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OPERATIONAL QUALIFICATION PROTOCOL

Make / ULTRA LOW DEEP FREEZER / Area Of Test
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OPERATIONAL QUALIFICATION
OF

ULTRA LOW DEEP FREEZER

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INDEX

SR. NO. DESCRIPTION PAGE

NO.
1.0 PROTOCOL APPROVAL 03
2.0 QUALIFICATION TEAM 04

3.0 PURPOSE, DEFINITION AND SCOPE OF OQ 05

3.1 RECOMMENDATIONS 05
4.0 ACCEPTANCE CRITERIA 05
4.1 RESPONSIBILITIES 05
4.2 EQUIPMENT VERIFICATION 06
5.0 OPERATIONAL QUALIFICATION (OQ) 06
5.1 TO VERIFY SWITCHING ON/OFF THE UNIT 06
TO VERIFY SWITCHING ON/OFF THE
5.2 GRAPHIC DISPLAY 06
5.3 PRODUCT INSTALLATION 07
6.0 OPERATING INSTRUCTIONS 08
6.1 ALARAM MANAGMENT 09
6.2 SETTING PARAMETERS 10

6.3 LOGIN 10

7.0 OPERATION QUALIFICATION REPORT 11

8.0 CERTIFICATION 12
OPERATIONAL QUALIFICATION APPROVAL
9.0 REPORT 12
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1.0) PROTOCOL APPROVAL

Operational Qualification of the Make Equipment, Model No:

Sr. No: ________________________________ has been reviewed and approved by the following
personnel.

Done By:
Company:
Name:
Designation:
Signature:
Date:

Approved By:
Company:
Name:
Designation:
Signature:
Date:
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2.0) QUALIFICATION TEAM.

The following team will be responsible for the execution of Operational Qualification protocol.

Sr. No. Name Department Designation Signature

Done By: Checked By:

Name: Name:
Signature & Date: Signature & Date:
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3.0) PURPOSE, DEFINITION AND SCOPE OF OQ.

This Operational Qualification Protocol is intended to be applied only on instruments which are new.
The following protocol has been written in order to help the user validate pre-defined specifications
within a specific environment. The protocol begins with checking the operational parameters.

General Definition:

Operational Qualification (OQ) is carried out to ensure that the equipment operates in the same way
as its manufacturer would intend it to operate, using pre-defined acceptance criteria which are
derived from the operational specifications.

3.1) RECOMMENDATIONS

The Operational Qualification (OQ) is carried out for new installation.

4.0) ACCEPTANCE CRITERIA:

The successful execution of this protocol in accordance with the desired requirement as
mentioned in the specification of the equipment will verify that the ULTRA LOW DEEP
FREEZER is operated and works as specified.

4.1) RESPONSIBILITIES:
 It is responsibility of the MEHROTRA BIOTECH PVT. LTD. to provide the operational
Qualification Document.
 SITEC LABS LTD. is responsible to review and approve the operational Qualification
document.

 Person overseeing the installation will perform the qualification and record the
information.
 The responsible engineer will verify the records and write the report.

Done By: Checked By:

Name: Name:
Signature & Date: Signature & Date:
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4.2) EQUIPMENT VERIFICATION

The details of the ULTRA LOW DEEP FREEZER instrument used for qualification include.

5.0) OPERATIONAL QUALIFICATION (OQ):

To verify Operational Checks

5.1) To verify Switching ON and OFF the Unit:

Step Action Display shows Confirms Remarks

Y/N/NA

1 Use the Main ON/OFF switch Unit turns ON

to Switch ON the Unit

2 Use the main ON/OFF switch Unit turns OFF

to Switch OFF the Unit

5.2) To verify Switching ON and OFF the Display:

Step Action Display shows Confirms Remarks

Y/N/NA

1 Use the MCB Switch to Switch Display turns ON

ON the Display

1 Use the MCB Switch to Switch Display turns OFF

OFF the Display

Done By: Checked By:

Name: Name:
Signature & Date: Signature & Date:
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/OQ/SITEC LABS/ /OQ1 shows Confirms Revision
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Equipment Y/N/NA
Display will show
5.3) Product Installation: GREEN, indicated no
 Ambient temperature: 16°C ~ 32°C, the mostactivated.
alarms ideal temperature is 18°C ~ 25°C, and the air conditioning
2 system shall
Movebe the
used when
front necessary.
glass out Display will show RED,
 Relative humidity: ≦80%RH.
of position. indicated respective
alarms
 There is no strong vibration and corrosive gasactivated.
around.
3 Close the front glass fully Display
 Avoid the existence of a large amount of dust. will show
and activate UV protocol YELLOW, indicated UV
 Avoid rocking or shaking the equipment.
mode in progress.
 Elevation of the working position of the equipment: less than 2000m.
 Indoor use, pollution degree 2, and overvoltage category II.
 For detailed input voltage AC with Proper UPS Line Or Stabilizer/ UPS System please refer to Specification
(Rated voltage ±10%).
 There is no direct sunlight, other cold and heat sources and strong electromagnetic interference, which will
affect the normal operation of the control system and directly damage the system in severe cases.
First Power-on
When using the equipment for the first time, please follow these steps:
 After the equipment is placed, leveled and cleaned, it shall stand for more than 24 hours, and then power it on to
ensure the normal operation of the equipment.
 Under no-load condition, connect the power cord to a special outlet with appropriate specifications.
 After switching on, turn on the power switch of the equipment (if the auxiliary cooling system is installed, turn off
the switch first).
 Set the required temperature in the freezer (in order to give full play to the best performance of the freezer, if the
user needs to use the freezer at a storage temperature below -80°C, please set the temperature at -80°C when
using it for the first time. After the system runs stably at -80°C for 3~4 hours, the temperature can be further
lowered to below - 80°C! ).
 In case of an alarm after power-on for the first time, click the mute button to eliminate the alarm sound.
 Check whether the operating temperature of the equipment reaches the required value, observe the normal start
and stop of the equipment for more than 24 hours, and put a small amount of items in the freezer after
confirming the normal performance.
 Please store items in batches, with the items not exceeding 1/3 of the freezer volume each time. Ensure that the
equipment is running properly after shutdown for more than 12 hours before putting in the next batch of items).
 Try not to open the door during cooling, otherwise the temperature will rise.
 Turn on the auxiliary cooling system if it is installed.

Operation after Power Failure

1.The equipment has a memory function for the set value. When the power is restored after power failure, the
equipment will continue to operate before power failure.
2.Once the equipment is powered off, it requires 5 minutes before it can be switched on again, so as to avoid
damaging the compressor.
We guarantee the normal operation of this equipment under above certain conditions, but we are not responsible
for any loss or damage of stored items after power failure
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6.0) OPERATING INSTRUCTIONS:

Status Bar First Row:

1. The upper part shows the current time of the system, and the lower part shows the
status of Wi-Fi and Bluetooth
2. Alarm status icon. If there is any alarm information, an alarm sound will be sent out and the red status indicator
will flash (the alarm flashing cannot be canceled until the fault is eliminated). Click the icon to turn on/off the alarm
sound, and long-press the icon to enter the alarm management interface (you do not need to log in before entering
the alarm management interface). If there are unread alarm messages, the number of unread messages will be
displayed in the upper-right corner of the icon
3. User status icon. After the user logs in, the last word of the user name will be displayed. Click the icon when you
do not log in, it will jump to the login page. Click the icon after you log in, a shortcut menu will pop up where you
can view the user information, modify the password, log out, set the fingerprint (optional), set the card wiping
(optional), set the face login (optional), etc. The initial user name is user001 and the initial password is 123456.
You need to change the password when logging in for the first time.

Status Bar second Row:

1. Display the ambient temperature
2. Display the real-time temperature
3. Display the setting temperature

Status Bar Third Row:

1. Access management entry. Click to enter the access management interface where you can conduct
access management for the items in the ultra low-temperature freezer. You need to log in before
entering this function interface;
2. Data view entry. Click to enter the data view page where you can view historical equipment running
data and operation data. You do not need to log in before entering this function interface;
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3. Data curve entry. Click to enter the data curve viewing interface where you can view the historical
temperature curves in the freezer. You do not need to log in before entering this function interface

4. Setting management entry. Click to enter the setting management interface where you can set various
parameters or functions of the equipment. You need to log in before entering this function interface

5. Message board entry. Click to enter the message board interface where you can post messages and view
messages. If there are unread messages, the corner mark in the upper-right corner will show the number.
You need to log in before entering this function interface

6.1) Alarm Management:

You can view the alarm contents, the alarm occurrence time, the release time, and the alarm time.
Click the screen button in the upper-left corner to filter the alarm time by date

Click the button to identify that the alarm entry has been viewed;

Click the button to return to the previous interface, click the button to return to the

Main interface, and click the button to pop up the help information.

Alarm Items Alarm description

Communication failure with the mainboard When the transmission signal between the display screen
and the main control board is interrupted, a
communication failure alarm will be triggered.
Alarm for the door being open for a long time When the door has been open for more than 1 minute
Ambient temperature sensor failure When the ambient temperature sensor fails
Condenser sensor failure When the condenser sensor fails
Temperature sensor failure When the temperature sensor fails
When the temperature in the cabinet is higher than the set
Pt1000 high-temperature alarm temperature of high temperature alarm
When the temperature in the cabinet is lower than the set
Pt1000 low temperature alarm temperature of low temperature alarm
When the condenser temperature is too high due to the
condenser filter screen blockage or high ambient
Alarm for high condenser temperature temperature
Alarm for high ambient temperature When the ambient temperature is too high
Low battery When the battery is too low
Battery power detection failure Battery power detection failure
Power failure When the main power supply fails

Done By: Checked By:

Name: Name:
Signature & Date: Signature & Date:
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6.2) Parameter Settings:

 Temperature setting: You can slide on the slider or click the temperature value to modify the set
temperature, and click the °C (Celsius temperature scale) or °F (Fahrenheit temperature scale) to switch
the temperature scale.
 . Alarm setting. You can slide on the slider or click the value to set the high-temperature alarm
value, the low-temperature alarm value, the high ambient temperature alarm value
 User management. The administrator can add or modify users. The user created by the
administrator is an ordinary user (ordinary users do not have the authority to add/modify contents). Click
Reset password to reset the user's login password. The initial password is 123456.
 System settings. You can adjust the equipment brightness, the time for the display screen to
automatically go off when there is no operation, the time for the display screen to automatically return to the
main interface when there is no operation, the volume, the alarm sound (the changed alarm sound will take
effect after the display screen returns to the main interface), the date and time, the automatic user logout
time, and the language;
 Network settings. You can set up the Wi-Fi connection to link to a wireless network
 Bluetooth settings. You can set up the Bluetooth connection
 Machine information. This page displays the current machine model, the software version, and the
hardware version. If the machine has been connected to the Internet, you can click the Check update
button on this page to check the software update. If a newer version exists, you can choose to download
and install the newer version
 Other settings. Only the administrator has the authority to view the page. In this page, the
administrator can set to hide/show virtual buttons, and set the initial password for new user login, whether
the exported Excel file is encrypted, the encryption password, the settable temperature interval, the printer
selection, and the equipment name setting

6.3) Login:
. Login with account number and password

Enter the correct account number and password to log in. The default password for new users is 123456. You will
be asked to change the password when logging in for the first time. The administrator can change the default
password for new users in Settings -> Other settings -> Set the initial password.

NOTE: For more details, please refer Operational manual of Ultra Low Deep freezer MDF86V778T

Done By: Checked By:

Name: Name:
Signature & Date: Signature & Date:
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7.0) OPERATIONAL QUALIFICATION REPORT:

RESULTS

CONCLUSIONS:

Done By: Checked By:

Name: Name:
Signature & Date: Signature & Date:
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8.0) CERTIFICATION

The equipment Operational Qualification for Make ULTRA LOW DEEP FREEZER Model No.:
equipment Sr. No._______________________________have been examined and found to be
acceptable. All the parameters mentioned in OQ are reviewed & found satisfactory.

9.0) OPERATIONAL QUALIFICATION APPROVAL REPORT:

The equipment Operational Qualification for Make ULTRA LOW DEEP FREEZER Model No.:
equipment Sr. No._______________________________ have been examined and found to
be acceptable. Report Prepared, reviewed and approved by following authority.

Preparation And Reviewed

Name Designation Signature

Preparation

Reviewed – Engineering

Reviewed By

Approved By-