Thermal

Mapping
Protocol
Template
[Protocol Number: XXXX]
[Revision: XXXX]

[Protocol Author: XXXXXXXX]

[Prepared Date: XXXXXXXX]
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You can buy a full version of this template in MS Word format that shall be completely editable,
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 Thermal Mapping Protocol Template
Protocol Number: Revision Area Name
XXXX 0 XXXXX
Page
1 of 20

Table of Contents
1.0 PURPOSE 2
2.0 SCOPE 2
3.0 ASSOCIATED DOCUMENTS 3
4.0 DEFINITIONS AND ACRONYMS 4
5.0 ROLES AND RESPONSIBILITIES- 4
6.0 GENERAL REQUIREMENTS - SAFETY 5
7.0 PRE-REQUISITES 5
8.0 TEST ATTRIBUTES AND CALIBRATION CERTIFICATES 6
9.0 AREAS COVERED BY THERMAL MAPPING – AREAS DIAGRAM 7
10.0 PROPOSED SCHEDULE FOR THE THERMAL MAPPING 8
11.0 LOAD MATERIAL DESCRIPTION AND LOCATIONS 9
12.0 THERMAL MAPPING INSTRUCTIONS 10
13.0 ACCEPTANCE CRITERIA 11
14.0 EVALUATION 11
15.0 EXCEPTIONAL CONDITIONS AND DISCREPANCIES 11
16.0 COMPLETION DOCUMENTATION 12
17.0 AREA AND PRODUCT DISPOSITION 12
18.0 ATTACHMENT LIST 12
19.0 HISTORY OF CHANGE 13
20.0 DOCUMENT APPROVALS 13
21.0 LEGAL DISCLAIMER – TERMS AND CONDITIONS 13
Attachment 1. Training Attendance Form 14
Attachment 2. Signature log Form 15
Attachment 3. Calibration Certificates 16
Attachment 4. Cleaning Activities Evidence 17
Attachment 5. Deviation Report 18
Attachment 6. Raw Data 19
Attachment 7. Statistical Summary Report 20

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Confidential Proprietary Information. All rights reserved. Copying and Distribution Prohibited. Unless otherwise specified, no part of
this document may be copied, distributed, reproduced or utilized in any form or by any means electronic softcopy or mechanical
hardcopy, including networking, scanning, digitalizing, photographing or video recording, without written permission.
 Thermal Mapping Protocol Template
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XXXX 0 XXXXX
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1.0 PURPOSE
This protocol provides instructions to perform the thermal mapping activities according
to the design specifications of the following area.

AREA DESCRIPTION:

AREA DESIGN SPECIFICATIONS DESCRIPTION

REFERENCE DOCUMENT NUMBER:

The following monitoring paramenters are considered as part of this protocol:

Temperature (T)
% Relative Humidity (R/H)
In addition, this protocol brings the instructions for the identification, execution,
documentation, and evaluation of the thermal mapping results.

2.0 SCOPE
This protocol can applies to the following areas and equipments:
Area Name Location Dimensions Intended Use, and Maximum Capacity
(L x W x H), Classification of Persons or
Number of Racks, Products
Shelfs, etc
Stability Room
Retain Samples
Refrigerator
Oven
Warehouse
Incoming Area
Autoclave
Clean room
Gowning room
Freezer
Lyophilizer
Storage Room
Tanks

You can buy a full version of this template in MS Word format that shall be completely editable,
ready to use according to your needs, visiting: https://ciqa.net?p=12091

Confidential Proprietary Information. All rights reserved. Copying and Distribution Prohibited. Unless otherwise specified, no part of
this document may be copied, distributed, reproduced or utilized in any form or by any means electronic softcopy or mechanical
hardcopy, including networking, scanning, digitalizing, photographing or video recording, without written permission.
 Thermal Mapping Protocol Template
Protocol Number: Revision Area Name
XXXX 0 XXXXX
Page
3 of 20

3.0 ASSOCIATED DOCUMENTS

3.1 Internal Documents
The following Internal documents are referenced in this protocol:

Document
Document Title
Number

3.2 External Documents

The following external documents are referenced in this protocol since it applies to the FDA
regulated industries and others entities.

Doc Number Document Title (as applicable)

21, Part 820 Quality System Regulations, Good Manufacturing Practice for the Medical
Devices (current revision)
Part 807 Establishment Registration And Device Listing For Manufacturers And Initial
Importers Of Devices
Part 610 General Biological Products Standards
Part 606 Current Good Manufacturing Practice For Blood And Blood Components
Part 600 Biological Products: General
Part 320 Bioavailability And Bioequivalence Requirements
Part 314 Applications For FDA Approval To Market A New Drug
Part 225 Current Good Manufacturing Practice For Medicated Feeds
Part 212 Current Good Manufacturing Practice For Positron Emission Tomography
Drugs
Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals
Part 210 Current Good Manufacturing Practice In Manufacturing, Processing, Packing,
Or Holding Of Drugs; General
Part 111 Current Good Manufacturing Practice In Manufacturing, Packaging, Labelling,
Or Holding Operations For Dietary Supplements
Part 110 Current Good Manufacturing Practice In Manufacturing, Packing Or Holding
Human Food
Part 11 Electronic Records; Electronic Signatures
ISO 13485 Medical Devices Quality Management Systems Requirements for Regulatory
Purposes (current revision)
MDD 93/42/EEC Medical Device Directive (current revision)

Confidential Proprietary Information. All rights reserved. Copying and Distribution Prohibited. Unless otherwise specified, no part of
this document may be copied, distributed, reproduced or utilized in any form or by any means electronic softcopy or mechanical
hardcopy, including networking, scanning, digitalizing, photographing or video recording, without written permission.
 Thermal Mapping Protocol Template
Protocol Number: Revision Area Name
XXXX 0 XXXXX
Page
4 of 20

4.0 DEFINITIONS AND ACRONYMS

The following key terms, definitions, and acronyms apply to this protocol:

Word or Acronym Definition

Area where the products forms containers and closures are exposed directly
Critical Area:
to the environment.
Area where product, in-process materials, and containers / closures are
prepared. These areas will include but are not limited to: staging; assembly,
Controlled Area: transport; and storage areas of containers and in-process products in
protected packages or bags; including processing rooms from which critical
areas are accessed.
Process executed by a testing agency that a clean room has been tested in
Room / Area Certification accordance with the latest revision of ISO Standard 14644 and that the
cleanliness class requirements have been achieved.
Critical Area in which the concentration of airborne particles is controlled to
Clean Zone:
meet a specified airborne particulate cleanliness class per ISO 14644.
Room (facility) in which the concentration of airborne particles is controlled
Clean room
and which contains one or more Clean Zones.
A room (facility) that is completed and ready for operation with all services
As Built Room connected and functional, but without equipment and operating personnel
in the facility.
Testing performed in a holded room, which is completed and has the
At-Rest/Static Conditions production equipment installed and operable, but has no personnel within
the room.
Operational / Dynamic
A room in normal operation, including production equipment and personnel.
Conditions

5.0 ROLES AND RESPONSIBILITIES

5.1 It is the responsibility of all personnel involved in this protocol to be trained on it. Also,
to be familiar and understand the company policies for operation and safety.
5.2 All persons involved in this protocol must complete the training form and Validation
Signature Log in Attachment A. They are responsible for carrying out the verification
tasks in accordance with the procedures in effect.
5.3 The Engineering Department is responsible to bring the applicable room(s) and
equipment in operational working conditions before initiate this protocol.
5.4 Final disposition of the approved qualification protocol will be in accordance with
company policies and procedure.

You can buy a full version of this template in MS Word format that shall be completely editable,
ready to use according to your needs, visiting: https://ciqa.net?p=12091

Confidential Proprietary Information. All rights reserved. Copying and Distribution Prohibited. Unless otherwise specified, no part of
this document may be copied, distributed, reproduced or utilized in any form or by any means electronic softcopy or mechanical
hardcopy, including networking, scanning, digitalizing, photographing or video recording, without written permission.
 Thermal Mapping Protocol Template
Protocol Number: Revision Area Name
XXXX 0 XXXXX
Page
5 of 20

6.0 GENERAL REQUIREMENTS- SAFETY

6.1 During the operation of any equipment related to this qualification, it is
imperative that signs and warnings are adhered to equipment and room at all
times to prevent serious injury or death to personnel and damage to equipment.
6.2 Ensure that all company policies regarding operational safety are followed at all
times.
6.3 Ensure that proper safety precautions are adhered to when working around high
voltage circuits.
6.4 Ensure that proper lifting techniques are used when lifting heavy equipment.
6.5 Wear safety glasses at all times while using equipment.

7.0 PRE-REQUISITES
The pre-requisites to this protocol are defined as:
7.1 The procedures or test method to be used as part of by this protocol must be
completed, approved, effective and released.
7.2 All personnel involved must be trained in this protocol and the corresponding
procedures. Attach training records in Attachment 1. Register the signature of
each person involved in the execution of this protocol, attach evidence in
Attachment 2.
7.3 Verify that all measuring instruments and equipment associated with this
protocol are properly calibrated before been used and contain an approved NIST-
traceable calibration certificate in Attachment 3.
7.4 Verify that the area was properly cleaned according to Company procedures,
document the cleaning activities in Attachment 4.

You can buy a full version of this template in MS Word format that shall be completely editable,
ready to use according to your needs, visiting: https://ciqa.net?p=12091

Confidential Proprietary Information. All rights reserved. Copying and Distribution Prohibited. Unless otherwise specified, no part of
this document may be copied, distributed, reproduced or utilized in any form or by any means electronic softcopy or mechanical
hardcopy, including networking, scanning, digitalizing, photographing or video recording, without written permission.
 Thermal Mapping Protocol Template
Protocol Number: Revision Area Name
XXXX 0 XXXXX
Page
6 of 20

8.0 TEST ATTRIBUTES AND CALIBRATIONS CERTIFICATED

Calibrated Temperature data loggers or equivalent instruments of measurement to be
used during this thermal mapping study shall be documented in the following table.
All certificates of calibration will be documented in the Attachment 3.
Instrument ID Instrument Name Calibration Expiration Date

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ready to use according to your needs, visiting: https://ciqa.net?p=12091

Confidential Proprietary Information. All rights reserved. Copying and Distribution Prohibited. Unless otherwise specified, no part of
this document may be copied, distributed, reproduced or utilized in any form or by any means electronic softcopy or mechanical
hardcopy, including networking, scanning, digitalizing, photographing or video recording, without written permission.
 Thermal Mapping Protocol Template
Protocol Number: Revision Area Name
XXXX 0 XXXXX
Page
7 of 20

9.0 AREAS COVERED BY THERMAL MAPPING – AREA DIAGRAM

Areas that should be covered in this protocol are include in this diagram:

IMPORTANT NOTE: Describe the in the above diagram the dimensions of the area and the
location of each calibrated data logger, chart recorders or equivalent measuring instruments
used during this protocol. Place a calibrated data logger(s) or equivalent instrument(s) near
to the permanent chart recorder(s) or sensor(s) on the area. Also, describe the location of
each rack, shelves, materials, products, machines, etc.

You can buy a full version of this template in MS Word format that shall be completely editable,
ready to use according to your needs, visiting: https://ciqa.net?p=12091

Confidential Proprietary Information. All rights reserved. Copying and Distribution Prohibited. Unless otherwise specified, no part of
this document may be copied, distributed, reproduced or utilized in any form or by any means electronic softcopy or mechanical
hardcopy, including networking, scanning, digitalizing, photographing or video recording, without written permission.