DT12 Automatic Dissolution Tester

QUALITY INSPECTION TEST

PT ANDARU PERSADA MANDIRI

Ruko Villa Bogor Indah 2 (VBI2) Blok BB1 No.22, Kedunghalang, RT.02/RW.02, Kedunghalang, Kec.
Bogor Utara, Kota Bogor, Jawa Barat 16158

Document number : 001/DT12/CP/APM/X/2023

 Plan review and approval

Post Signature Date

Product
Manager

Director

User unit:

Post Signature Date

Engineer

User

Manager

Version history:

version Change description

00 NA

Declaration: This Quality Inspection Protocol reserves the right to modify and is subject to updates
without prior notice.

Document number : 001/DT12/CP/APM/X/2023

1. Installation Inspection

1.1 Device Information

Instrument Instrument

Name model

Instrument
Manufacturer
number
Using Place of

departments placement

1.2 Environmental requirements

Table 1 Confirmation of instrument installation environment requirements

Inspection
Require Test method Result Yes/No
content
No strong electromagnetic fields
and high-frequency instruments;
Good ventilation and no high
concentration of dust; No strong
vibration, no corrosive gas; No
direct sunlight or direct radiation
Environment from other heat sources. visualization Yes□ No□

Environmental Hygrothermograph
10℃—28℃ Yes□ No□
temperature

Relative ≤80% Hygrothermograph

Yes□ No□
humidity

A stable and horizontal

Installation experimental table with an area
position visualization Yes□ No□
recommended to be greater than

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 100cm × 80cm, with a
load-bearing capacity greater than
150Kg.

Acceptable standards Yes/No

All environmental conditions and public facilities meet the

Yes□ No□
requirements

Notes:

Implementer Date

Reviewer Date

1.3 File check

Table 2 File confirmation

File description File name Storage location Yes/No

Instrument DT12 Automatic Dissolution

Yes□ No□
manual Tester User Manual

DT12 Automatic Dissolution

Packing list Yes□ No□
Tester User Manual

Acceptable standards Yes/No

All reference documents are available Yes□ No□

Notes:

Page 2 of 14
 Implementer Date

Reviewer Date

1.4 Installation checklist

Table 3 Installation Confirmation Checklist

Project Content Test method Yes/No

1.The instrument packaging is intact, without any

unpacking, damage, collision, wetting, moisture,
visualization Yes□ No□
deformation.

2.After unpacking, the appearance of the

instrument and accessories should be free of
damage, rust, or scratches; Instruments should be
labeled with information such as instrument name,
instrument model, instrument number, manufacturer,
etc. visualization Yes□ No□

Unpacking
situation
3.Check the specifications, models,
configurations, and quantities of the host and
accessories, which should comply with the instrument
packing list and contract requirements. visualization Yes□ No□

4.The inspection instrument should be

visualization Yes□ No□
accompanied by instructions, technical guidance

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 materials, and a certificate of conformity. The relevant
information of the certificate should be consistent
with the instrument nameplate.

5.Record of other configuration parts beyond the

packing list configuration.
visualization Yes□ No□

1.The instrument should be placed on a

horizontal test bench without vibration effects, and
the back of the instrument should be at least 20cm
away visualization Yes□ No□
from the wall.

2.The dissolution cup number corresponds to the

Key
visualization Yes□ No□
installation
instrument number one by one.
points
3.The paddle pole, basket pole, and net basket
numbers correspond to the instrument numbers one
visualization Yes□ No□
by one.

4.Press the constant high clutch to the bottom. visualization Yes□ No□

Acceptable standards Yes/No

The quantity of the host and accessories is consistent with the list, and there is
Yes□ No□
no damage; All required key points have been installed normally.

Notes:

Implementer Date

Reviewer Date

Page 4 of 14
2. Operation Inspection

2.1 Instrument operation confirmation

Table 4 Confirmation of instrument operation

Project Instrument operation description Test method Yes/No

After the power on self-test is

completed, enter the user login
interface, select admin as the
username, enter the initial
password jnhs, and click [Login]
Power on to Yes□ No□
enter the main interface。

Enter the [Automatic Control]

interface to edit and delete
Automatic control Yes□ No□
methods by sliding left and right.

Enter the [Manual Control]

interface to edit the experimental
parameters of the [Dissolution]
interface; The [Zone] interface
allows for editing of experimental
Manual control parameters for the left Yes□ No□
and right zones respectively.
As described
Operation
execution
Enter the [Data Query] interface：

Can edit, view, export, and

print [experimental data].
Can view, export, and print
Data query [Scheme Data] and [Correction Yes□ No□
Data].

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 Enter the [System Settings]
interface to perform basic settings
such as self check, preheating,
password modification, and
System settings advanced settings such as Yes□ No□
calibration, network settings, and
system upgrades.

Enter the [Debugging] interface to

test the functions of speed,
Debug temperature, dosing, sampling rack Yes□ No□
lifting, and machine head lifting

Enter the [Help] interface to view

information about this machine
Help Yes□ No□
and error notifications.

End the test and press the

instrument power switch to turn off
Power offe the instrument. Yes□ No□

Acceptable standards Yes/No

The instrument can be shut down normally according

to Yes□ No□

the operating manual without any abnormalities.

The instrument can operate normally, and all buttons of
Yes□ No□
the instrument can operate normally.

Notes:

Implementer Date

Reviewer Date

Page 6 of 14
2.2 Confirmation of user management

Table 5 Confirmation of user management

Permission Permission type Administrators Tester Test method Yes/No
setting
Delete data √ × Perform Yes□ No□

confirmation Delete modify operations that

√ × meet the Yes□ No□
administrator user corresponding
level and are
Delete and modify
not allowed, or
the experimenter
√ × check Yes□ No□
user
permission
settings
Create administrator
√ × Yes□ No□
user
Create an
√ × Yes□ No□
experimenter user

View traceability √ √ Yes□ No□

Modify create delete

√ √ Yes□ No□
method

Sample testing √ √ Yes□ No□

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 Project Procedure Require Yes/No

Log in as administrator and enter the

Login succeeded Yes□ No□
correct password
Login as administrator with incorrect
Login failed Yes□ No□
password
Log in as an experimenter and enter the
Login succeeded Yes□ No□
correct password
User name and
Login as an experimenter with incorrect
password settings Yes□ No□
Login failed
check password
After entering the fingerprint, you can
successfully log in with the
fingerprint password Login succeeded Yes□ No□

No fingerprint input, login failed with

Login failed Yes□ No□
fingerprint password

Acceptable standards Yes/No

Each group's permissions meet system requirements Yes□ No□

The operating system has at least 2 levels of operation and management permissions,
Yes□ No□
and the corresponding permissions at each level meet the system security requirements.

Only those who enter the correct password or successfully enter their fingerprint are
allowed to access their user level. Those who enter the wrong password or have no
fingerprint will be rejected. Yes□ No□

Notes:

Implementer Date

Reviewer Date

Page 8 of 14
2.3 Confirmation of audit trail

Table 6 Confirmation of audit trail

Project Content Test method Yes/No

Operation records visualization Yes□ No□

login/logout visualization Yes□ No□

Audit trail Sample test visualization Yes□ No□

Method edit visualization Yes□ No□

Acceptable standards Yes/No

For operation records, user login, etc., there are records that
can Yes□ No□

be queried.
Notes:

Implementer Date

Reviewer Date

Page 9 of 14
3. Performance Inspection
3.1 Mechanical parameter confirmation
Table 7 Dissolution meter mechanical verification record form Basket Apparatus

Technical
Parameters Tools Measurement points requirement Result

1 up1: down2:
2 up1: down2:
3 up1: down2:
4 up1: down2:
Coaxiality 5 up1: down2:
between 6 up1: down2:
dissolution cup Upper measurement 7 up1: down2:
and basket shaft Dialgage point and lower ≤2.0mm 8 up1: down2:
measurement point 9 up1: down2:
10 up1: down2:
11 up1: down2:
12 up1: down2:

1. 2.
3. 4.
20mm on
Basket 5. 6.
Dialgage the upper edge ≤1.0mm
axis swing 7. 8.
of the
9. 10.
basket
11. 12.
1. 2.
3. 4.
Basket Bottom edge 5. 6.
Dialgage ≤1.0mm 7. 8.
swing of basket
9. 10.
11. 12.
1. 2.
3. 4.
Basket Basket lower 5. 6.
Set high ball 25±2mm
depth edge 7. 8.
9. 10.
11. 12.

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 50rpm
1. 2.
3. 4.
5. 6.
7. 8.
Basket shaft speed
9. 10.
Tachometer 11. 12.
±4% 100rpm
1. 2.
3. 4.
5. 6.
7. 8.
9. 10.
11. 12.

1. 2.
Temperatur e 3. 4.
inside the Tachometer Dissolve out of 5. 6.
dissolution cup 37℃±0.5℃
the cup 7. 8.
9. 10.
11. 12.

Acceptable standards Yes/No

Comply with the technical requirements of the "Guiding Principles for Mechanical
Yes□ No□
Validation of Drug Dissolution Meters".

Notes:

Implementer Date

Reviewer Date

Page 11 of 14
 Table 8 Dissolution meter mechanical verification record form Paddle Apparatus

Technical
Parameters Tools Measurement points Result
requirement
1 up1: down2:
2 up1: down2:
3 up1: down2:
4 up1: down2:
Coaxiality 5 up1: down2:
between 6 up1: down2:
dissolution Upper measurement point 7 up1: down2:
cup and Dialgage and lower measurement ≤2.0mm 8 up1: down2:
paddle point 9 up1: down2:
shaft 10 up1: down2:
11 up1: down2:
12 up1: down2:

1. 2.
3. 4.
Paddle axis 5. 6.
Dialgage Bottom edge of ≤1.0mm 7. 8.
swing
Paddle 9. 10.
11. 12.
1. 2.
3. 4.
Paddle Set high 5. 6.
Paddle lower edge 25±2mm
depth ball 7. 8.
9. 10.
11. 12.

50rpm
1. 2.
3. 4.
5. 6.
7. 8.
9. 10.
Tachom eter
11. 12.
Paddle
±4% 100rpm
shaft speed
1. 2.
3. 4.
5. 6.
7. 8.
9. 10.
11. 12.
1. 2.

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 3. 4.
Temperature
Tachom eter 5. 6.
inside the
7. 8.
dissolution Dissolve out of the cup 37℃±0.5℃
9. 10.
cup 11. 12.

Acceptable standards Yes/No

Comply with the technical requirements of the "Guiding Principles for Mechanical
Yes□ No□
Validation of Drug Dissolution Meters".

Implementer Date

Reviewer Date

Page 13 of 14
4. Review and approval of execution
Review the Quality Inspection results conclusion of the DT12 automatic dissolution tester:
 The implementation process and results meet the requirements.
 The implementation and results cannot fully meet the requirements. There are
unresolved deviations that do not affect the final result of the validation.
 Implemented and results did not meet the requirements. There are unresolved deviations that
affect the final result of the validation. Further measures must be taken. Record the correction

Comment:
All inspection items of this dissolution instrument meet the quality inspection confirmation all meet
the requirements, meeting the guidelines for mechanical validation of drug dissolution in China, as
well as regulatory requirements such as FDA DPA-LOP.002 and ASTME2503-07 in the United States.

Implementer Date

Approver Date

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