1295878051-Sample IQOQ UC 600 UV TM PDF

IQ / OQ
Installation / Operation
Qualification Protocol
Ultra-pure water system

UF 600 UV
Order No.:
Tested system: UF 600 UV Ultra-pure water system
Procedure: The IQ/OQ for the listed water purification system is

accomplished utilizing the information contained in this
document.
Result: All test requirements listed are accomplished and complete..
Confirmed by: ____________________ Date:________________

Quality manager or authorized representative QM
Only the original document is valid!
SG Wasseraufbereitung und Regenerierstation GmbH

Germany
Tel.: ++49(0)40/670868-6 * Fax.: ++49(0)40/670868-44
www.sgwater.de * e-mail: info@sgwater.de
Customer Name: _________________________________________
Address: _________________________________________
_________________________________________
System Location: _________________________________________
This document is designed to comply with

21 CFR, 210/211 GMP and Annex 15, EG-GMP
Table of content
1. Introduction ......................................................................................................................................1
2. Approval of the IQ OQ protocol .................................................................................................1
2.1. Predefinition of the responsible persons .......................................................................................1
3. Installation Qualification ( IQ ) ...................................................................................................2
3.1. Flow sheet UF 600 UV Ultra pure water system ...........................................................................4
3.2. Functionality ..................................................................................................................................4
3.3. List of the test devices and the reference devices ........................................................................4
3.4. Identification of the system and the consumables ........................................................................5
3.5. Check of the documentation regarding correctness and completely ness....................................7
3.6. Check of the system and the components against damages .......................................................8
3.7. Check of the operation conditions and operation requirements....................................................9
3.8. Installation check of the system ..................................................................................................10
3.9. Settings in the menu of the system electronic.............................................................................11
3.10. Result of the Installation Qualification .......................................................................................12
3.11 Report of the result.....................................................................................................................12
3.12 Approval for the IQ .....................................................................................................................12
4. Operation Qualification ( OQ ) .................................................................................................13
4.1. Function check of the system......................................................................................................13
4.2. Total pyrogen amount and total germ amount in the product waterFehler! Textmarke nicht
definiert.
4.3. Report of the result......................................................................................................................16
4.4. Approval for the OQ ...................................................................................................................16
1. Introduction
The Installation Qualification and Operation Qualification (IQ / OQ ) documents that the delivered
system corresponds to the specifications defined in the operating manual and order confirmation.
2. Approval of the IQ OQ protocol

Depending of the quality standards of the customer the protocol of the Installation Qualification and
Operation Qualification will be approved by the responsible QA division or specified representative of
the customer. .The person or persons listed will review the documentation to ensure all items are
complete.
Approved by:
Company and division Name and title Signature Date
2.1. Assignment of the responsible persons

The qualification can be performed by the customer, by the user or by a validation appointee of the
company SG Wasseraufbereitung und Regenerierstation GmbH. Assignment of the executing and
testing persons.
Company and division Name and title Signature Date
1
SG Wasseraufbereitung und Regenerierstation GmbH * Fahrenberg 8 * 22885 Barsbu ttel
Telefon ++49 (40) 67 08 68-6 * Telefax ++49 (40) 67 08 68-44 * info@sgwater.de * www.sgwater.de
3. Design Qualification DQ
3.1. Flow sheet check

Purpose:
Varify the design of the system.
Method:
Visual check of all components. Compare the flow sheet to the UC 600 UV system and mark
components in table.
Acceptance criteria:
Al components are available.
List of components
Components
Available
Yes No
V6.1 Check valve
QISA Q 6.1 Conductivity measurement
C=0,2
FIS+ 6.1 Flow meter
UV 6.1 Oxidator
F6.1 Activ carbon fiter
F6.2 Polisher cartridge
F6.3 UF-Module
V6.4 Solenoid valve
F6.4 Sterile filter
V 6.5 Sample valve
V6.3 Membrane valve
QIA Q6.1 Conductivity measurement
C=0,1
V6.2 Check valve
QIA Q4.1 Conductivity measurement
P6.1 circulation pump
E1 Controller
Comments:
2
Declaration:
Yes No
Al components are available.
Validation Representative: _______________________ Date: __________________
Q/A Manager or Repr: _______________________ Date: __________________
3.2. Functionality
The water purification system UC 600 UV produces ultra-pure water for direct use from a pretreated
feed water source.
The feed water flows through the inlet of the system into the UV chamber (UV6.1). The water flows
into an activated carbon filter (F6.1) after is has passed the UV chamber. This filter removes particles
from a size of 5m, free chlorine and/or organic materials.
Water passes from the activated carbon filter into the polishing cartridges (F6.2). These cartridges are
filled with high grade mixed bed deionizer resins of semiconductor quality. The polishing cartridges are
designed to remove the final trace level of salts and produce reagent water with a conductivity of 0,055
S/cm ( 18,2 M ).
After the polishing cartridges the water flows into an ultra-filtration modules (F6.3). The function of the
UF modules is to remove endotoxins and bacteria, which may be present in the water.
After the UF modules the water flows into a conductivity cell (QIA 6.1) so the conductivity of the water
can be monitored (E1). The measured valves in S/cm or M are displayed on the screen of the
system.
The final sterile filter (F6.4) removes particles from a size of 0.2m from the water. The water flows to
membrane valve (V6.3) after the sterile filter.
The water flows over a check valve (V6.2) back into a circulation pump (P6.1). The circulation pump
recirculates the water back into the UV chamber if water is not being drawn. if .
3
4. Installation Qualification ( IQ )
The Installation Qualification is performed after the installation of the system. The IQ documents the
correct installation and confirms that the unit is installed in accordance with the operating instructions
or owners manual. Refer to the purchase order and order confirmation for system identification.
4.1. List of the test devices and the reference instruments

The measuring instruments which are used for testing the quality relevant measuring parameters must
be calibrated before starting the tests. The calibration must be effected and confirmed by the
manufacturer of the measuring device or by an authorized measuring laboratory. A calibration must be
performed once a year. The calibration protocol has to be attached to the IQOQ protocol.
Last Next
Measuring devices Test criteria Range Precision
calibration calibration
Conductivity
Conductivity meter 0,0 ..... 1999 2,0 %
S/cm
Temperature
Temperature sensor -5 ..... 100 4,0 %
C
Comments:
Yes No
The reference devices are complete and calibrated
Q/A Manager or Representative: _______________________ Date: __________________
4
4.2. Identification of the system and the consumables
Remark:
All consumables must be available onsite to complete the installation qualification.
Purpose:
Check all system components according to the purchase order specifications.
Procedure:
Check of the system type and the serial number based on the identification plate or label.
Compare system data with quotation and order specification
Check the software version by starting the system. The version number will be shown on the
display of the system during the first few seconds of the start-up procedure.
Check any additional system components and the consumables based on the delivery note
and the following table
Enter data in the following table.
The system and the consumables are identified. The data correspond to the specifications.
System identification
Model UC 600 UV Yes No
Serial No.
Pressure min / max. 1-6 [bar]
Temperature max. 35 [C]
Flow rate 600 [l/h]
Electrical connection 230 V, 50 Hz
Power input 1,5 [kW]
Article no. 20253-600
Software version V 1.39
5
List of the consumables necessary for operation
Flow Article No. of Available

Consumable
sheet No No. pieces Yes No
08767-
UV 6.1 UV lamp 1
115
87040-
F6.1 Active carbon filter 1
75342
10184-
F6.2 Deionizer cartridge 1
75342
F6.3 Ultra filtration cartridge 08883 1
F6.4 Rinsing valve 04990 1
Comments:
Declaration:
The components and consumables are identified and the data correspond to the Yes No
specifications.
Q/A Manager or Rep: _______________________ Date: __________________
6
4.3. Documentation check
Purpose:
To ensure that documentation is correct and complete. .
The documentation is correct and complete.
Purpose: To ensure that the owners manual and/or any other required documents are present. .
List documents
Documents Available
Operating instructions Yes No
IQOQ documentation / register 6 Yes No
Certificate flow meter Yes No
Certificate conductivity cell 1 Yes No
Certificate conductivity cell 2 Yes No
Comments:
Declaration:
The system documentation is correct and available. Yes No
Validation Representative: _______________________ Date: _________________
Q/A Manager or Rep: _______________________ Date: _________________
7
4.4. System check for damages
Puropse:
Check system against damage.
Method:
Visual check of all components and consumables
No damage visable.
Comments:
Result:
The systems, components and the consumables are free of visible damage Yes No
Validation representative: _______________________ Date: __________________
8
4.5. Check of the operation conditions and operation requirements
Purpose:
It will be ensured, that the appropriate conditions for the operation of the system are available.
Method:
Measuring of the ambient temperature by a thermometer..
Annotation: Is the system located in an area that will not freeze?
Identification of the electrical connection and the protection.
Check of the water supply. Ensure, that the system will be provided with permeate from a
reverse-osmosis system or pure water from a deionizer.
Refer to the following table.
Acceptance criterium:
All requirements are fulfilled according to the specifications of the table below.(Need certified pressure
gauge for loop.)
Specification
Requirement Specification Measured data fulfilled
Yes No
Ambient temperature 5-35 C
Power supply 115VAC, 60 Hz,1 Phase
fused with 16 A
Water supply Reverse-osmosisor DI
Feed water temperature 5-35 C
Feeding pressure 1,0 6,0 bar
Conductivity feed water max. 2,0 S/cm
Comments:
Result:
Yes No
The operation conditions and operation requirements are in specification
Validation representative: _______________________ Date: __________________
9
4.6. Installation check of the system
Purpose:
To determine that the system is placed properly and utilities are available. .
Method:
The installation will be checked by the data of the table below.
Acceptance criterium:
The installation of the water purification system was realized without deficiencies.
Specification
Requirement Specification fulfilled
Yes No
Floor space Are the system placed on a horizontal and planar
surface?
Drain connection Are the drain connection established
Water connections Are all water connections established? Are the screw-
joints hand-tight fixed?
Power supply Is the power supply according the operation
instructions established?
Comments:
Result :
Yes No
The installation of the water purification system is complete and correct..
Validation representative: _______________________ Date: _______________________
Approved: _______________________ Date: _______________________
10
4.7. System Menu Settings
Purpose:
To ensure that the menu settings are correct.
Method:
Check the menu settings based on the SG test protocol ( see attachment ) and the operating
instructions.
All menu settings are in compliance with the SG test protocol.
List of menu basis setting
First press key MENU

Return to operating mode press key MENU
Menu setting Data Press button

Correct
Language english Yes No ENTER
Display range S/cm or M S/cm Yes No ENTER
Date / time - Yes No MENU
Limit CON 1 5,0 S/cm Yes No ENTER
Limit CON 2 0,2 S/cm Yes No ENTER
Comment:
Completion declaration:
Yes No
All menu settings are in compliance with the SG test protocol
Validation Representative: _______________________ Date: _________________
Q/A Manager or Rep: _______________________ Date: _________________
11
4.8. Result of the Installation Qualification
All parameters of the Installation Qualification are listed below. It is confirmed that all are executed.
Differences or variations which are verified during the Installation Qualification are documented.
chapter Check carried out, no deviants existing. Yes No
4.1 List of the test and reference measuring devices
4.2 Identification of the system and the consumables
4.3 Documentation is correct and complete
4.4 System check for damages
4.5 Operation conditions / requirements
4.6 Check of the Installation of the systems
4.7 Menu settings of the system
4.9. Report of the result
No differences or errors are found during the Installation Qualification. The

Installation Qualification is successfully. According to the Installation Qualification is
the system approved.
Small differences or errors are found during the Installation Qualification. The
differences and errors are documented. In spite of this differences and errors is the
system according to the Installation Qualification approved.
Considerable differences or errors are found during the Installation Qualification.
The system is not approved according to the Installation Qualification. The
corresponding tests have to be repeated and documented.
4.10. Approval for the IQ
Yes No
The system is approved according to the Installation Qualification.
Q/A Manager or Rep: _______________________ Date: __________________
12
5. Operation Qualification ( OQ )
The Operation Qualification verifies the function and proper operation of the system.. All data will be
recorded as indicated in the following pages.
5.1. Operation evaluation of the system

Purpose:
To ensure that all operating parameters function as defined in the system owner s manual.
Operation parameters include:
Display of operation mode

Flow rates product water
Measurement temperature and conductivity verification
Display of operation
The operation mode will be displayed in the status line on the screen of the system ( see operating
instructions ). All important functions can be checked here. The activation of valves, pumps and the
UV oxidation chamber will be displayed by a hash mark below the corresponding symbol.
Display and operation verification: :
OP mode The system is in operation (see owners manual).
ST V1 V2 V3 P1 P2 UV El-Ion (Function confirmed ( Yes/No)

OP
Note: V1, V2, V3, El-Ion without function
Flow rate product water
Determine the flow rate of the product water. See flow meter FlS 6.1
Note: All measuring devices, installed in the system, are certificated. The certificates are attached at
the appendix of this document. All systems should have been adjusted and functioning properly
before the OQ validation study began. However, the system may need further adjustment to
ensure proper function. Adjust unit as or if needed to ensure proper function. See owners
manual.
Reporting of the measured values
Parameters Nominal Data Measured Data Specification fulfilled

Yes No
Product water flow rats 570 630 l/h
13
Measurement temperature and conductivity verification
The Calibration of the meter is done by the factory. Only the conductivity and temp should be checked
for accuracy with a reference meter and reported. Calibration should only be done if the system fails.
Note: The procedure of calibration is attached at the appendix of this document.
Criteria of Acceptance:
The deviation of the temperature measurement should be maximum 2% *) of the reading.
If the deviation is smaller there are no setting changes needed.
Temperature Reference Measurement
Data before adjustment Data after adjustment

Measurement RO Controller C C
Reference Measurement C C
Deviation % %
Carry out a reference measurement of the conductivity and enter the readings into the following table.
The adjustment of the conductance will be effected by changing the sensor constant LF2 in the service
menu.
Criteria of Acceptance:
The deviation of the conductivity measurement should be maximum 3% *) of the reading.
If the deviation is smaller there are no setting changes needed.
Tab. Conductivity Measurement

Data before adjustment Data after adjustment
Display LF2 RO Controller S/cm S/cm
Reference Measurement S/cm S/cm
Deviation % %
*) The deviation of the temperature and conductivity measurement results from the total of the
deviations of the control electronics, the measuring sensors and temperature compensation.
5.2 Summary of the Operational check
Parameter Acceptance criterium Yes No

All functions of the system electronic are
Display of the operation mode checked and the system operates
successful.
The flow rates correspond with the
Flow rate product water specifications.
Measurement temperature and The temperature measuring and the

conductivity verification conductivity measuring are checked and in
tolerance.
14
Comments:
Result :
Yes No
The system has passed all IQ requirements.
Validation appointee: _______________________ Date: __________________
Approved: _______________________ Date: __________________
15
5.3. Report of the result
No differences or errors are found during the Operation Qualification. The

Operation Qualification is successfully. According to the Operation Qualification is
the system approved.
Small differences or errors are found during the Operation Qualification. The
differences and errors are documented. In spite of this differences and errors is the
system according to the Operation Qualification approved.
Considerable differences or errors are found during the Operation Qualification.
The system is not approved according to the Operation Qualification. The
corresponding tests have to be repeated and documented.
5.4. Approval for the OQ
Yes No
The water purification system is approved fort he production.
Validation Representative: _______________________ Date: ___________________
Approvedr: _______________________ Date: ___________________
16

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IQ / OQ

Ultra-pure water system

Tested system: UF 600 UV Ultra-pure water system

Procedure: The IQ/OQ for the listed water purification system is

Result: All test requirements listed are accomplished and complete..

Confirmed by: ____________________ Date:________________

Only the original document is valid!

SG Wasseraufbereitung und Regenerierstation GmbH

System Location: _________________________________________

This document is designed to comply with

2. Approval of the IQ OQ protocol

Company and division Name and title Signature Date

2.1. Assignment of the responsible persons

Company and division Name and title Signature Date

3.1. Flow sheet check

Validation Representative: _______________________ Date: __________________

Q/A Manager or Repr: _______________________ Date: __________________

4.1. List of the test devices and the reference instruments

Validation Representative: _______________________ Date: __________________

Q/A Manager or Representative: _______________________ Date: __________________

Model UC 600 UV Yes No

Pressure min / max. 1-6 [bar]

Temperature max. 35 [C]

Flow rate 600 [l/h]

Electrical connection 230 V, 50 Hz

Power input 1,5 [kW]

Article no. 20253-600

Software version V 1.39

Flow Article No. of Available

F6.4 Rinsing valve 04990 1

Validation Representative: _______________________ Date: __________________

Q/A Manager or Rep: _______________________ Date: __________________

Operating instructions Yes No

IQOQ documentation / register 6 Yes No

Certificate flow meter Yes No

Certificate conductivity cell 1 Yes No

Certificate conductivity cell 2 Yes No

The system documentation is correct and available. Yes No

Validation Representative: _______________________ Date: _________________

Q/A Manager or Rep: _______________________ Date: _________________

Validation representative: _______________________ Date: __________________

Q/A Manager or Repr: _______________________ Date: __________________

Validation representative: _______________________ Date: __________________

Q/A Manager or Repr: _______________________ Date: __________________

Validation representative: _______________________ Date: _______________________

Approved: _______________________ Date: _______________________

List of menu basis setting

First press key MENU

Menu setting Data Press button

Validation Representative: _______________________ Date: _________________

Q/A Manager or Rep: _______________________ Date: _________________

chapter Check carried out, no deviants existing. Yes No

4.1 List of the test and reference measuring devices

4.2 Identification of the system and the consumables

4.3 Documentation is correct and complete

4.4 System check for damages

4.5 Operation conditions / requirements

4.6 Check of the Installation of the systems

4.7 Menu settings of the system

4.9. Report of the result

No differences or errors are found during the Installation Qualification. The

4.10. Approval for the IQ

Validation Representative: _______________________ Date: __________________

Confirmed by: ____ Date:

Validation Representative: _____ Date:

Q/A Manager or Repr: _____ Date:

Validation Representative: _____ Date:

Q/A Manager or Representative: _____ Date:

Validation Representative: _____ Date:

Q/A Manager or Rep: _____ Date:

Validation Representative: _______ Date: _

Q/A Manager or Rep: _______ Date: _

Validation representative: _____ Date:

Q/A Manager or Repr: _____ Date:

Validation representative: _____ Date:

Q/A Manager or Repr: _____ Date:

Validation representative: _ Date: _

Approved: _ Date: _

Validation Representative: _______ Date: _

Q/A Manager or Rep: _______ Date: _

Validation Representative: _____ Date:

Q/A Manager or Rep: _____ Date:

Validation appointee: _____ Date:

Approved: _____ Date:

Validation Representative: _____ Date: _

Approvedr: _____ Date: _