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IQ OQ Cool Incubator

IQ Incubator

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uzair
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288 views10 pages

IQ OQ Cool Incubator

IQ Incubator

Uploaded by

uzair
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
You are on page 1/ 10

Cool Incubator

Model: INB-15023CT

Installation and Operational Qualifications

(IQ & OQ Documents)

Page 1 of 10
INSTALLATION & OPERATIONAL QUALIFICATION

OBJECTIVES:

Installation Qualification (IQ) is used to verify that the instrument has been installed to the
manufacturer’s requirement before the operation.

Operation Qualification (OQ) means that the instrument is operating as per manuals and training has
been provided to the user.

EQUIPMENT:

The Cool Incubator Model: INB-15023CT is supplied with the followings

 2 Shelves
 IQ OQ Document

All users should complete the qualification forms using the following guidelines.

 Complete all items on the forms where ever mentioned as actual


 Any deviation from defined protocol must be recorded
 Write additional comments & corrections on addendum sheets with following information.
1. Name
2. Initial
3. Date

 Make all entries in permanent Ink

Any of the following condition requires re-qualification / re-calibration;

1. Pre-determined time period or use


2. Service (minor/ major) has been done
3. Replacement of the parts
4. System has been removed from original place of installation
5. System is modified/ upgraded

Page 2 of 10
INSTALLATION & OPERATIONAL QUALIFICATION

Section 1: DESCRIPTION, IDENTIFICATION & QUANTITY


 Main Unit
 Sub Components

1. Compressor

If any thing is not as mentioned above, please record in the addendum sheets.

Section 2: EQUIPMENT DOCUMENTS


 Packing List

 Installation Qualification

 Operational Qualification

 Calibration Certificate

Performed By: Date:

Reviewed By: Date:

Page 3 of 10
Section 3: SITE REOUIRMENT FOR INSTALLATION
Electrical:

Parameter Required Actual


Voltage 220 V± 20
Frequency 50/60

Operating Environment:

Parameter Required Actual


Temperature oC 15-40

Support weight approx. 40 kg

Clearance:

At least 4 inches side and rear clearance is required.

Approximately dimensions of the system are 21”x33”x42” (WxDxH)

Section 4: END USERINFORMATIONS


Company;

Address:

Name of the Person (who got/Attended training session)

Person 1 :

Person 2 :

Person 3 :

Page 4 of 10
INSTALLATION & OPERATIONAL QUALIFICATION

Section 5: INSTALLATION PROCEDURE

 Unpack the instrument after placing on proper place.


 Plug in to 220-volt AC.
 Power on from back switch of main unit and wait the instrument display the main menu.
 Press the related no of required function.
 Then the test can be performed as per manual.

Performed By: Date:

Reviewed By: Date:

Page 5 of 10
Section 6: OPERATIONAL PROCEDURE

 Click on the settings icon to enter the settings menu.


 Click on temperature and set the desired values on the screen.
 On the main screen press the light button to toggle on and off the light inside chamber.

Performed By: Date:

Reviewed By: Date:

Page 6 of 10

Section 7: COMMENTS
The installation Qualification and Operational Qualification according to the system described above
accomplished as per valid IQ/OQ procedure to have performance as described by manufacturer.

Performed By: Date:

Reviewed By: Date:

Page 7 of 10
OBJECTIVE:

To assure that the equipment used for analysis, is operated, and qualified according to the
specifications mentioned in the equipment catalog and complies with company and regulatory
standards and guidance.

SCOPE:

This protocol applies only to “Cool Incubator” for its Operational qualification (OQ).Qualification of
support utilities is not within the scope of this qualification protocol.

EQUIPMENT/ SYSTEM DESCRIPTION:

EQUIPMENT NAME: Cool Incubator

MODEL: INB-15023CT

MANUFACTURER: Biotroll International

DESCRIPTION: Cool Incubator with the following specifications:

1. Model INB-15023CT
2. No. of Shelves 2 Shelves
3. Temperature range 0 to 60 oC
4. Power Supply 220 V /50/60 Hz

Performed By: Date:

Reviewed By: Date:

Page 8 of 10

QUALIFICATION NOTES
Performed By: Date:

Reviewed By: Date:

Page 9 of 10

DEVIATION NOTES
Performed By: Date:

Reviewed By: Date:

Page 10 of 10

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