TEMPERATURE

MAPPING PROTOCOL

LOCATION: VISUAL INSPECTION ROOM II

Document Number: TMP-015-00

Version Number: 00

Effective Date:

1.0 REVISION HISTORY

Version
S.No. Reason for Change Effective No.
No.

01 00
2.0 PROTOCOL APPROVAL
Signing in this approval page of Performance Qualification indicates agreement with this
document. Incase of any Modifications or changes to the Performance Qualification, an
addendum will be prepared and approved to accompany the protocol.

TABLE OF CONTENTS Page No

1.0 Revision History 1
2.0 Protocol Approval 2

Prepared by Signature Date

Quality Assurance

Checked By Signature Date

Quality Control

Production

Engineering

Reviewed By Signature Date

Quality Assurance

Approved By Signature Date

Plant Head

Head Quality
3.0 Overview 4
3.1 Objective 4
3.2 Scope 4
3.3 Responsibility 4
4.0 Requalification 4
5.0 Reference Document 5
6.0 Numbering of the Protocol 5
7.0 Methodology 5
7.1 Room Description 5
7.2 Section Criteria of Placing Temperature Data Logger 5
7.3 Equipment Used 6
7.4 Conditions Required 6
7.5 Duration of Temperature monitoring 6
7.6 Selection criteria for number data logger to be use 6
7.7 Calibration Details of Data Logger 7
7.8 Calculation of the MKT 7
8.0 Deviation 7
9.0 Incident/Failure 7
10.0 Acceptance Criteria 8
11.0 Abbreviation 8
3.0 OVERVIEW
3.1 Objective
The purpose of this document is to lay down the procedure and method to record
the temperature in Visual Inspection Room II (I.D. No.GPA 58) of General Block
for temperature mapping to identify the hot point based on the mean kinetic
temperature. This study is meant for the incubation of Media fill Ampoules at a
controlled temperature .
3.1 Scope
This protocol is limited to temperature mapping of Visual Inspection Room II
(I.D. No.GPA 58) area.
3.2 Responsibility
The temperature mapping team comprises of representatives from each of the
following departments, who shall be responsible for the overall compliance of this
protocol:
• Quality Assurance Department
• Quality Control Department
• Production Department
• Engineering Department
Quality Assurance shall be responsible for preparation and execution of the
protocol.
Quality Control, Production and Engineering shall be responsible for checking and
reviewing the temperature mapping data.
Quality Assurance will prepare the summary and conclusion report based on the
data reviewed.
The approval of the protocol shall be done by the Plant Head and Quality Head.
4.0 REQUALIFICATION
Re-Qualification of temperature mapping process shall be carried out at every 3 year
frequency.
Re-Qualification should also be performed additionally in following case
• Any major modification in HVAC system and area after the last performance
qualification. This must be properly documented through a change control system.

5.0 REFERENCE DOCUMENT

Following documents are referred during preparation of the protocol.
 Document Name
Operational Manual
SOP of temperature monitoring
Note: Room should have a lock and key provision and should be open only during the
temperature recording.

6.0 NUMBERING OF THE PROTOCOL

The numbering of the protocol will be the format of the TMP-XXX-YY.
Where “TMP” stands for Temperature Mapping Protocol and XXX are serial number
in the form starting from 001 and YY denotes the version number.

7.0 METHODOLOGY
7.1 Room Description
Visual Inspection Room II (I.D. No.GPA 58) is meant for incubation of media filled
Ampoules in controlled temperature condition. The air is circulated in the room
through four supply grill and two return air grill located at the ceiling in both room.
7.1.1 Room Dimensions
Room Name & Number : Visual Inspection Room II (GPA58)
Length : 6550 mm
Breadth : 4150 mm
Area (Sq. Mts) : 21.18 (Approx.)
7.2 Selection criteria of placing temperature data logger
Right Side Corner
Near the Man entry door
Top corners of the room
Bottom corners of the room
Centre of the room
Near the material entry doors
7.3 Equipment Used
Data logger shall be used to measure temperature in each area.
Name of Data Logger: Testo Wireless Data logger
Make: Testo (Germany)
Model: 174 T
7.4 Conditions Required
The room temperature shall be maintained between 32 – 35 OC
 7.5 Duration of Temperature Monitoring
Temperature monitoring in the area shall be carried out for a period of NLT 72
hours. The data shall be recorded and monitored in the area.
The temperature of each probe shall be recorded at an interval of 5 minutes.
7.6 Selection Criteria for Number Data Logger to be Use
Calculate the room area in meter2 and then calculate the root of the area for the no
of Data logger required for Study

Sr. Room No. Room area Required Data logger

No. meter2 √ Area (Nos)

1. Visual Inspection Room II 27.183 5.21 5

Apart from above calculation 01 additional wireless data logger will be used as a
reference temp. data logger that will be kept outside the Visual Inspection Room I.
Place the wireless data logger as per point no. 7.2 selection criteria.
If the area is smaller or not a perfect square then logically keep minimum 04 data
logger for study.
Locations of data logger will be marked in Temperature Mapping Report.
7.7 Calibration Details of Data Logger and Data logger
Calibration certificates of data logger shall be mentioned in Temperature mapping
report.
It data logger is probe type or non wireless. Pre post calibration of test data logger
will be required.
7.8 Calculation of the MKT
Mean kinetic temperature can be calculated by using the formula given as follows.
MKT = ∆H / R______________________
-In { е-∆H/ RT1 + е-∆H/
} RT2 + е-∆H/ RT3 +….+ е-∆H/ RTn
n
Where: R is the universal Gas Constant = 83.144kJ. mole -1
∆H = Heat of activation
T1 = Temperature in the first period.
Remarks: MKT has been calculated by the using the software from ScienTeK
Software, lnc.
 By reviewing all the data and reports, the highest MKT will be identified amongst
04 MKT found from 04 locations. The routine monitoring of temperature shall be
performed at the identified hot point.

8.0 DEVIATION OBSERVED

Note down any deviation if occur during the Temperature Mapping Study of Visual
Inspection Room II. ID. No. (GPA58).

9.0 INCIDENT/FAILURE
Note down any incidence/failure, suggests appropriate corrective action any
preventive action.

10.0 ACCEPTANCE CRITERIA

Temperature Mapping Qualification shall be considered acceptable when all the
conditions specified in various data sheets of report will be met.
Any Deviation from the acceptance criteria of the specified check points shall be
reported and decision shall be taken.

11.0 ABBREVIATIONS
Temp : Temperature
No. : Number
mm : Mili Meter
Sq. : Square
Mtr : Meters
HVAC : Heating Ventilatin Air Conditioning System