MP English

MP (Automatic) Video melting point apparatus
Installation, operation, and performance validation scheme / report
HANON ADVANCED TECHNOLOGY GROUP

CO., LTD.
Program review and approval
Manufacturer: HANON ADVANCED TECHNOLOGY GROUP CO., LTD.

date
function sign one's name
(year.moon.sun)
compile Validation Kai-di wang 2019.12.15

Engineer
Audit Validation Manager Lou Xiaoqian 2019.12.20
Approval leading official Liu Yifeng 2019.12.23
User unit:
Date
Functions Signature
(Year.Month.Day)
Audit
Audit
Approval
Version History:
edition Change description
01 In April, 2020
Statement: This verification scheme reserves the right to modify it and is subject to
update without notice.
If you have any valuable suggestions or comments on this validation protocol, please
contact us below.
Manufacturer: HANON ADVANCED TECHNOLOGY GROUP CO., LTD.
Address: Floor 4, Building A3-1, Hanyu Jinyu Valley, No.7000,10 Road, High-tech Zone,
Jinan, China
Service Tel.: 400-618-6188
Email: China@hanon.cc
URL:www.hanon.cc
1
operation and performance confirmation scheme / report
catalogue
1 Purpose.................................................................................................................................................................................3
2 Reference file...................................................................................................................................................................3
2.1 Instrument verification procedures.......................................................................................................................3
2.2 Operation file...............................................................................................................................................................3
3. Analysis of the risk factors.....................................................................................................................................3
4 Scope of application.......................................................................................................................................................3
5 Responsibilities...............................................................................................................................................................3
5.1 Responsibilities of sea energy instruments.......................................................................................................3
5.2 Responsibilities of the user unit.........................................................................................................................3
6 Personnel training..................................................................................................................................................................4
7 Installation confirmation.............................................................................................................................................5
7.1 Instrument information...............................................................................................................................................5
7.2 Environmental requirements.......................................................................................................................................5
7.3 Document inspection.....................................................................................................................................................6
7.4 Control system inspection.........................................................................................................................................8
7.5 Installation Checklist...............................................................................................................................................9
8 Run confirmation.............................................................................................................................................................11
8.1 Instrument operation confirmation.......................................................................................................................11
8.2 Confirmation of user management...........................................................................................................................13
8.3 Confirmation of the audit tracking.....................................................................................................................15
8.4 Test confirmation under extreme conditions.....................................................................................................17
9 Performance confirmation.............................................................................................................................................18
9.1 Confirmation of the instrument display value error and repeatability.................................................18
10 Deviation report...........................................................................................................................................................21
11 Annex List.......................................................................................................................................................................23
12 Review and approval performed.................................................................................................................................24
2
1 Purpose
This verification scheme is to confirm the sea energy instrument MP4 (Fully automatic)
The video melting point apparatus has been correctly installed in the user unit, which can
meet the operation and use of the instrument in the current laboratory environment, and can
meet the needs of acceptable standards and daily work needs.
2 Reference file
2.1 Instrument verification procedures
JJG 701-2008 melting point tester verification procedure

2.2 Operation file
Instrument use instructions

3. Analysis of the risk factors
Please prepare relevant test reagents and installation requirements according to the
manufacturer to prevent the installation, operation and performance confirmation scheme of
the equipment due to unsatisfactory conditions.
4 Scope of application
The verification scheme is applicable for the sea energy instrument MP4 (automatic)
video melting point apparatus, used to confirm the correct installation of the MP4
(automatic) video melting point apparatus, and the instrument is running normally, so that
the installation and operation evaluation meet the requirements of the sea energy
instrument.
5 Responsibilities
5.1 Responsibilities of Haineng Company
1. Program preparation
2. Guide the execution of IQ, OQ, and PQ tests
3. Prepare for deviation reports and recommendations for deviations
4. In case of deviation, coordinate with an authorized person of the customer
5.2 Responsibilities of the user unit
1. Review and approve of this plan before implementation
2. Participate in the execution of IQ, OQ, and PQ tests
3. Preparation of the report
3
4. Define solutions for non-conformities

5. Review and approve the verification report
6 Personnel training
1. Purpose
Confirm all program personnel and confirm that program personnel have been trained.
2. Program
All personnel involved in the program implementation should be trained to implement it.
3. Acceptable standards
All personnel (names, signatures and departments) have been recorded.
All programpersonnel have been trained.
4. Results
Fill in Form 1, if not applicable, "N / A" and indicate the reason in the remarks column.
Nonconformities occurring during implementation are recorded in the deviation report.
Table 1 Personnel confirmation

Training has been
surname and Department /
duty date
received?
personal name Company
(Yes / No)
Is □, no □
Is □, no □
Is □, no □
Is □, no □
Is □, no □
Is □, no □
Is □, no □
Acceptable standards Yes / no
All personnel have confirmed their names, signatures and department / Is □, no □

company
All the personnel have been trained Is □, no □
remarks:
4
executor date
auditor date
7 Installation confirmation
7.1 Instrument information
7.1.1 Instrument description
The MP4 (fully automatic) video melting point apparatus is launched by Hanon to meet
the needs of modern laboratories, which allows you to get the experimental results faster,
making the experimental analysis more flexible and more efficient.The image detection and
video shooting technology into the melting point measurement, not only provides users with
stable and reliable melting point test function, but also can clearly intuitive sample
change curve and real-time high-definition sample image, and realize the automatic
recording video, video add watermark, video playback and map synchronization function,
easily through real-time video images observe color change and decomposition temperature.The
use of layered insulation design is to effectively resist external environmental
interference to ensure a stable and accurate temperature, and has a faster heating and
cooling speed to reduce the waiting time.Instruments can be widely used in chemical
industry and pharmaceutical research. It is one of the necessary instruments to produce
drugs, spices, dyes and measure other organic crystal materials.
Instrument principle: an instrument that judges the melting range through the change of
light transmittance of a solid melt usually adopts photoelectric measurement, which can
measure the initial and final melting temperature of a solid.
7.1.2 Equipment information
Instrument name Instrument model
manufacturer Instrument number
5
7.2 Environmental requirements

1. Purpose
Confirm the installation environment of the instrument and will not affect the normal placement and
operation of the instrument.
2. Program
Check the instrument use environment and record the information including ambient temperature and
humidity, and power supply voltage.
All environmental conditions comply with the requirements.

4. Results
Fill in Form 2, if the requirements are not applicable, fill "N / A" and indicate the
reason in the remarks column.
Table 2 Confirmation of the instrument installation environment requirements

Whether in
scope of
ask test method bear fruit
conformity with
examination
(Yes / No)
No strong electromagnetic field and
Work, high frequency instruments; good

visualization Is □, no □
environment ventilation, no high concentration of
dust; no strong vibration, no
corrosion or corrosive gas; no direct
sunlight or other heat sources.
Relative No more than 80% hygrothermo

Is □, no □
humidity of graph
6
environment
The instrument shall be installed
away from the large electrical
installation site equipment without strong visualization Is □, no □
electromagnetic field interference,
and the instrument shall be at least
10cm away from the wall to ensure
timely heat dissipation.
Instrument power supply AC voltage:

Instrument
source 110240V, 50Hz (use AC stabilizer if frequency: Is □, no □
measuremen
voltage instability) and ensure landing:
t
reliable grounding foot.
All environmental conditions and utilities shall comply with the

Is □, no □
requirements
remarks:
executor date
auditor date
7.3 Document inspection

1. Purpose
Ensure that the documentation required for the installation, operation, and maintenance
of the instrument are available.
2. Program
Verify that the following documents are complete
Instrument instructions, and list of accessories
All of the required files must be available.
4. Results
7
Table 3 Document confirmation
Is available
FD document name
(Yes / No)
Instrument specification Is □, no □
List of accessories Is □, no □
certificate Is □, no □
All of the reference files are available Is □, no □
remarks:
executor date
auditor date
7.4 Control system inspection

1. Purpose
Ensure that the hardware composition and parameters of the control system shall meet the
requirements.
2. Program
Record the application software information.
The hardware composition and parameters of the control system shall meet the instrument
requirements.
4. Results
8
Table 4 Inspection of the control system
project content test method physical truth
vender visualization
Software
information
edition visualization
The hardware composition and equipment parameters of the Is □, no □

control system meet the instrument requirements
remarks:
executor date
auditor date
7.5 Installation Checklist
1. Purpose
Verify that the instrument is open and install key points in the installation process.
2. Program
Check whether the number of host, accessories and the list correspond without damage;
confirm that the installation key points have been correctly installed, with no abnormality.
The host and accessories match the list with no damage; the required key points have been
installed normally.
4. Results
reason
9
in the remarks column.

Table 5 Installation confirmation list

Whether in
test
project content
conformity
method
with
1. The instrument packaging is intact, without

visualiz Is □, no
disassembly, damage, touch, soaking, damp, ation □
deformation, etc.
2. No external appearance damage, rust, touch, etc.;

visualiz Is □, no
the instrument shall identify the instrument name,
ation □
instrument model, instrument number, manufacturer and
Out of the other information.
box
3. Check the specifications, models, configuration and
visualiz Is □, no
quantity of the host machine and accessories, which
ation □
shall meet the instrument packing list and contract
requirements.
4. The inspection instrument shall be equipped with the
technical instructions of the instructions and the visualiz Is □, no
instrument qualification certificate. The relevant ation □
information of the qualification certificate shall be
consistent with the instrument nameplate.
5. Records of other configuration parts besides the

visualiz Is □, no
packing list configuration: □
ation
10
1. Place the instrument flat on the solid instrument visualiz Is □, no
Install key operating table at least 10cm away from the wall. ation □
points 2. Use AC 110-240V, 50Hz AC power supply, plug the visualiz Is □, no
power plug into the power socket and ensure that the ation □
grounding
foot is reliably grounded.

The host and accessories match the list with no damage; the required key Is □, no
points
□
have been installed normally.
remarks:
executor date
auditor date
8 Run confirmation
8.1 Instrument operation confirmation
1. Purpose
Verify that the instrument can be normally started, operated and turned off.
2. Program
Start the instrument according to the instrument operation manual and enter the working
interface. After the instrument components operate normally, press the operation manual
normally
shut down.All operating procedures can meet the expected requirements.
The instrument can be switched on and off according to the operation manual without
abnormality.
The instrument can operate normally, and the instrument keys can operate normally.
4. Results
Fill in Form 6, if not applicable, "N / A" and indicate the reason in the remarks column.
11
Table 6 Confirmation of the instrument operation

inspection Description of instrument operation Check the Whether in
item method conformity
with
Instrument Plug in the power, turn on the instrument switch and Is □, no

boot enter the main interface window. □
Select the user name and enter the password to enter

Is □, no
users login
the instrument operation interface (M P420 is not □
required).
The parameter setting of selecting the test boundary

parameter
face menu can be entered to the parameter setting Is □, no □
setting
interface, thus setting the starting temperature,
As described
termination temperature, heating rate, etc.
Operation
Enter the test interface, when the instrument warms up execution
to the starting temperature, put the sample and start

test Is □, no □
to heat up after stabilization. The instrument can
automatically test or manually test the initial
melting and final melting points.
Select the data menu, you can query historical data,

Data query,
select single data, single page data and all data,
delete, Is □, no □
selected data can be deleted and printed, view the
print, and
details of individual data, you can export P DF
export
files
to the U disk.
Basic Go to the basic setting, you can set the time
Is □, no □
language,
Settings
etc
Enter the method library setting interface, you can
Method
Is □, no □
perform the method to edit, modify, delete and
setting
other
operations.
Other You can make the connection settings for the network. Is □, no □
12
settings
Melting Entering the calibration interface, the instrument can
point be calibrated using standard samples. Is □, no □
calibratio
Instrument Turn off the instrument power supply, and the

Is □, no □
shutdown instrument can be turned off normally
The instrument can be shut down normally according Is □, no □

to
the operation manual without abnormality
The instrument can operate normally, and the Is □, no □
instrument
keys can operate normally
remarks:
executor date
auditor date
8.2 Confirmation of user management (MP420 model excluding)

1. Purpose
Verify that only pre-authorized users have access to the control system.
2. Program
For each user level, enter the correct and incorrect password to check if access is
allowed. Try to perform the appropriate level and check for design compliance.
Enter the appropriate password to allow access to its user level, and entering the wrong
password is denied.
An admin administrator can create and delete supervisor and operator, supervisor cannot
create and delete supervisor, and operator cannot create and delete operator.
4. Results
reason
13

Table 7 Confirmation of User Management
system be Whether in
console
Permission type test method
administr respons operator conformity with
ator ible (Yes / No)
for
□ data deleted √ Is □, no □
□ data Is □, no □
√
printing
Perm
□ data export √ Is □, no □
issi An admin
The □ creates administrator Is □, no □
on
√
Sett / deletes the can create and
ings user delete
affi □ user supervisor and Is □, no □

√
rm management operator,
supervisor
□ Basic Is □, no □
√ cannot create
Settings
and delete
□ way base √ Is □, no □
supervisor, and
□ network operator Is □, no □
√
settings cannot create
□ melting and delete Is □, no □

√ operator
point
calibration
Light Is □, no □
√
adjustment was
detected by □
□ Factory Is □, no □
√
Settings
□ audit trial √ Is □, no □
14
□MD5 √ Is □, no □
□ update √ Is □, no □
Whether in
inspection
order ask
item conformity with
(Yes / No)
Enter the correct user name and the correct Is □, no □

entry
password, you can log in normally, enter the wrong
Username and
password user name and password can not log in
settings Turn on the automatic login and jump to the test Is □, no □

Automatic login
check interface
Log out and Is □, no □

It can be introduced to the login interface
modify the to modify the password
password
The privileges of each group meet the system requirements. Is □, no □
An admin administrator can create and delete supervisor and operator, supervisor Is □, no □
cannot create and delete supervisor, and operator cannot create and delete operator.
Enter the appropriate password to allow access to its user level, and entering the Is □, no □
wrong
password is denied
remarks:
executor date
auditor date
8.3 Confirmation of the audit tracking
1. Purpose
Verify that the instrument has the audit tracking function, track the use and operation
records of the instrument, and leave the basis for query information to the operation content
15
for the historical operator.

2. Program
Check if the contents of the operation can be logged.
For operation records, user login and other records, you can query.
This feature is excluded from the MP420 and MP450 models.
4. Results
Fill in Form 8, if the requirements are not applicable, complete "N / A" and indicate the
Table 8 Confirmation of the audit tracking
project content test method Whether in conformity with
Log in / log out visualization Is □, no □
File MD5 visualization Is □, no □

audit trial
Data export visualization Is □, no □
Time modification visualization Is □, no □
calibration visualization Is □, no □
Method editing visualization Is □, no □
For operation records, user login and other records, you Is □, no □

can
query
remarks:
executor date
auditor date
16
8.4 Test confirmation under extreme conditions

1. Purpose
Conify that the function of the instrument is affected under extreme test conditions.
2. Program
Testing of extreme use conditions, such as sudden power outage, abnormal parameter
setting, etc.See if it meets the use requirements.
After power off, power will not cause damage to the equipment.The instrument does not
operate after the parameter is input over the range.
4. Results
Fill in Form 9, if requirements are not applicable, fill "N / A" and indicate the reason
Table 9 Confirmation of operations under extreme conditions
Whether in
inspectio
order ask
n item conformity with
(Yes / No)
Inspectio Suddenly power off, then on The instrument is used Is □, no □

normally
n of the
Is □, no □
extreme The parameter settings are The instrument will prompt that
condition beyond the range the action is not performed
Sudden power off and then power instrument is normal use, parameter
Is □, no □
setting
abnormal instrument will not operate.
17
remarks:
executor date
auditor date
9 Performance confirmation
9.1 Confirmation of the instrument display value error and repeatability
1. Purpose
Verify that the display value error and repeatability of the MP4 (fully automatic)
video melting point apparatus are within the scope required by the instrument without
affecting the experimental accuracy.
2. Program
The GBW13238 approved No.335 (1989).This instrument uses three of the standard substances for testing
and verification, generally using naphthalene, hexadienic acid, anthraquinone, or p-nitrobenzoic acid.
The samples to be tested were prepared in an agate mortar and dried.Take a long dry, clean glass tube of
about 80cm and stand upright on the glass plate.The capillary equipped with the tested sample was placed from
the top mouth to fall freely and repeatedly dropped several times, so that the sample powder is tightly
assembled at the bottom of the tube, at a height of about 3-5mm.
Enter the parameter setting page, enter the sample number, sample name, start temperature, stop
temperature and coordinate axis length, select the automatic detection or manual test items, and click "OK" to
enter the corresponding interface.When the actual temperature stabilizes to the set starting temperature, put in
the tested sample and click the "Start Heating" key.The test was completed, the initial and final melting
temperature was displayed, the experimental data was recorded, and the measured samples were removed.
The schematic value error indicating the instrument is calculated by formula (1):∆
18
∆ = ̅ − ……………………………………（1）
In formula:
∆—— indicating error

̅Meverage of —— melting point measurements
Standard values of the standard material at the —— melting point
The difference between the instrument measurement mean and standard value is the value error of the
measurement.
The experimental standard deviation s indicates the repeatability of the instrument as calculated by formula
(2):
2
∑ （ −̅
）
=1
= −1
……………………………………（2）
In formula:
—— experimental standard deviation;
—— The schematic value of each measurement;
̅ —— schematic value average;
n —— n =6, number of measurements.
indicating error:
±0.4℃（＜200℃），±0.7℃（＜400℃）
repetitiveness:
At a heating rate of 1℃ / min, S ≤0.4
4. Results
Fill in Form 10, if not applicable, "N / A" and indicate the reason in the remarks
column. Nonconformities occurring during implementation are recorded in the deviation
report.
19
Table 10 Confirmation of the instrument indicated value error and reproducibility
RM Criteria value of melting point
Number of measurements 1 2 3 4 5 6
test value
Measure the mean
indicating error
standard deviations s
test value
Measure the mean
indicating error
test value
Measure the mean
indicating error
Show value error: ± 0.4℃ (<200℃), ± 0.7℃ (<400℃) Is □, no □
Repeatability: s ≤0.4 Is □, no □
remarks:
executor date
auditor date
20
10 Deviation report
All deviations that do not meet user requirements and GMP requirements must be formally
recorded in the Form 11 differential report.In Table 12 record all the deviations occurring
in, execution.
11 Annex List
Record all the attachments attached to this document in Table 13.
12 Review and approval performed
At the end, the implementation results are reviewed and approved by relevant personnel,
see Table 14
Table 11 Deviation report

test report The deviation number
Description of the deviation and the proposed corrective measures
Authenticator
date
signature
Review and approval of corrective measures
Signature of the
date
auditor
Result tracking
Manager
date
signature
Yes / no
Is the deviation resolved?
Yes, no
21
Table 12 The deviation list

number description remarks
22
Table 13 List of attachments

number description paginal remarks
23
Table 14 Review and approval performed

The test results and the raw data were reviewed, and the MP4 was obtained Final
conclusion of the (fully automatic) video melting point apparatus:
The implementation process and results meet the requirements.No unresolved bias exists.
The implementation and the results do not fully meet the requirements.There were
unresolved biases present, but they did not affect the final results of the validation.
The implementation and the results do not meet the requirements.There are unresolved
deviations present and which affect the final results of the validation.Further measures
must be taken.The correction results were recorded separately.
explanatory note:
24

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MP (Automatic) Video melting point apparatus

Installation, operation, and performance validation scheme / report

HANON ADVANCED TECHNOLOGY GROUP

Manufacturer: HANON ADVANCED TECHNOLOGY GROUP CO., LTD.

compile Validation Kai-di wang 2019.12.15

Approval leading official Liu Yifeng 2019.12.23

JJG 701-2008 melting point tester verification procedure

Instrument use instructions

4. Define solutions for non-conformities

Table 1 Personnel confirmation

Acceptable standards Yes / no

All personnel have confirmed their names, signatures and department / Is □, no □

All the personnel have been trained Is □, no □

Instrument name Instrument model

manufacturer Instrument number

7.2 Environmental requirements

operation of the instrument.

humidity, and power supply voltage.

All environmental conditions comply with the requirements.

Table 2 Confirmation of the instrument installation environment requirements

No strong electromagnetic field and

Work, high frequency instruments; good

dust; no strong vibration, no

corrosion or corrosive gas; no direct

sunlight or other heat sources.

Relative No more than 80% hygrothermo

The instrument shall be installed

away from the large electrical

installation site equipment without strong visualization Is □, no □

electromagnetic field interference,

and the instrument shall be at least

10cm away from the wall to ensure

timely heat dissipation.

Instrument power supply AC voltage:

Acceptable standards Yes / no

All environmental conditions and utilities shall comply with the

7.3 Document inspection

Acceptable standards Yes / no

All of the reference files are available Is □, no □

7.4 Control system inspection

Nonconformities occurring during implementation are recorded in the deviation report.

Table 4 Inspection of the control system

project content test method physical truth

Acceptable standards Yes / no

The hardware composition and equipment parameters of the Is □, no □

7.5 Installation Checklist

in the remarks column.

Table 5 Installation confirmation list

1. The instrument packaging is intact, without

2. No external appearance damage, rust, touch, etc.;

4. The inspection instrument shall be equipped with the

technical instructions of the instructions and the visualiz Is □, no

instrument qualification certificate. The relevant ation □

information of the qualification certificate shall be

consistent with the instrument nameplate.

5. Records of other configuration parts besides the

1. Place the instrument flat on the solid instrument visualiz Is □, no

points 2. Use AC 110-240V, 50Hz AC power supply, plug the visualiz Is □, no

foot is reliably grounded.

Table 6 Confirmation of the instrument operation

item method conformity

Instrument Plug in the power, turn on the instrument switch and Is □, no

Select the user name and enter the password to enter