PR 1400 Iq, Oq, PQ

Qualification Document for ARCTIKO Pharmaceutical Refrigerator
MANAGEMENT / OWNERS APPROVAL OF QUALIFICATION

PROCEDURE
The undersigned nominee of the management / owner approved the qualification
procedures recommended in this manual, for qualifying ARCTIKO Pharmaceutical
Refrigerator PR 1400 for M/s. ARCTIKO ,DENMARK.
Name Signature Initials
Manager:
Title Date
Head,
PERFORMER REVIEWER
NAME
SIGNATURE
DATE
Tecpharma Systems Inc. Version 2.0

Page 1 of 27
QUALIFIERS IDENTIFICATION
Qualification for Performer: Performer should be a trained performer of the manufacturer

or their authorized representative company.
Qualification for Reviewer: Reviewer should be a qualified person having experience in an

analytical / clinical laboratory.
The undersigned performer / reviewers certify that they are trained and qualified to perform
complete qualification procedure for the ARCTIKO Pharmaceutical Refrigerator PR 1400
for M/s. ARCTIKO ,DENMARK
Performed by:
Name Designation/ Department Sign/Date
Service Engineer
Reviewed by:
Name Designation/ Department Sign/Date
PERFORMER REVIEWER
NAME
SIGNATURE
DATE

Page 2 of 28
1. Installation Qualification (IQ)
v Installation Report
v Overview
v IQ Certificate
PERFORMER REVIEWER
NAME
SIGNATURE
DATE

Page 3 of 28
IQ Installation Report 1 of 1
Module Pharmaceutical Refrigerator
Model PR 1400
Serial No.
Installation Report
No. Action Result
1. Check Packing list
2. Unpack
3. Check for completeness (compare with packing list)
4. Check for transport damage
5. Remove transport screws
6. Set up the Refrigerator at suitable location (See Instruction Manual)
7. Let the Refrigerator compartment air out with the doors open
8. Wire up the system
9. Connect the power cable to the power supply and turn on the switch.
10. Connect the battery cables to battery
11. Check whether display is coming in the temperature display that is in the
control panel showing actual temperature of the Refrigerator
compartment and recorder is recording the same temperature which is in
the display of the control Panel.
12. Set operating mode for desired application i.e., set the desired
temperature (see Instruction Manual)
13. Leave the Refrigerator ON to cool down (reach) to the desired
temperature
14. Instruct the customer in using the system.
Safety instructions
Operating Principle of Pharmaceutical Refrigerator & Recorder
Operating and function elements & Setting the desired temperature
Checking the instrument and the GLP functions
Simple maintenance procedures and replacement of parts & accessories
15. Handover the Instrument Documentation to the Customer
Instruction Manual
16. Comments:
Successfully Installed the Pharmaceutical Refrigerator as per the
procedure.
PERFORMER REVIEWER
SIGNATURE
DATE

Page 4 of 28
Installation Qualification
Over View of the Installed Instruments
Installation Documents
Instruction
Instrument/ Model Serial No. Report Handed
Performed
Prepared Over
Yes / No Yes / No Yes / No
Pharmaceutical
Refrigerator
Model: PR 1400
PERFORMER REVIEWER
SIGNATURE
DATE

Page 5 of 28
2. Operational Qualification (OQ)
v Test Reports
v Operating Procedures (SOP)
v Overview
v OQ Certificate
PERFORMER REVIEWER
SIGNATURE
DATE

Page 6 of 28
OQ Test Report 1 of 5
Model PR 1400
Serial No.
Function Test
No Item Tested Setting Specifications Result
1.
a. Display Buttons Press ON /OFF LCD Display will show
Power Supply Switch Button Once. the actual Temperature
of Pharmaceutical
Switch ON (move Refrigerator
to l position) the compartment, Date Time,
battery. Ambient temperature,
Battery level, Alarm
Indication, Alarm Icon
and compressor position.
Total Pharmaceutical
Press ON /OFF Refrigerator will turn off.
Button Once again.
.
PERFORMER REVIEWER
SIGNATURE
DATE

Page 7 of 28
1.b. Up& Down Arrow keys Press key A beep sound will be heard
once and the display will show
the set numerical value,
icon.
Ex. 4.0
Press key Using with the up arrow key

once the value of the set
temperature will increase.
Ex. 5.0
Using with the down arrow

key the value of the set
temperature will decrease.
Ex. 4.0
Model PR 1400
Serial No.
Function Test
No. Item Tested Setting Specifications Result
1.c. Left & Right Arrow Press key A beep sound will come and
keys once the display left digit will blink
the numerical value, icon.
Ex. 4.0
Press key A beep sound will come and

once the display Right digit will
blink the numerical value,
icon.
Ex. 4.0
1.d. Enter & accesses Press Display will show the Menu
the key once for mode.
menu Key access mode.
After setting the

values press once Memories the set values.
again key.
PERFORMER REVIEWER
SIGNATURE
DATE

Page 8 of 28
1.e. Return Key Press Esc Key Return the display window.
once after enter the
values

Model PR 1400
Serial No
Function Test
No. Item Tested Setting Specification Result
2. Alarms & indicators on the Display Panel
2.a 1. Alarm Lamp Switch ON the Indicating Alarm
Pharmaceutical
Refrigerator
2. Battery Alarm Lamp Low Battery N/A
2.b Ambient temperature Switch ON the This Indicator displays
display Pharmaceutical the present ambient
This display shows the Refrigerator temperature.
present room temperature Ex. 28 C
2.c. Mute key Switch OFF the Power off led will glow
Pharmaceutical and continuous beep
Refrigerator sound will be come.
This key is used to silence
the audible alarm. The beep sound will stop
Should a further Press the key once but led will be on.
abnormality occurs, the
buzzer would sound
automatically.
PERFORMER REVIEWER
SIGNATURE
DATE

Page 9 of 28
2.d. Temperature Indicator Switch ON the Displays the actual Inner
Pharmaceutical chamber temperature
Refrigerator .Ex: 4.1
2.e. Compressor Indicator Switch ON the Compressors indicator
This indicator will show Pharmaceutical will show Running
compressors mode. Refrigerator and set
the Pharmaceutical
Refrigerator
temperature. Compressors indicator
After reached the will show Stopped.
set temperature
2.f. High Set the
Temperature Pharmaceutical Led & Alarm icon will
Alarm Icon Refrigerator show and buzzer
Alarm indicates high temperature below sounds.
temperature Icon high alarm value
2.g. Low Set the
Temperature Pharmaceutical Led & Alarm icon will
Alarm Icon Refrigerator show and buzzer
Alarm indicates low temperature above sounds.
temperature Icon low alarm value

Model PR 1400
Serial No
Function Test
No. Item Tested Setting Specification Result
Power Failure
Led & Alarm icon will
Alarm Icon Disconnected the
2.h. show and buzzer
power supply.
sounds.
Power off indication
Probe Failure
Alarm Icon
This Alarm Icon

Indicates the sensors
(Pharmaceutica Sensor error occurred.
2.i. NA
l Refrigerator NA
control,
condenser,
ambient,
evaporator)
failures.
PERFORMER REVIEWER
SIGNATURE
DATE

Page 10 of 28
Low Battery
Alarm Icon
This alarm indicates to Led & Alarm icon will

2.j. recommend the Switch off the battery show and buzzer
battery sounds.
replacement or
battery switch is
not turned on.
Door Open
Alarm Icon
Led &Alarm icon will
Open the door for few
2.k. This alarm indicates when show and buzzer
minutes.
the door was sounds.
open for few
minutes.
3. USB Data Port
USB Port
Place the USB pen drive

in the
connection on The Data upload will
Transfer complete
the display and be shown in the
will be showing on
press the display when the data
the display when the
button right for is loading to USB pen
loading is finished
upload data to drive
USB from the
unit.
SOP PR 1400 1 of 1
OQ
Standard Operating Procedure for Pharmaceutical Refrigerator
Objective To ensure that the analyst operates the instrument as per the
requirement
Operating Procedure
PERFORMER REVIEWER
SIGNATURE
DATE

Page 11 of 28
Setting the Temperature Setting Range 1C to 10C.

Temperature
Switch on the Power Main Switch.
Switch on the control panel ON/OFF key.
LCD Display will show the actual Temperature of Pharmaceutical
Refrigerator compartment, Date Time, Ambient temperature,
Battery level, Alarm Indication, Alarm Icon and compressor
position.
Ex.4.0
Once press the Enter key LCD displays setting Icons.
By using arrow keys chose the custom setting icon. Then Press
Enter Key. Displays Enter password Icon
.
Now enter password 0000 and press Enter key

Displays Setpoints Icon and Alarm Setting Icon
By using arrow keys chose the Set point icon. Then Press
Enter Key. Displays the previous set temperature value.
Set the desire temperature by using Arrow keys and press Enter
key.
Ex. 4.0
Now press the Esc key for exit.
set temperature will be memorized and actual temperature of the
Pharmaceutical Refrigerator compartment will be displayed.
Ex. 4.0
Operational Qualification (OQ)
PERFORMER REVIEWER
SIGNATURE
DATE

Page 12 of 28
Over View
Documents Necessary
Test Result
Handed Corrective
Instrument/ Model Serial No. Confirmation
Over Action
Pharmaceutical
Refrigerator
Model: PR 1400
3. Performance Qualification (PQ)
PERFORMER REVIEWER
SIGNATURE
DATE

Page 13 of 28
v Description of the PQ Procedures
v Environment Conditions
v Materials Used
v PQ Procedures
v Test Reports
v Overview
v PQ Certificate
Description of the Performance Qualification Procedure

PERFORMER REVIEWER
SIGNATURE
DATE

Page 14 of 28
for Pharmaceutical Refrigerator
Introduction:
The described PQ procedure serves to check the Pharmaceutical Refrigerator and

Temperature recorder are functioning with the specifications given by the manufacturer.
The Pharmaceutical Refrigerator is mainly used for storing different samples under the
set temperature (+1C to +10 C). So, the Pharmaceutical Refrigerator should maintain
the set (required) temperature and the temperature distribution throughout the
Pharmaceutical Refrigerator chamber should be uniform (within the limits of tolerances
specified by the manufacturer) so that the samples kept in any part of the chamber will
also have the same temperature.
Aim
A To check whether Pharmaceutical Refrigerator will achieve the set temperature

within the specified time given by the manufacturer or not. (According to the
manufacturer this Pharmaceutical Refrigerator should achieve+5 C when room
temperature is 28 C or below within 4 hours). To check whether the temperature
distribution in the Pharmaceutical Refrigerator chamber is uniform (within the
limits 3 specified by the manufacturer) or not. According to the manufacturer the
freezing temperature is different at each position inside the chamber of the
Pharmaceutical Refrigerator. Distribution check at different temperatures and 24
hours temperature mapping at +5C.
A Door Open and Alarm test.
A Power failure Test.
PERFORMER REVIEWER
SIGNATURE
DATE

Page 15 of 28
Environment conditions for ARCTIKO
Pharmaceutical Refrigerator
The environmental conditions that are given by the manufacturer to operate the
Refrigerator for best performance are given below. If the environmental conditions are
not according to the specified ones the performance of the Refrigerator may not be up to
the specifications given by the manufacturer.
The HAIER Pharmaceutical Refrigerator is designed to be safe under the following
conditions:
Indoor use
Altitude up to 2000 meters.
Temperature 5C to 40C.
Maximum relative humidity 80% for temperature up to 31C decreasing linearly to
50% relative humidity at 40C.
Main supply voltage fluctuations not to exceed 10% of the nominal voltage.
Other supply voltage fluctuations as stated by the manufacturer.
Transient over voltage according to installation categories (Over voltage
categories) II, for mains supply the minimum and normal category is II.
POLLUTION DEGREE 2 in accordance with IEC 664.
PERFORMER REVIEWER
SIGNATURE
DATE

Page 16 of 28
Materials Used
1. The details of the calibrated data scanner are given below:
Item Detail / Make : Digital data logger With 8 Probes

Model : TC-800D
Serial No. :
Temperature Range : -100 0C to 400 0C (RTD/PT-100)
Calibration Date :
Calibration Due :
The Calibration Certificate for data scanner is enclosed at the end of the section.
PERFORMER REVIEWER
SIGNATURE
DATE

Page 17 of 28
PQ Procedure for Pharmaceutical Refrigerator

1. Refrigerator pull down performance should be done as follows & Checking of
the temperature distribution in the refrigerator temperature is uniform or not?
24 hours mapping at 5C (30C) should be done as mentioned below.
1. Switch ON the Pharmaceutical Refrigerator.
2. Note down the Pharmaceutical Refrigerator Temperature shown in the display.
3. Set the Pharmaceutical Refrigerator Temperature as +5C.
4. Note down the starting time.
5. Note down the time at different temperature say: initial temperature 15C,
10C and 5C as shown in Test Report1
6. Record the observations in a table, which is in the Test Report-1. Calculate

the time taken by the refrigerator to reach different temperatures .
7. See the Fig.1 of the refrigerator chamber. Total 6 points are shown to measure
the temperature.
8. Set the refrigerator temperature 5c and by keeping the calibrated data scanner
at all points shown in Fig.1. Note down the temperature values shown by the data
scanner and refrigerator display.
9. Data scanner connects to the printer for 24 hours data, with 1 Minute print interval.
Compare them whether they are within the tolerance limits specified by the
manufacturer.
10. Data enclosed with this document.
PERFORMER REVIEWER
SIGNATURE
DATE

Page 18 of 28
Door open & Power failure test
2.a. Checking Of the Temperature
1. After reached the Pharmaceutical Refrigerator 5C,
2. Open the door for one minute.
3. Close the door for the Refrigerator reached the set temperature.
4. repeat the above procedure for 3min,5min&10min. as shown in test report - 2a
2.b. Power Failure Test
1. After reached the Pharmaceutical Refrigerator 5C,
2. Switch of the Refrigerator 5min.
3. Record the time & temperature as shown in test report - 2b.
PERFORMER REVIEWER
SIGNATURE
DATE

Page 19 of 28
PQ Procedure for Pharmaceutical Refrigerator
3. Checking of the high and low temperature alarms at 7C, 1C.
1 After reached the Pharmaceutical Refrigerator 5C, set the Pharmaceutical

Refrigerator temperature 1C
2 And set the lower alarm temperature value 7C.
3 Now the Pharmaceutical Refrigerator temperature is too low, check the low alarm
temperature activated or not.
4 After reached the freezer 4C, set the high alarm temperature value 1C.
5 And open the doors little time.
6 The Pharmaceutical Refrigerator temperature will pull up to 8C check the high

alarm temperature activated or not.
7 Record alarm activations are in the table (Test Report - 3).
PERFORMER REVIEWER
SIGNATURE
DATE

Page 20 of 28
PQ Test Report 1 1 of 1
Model PR 1400
Serial No.
Pull down Performance of the Pharmaceutical Refrigerator
Time taken by the Time taken to
Pharmaceutical reach the Set
Temperature on
No. Time Refrigerator to Temperature Result
the Display
reach Set according to
Temperature manufacturer
1. Initial Temperature
2. 15C
3. 10C
4. 5C 4 Hours
5. Comments:
PERFORMER REVIEWER
SIGNATURE
DATE

Page 21 of 28
PQ Test Report 2.A 1 of 1

Model PR 1400
Serial No.
2.a. Door open test
Temperature
No.
Set temperature Time Minimum Maximum Result
1. 5C 1Min.
2. 5C 3Min.
3. 5C 5Min.
4. 5C 10Min.
5. Comments:
PQ Test Report 2.B 1 of 1

Model PR 1400
Serial No. 49.12 5371
2.b. Power failure test.
No. Temperature Temperature Time Result
1. Initial
temperature
2. After 5 min.
PERFORMER REVIEWER
SIGNATURE
DATE

Page 22 of 28
PQ Test Report 3 1 of 1
Model PR 1400
Serial No.
Checking of the Temperature high and low alarm at +7C, +1C,
Pharmaceutical
No. Temperature Alarm Activation Result
Refrigerator display
1. Initial Temperature +5C
2. Set the Pharmaceutical +5C
Refrigerator
temperature
3. Set the low alarm +1C
temperature
4. Initial Temperature +5C
5. Set the high alarm +7C
temperature
6. Temperature of the +10C
Pharmaceutical
Refrigerator after doors
open
7. Comments:
PERFORMER REVIEWER
SIGNATURE
DATE

Page 23 of 28
Performance Qualification (PQ)
Over View of the Qualification Done
Documents Necessary
PQ Result
Instrument / Handed Corrective
Serial No. Confirmation
Model Over Action
Pharmaceutical
Refrigerator
Model: PR 1400
PERFORMER REVIEWER
SIGNATURE
DATE

Page 24 of 28
4. Maintenance
a. Maintenance of the Pharmaceutical Refrigerator
The Refrigerator is guaranteed for one year from the date of

Installation against any manufacturing defects. The guarantee covers the
following parts:
A Compressor
A All Electronic Parts
Note: After guarantee period the customer should enter into Annual
Maintenance Contract (AMC) with the Indian Agent M/s Tec Pharma Systems
Inc.
a. Procedure for Cleaning
The appliance should be cleaned once a month.
Wipe clean the external surfaces and internal accessories of the appliance. Mild
detergent can be used if necessary.
Dry the appliance both inside with soft cloth after cleaning with water.
Do not use excessive water for cleaning the appliance to avoid damage to the
installation materials.
Do not use any lubrication inside the appliance since the compressor and other
mechanical accessories are all tightly sealed.
b. Lamp replacement
Unplug the appliance.
Hold lamp holder and remove the lampshade.
Rotate to remove the lamp, replace with a new lamp.
Connect the appliance to a power source.
Unplug the appliance and remove the starter.
Tightly installed the new one, connect the appliance to a power source.
PERFORMER REVIEWER
SIGNATURE
DATE

Page 25 of 28
b) Maintenance of the Temperature Recorder

v Chart should be replaced for every 7 days.
v Open the door of the printer located at the bottom of the unit. Press the 3 key the
pointer will move to lifter end.
v Remove the chart hub cover, and then replace the recording chart. Place the
chart hub cover. Set the correct time.
b. S A F E T Y P R E C A U T I O N S
1. Power Source Precautions

This appliance requires 220V-/50Hz supply.
A regulator with a capacity of 4000W or higher must be installed if the voltage is

below 198V or higher than 242V.
If the electric cord is to be extended, the wire with a cross section > mm2 and
length less than 3 meters can be used.
A separate earthed socket is required.
The appliance is supplied with a standard three-pin plug, of which the one for
grounding should never be removed.
Warning: The electric plug should firmly secure in the socket, otherwise fire may
result.
2. Inflammable Precautions
Never store inflammable, explosive or corrosive materials in the appliance.
Do not use inflammable spray near the appliance.
If inflammable gas leaks in the vicinity of the appliance, Turn off any leaking
valve;
Open doors and windows do not plug or unplug the appliance.
Allow a 5-minute lapse before restarting the appliance if power is interrupted and
then resupplied for safety of the compressor and cooling system. Unplug the
appliance when repair or maintenance is intended.
Protect your hands from frost damage when you are loading or unloading the
appliance.
3. Installation Location
The appliance should be located on a solid surface without any packing material.
When the appliance is moved, never tilt it over 45 nor apply force on pipes, door
and/or handle, otherwise damages may result.
Keep the appliance away from direct sunlight or heat source. The appliance
PERFORMER REVIEWER
SIGNATURE
DATE

Page 26 of 28
should be operated with an ambient temperature below 32C.
The application should be kept clear around for good ventilation
Do not operate the appliance in temperature below good ventilations. The best
ambient temperature for the appliance is 18C-25C.
Do not locate the appliance at a damp area or near a sink to avoid water splashes.
Wipe down the appliance with soft fabric. Never place the appliance in an open area.
5. Instrument Documents
Over View of the Documents Handed Over
Instrument / Model Documents Handed Over
Ultra - low Temperature Refrigerator
MODEL: PR 1400
Serial No.:
PERFORMER REVIEWER
SIGNATURE
DATE

Page 27 of 28
6. Spare Parts
1. Spares received for Pharmaceutical Refrigerator : Nil
PERFORMER REVIEWER
SIGNATURE
DATE

Page 28 of 28

PR 1400 Iq, Oq, PQ

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

PR 1400 Iq, Oq, PQ

Uploaded by

Copyright:

Available Formats

Qualification Document for ARCTIKO Pharmaceutical Refrigerator

MANAGEMENT / OWNERS APPROVAL OF QUALIFICATION

Name Signature Initials

Tecpharma Systems Inc. Version 2.0

Qualification for Performer: Performer should be a trained performer of the manufacturer

Qualification for Reviewer: Reviewer should be a qualified person having experience in an

Name Designation/ Department Sign/Date

Name Designation/ Department Sign/Date

Tecpharma Systems Inc. Version 2.0

1. Installation Qualification (IQ)

Tecpharma Systems Inc. Version 2.0

Tecpharma Systems Inc. Version 2.0

Over View of the Installed Instruments

Tecpharma Systems Inc. Version 2.0

2. Operational Qualification (OQ)

v Operating Procedures (SOP)

Tecpharma Systems Inc. Version 2.0

Tecpharma Systems Inc. Version 2.0

Press key Using with the up arrow key

Using with the down arrow

Press key A beep sound will come and

After setting the

Tecpharma Systems Inc. Version 2.0

Module Pharmaceutical Refrigerator

Tecpharma Systems Inc. Version 2.0

Module Pharmaceutical Refrigerator

This Alarm Icon

Tecpharma Systems Inc. Version 2.0

This alarm indicates to Led & Alarm icon will

Place the USB pen drive

Standard Operating Procedure for Pharmaceutical Refrigerator

Tecpharma Systems Inc. Version 2.0

Setting the Temperature Setting Range 1C to 10C.

Now enter password 0000 and press Enter key

Operational Qualification (OQ)

Tecpharma Systems Inc. Version 2.0

Yes / No Yes / No Yes / No

3. Performance Qualification (PQ)

Tecpharma Systems Inc. Version 2.0

v Description of the PQ Procedures

Description of the Performance Qualification Procedure

Tecpharma Systems Inc. Version 2.0

The described PQ procedure serves to check the Pharmaceutical Refrigerator and

A To check whether Pharmaceutical Refrigerator will achieve the set temperature

A Door Open and Alarm test.

A Power failure Test.

Tecpharma Systems Inc. Version 2.0

Tecpharma Systems Inc. Version 2.0

1. The details of the calibrated data scanner are given below:

Item Detail / Make : Digital data logger With 8 Probes

Tecpharma Systems Inc. Version 2.0

PQ Procedure for Pharmaceutical Refrigerator

1. Switch ON the Pharmaceutical Refrigerator.

2. Note down the Pharmaceutical Refrigerator Temperature shown in the display.

3. Set the Pharmaceutical Refrigerator Temperature as +5C.

4. Note down the starting time.

6. Record the observations in a table, which is in the Test Report-1. Calculate

10. Data enclosed with this document.

Tecpharma Systems Inc. Version 2.0

Door open & Power failure test

2.a. Checking Of the Temperature

1. After reached the Pharmaceutical Refrigerator 5C,

2. Open the door for one minute.