certificates for Loggers utilised in the study.

The following documents are provided in the Mapping Report:

Detailed report of any excursions beyond the defined limits

7 DeliverablesThere is a start up delay of 4 hours to allow for the loggers to acclimatise.

Once started, the loggers will stop automatically after the pre-programmed period. They may also be stopped manually if required. Once they have stopped the loggers must be returned to the supplier. The returned package must indicate the RGA number as detailed on page 3 of this document.

The mapping report will be delivered within 30 days of receiving the loggers.

14 Data CD CD contains copies of the report documents and data files.15 Data CD CD contains copies of the report documents and data files.

Logger Validation Report A table showing the Logger validation references

Report Authorisation Report Template Authorisation

A Data CD containing copies of the report documents and data files is also included




Created - 26-07-10 10:21:44


Column Description

Type

The Unique Identification number assigned to the logger and indicated on the label attached to the logger.

Serial Number

Logger ID

Location

Duration

The type of excursion.

This value is the sum of the individual excursion measurement values multiplied by the logging interval or the approximate 'area' of the excursion expressed in Centigrade minutes.

The time difference between the start of the excursion and the end of the excursion.

Peak (C)

The Descriptive location of the logger placement during the mapping period.

9 Excursions ReportThe following table describes how each value in the following Excursions report is derived.

The serial number of the logger

Area (C/min)

Start

High - indicates that the data value(s) exceeded the high Alarm set point.

End

Low - indicates that the data value(s) exceeded the low Alarm set point.The maximum data reading for the excusrion.

Start time of the excursion

End time of the excursion

All Excusrions are shown

Page 7Atlas Technology Limited - www.atlastechnology.co.uk


Document Reference TEM281707080702 Project Code DEMO VERSIONDocument Revision 1

Excursions Report

1Logger ID Serial Number 3444619660 Location Office 2

NO EXCURSIONS FOR THIS LOGGER









6Logger ID Serial Number 3438616797 Location Fridge 1

NO EXCURSIONS FOR THIS LOGGER 06-07-2010 06-07-2010


















Excursions Report





















24Logger ID Serial Number 3444620555 Location Freezer 1









Excursions Report
















Created - 26-07-10 10:21:44


8 Recommendations

This section describes and specific recommendations that are advised as a result of analysing the results of the mapping exercise that this report relates to.

These recommendations are based on the current guide lines, Directives and best working practises currently in place and published by the regulatory bodies.

1Inspectors look for proof that Warehouse and Cold room and storage cabinet mapping exercises have been completed. They want to see a document showing the work completed with full results, indicating

Regulatory Recommendations

2After a mapping has been completed, monitors should be placed for continuous monitoring where hot & cold spots occurred.

3Mapping should be carried out during extremes of external temperatures and if possible once during summer and once in winter, but companies are only required to complete one

4Warehouses and storage units - Mapping should be carried out every 2-3 years or after any major changes are made (re-fits, installation of new heating systems, major racking changes).5Cold Rooms Fridges Freezers - Mapping should be carried out every year and after any major change, unless multiple recording probes are employed for routine monitoring.6Stationary, packaging material and any other products that are not related to the medicines being stored are not required to be included in the mapping.




Created - 26-07-10 10:21:44


Recommendations




Created - 26-07-10 10:21:44


Value Description

Min

This is the Logger Reference Identification number used throughout the report to identify each logger

Serial no.

Logger

Location

Mean

The lowest data value recorded by this logger during the mapping period

The highest data value recorded by this logger during the mapping period

The average value of the data points recorded by this logger during the mapping period

Max

The location of logger during the mapping excercise as identified on the floor plan or placement map

10 Statistical ReportThe following table describes how each value in the following Statistical report is derived.

The serial number of the logger referenced by the ID number

Std The standard deviation value of the data points recorded by this logger during the mapping period

MKT The Mean Kinetic Temperature value of the data points recorded by this logger during the mapping period

Sum of Values / Number of values

The Following formula is used to calculate the Mean Kinetic Temperature.

?H / R _______________________________________________

MKT = - ?H / RT - ?H / RT -ln(e^ 1 . . . . . . . . . . . . . . . e^ n) _______________________________________

nWhere?H = Heat of ActivationR = Universal Gas Constantn = Number of 'T' valuesT = mean of 'T' valuese = natural log




Logger Min (C) Max (C) Mean (C) Std (C)Location MKT (C)

Statistical Data Report

Serial no.

20.9 26.3 24.1527 1.3547Office 21 24.2536344461966019.7 24.6 22.2985 1.2206Office 22 22.3732344660957619.1 22.4 20.7536 0.7476Office 23 20.7736343670944019.9 25.3 22.7119 1.2733Office 24 22.7967344461964919.1 24.2 22.1559 1.3273Office 25 22.245534466095354.3 22.6 5.6245 2.9793Fridge 16 6.293534386167975.4 22.6 6.3958 2.7555Fridge 17 6.937234367094364.7 22.6 5.7488 2.8725Fridge 18 6.357534446213183.2 22.3 4.7113 3.0108Fridge 19 5.38534446008514.4 22.3 5.366 2.84Fridge 110 6.209234367054303.8 22.6 4.9934 2.9051Fridge 111 5.877134386139876.6 22.6 7.4503 2.4383Fridge 112 8.019734466095625.7 22.6 6.597 2.5145Fridge 113 7.221634367094665.8 21.9 6.646 2.4156Fridge 114 7.21233446609507-25.7 22.3 -20.9092 7.5229Freezer 124 -6.73363444620555-25.2 22.2 -20.564 7.5072Freezer 125 -6.68893444600857-26.6 21.9 -21.3857 7.6142Freezer 126 -7.16983446610419-26.4 22.2 -22.9928 7.7445Freezer 127 -7.02833444621160-26.8 22 -23.2564 7.717Freezer 128 -7.29733444620580-26.8 22.1 -23.0359 7.8257Freezer 129 -6.99123436706633-26.7 21.9 -23.4007 7.8114Freezer 130 -7.12743444621114-26.2 22.2 -22.9202 7.8274Freezer 131 -6.46213438616773-26 22.6 -22.8879 7.8882Freezer 132 -6.22483446610427




Created - 26-07-10 10:21:44


11 MultigraphsThe following graphical reports detail the historical logged data.



Document Reference TEM281707080702 Project Code MQMS1305103Document Revision 1

Logger 1 Logger 2 Logger 3 Logger 4 Logger 5 High AlarmLow Alarm

Zone 1 Graph for Loggers 1, 2, 3, 4, 5

Date / Time05-07-10 00:0003-07-10 00:0001-07-10 00:00

Deg

rees

Ce

ntigr

ade

(C)

4038363432302826242220181614121086420

-2

Logger 6 Logger 7 Logger 8 Logger 9 Logger 10 Logger 11 Logger 12 Logger 13 Logger 14 High AlarmLow Alarm

Zone 2 Graph for Loggers 6, 7, 8, 9, 10, 11, 12, 13, 14

Date / Time05-07-10 00:0003-07-10 00:0001-07-10 00:00

Deg

rees

Ce

ntigr

ade

(C)

14131211109876543210

-1-2-3



Document Reference TEM281707080702 Project Code MQMS1305103Document Revision 1

Zone 3 Graph for Loggers

Date / Time30-12-99 00:00

Deg

rees

Ce

ntigr

ade

(C)

14131211109876543210

-1-2-3

Logger 24 Logger 25 Logger 26 Logger 27 Logger 28 Logger 29 Logger 30 Logger 31 Logger 32 High AlarmLow Alarm

Zone 4 Graph for Loggers 24, 25, 26, 27, 28, 29, 30, 31, 32

Date / Time05-07-10 00:0003-07-10 00:0001-07-10 00:00

Deg

rees

Ce

ntigr

ade

(C)

10

5

0

-5

-10

-15

-20

-25

-30

-35



Document Reference TEM281707080702 Document Revision 1 Project Code DEMO VERSION

12 Floor Plans / Placement PlansThe following section contains the logger placement plans used for this mapping project



Document Reference TEM281707080702 Document Revision 1 Project Code ProjectCode

Floor Plan / Placement Plan Number 1




Created - 26-07-10 10:21:46


Section Description

SP High

The Unique identification number assigned to each logger and indicated on the logger label.

Serial no

SP Low

Location

The High Alarm set point. Data values higher than this are considered an excursion.

The logging interval for the logger. Data is captured at this interval.

The Descriptive location of the logger placement during the mapping period.

Interval

The Low Alarm set point. Data values lower than this are considered an excursion.

13 Logger Configuration ReportThis section details the configuration used for each logger used in the mapping project.

The following table describes the meaning of each column in the Logger configuration Report

The serial number of the logger

Logger ID

Zone This is a cross reference idetification used to group the individual loggers so that they can represented on overlaid graphs.




Logger Configuration Report

Logger ID Serial no SP High (C) SP Low (C) Interval Location Zone1 3444619660 10 6 135 Office 22 3446609576 10 6 135 Office 23 3436709440 10 6 135 Office 24 3444619649 10 6 135 Office 25 3446609535 10 6 135 Office 26 3438616797 2 6 28 Fridge 17 3436709436 2 6 28 Fridge 18 3444621318 2 6 28 Fridge 19 3444600851 2 6 28 Fridge 110 3436705430 2 6 28 Fridge 111 3438613987 2 6 28 Fridge 112 3446609562 2 6 28 Fridge 113 3436709466 2 6 28 Fridge 114 3446609507 2 6 28 Fridge 115 3446609589 2 6 38 Fridge 216 3446609679 2 6 38 Fridge 217 3436709554 2 6 38 Fridge 218 3438624159 2 6 38 Fridge 219 3436709439 2 6 38 Fridge 220 3446610438 2 6 38 Fridge 221 3446610443 2 6 38 Fridge 222 3436709480 2 6 38 Fridge 223 3444621351 2 6 38 Fridge 224 3444620555 -30 6 4-15 Freezer 125 3444600857 -30 6 4-15 Freezer 126 3446610419 -30 6 4-15 Freezer 127 3444621160 -30 6 4-15 Freezer 128 3444620580 -30 6 4-15 Freezer 129 3436706633 -30 6 4-15 Freezer 130 3444621114 -30 6 4-15 Freezer 1




Logger Configuration Report

Logger ID Serial no SP High (C) SP Low (C) Interval Location Zone31 3438616773 -30 6 4-15 Freezer 132 3446610427 -30 6 4-15 Freezer 1




Created - 26-07-10 10:21:46


Column Description

Logger Type

The serial number of the loggerValiadtion Due

Serial Number

Validation Certificate Number

The type of data logger

Validation Certificate number for the logger

14 Validation ReportThe report details the Validation Certification for the data loggers utilised in the study.

The following table describes meaning of the columns in the logger Validation Report

The data that the logger is due to be validated




Logger Validation Report

Serial Number Validation Due Validation Certificate Number Logger Type

TT4 - Temperature05/06/20113444619660 AT_LV0804101TT4 - Temperature05/06/20113446609576 AT_LV0804101TT4 - Temperature05/06/20113436709440 AT_LV0804101TT4 - Temperature05/06/20113444619649 AT_LV0804101TT4 - Temperature05/06/20113446609535 AT_LV0804101TT4 - Temperature05/06/20113438616797 AT_LV0804101TT4 - Temperature05/06/20113436709436 AT_LV0804101TT4 - Temperature05/06/20113444621318 AT_LV0804101TT4 - Temperature05/06/20113444600851 AT_LV0804101TT4 - Temperature05/06/20113436705430 AT_LV0804101TT4 - Temperature05/06/20113438613987 AT_LV0804101TT4 - Temperature05/06/20113446609562 AT_LV0804101TT4 - Temperature05/06/20113436709466 AT_LV0804101TT4 - Temperature05/06/20113446609507 AT_LV0804101TT4 - Temperature05/06/20113446609589 AT_LV0804101TT4 - Temperature05/06/20113446609679 AT_LV0804101TT4 - Temperature05/06/20113436709554 AT_LV0804101TT4 - Temperature05/06/20113438624159 AT_LV0804101TT4 - Temperature05/06/20113436709439 AT_LV0804101TT4 - Temperature05/06/20113446610438 AT_LV0804101TT4 - Temperature05/06/20113446610443 AT_LV0804101TT4 - Temperature05/06/20113436709480 AT_LV0804101TT4 - Temperature05/06/20113444621351 AT_LV0804101TT4 - Temperature05/06/20113444620555 AT_LV0804101TT4 - Temperature05/06/20113444600857 AT_LV0804101TT4 - Temperature05/06/20113446610419 AT_LV0804101TT4 - Temperature05/06/20113444621160 AT_LV0804101TT4 - Temperature05/06/20113444620580 AT_LV0804101TT4 - Temperature05/06/20113436706633 AT_LV0804101TT4 - Temperature05/06/20113444621114 AT_LV0804101




Logger Validation Report

Serial Number Validation Due Validation Certificate Number Logger Type

TT4 - Temperature05/06/20113438616773 AT_LV0804101TT4 - Temperature05/06/20113446610427 AT_LV0804101




Created - 26-07-10 10:21:46


BPF2_ProjectCode

15 Lost Loggers ReportData for the following Loggers is not

Logger Serial Number 3446609589 ID 15Logger Serial Number 3446609679 ID 16

Rationale for completion of the report without the inclusion of data from the loggers listed above

It has been determined that there was still sufficient data available to create a valid

Page 29

Document Reference TEM281707080702


Document Revision 1 Project Code DEMO VERSION

16 Report Authorisation

Date Document Status Authorisation

12th March 2010 Initial Release

Page 30

Documents

De Cuong Tham Dinh Nhiet Do Kho