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RAYS TECHNOLOGIES

Installation Qualification
&
Operational Qualification

For

INCUBATOR
IN-260
(Memmert- Germany)
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Table of Contents

1. Installation Qualification

1.1 Pre-Approval
1.2 Instructions
1.3 Scope

2. Installation Qualification Procedure

2.1 Instructions Listing

2.2 Installation Requirement
2.3 Installation

3. Operational Qualification

3.1 Pre-Approval
3.2 Scope
3.3 Operational Qualification
3.4 Operational Qualification Certificate

4. Operational Qualification Reference

4.1 Certificate of Training

4.2 List of Manual
4.3 Maintenance
4.4 Certificate
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1. Installation Qualification
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1.1 Pre-Approval

This Pre-Approval of the attached validation protocol shall be the

responsibility of the following person at RAYS TECHNOLOGIES.

Protocol Prepared By: RAYS TECHNOLOGIES

Name: ________________

Title: Service Engineer

Initial / Date: ___________

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1.2 Instructions

1. This document is to be completed at the time instrument is to be

setup for operation.

2. An Authorized Rays Technologies representative will check out the

instrument and perform the various tests as outlined in Installation
and Operating qualification. Each result will be noted and added.

3. An employee of ______________________________ will verify each

result and sign and date the entry as representative of instrument
owner.

4. All deviations from normal specification to include any problems with

Installation will be noted under COMMENTS. All resolution to such
problems will also be noted in the COMMENTS section. Additional
space is provided at the end of each section.
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1.3 Scope

This installation & operational qualification protocol will be performed on

the instrument located in Building Instrumentation Laboratory. QC/QA
Department at _________________________________.

This protocol will define the methods and documentation that will be used
to evaluate the instrument to accordance with the manufacturer’s
specifications and intended use. Successful completion of the protocol will
verify that the instrument operates in accordance with the intended usage.

Installation check will be performed to verify that the instrument has been
installed with the proper connections and utilities.

Any exceptional conditions encountered during the qualification studies will

be identified review. Exceptional conditions will be investigated and the
appropriate course of action will be determined. All data will be
documented.

On any page that contains a written entry or data gathered by

_______________________________ representative or Rays Technologies
representative, the page must be signed and dated.
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2. Installation Qualification Procedure

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2.1 Instrument

2.1.1 Main Unit

Incubator (Memmert, Germany)

Model No.: IN-260

Serial No.: ______________

Performed By: ____________________________________ Date: ______________

Approved By: _____________________________________ Date: ______________

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2.2 Installation Requirement

The instrument is to be placed on a level surface in a laboratory or a

relatively dust free environment.

Surface Location Leveled Angled

Sunlight Yes ___ No___

Proper Ventilation Yes ___ No___

Free of Heat Radiation Yes ___ No___

Free of Vibrations Yes ___ No___

Electrical Voltage Supplied ~ ______ Volts

Performed By: _____________________________ Date: ______________

Approved By: ______________________________ Date: ______________

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2.3 Installation

2.3.1 Power Checkout

 Your Supply is Single – Phase A.C. of the Stated Frequency.

 Electric Supply Voltage is written the Stated Range.

2.3.2 Set-Up

 Adjust the horizontal level.

 Check for vibration free surface.

2.3.3 Instrument Power Up

 Connect the power chord to a rated power supply.

 Turn ON the power switch.

 Set the desired temperature. Press and turn the turning knob to adjust

the temperature.

 The temperature will automatically start to rise to achieve its set value.

Performed By: _____________________________ Date: ______________

Approved By: ______________________________ Date: ______________

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3. Operational Qualification
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3.1 Pre-Approval

This pre-approval of the attached validation protocol shall be joint

responsibility of the following person at RAYS TECHNOLOGIES.

Protocol Prepared By: RAYS TECHNOLOGIES

Name: ________________

Title: Service Engineer

Initial / Date: ___________

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3.2 Scope

This installation & operational qualification protocol will be performed on

the instrument located in Building Instrumentation Laboratory. QC/QA
Department at _________________________________

This protocol will define the methods and documentation that will be used
to evaluate the instrument to accordance with the manufacturer’s
specifications and intended use. Successful completion of the protocol will
verify that the instrument operates in accordance with the intended usage.

Installation check will be performed to verify that the instrument has been
installed with the proper connections and utilities.

Any exceptional conditions encountered during the qualification studies will

be identified review. Exceptional conditions will be investigated and the
appropriate course of action will be determined. All data will be
documented.

On any page that contains a written entry or data gathered by

_______________________________ representative or Rays Technologies
representative, the page must be signed and dated.
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3.3 Operational Qualification

3.3.1 ON/OFF Switch

To turn ON/OFF the incubator.

3.3.2 Turning Knob

To increase or decrease the temperature value.

3.3.3 Flap Switch

To exhaust the internal air or fumes.

Performed By: _____________________________ Date: ______________

Approved By: ______________________________ Date: ______________

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3.4 Certification

Data obtained has determined that the system described in the document
either meets all criteria in this installation qualification protocol or
exceptional condition(s) has/have been identified and documentation
included.

Exceptional conditions, if any, have been addressed.

The system is ready for Specified Qualification.

Report Prepared By: Rays Technologies

Name: ____________________

Title: Service Engineer

Initial / Date: _______________

Customer: _________________________

Name: ____________________

Title: _____________________

Initial / Date: _______________

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4. Operational Qualification References

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4.1 Certificate of Training

4.1.1 Analyst Training

This certifies that the analysts listed blow have received training in the
following categories for the instrument described in this equipment
qualification.

The training has been conducted by

_____________________________
(Certified by Rays Technologies to conduct such training)

Analyst Name: ________________________________

Initial / Date

Instrument Setup ________________

Troubleshooting ________________

4.1.2 Operator Training

The operators that will be Department Initial By Date

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4.2 List of Manuals

Title Part No. Location Initial / Date

4.3 Maintenance

The instrumentation listed within this document will be placed under the
control of the purchasing institution with respect to proper maintenance
procedures as detailed in the operations manual.

A trained analyst using the manual provided with the instrumentation can
perform simple maintenance. Rays Technologies has trained service
representative who performs service on an as-call basis.
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4.4 Certification

Data obtained has determined that the system described in the document
either meets all criteria outlined in this installation qualification protocol or
exceptional conditions have been identified and documentation included.

Exceptional conditions, if any, have been addressed.

The system is ready for Specified Qualification.

Report Prepared By: Rays Technologies

Name: ____________________

Title: Service Engineer

Initial / Date: _______________

Customer: _________________________

Name: ____________________

Title: _____________________

Initial / Date: _______________

Name: ____________________

Title: _____________________

Initial / Date: _______________