Download IQ Purified Water PDF

TitleIQ Purified Water
File Size615.5 KB
Total Pages127
Table of Contents
                            TABLE OF CONTENTS
PURPOSE AND OBJECTIVE(S)
BACKGROUND
SCOPE
REFERENCES
RESPONSABILITIES
	Validation Specialist
	Quality Dept.
	Facility Dept.
METHODOLOGY
	Verification Data Sheet
	Deviation Report
	Signature Log Sheet
	Test Instruments Calibration
EQUIPMENT/PROCESS DESCRIPTION
	Water Softener
	Ozone Generator
	Reverse Osmosis
	Mixed Bed
	Ozone Destructor
	De-gasifier
	UV lights
	Filters
	Distribution Pumps
	Tanks
 6, 000 and 8, 000 Gal. Tanks
 30 um filters (2)
 Distribution Pumps (4)
 1 um filters (4)
 Dual Reverse Osmosis unit
 0.2 um filters (4)
 Dual Mix Bed unit
 Dual Softener unit
 UV lamps (4)
 Ozone Generator
 Degasification unit
 Ozone Destructor
 Microza filters (18)
APPENDIX I: DEVIATION REPORT
APPENDIX II: SIGNATURE IDENTIFICATION LOG SHEET
APPENDIX III: TESTING INSTRUMENTS LOG SHEET
IQ CHECKLIST VERIFICATION
                        
Document Text Contents
Page 1

INSTALLATION QUALIFICATION PROTOCOL


For the


NEW PURIFIED WATER SYSTEM


Prepared by



____________________________________

Page 2

TABLE OF CONTENTS
1.0 PURPOSE AND OBJECTIVE(S) .................................................................................................................................... 4

2.0 BACKGROUND .............................................................................................................................................................. 4

3.0 SCOPE ........................................................................................................................................................................... 4

4.0 REFERENCES ............................................................................................................................................................... 4

5.0 RESPONSABILITIES ...................................................................................................................................................... 5

5.1 Validation Specialist ................................................................................................................................................... 5

5.2 Quality Dept. ............................................................................................................................................................... 5

5.3 Facility Dept. ............................................................................................................................................................... 5

6.0 METHODOLOGY ............................................................................................................................................................ 6

6.1 Verification Data Sheet ............................................................................................................................................... 6

6.2 Deviation Report ......................................................................................................................................................... 6

6.3 Signature Log Sheet ................................................................................................................................................... 6

6.4 Test Instruments Calibration ....................................................................................................................................... 6

7.0 EQUIPMENT/PROCESS DESCRIPTION ....................................................................................................................... 7

7.1 Water Softener ........................................................................................................................................................... 7

7.2 Ozone Generator ........................................................................................................................................................ 7

7.3 Reverse Osmosis ....................................................................................................................................................... 7

7.4 Mixed Bed................................................................................................................................................................... 7

7.5 Ozone Destructor ....................................................................................................................................................... 7

7.6 De-gasifier .................................................................................................................................................................. 8

7.7 UV light ....................................................................................................................................................................... 8

7.8 Filter ........................................................................................................................................................................... 8

APPENDIX I: DEVIATION REPORT .......................................................................................................................................... 11

APPENDIX II: SIGNATURE IDENTIFICATION LOG SHEET .................................................................................................... 12

APPENDIX III: TESTING INSTRUMENTS LOG SHEET ........................................................................................................... 13

IQ-01 EQUIPMENT VERIFICATION .......................................................................................................................................... 15

IQ-02 DOCUMENT INVENTORY VERIFICATION .................................................................................................................... 37

IQ-03 DRAWING VERIFICATION .............................................................................................................................................. 56

IQ-04 SYSTEM DESIGN VERIFICATION .................................................................................................................................. 58

IQ-05 PLACEMENT VERIFICATION ......................................................................................................................................... 60

IQ-06 UTILITY VERIFICATION .................................................................................................................................................. 67

IQ-07 INSTRUMENTATION VERIFICATION ............................................................................................................................. 86

IQ-08 MAINTENANCE VERIFICATION ..................................................................................................................................... 88

IQ-09 SAFETY & ERGONOMICS VERIFICATION .................................................................................................................. 107

IQ-10 PROCEDURE VERIFICATION ...................................................................................................................................... 109

IQ CHECKLIST VERIFICATION .............................................................................................................................................. 127

Page 63

PLACEMENT VERIFICATION IQ-05


SKID #3 - Distribution Pumps 1A, 1B ; UV lamps 1A, 1B & Filter set 3A, 3B


SPEC EXPECTED RESULT ACTUAL RESULT PASS/FAIL
PERFORMED

BY/DATE

Position
The equipment shall

be located along open
type waste drains.



Environment
The equipment is not

placed on direct
sunlight or other
sources of heat.



Comments/Observations:

Conformance to the acceptance criteria was evaluated and the final determination is as follows:
Acceptance Criteria met? (YES/NO) __________ If NO, refer to Deviation # __________

Reviewed by: Date:

Page 64

PLACEMENT VERIFICATION IQ-05


SKID #4 - R. O. Piping/Valves


SPEC EXPECTED RESULT ACTUAL RESULT PASS/FAIL
PERFORMED

BY/DATE

Position
The equipment shall

be located along open
type waste drains.



Environment
The equipment is not

placed on direct
sunlight or other
sources of heat.



Comments/Observations:

Conformance to the acceptance criteria was evaluated and the final determination is as follows:
Acceptance Criteria met? (YES/NO) __________ If NO, refer to Deviation # __________

Reviewed by: Date:

Page 126

PROCEDURE VERIFICATION IQ-10


Microza “ultra filtration” filters


SOP
EXPECTED

RESULT
ACTUAL RESULT

(DOC. NO., REV. NO., TITLE, STATUS)
PASS/FAIL

PERFORMED
BY/DATE

Operating
Procedure

A procedure
exists at least in

Draft form.


Maintenance
Procedure

A procedure
exists at least in

Draft form.


Comments/Observations:

Conformance to the acceptance criteria was evaluated and the final determination is as follows:
Acceptance Criteria met? (YES/NO) __________ If NO, refer to Deviation # __________

Reviewed by: Date:

Page 127

IQ CHECKLIST VERIFICATION


Verify each of the respective IQ tests and document completion and status.


TEST
NUMBER TEST TITLE

TEST
EXECUTED
(YES/NO)

ACCEPTANCE
CRITERIA

MET?
(YES/NO)

DEVIATION
NUMBER

(if applies)

DEVIATION
SOLVED

(YES/NO)

IQ-01 EQUIPMENT VERIFICATION

IQ-02 DOCUMENT INVENTORY VERIFICATION

IQ-03 DRAWING VERIFICATION

IQ-04 SYSTEM DESIGN VERIFICATION

IQ-05 PLACEMENT VERIFICATION

IQ-06 UTILITY VERIFICATION

IQ-07 INSTRUMENTATION VERIFICATION

IQ-08 MAINTENANCE VERIFICATION

IQ-09 SAFETY AND ERGONOMICS VERIFICATION

IQ-10 PROCEDURE VERIFICATION

Performed by: Date:

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