iq / oq installation / operation qualification protocol iqoq uc 6… · table of content 1....

SG Wasseraufbereitung und Regenerierstation GmbHGermany

Tel.: ++49(0)40/670868-6 * Fax.: ++49(0)40/670868-44www.sgwater.de * e-mail: [email protected]

IQ / OQInstallation / OperationQualification Protocol

Ultra-pure water systemUF 600 UV

Order No.:

Tested system: UF 600 UV Ultra-pure water system

Procedure: The IQ/OQ for the listed water purification system isaccomplished utilizing the information contained in thisdocument.

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

Confirmed by: ____________________ Date:________________ Quality manager or authorized representative QM

Only the original document is valid!

Customer Name: _________________________________________

Address: _________________________________________

_________________________________________

System Location: _________________________________________

This document is designed to comply with21 CFR, 210/211 GMP and Annex 15, EG-GMP

Table of content1. Introduction ......................................................................................................................................12. Approval of the IQ OQ protocol.................................................................................................1

2.1. Predefinition of the responsible persons .......................................................................................13. Installation Qualification ( IQ ) ...................................................................................................2

3.1. Flow sheet UF 600 UV Ultra pure water system...........................................................................43.2. Functionality ..................................................................................................................................43.3. List of the test devices and the reference devices ........................................................................43.4. Identification of the system and the consumables ........................................................................53.5. Check of the documentation regarding correctness and completely ness....................................73.6. Check of the system and the components against damages .......................................................83.7. Check of the operation conditions and operation requirements....................................................93.8. Installation check of the system ..................................................................................................103.9. Settings in the menu of the system electronic.............................................................................113.10. Result of the Installation Qualification .......................................................................................123.11 Report of the result .....................................................................................................................123.12 Approval for the IQ .....................................................................................................................12

4. Operation Qualification ( OQ ) .................................................................................................134.1. Function check of the system......................................................................................................134.2. Total pyrogen amount and total germ amount in the product waterFehler! Textmarke nichtdefiniert.4.3. Report of the result ......................................................................................................................164.4. Approval for the OQ ...................................................................................................................16

1SG Wasseraufbereitung und Regenerierstation GmbH * Fahrenberg 8 * 22885 Barsbu ttel

Telefon ++49 (40) 67 08 68-6 * Telefax ++49 (40) 67 08 68-44 * [email protected] * www.sgwater.de

1. Introduction

The Installation Qualification and Operation Qualification (IQ / OQ ) documents that the deliveredsystem 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 andOperation Qualification will be approved by the responsible QA division or specified representative ofthe customer. .The person or persons listed will review the documentation to ensure all items arecomplete.

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 thecompany SG Wasseraufbereitung und Regenerierstation GmbH. Assignment of the executing andtesting persons.

Company and division Name and title Signature Date



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 markcomponents in table.

Acceptance criteria:Al components are available.

List of components

AvailableComponents

Yes NoV6.1 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:



Declaration:

Al components are available.Yes

No

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 pretreatedfeed water source.The feed water flows through the inlet of the system into the UV chamber (UV6.1). The water flowsinto an activated carbon filter (F6.1) after is has passed the UV chamber. This filter removes particlesfrom a size of 5°m, free chlorine and/or organic materials.Water passes from the activated carbon filter into the polishing cartridges (F6.2). These cartridges arefilled with high grade mixed bed deionizer resins of semiconductor quality. The polishing cartridges aredesigned to remove the final trace level of salts and produce reagent water with a conductivity of 0,055°S/cm ( 18,2 MΩ ).After the polishing cartridges the water flows into an ultra-filtration modules (F6.3). The function of theUF 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 watercan be monitored (E1). The measured valves in °S/cm or M are displayed on the screen of thesystem.The final sterile filter (F6.4) removes particles from a size of 0.2°m from the water. The water flows tomembrane 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 pumprecirculates the water back into the UV chamber if water is not being drawn. if .



4. Installation Qualification ( IQ )

The Installation Qualification is performed after the installation of the system. The IQ documents thecorrect installation and confirms that the unit is installed in accordance with the operating instructionsor 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 mustbe calibrated before starting the tests. The calibration must be effected and confirmed by themanufacturer of the measuring device or by an authorized measuring laboratory. A calibration must beperformed once a year. The calibration protocol has to be attached to the IQOQ protocol.

Measuring devices Test criteria Range Precision Lastcalibration

Nextcalibration

Conductivity meter Conductivity°S/cm 0,0 ..... 1999 ± 2,0 %

Temperature sensor TemperatureC– -5 ..... 100 ± 4,0 %

Comments:

The reference devices are complete and calibrated Yes

No


Q/A Manager or Representative: _______________________ Date: __________________



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.

Acceptance criteria: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



List of the consumables necessary for operation

AvailableFlowsheet No Consumable Article

No.No. ofpieces Yes No

UV 6.1 UV lamp 08767-115 1

F6.1 Active carbon filter 87040-75342 1

F6.2 Deionizer cartridge 10184-75342 1

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 thespecifications.

Yes

No


Q/A Manager or Rep: _______________________ Date: __________________



4.3. Documentation check

Purpose:To ensure that documentation is correct and complete. .

Acceptance criteria:The documentation is correct and complete.

Purpose: To ensure that the owners manual and/or any other required documents are present. .

List documentsDocuments 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: _________________



4.4. System check for damages

Puropse:Check system against damage.

Method:Visual check of all components and consumables

Acceptance criteria:No damage visable.

Comments:

Result:

The systems, components and the consumables are free of visible damage Yes

No

Validation representative: _______________________ Date: __________________




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 pressuregauge for loop.)

SpecificationfulfilledRequirement Specification Measured data

Yes NoAmbient 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:

The operation conditions and operation requirements are in specificationYes

No

Validation representative: _______________________ Date: __________________




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.

SpecificationfulfilledRequirement Specification

Yes NoFloor 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 operationinstructions established?

Comments:

Result :

The installation of the water purification system is complete and correct.. Yes

No

Validation representative: _______________________ Date: _______________________

Approved: _______________________ Date: _______________________



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 operatinginstructions.

Acceptance criteria:All menu settings are in compliance with the SG test protocol.

List of menu basis setting

First press key MENUReturn to operating mode press key MENU

Menu setting DataCorrect

Press button

Language english Yes No ENTERDisplay range °S/cm or MΩ °S/cm Yes No ENTERDate / time - Yes No MENULimit CON 1 5,0 °S/cm Yes No ENTERLimit CON 2 0,2 °S/cm Yes No ENTER

Comment:

Completion declaration:

All menu settings are in compliance with the SG test protocol Yes

No

Validation Representative: _______________________ Date: _________________

Q/A Manager or Rep: _______________________ Date: _________________



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. TheInstallation Qualification is successfully. According to the Installation Qualification isthe system approved.

Small differences or errors are found during the Installation Qualification. Thedifferences and errors are documented. In spite of this differences and errors is thesystem 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. Thecorresponding tests have to be repeated and documented.

4.10. Approval for the IQ

The system is approved according to the Installation Qualification. Yes

No


Q/A Manager or Rep: _______________________ Date: __________________



5. Operation Qualification ( OQ )

The Operation Qualification verifies the function and proper operation of the system.. All data will berecorded 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 owners manual.Operation parameters include:

Display of operation modeFlow rates product waterMeasurement temperature and conductivity verification

Display of operation

The operation mode will be displayed in the status line on the screen of the system ( see operatinginstructions ). All important functions can be checked here. The activation of valves, pumps and theUV 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 atthe appendix of this document. All systems should have been adjusted and functioning properlybefore the OQ validation study began. However, the system may need further adjustment toensure proper function. Adjust unit as or if needed to ensure proper function. See ownersmanual.

Reporting of the measured values

Specification fulfilledParameters Nominal Data Measured DataYes No

Product water flow rats 570 ’ 630 l/h



Measurement temperature and conductivity verification

The Calibration of the meter is done by the factory. Only the conductivity and temp should be checkedfor 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 adjustmentMeasurement RO Controller –C –CReference 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 servicemenu.

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 MeasurementData before adjustment Data after adjustment

Display LF2 RO Controller °S/cm °S/cmReference Measurement °S/cm °S/cm

Deviation % %

*) The deviation of the temperature and conductivity measurement results from the total of thedeviations of the control electronics, the measuring sensors and temperature compensation.

5.2 Summary of the Operational check

Parameter Acceptance criterium Yes No

Display of the operation modeAll functions of the system electronic arechecked and the system operatessuccessful.

Flow rate product waterThe flow rates correspond with thespecifications.

Measurement temperature andconductivity verification

The temperature measuring and theconductivity measuring are checked and intolerance.



Comments:

Result :

The system has passed all IQ requirements. Yes

No

Validation appointee: _______________________ Date: __________________

Approved: _______________________ Date: __________________



5.3. Report of the result

No differences or errors are found during the Operation Qualification. TheOperation Qualification is successfully. According to the Operation Qualification isthe system approved.

Small differences or errors are found during the Operation Qualification. Thedifferences and errors are documented. In spite of this differences and errors is thesystem 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. Thecorresponding tests have to be repeated and documented.

5.4. Approval for the OQ

The water purification system is approved fort he production. Yes

No

Validation Representative: _______________________ Date: ___________________

Approvedr: _______________________ Date: ___________________