IQ Purified Water

(1)

INSTALLATION QUALIFICATION PROTOCOL

For the

NEW PURIFIED WATER SYSTEM

Prepared by

(2)

REVISION HISTORY

(4)

1.0 PURPOSE AND OBJECTIVE(S)

This protocol (___) intends to provide documented evidence that the new Purified Water System

was installed according to manufacturer’s specifications and _ _ requirements.

This Installation Qualification will provide documented evidence that all key aspects of the Purified

Water System equipment’s assembly and its auxiliary systems is as intended by manufacturer

design and in accordance to ___’s requirements.

At the end of the execution activities, a final report will be developed with a summary of the

executed tests results and the recommendation(s) necessary for the Installation Qualification.

Potential risks involved with the new Purified Water System installation when connected to the

manufacturing processes has already being evaluated by Risk Assessment PLS 0410.

2.0 BACKGROUND

In order to meet the new purified water utility demands at _ I in _ _, _ ___, a new purified

water system was purchased to replace the existing system. It is expected that this new purified

water system will increase the supply to up to 100 GPM. Additionally, it is intended to produce a

water quality that meets or exceeds current Purified Water USP and EP standards.

3.0 SCOPE

This protocol applies to the new equipment and auxiliary components that constitute the Purified

Water System, installed at _ in _ _, _ ___

4.0 REFERENCES

(5)

5.0 RESPONSABILITIES

5.1 Validation Specialist

• Prepare the documents that are applicable to the Validation exercise

• Coordinate efforts and resources, along with Facilities Dept., to perform the Validation

exercise

• Execute and collect the verification data for the Validation protocol

• Verify data against Acceptance Criteria and initiate deviation, as applicable

• Investigate, justify, and correct any deviation encountered during Validation execution

• Prepare validation Final Report

5.2 Quality Dept.

• Evaluate with the originator the extent of the validation required

• Review and approve documents for the validation exercise

• Review and approve validation activities for compliance and adherence to ___’s policies,

practices, and procedures

• Check that the collected data meets the acceptance criteria and that all the deviations (if

applicable) are properly resolved

• Once executed, review any deviations generated to confirm that investigation and

resolutions are complete

• Cooperate with Validation Specialist to investigate, justify, and correct any deviation

encountered during Validation execution

• Review and approve Final Report

• Maintain original validation documentation, except for drawings and equipment manuals

that will remain in the equipment information files

• Store the Validation Package in a designated filing area

5.3 Facility Dept.

• Review and approve documents for the validation exercise

• Coordinate efforts and resources to perform the validation activities

• Supply documentation and tools needed for the protocol execution

• Provide training in this protocol to all employees involved (internal and external) during the

execution of this protocol and ensure that all signatures are collected on Signature Log

Sheet

• Assist to document, investigate, justify, and correct any deviation encountered during the

IQ protocol execution

(6)

6.0 METHODOLOGY

6.1 Verification Data Sheet

All data resulting from test execution will be entered in Verification Data Sheets that will

pre-define the objective(s) to be attained with the verification, the procedure that will be followed

to reach such objective(s), the reference material to be used, and the criteria to evaluate as

to accept or not the testing results. All data entry will be properly signed and dated by the

executor in the “Performed By” and “Date” spaces. In cases where a Field Verification is

requested, a “Fail” condition will be applied to unverifiable information.

The comments/observations section included in each Data Collection Form will be used to

describe any additional information considered of importance for describing the validated

condition and/or discrepancies and resolution activities produced during the execution. The

comments/observations included must be signed or initialed and dated.

When the test execution is finished, a subject matter expert will sign and date on the

“Reviewed by” and “Date” spaces respectively, to state the completeness and correctness of

the data.

6.2 Deviation Report

The following deviations must be documented using the Deviation Report Form attached to

this protocol:

• Results invalidated and/or not in compliance with their pre-established Acceptance Criteria

• Testing procedure and/or sampling plan not followed or that could not be completed as

planned

These deviations will be handled as per _ _ PR

The investigation process due to deviated sampling results will be handled by contract

laboratory, following their own investigation procedures. These incidents will be informed to

who oversees the validation project in _ _, ___ PR, which in turn will open a deviation

report to follow the lifecycle of the investigation and to implement any possible changes due

to investigation resolution.

Typographic, text edit and syntax errors will be documented as such in the “Comments”

section under the corresponding test script, and considered as a minor issue that may not

invalidate a test or become cause for writing a deviation report. These will be explained in the

Final Report.

6.3 Signature Log Sheet

Each individual who signs or initials any page included in this protocol shall be identified

using the Signature Log Sheet by type/printed name, full signature, written initials and

department represented.

(7)

7.0 EQUIPMENT/PROCESS DESCRIPTION

Purified Water

▲

is water obtained by distillation, ion-exchange treatment, reverse osmosis, and

other suitable processes. It is prepared from water complying with the regulations of U.S.

Environmental Protection Agency (EPA) with respect to drinking water. It contains no added

substances.

The Purified Water system includes the following equipment, along with associated components:

• 30 um filters (2) • 6, 000 and 8, 000 Gal. Tanks

• 1 um filters (4) • Distribution Pumps (4)

• 0.2 um filters (4) • Dual Reverse Osmosis unit

• Dual Softener unit • Dual Mix Bed unit

• Ozone Generator • UV lamps (4)

• Ozone Destructor • Degasification unit

• Microza filters (18)

7.1 Water Softener

The Water Softener reduces the levels of calcium and other scale creating elements from the

process stream. Water softeners also remove aluminum, copper and other trace metals. The

removal process occurs by ion exchange. The softener vessel is filled with sodium form cation

resin. The calcium, magnesium, barium, strontium, and other ions removed by the resin are

replaced with sodium ions. The cation resin has a fixed capacity for ion removal and must be

regenerated when that capacity has been exhausted.

7.2 Ozone Generator

The Ozone Generator is employed to produce the Ozone used to sanitize the Softened Water

that passes through to the 6,000 Gallon Tank.

7.3 Reverse Osmosis

The Reverse Osmosis unit processes water by means of semi-permeable membranes, which

allow pressurized water to freely pass through the membranes, but almost totally reject

dissolved and suspended substances in the feed water.

7.4 Mixed Bed

The Mixed Bed de-mineralizes water by using the ion exchange process. The influent water

passes through a bed of Cation and Anion resin that are intimately mixed. The mixed bed

configuration functions similarly to a two-bed configuration in regards to the ion exchange

process; however, it is much more efficient and therefore produces water of much greater

(8)

7.6 De-gasifier

De-gasifier membranes are employed to reduce the oxygen level of the water. Membrane

contactors make it possible to transfer gas from an aqueous stream without dispersion. By

virtue of surface tension, the water on one side of the membrane is exposed to the gas side of

the membrane with no liquid transfer, providing a large surface area for gas/liquid contact and

transfer. Dissolved O

2

passes from the water surface into the gas side by diffusion and is

swept out by a combined vacuum/air flow.

7.7 UV lights

Ultraviolet lamps produce UV-C (germicidal UV), which is a radiation that when harmful

microbes are exposed to the UV rays, scrambles the DNA structure of the organism,

rendering it sterile and can no longer reproduce.

Almost all of a UV lamp’s output is concentrated in the 254 nanometers (nm) region in order to

take full advantage of the germicidal properties of this wavelength. The lamp is mounted such

that water passing through a flow chamber is exposed to the UV-C light rays.

7.8 Filters

At the first stage, the raw water enters a 30 µm pre-filter to trap any heavy sediment before it

enters the softeners. The 1 µm filters will act as a resin trap and removes suspended from the

softeners. The absolute 0.2 micron rated filters significantly enhances the water quality with its

capacity to remove the majority of microorganisms. The Microza ultra filters that are at the end

of the purified water system uses fiber hollow technology that will remove endotoxins and

viruses.

7.9 Distribution Pumps

Two pairs of distribution pumps will provide constant flow of the processed water throughout

the Purified Water System pipelines. Although its functionality will not contribute directly to the

processing of Purified Water, by providing a constant flow will indeed significantly reduce the

chances of microbial growth due to stagnant water.

7.10 Tanks

Two storage tanks will provide storage capacity to the Purified Water System. A 6,000 gallon

tank will store ozone-treated softened water that will supply constant feed to the dual R.O.

unit, while an 8,000 gallon tank will store water post reverse osmosis and de-ozonization

treatment, which will supply constant feed to the main loop.

(9)

With this configuration in place, a Purified Water (USP, EP) quality is intended to be achieved through the following processes:

• Filtration (by means of 30 um filters, 1 um filters, 0.2 um filters, and R.O. Unit, and “Microza” filters)

• Ion exchange (by means of Softener and Mix Bed)

• Sanitation (by means of Ozone Injection and UV light radiation)

• Degasification (by means of a de-gasifier unit)

(10)

(11)

DEVIATION DESCRIPTION

Deviation reported by:_________________________________ Date: _________________ ENGINEERING INVESTIGATION

Attach additional pages, if necessary

Root Cause:

□

Manpower

□

Methods

□

Equipment

□

Materials

□

Environment

CORRECTIVE / PREVENTIVE ACTION

Evaluation performed by:____________________________________ Date: _________________ Testing required after Corrective action implemented? (YES/NO) ______________

Test results (PASS/FAIL/NA) ________________

APPENDIX I: DEVIATION REPORT

Deviation Number: _________________ Test Description/Test Number:

(12)

APPENDIX II: SIGNATURE IDENTIFICATION LOG SHEET

This sheet is intended to record each individual who takes part of the execution process and is not

included in the front page. The scope of this sheet applies to anyone who signs or initials any page

included in the attached qualification documents. Each person shall be identified by typed or printed

name, full signature, written initials, and department represented.

(13)

APPENDIX III: TESTING INSTRUMENTS LOG SHEET

This sheet is intended to record all field test instrument that assists in the execution process.

INSTRUMENT ID DESCRIPTION TEST ID CALIBRATION

DATE/DUE DATE COPY OF CERTIFICATE ATTACHED? (YES/NO) PERFORMED BY/DATE

(14)

VERIFICATION DATA SHEETS

INSTALLATION QUALIFICATION

(15)

MAIN COMPONENT VERIFICATION

IQ-01

Objective:

• Assure that all main and auxiliary components of the Purified Water System are as per

manufacturer/vendor specifications (Manuals, Spec sheets, P & ID’s, etc.)

Pr

a. Per equipment, collect and document the required information thru physical inspection (tag,

engrave, plate, sticker, etc)

ocedure:

b. Evaluate findings against specifications

References Required:

• Note: Vendor/Manufacturer documentation (Manuals, Spec sheets, P & ID’s, etc.) does not

count as “Actual Result” reference

Acceptance Criteria:

(16)

MAIN COMPONENT VERIFICATION

IQ-01

Filter set 1A & 1B

SPEC EXPECTED

RESULT ACTUAL RESULT PASS/FAIL

PERFORMED BY/DATE 1A Tag ID Cartridge Manufacturer Cartridge Part No. Housing Manufacturer Housing Part No. Quantity 1B Tag ID Cartridge Manufacturer Cartridge Part No. Housing Manufacturer Housing Part No. Quantity Comments/Observations:

(17)

MAIN COMPONENT VERIFICATION

IQ-01

(18)

MAIN COMPONENT VERIFICATION

IQ-01

(19)

MAIN COMPONENT VERIFICATION

IQ-01

(20)

MAIN COMPONENT VERIFICATION

IQ-01

Filter set 5A & 5 B

(21)

MAIN COMPONENT VERIFICATION

IQ-01

Ozone Generator

PERFORMED BY/DATE Tag ID Manufacturer Model Serial No. B oos te r pu m p Tag ID Manufacturer Model Serial No. R eci rcu lat io n p u m p Tag ID Manufacturer Model Serial No. Comments/Observations:

(22)

MAIN COMPONENT VERIFICATION

IQ-01

Ozone Destructor

PERFORMED BY/DATE Tag ID Manufacturer Model Serial No. U V l ight Tag ID Manufacturer Model Serial No. Comments/Observations:

(23)

MAIN COMPONENT VERIFICATION

IQ-01

Dual Softener unit

PERFORMED BY/DATE Un it A Tag ID Manufacturer Model Serial No. Un it B Tag ID Manufacturer Model Serial No. C o n tr o l P a n e l Manufacturer Model R esi n Type Comments/Observations:

(24)

MAIN COMPONENT VERIFICATION

IQ-01

Dual Softener unit (Brine Tank)

PERFORMED BY/DATE Tag ID Manufacturer Model Serial No. Comments/Observations:

(25)

MAIN COMPONENT VERIFICATION

IQ-01

6,000 Gal. Tank

PERFORMED BY/DATE Tag ID Manufacturer Description V e n t F il te r Cartridge Manufacturer Cartridge Part No. Housing Manufacturer Housing Part No. L evel Manufacturer Part No. Comments/Observations:

(26)

MAIN COMPONENT VERIFICATION

IQ-01

Distribution Pumps (1A, 1B)

PERFORMED BY/DATE 1A Tag ID Manufacturer Model Serial No. 2A Tag ID Manufacturer Model Serial No. Comments/Observations:

(27)

MAIN COMPONENT VERIFICATION

IQ-01

8,000 Gal. Tank

PERFORMED BY/DATE Tag ID Manufacturer Description V e n t F il te r Cartridge Manufacturer Cartridge Part No. Housing Manufacturer Housing Part No. L evel Manufacturer Part No. Comments/Observations:

(28)

MAIN COMPONENT VERIFICATION

IQ-01

PERFORMED BY/DATE 2A Tag ID Manufacturer Model Serial No. 2B Tag ID Manufacturer Model Serial No. Comments/Observations:

(29)

MAIN COMPONENT VERIFICATION

IQ-01

UV lamps (1A, 1B)

(30)

EQUIPMENT VERIFICATION

IQ-01

(31)

MAIN COMPONENT VERIFICATION

IQ-01

Dual Reverse Osmosis (Service unit A)

SPEC EXPECTED RESULT ACTUAL RESULT PASS/FAIL PERFORMED

BY/DATE Tag ID Manufacturer Model Serial No. Fe e d P um p Tag ID Manufacturer Model Serial No. A n ti scal an t D o s in g S yst em Tag ID Manufacturer Model Serial No. C ont rol P a ne l Manufacturer Model Comments/Observations:

(32)

MAIN COMPONENT VERIFICATION

IQ-01

Dual Reverse Osmosis (Service unit B)

BY/DATE Tag ID Manufacturer Model Serial No. Fe e d P um p Tag ID Manufacturer Model Serial No. A n ti scal an t D o s in g S yst em Tag ID Manufacturer Model Serial No. C ont rol P a ne l Manufacturer Model Comments/Observations:

(33)

MAIN COMPONENT VERIFICATION

IQ-01

Dual R.O. unit (Cleaning Skid)

BY/DATE Tag ID Manufacturer Model Serial No. C le a ni ng P um p Tag ID Manufacturer Model Serial No. Comments/Observations:

(34)

MAIN COMPONENT VERIFICATION

IQ-01

De-gasification unit

PERFORMED BY/DATE Tag ID Manufacturer Model Serial No. Pu m p Tag ID Manufacturer Model Serial No. Comments/Observations:

(35)

MAIN COMPONENT VERIFICATION

IQ-01

Dual Mixed Bed unit

PERFORMED BY/DATE Un it A Tag ID Manufacturer Model Serial No. Un it B Tag ID Manufacturer Model Serial No. C ont rol P a ne l Manufacturer Model Ac id & C au st ic Type Comments/Observations:

(36)

MAIN COMPONENT VERIFICATION

IQ-01

Microza “ultra filtration” filters

PERFORMED BY/DATE Tag ID Manufacturer Part No. Serial No. Comments/Observations:

(37)

DOCUMENT INVENTORY VERIFICATION

IQ-02

Objective:

• Assure that all the basic literature required for the system operation/maintenance of the Purified

Water system is available and properly stored

Pr

a. Per equipment, collect all related documentation

ocedure:

b. Document all relevant information according to “Document Info” column

c. If any of the “document type” is not applicable, write an Not Apply to the “Document Info”

column and explain in the “Comments/Observations” section

References Required:

• Manufacturer’s Documentation - Installation and Operational Manuals, Wiring Diagrams, Spare

Parts List, P & ID’s, etc.

• Vendor’s Documentation - Purchase Order, etc.

Acceptance Criteria:

• At least the basic literature (see document type) was found for all equipment and was found to

be properly stored

(38)

DOCUMENT INVENTORY VERIFICATION

IQ-02

Filter set 1A & 1B DOCUMENT

TYPE

DOCUMENT INFO

(DOC #, TITLE, REV., LOCATION)

DOCUMENT STORAGE (LOCATION) PERFORMED BY/DATE Installation and Operation Manual Purchase Order Drawings P & ID’s Other Documents Comments/Observations:

(39)

DOCUMENT INVENTORY VERIFICATION

IQ-02

TYPE

DOCUMENT INFO

(40)

DOCUMENT INVENTORY VERIFICATION

IQ-02

TYPE

DOCUMENT INFO

(41)

DOCUMENT INVENTORY VERIFICATION

IQ-02

TYPE

DOCUMENT INFO

(42)

TYPE

DOCUMENT INFO

(43)

TYPE

DOCUMENT INFO

(44)

DOCUMENT INVENTORY VERIFICATION

IQ-02

Dual Softener unit DOCUMENT

TYPE

DOCUMENT INFO

DOCUMENT STORAGE (LOCATION) PERFORMED BY/DATE Installation and Operation Manual Purchase Order Electrical Drawings Mechanical Drawings P & ID’s PLC Software Backup & Report MSDS Other Documents Comments/Observations:

(45)

DOCUMENT INVENTORY VERIFICATION

IQ-02

6,000 Gal. Tank DOCUMENT

TYPE

DOCUMENT INFO

(46)

DOCUMENT INVENTORY VERIFICATION

IQ-02

Distribution Pumps (1A, 1B) DOCUMENT

TYPE

DOCUMENT INFO

DOCUMENT STORAGE (LOCATION) PERFORMED BY/DATE Installation and Operation Manual Purchase Order Electrical Drawings Mechanical Drawings P & ID’s Other Documents Comments/Observations:

(47)

DOCUMENT INVENTORY VERIFICATION

IQ-02

8,000 Gal. Tank DOCUMENT

TYPE

DOCUMENT INFO

(48)

DOCUMENT INVENTORY VERIFICATION

IQ-02

Distribution Pumps (2A, 2B) DOCUMENT

TYPE

DOCUMENT INFO

(49)

DOCUMENT INVENTORY VERIFICATION

IQ-02

Ozone Generator DOCUMENT

TYPE

DOCUMENT INFO

DOCUMENT STORAGE (LOCATION) PERFORMED BY/DATE Installation and Operation Manual Purchase Order Electrical Drawings Mechanical Drawings P & ID’s PLC Software Backup & Report Other Documents Comments/Observations:

(50)

DOCUMENT INVENTORY VERIFICATION

IQ-02

Ozone Destructor DOCUMENT

TYPE

DOCUMENT INFO

DOCUMENT STORAGE (LOCATION) PERFORMED BY/DATE Installation and Operation Manual Purchase Order Electrical Drawings P & ID’s PLC Software Backup & Report Other Documents Comments/Observations:

(51)

DOCUMENT INVENTORY VERIFICATION

IQ-02

UV lamps (1A, 1B, 2A, 2B) DOCUMENT

TYPE

DOCUMENT INFO

DOCUMENT STORAGE (LOCATION) PERFORMED BY/DATE Installation and Operation Manual Purchase Order Electrical Drawings P & ID’s Other Documents Comments/Observations:

(52)

DOCUMENT INVENTORY VERIFICATION

IQ-02

Dual Reverse Osmosis unit DOCUMENT

TYPE

DOCUMENT INFO

DOCUMENT STORAGE (LOCATION) PERFORMED BY/DATE Installation and Operation Manual Purchase Order Electrical Drawings Mechanical Drawing P & ID’s PLC Software Backup & Report MSDS Other Documents Comments/Observations:

(53)

DOCUMENT INVENTORY VERIFICATION

IQ-02

Degasification unit DOCUMENT

TYPE

DOCUMENT INFO

(54)

DOCUMENT INVENTORY VERIFICATION

IQ-02

Dual Mixed Bed unit DOCUMENT

TYPE

DOCUMENT INFO

DOCUMENT STORAGE (LOCATION) PERFORMED BY/DATE Installation and Operation Manual Purchase Order Electrical Drawings P & ID’s PLC Software Backup & Report Other Documents Comments/Observations:

(55)

DOCUMENT INVENTORY VERIFICATION

IQ-02

Microza “ultra filtration” filters DOCUMENT

TYPE

DOCUMENT INFO

DOCUMENT STORAGE (LOCATION) PERFORMED BY/DATE Installation and Operation Manual Purchase Order Electrical Drawings P & ID’s Other Documents Comments/Observations:

(56)

DRAWING VERIFICATION

IQ-03

Objective:

• Assure concordance between drawings (P & I D’s and Electrical Schematics, etc.) and field

installation of the Purified Water System

Pr

a. Collect and document the drawings found thru IQ - 02: “Document Inventory Verification”

ocedure:

b. Verify against field installation by performing a physical inspection and redline drawings, if

discrepancy occurs

c. Sign, date & submit discrepancies to Facilities Dept. for review

d. Upon review, determine if drawings and/or field installation needs to be updated

e. Attach verified drawings to this protocol

References Required:

• Process and Instrument Diagrams (P & I D’s)

• Electrical Schematics

Acceptance Criteria:

• Drawings match field installation and vice versa

• Discrepancies between drawings and field installation were satisfactorily resolved by submitting

changes and updating drawings and/or field installation

(57)

DRAWING VERIFICATION

IQ-03

Sheet ______ of ______

Use additional pages as necessary

DRAWING

TYPE & ID TITLE & REVISION

REDLINED? (YES/NO) UPDATE? (DWG, FLD, NA) PERFORMED BY/DATE Comments/Observations:

(58)

SYSTEM DESIGN VERIFICATION

IQ-04

Objective:

• Assure that the installation design is in compliance with the specified requirements for systems

capable of producing Purified Water

Pr

• Verify system installation as per specifications by performing a physical verification and/or

providing documented evidence

ocedure:

• Document findings and evaluate against expected results

Note: This verification is best performed during “Drawing Verification”

References Required:

• P & ID’s

• Material Safety Data Sheets

• Chemical Analysis Sheets

Acceptance Criteria:

(59)

SYSTEM DESIGN VERIFICATION

IQ-04

BY/DATE

Feed water

The raw water source supplied to the system must be from Well or City Water

Processing

The system contains equipment capable of performing Deionization and Reverse Osmosis or

Distillation.

Piping

Piping will provide constant circulation of Purified water. Piping does not have an unused portion greater in length than six diameters of the unused pipe measured from the axis of the pipe in use (dead leg).

Contact material

All material in direct contact shall be non-reactive to Purified Water. Comments/Observations:

(60)

PLACEMENT VERIFICATION

IQ-05

Objective:

• Assure that the equipments have the appropriate conditions to perform setup and maintenance

and to operate accordingly.

Pr

• Per equipment, verify field conditions by performing a physical inspection as per expected

results

ocedure:

• Document and evaluate findings against expected results

References Required:

• Skid Drawings

Acceptance Criteria:

(61)

PLACEMENT VERIFICATION

IQ-05

SKID #1 - Filter Set 1A, 1B

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.

(62)

PLACEMENT VERIFICATION

IQ-05

SKID #2 - Filter set 2A, 2B

BY/DATE

Position

Environment

(63)

PLACEMENT VERIFICATION

IQ-05

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

BY/DATE

Position

Environment

(64)

PLACEMENT VERIFICATION

IQ-05

SKID #4 - R. O. Piping/Valves

BY/DATE

Position

Environment

(65)

PLACEMENT VERIFICATION

IQ-05

SKID 5 - Pumps 2A, 2B

BY/DATE

Position

Environment

(66)

PLACEMENT VERIFICATION

IQ-05

SKID 6 - UV lamps 2A, 2B & Filter 4A, 4B

BY/DATE

Position

Environment

(67)

PLACEMENT VERIFICATION

IQ-05

SKID 7 - Filter set 5A, 5B

BY/DATE

Position

Environment

(68)

Water Softener Skid

BY/DATE

Position

Environment

(69)

Ozone Generator Skid

BY/DATE

Position

Environment

(70)

PLACEMENT VERIFICATION

IQ-05

Ozone Destructor Skid

BY/DATE

Position

Environment

(71)

R.O. Skid

BY/DATE

Position

Environment

(72)

R.O. Cleaning Skid

BY/DATE

Position

Environment

(73)

• Assure that the installed utility meets the Purified Water System requirements

Pr

•

Utility Verification

ocedure:

a. Per equipment, perform utility verification as per expected results by using a calibrated test

instrument (when required), and document results

b. Attach copy of instrument calibration certificate and ensure it is up to date

c. Ensure that each utility connection is properly labeled

• Electrical Verification

a. Perform verification as per Utility Verification thru a certified electrician

b. Attach copy of Electrician’s license and ensure it is up to date

Note: All readings will apply a ±10% tolerance

References Required:

• Test Instruments calibration certificates

• Copy of Electrician’s license

Acceptance Criteria:

• Utilities comply with expected results (manufacturer specifications)

• All calibrations/certifications are up to date

(74)

UTILITY VERIFICATION

IQ-06

Dual Softener unit ELECTRICAL

SPECS EXPECTED RESULT ACTUAL RESULT PASS/FAIL

PERFORMED BY/DATE Voltage Phase Amperage Frequency Panel ID

To be filled by a licensed electrician or electrical engineer with PE license

Does electrical installation comply with NEC standards? (YES/NO) _______________

Electrician signature: ____________________________ License Number: ____________________________

OTHER SPECS EXPECTED RESULT ACTUAL RESULT PASS/FAIL PERFORMED

BY/DATE Compressed Air

Chemical

(75)

UTILITY VERIFICATION

IQ-06

Ozone Generator ELECTRICAL

SPECS

EXPECTED

PERFORMED BY/DATE OZ -1 Voltage Phase Amperage Frequency Panel ID P -O Z 1 Voltage Phase Amperage Frequency Panel ID P -O Z 2 Voltage Phase Amperage Frequency Panel ID T ran sf o rmer Voltage Phase Amperage Frequency Panel ID

Electrician signature: ___________________________ License Number: ___________________________

OTHER SPECS EXPECTED

PERFORMED BY/DATE Compressed Air 90-110 psig

(76)

UTILITY VERIFICATION

IQ-06

Ozone Destructor ELECTRICAL

PERFORMED BY/DATE Voltage Phase Amperage Frequency Panel ID Bulb installation

Electrician signature: ____________________________ License Number: ____________________________

(77)

UTILITY VERIFICATION

IQ-06

UV lamps (1A, 1B) ELECTRICAL

Electrician signature: ____________________________ License Number: ____________________________ Comments/Observations:

(78)

UTILITY VERIFICATION

IQ-06

UV lamps (2A, 2B) ELECTRICAL

Electrician signature: ____________________________ License Number: ___________________________ Comments/Observations:

(79)

UTILITY VERIFICATION

IQ-06

Distribution Pumps (1A, 1B) ELECTRICAL

(80)

UTILITY VERIFICATION

IQ-06

Distribution Pumps (2A, 2B) ELECTRICAL

(81)

UTILITY VERIFICATION

IQ-06

Dual Reverse Osmosis unit ELECTRICAL

SPECS

EXPECTED

PERFORMED BY/DATE U n it A Voltage1 Voltage2 Phase1 Phase2 Amperage1 Amperage2 Frequency Panel ID U n it B Voltage1 Voltage2 Phase1 Phase2 Amperage1 Amperage2 Frequency Panel ID

Electrician signature: ____________________________ License Number: _____________________________

BY/DATE Compressed Air 80-110 psig

Comments/Observations: 1Assembly power to assembly panel (PLC) 2Plant power to assembly power

(82)

UTILITY VERIFICATION

IQ-06

Dual Reverse Osmosis unit (Cleaning Skid) ELECTRICAL

PERFORME D BY/DATE Voltage Phase Amperage Frequency Panel ID

Electrician signature: ____________________________ License Number: _________________________

OTHER SPECS EXPECTED RESULT ACTUAL RESULT PASS/FAIL PERFORME

D BY/DATE Chemicals

(83)

UTILITY VERIFICATION

IQ-06

Dual Reverse Osmosis unit (pumps) ELECTRICAL

PERFORMED BY/DATE R .O F e e d P u m p Voltage Phase Amperage Frequency Panel ID R .O . C le a n in g Pu m p Voltage Phase Amperage Frequency Panel ID A D S Pu m p Voltage Phase Amperage Frequency Panel ID

Electrician signature: ____________________________ License Number: ____________________________ Comments/Observations:

(84)

Degasification unit ELECTRICAL

SPECS

EXPECTED

PERFORMED BY/DATE D eg as P an e l Voltage Phase Amperage Frequency Panel ID V a c u u m P u m p Voltage Phase Amperage Frequency Panel ID

Electrician signature: ___________________________ License Number: _____________________________

OTHER SPECS EXPECTED

PERFORMED BY/DATE Compressed Air

(85)

UTILITY VERIFICATION

IQ-06

Dual Mixed Bed unit ELECTRICAL

Electrician signature: ___________________________ License Number: ____________________________

BY/DATE Compressed Air (control panel) Clean Compressed Air (MB column) Chemicals Comments/Observations:

(86)

INSTRUMENTATION VERIFICATION

IQ-07

Objective:

• Assure that all the instrumentation installed in the Purified Water System that requires

calibration are added to a calibration program

Pr

a. Inspect all instruments evaluated with the “Calibration Program Addition Form” and verify that all

instruments installed at the Purified Water System were included

ocedure:

b. Record instruments (ID & type) that requires calibration according to the “Calibration Program

Addition Form”

c. Verify if the instrument that requires calibration is currently calibrated and record finding

d. Attach calibration certificate of all calibrated instruments

References Required:

Acceptance Criteria:

• Instruments that required calibration were included in site calibration program

• Instruments are currently calibrated

(87)

INSTRUMENTATION VERIFICATION

IQ-07

Sheet ______ of ______

Use additional pages as necessary

INSTRUMENT ID INSTRUMENT TYPE IT IS CURRENTLY CALIBRATED? (YES/NO/NA) CALIBRATION DUE DATE PERFORMED BY/DATE Comments/Observations:

(88)

MAINTENANCE VERIFICATION

IQ-08

Objective:

• Assure that the Purified Water System is included in a Preventive Maintenance Program and a

spare parts list exists

Pr

a. Per equipment, verify and document the required information by collecting documented

evidence (i.e. PM checklist, PM schedule) of the inclusion of the Purified Water System

components into ___’s Preventive Maintenance Program

ocedure:

b. Collect the Spare Parts list; verify & document the required information

c. Collect the Lubricants list; verify & document the required information

d. If lubricant specifications is not applicable, write a Not Apply to the “Actual Result” column and

explain in the “Comments/Observations” section

References Required:

• Evidence of PMP inclusion - PM checklist, PM schedule, PM program printouts, etc.

• Spare Parts list

• Lubricants list

• FOP 4.1 “Scheduled Preventive Maintenance”

Acceptance Criteria:

• All equipment is included in a PM schedule

• All equipment has spare part list

(89)

MAINTENANCE VERIFICATION

IQ-08

Filter set 1A &1B

BY/DATE

PMP

A PM checklist, schedule or similar is available as evidence of inclusion into the

PM program.

Spare Parts

Spare parts inventory is available for the

equipment.

Lubricants

Lubricants inventory is available for the

equipment.

(90)

MAINTENANCE VERIFICATION

IQ-08

BY/DATE

PMP

PM program.

Spare Parts

equipment.

Lubricants

equipment.

(91)

MAINTENANCE VERIFICATION

IQ-08

BY/DATE

PMP

PM program.

Spare Parts

equipment.

Lubricants

equipment.

(92)

MAINTENANCE VERIFICATION

IQ-08

BY/DATE

PMP

PM program.

Spare Parts

equipment.

Lubricants

equipment.

(93)

MAINTENANCE VERIFICATION

IQ-08

BY/DATE

PMP

PM program.

Spare Parts

equipment.

Lubricants

equipment.

(94)

MAINTENANCE VERIFICATION

IQ-08

Dual Softener unit

BY/DATE

PMP

PM program.

Spare Parts

equipment.

Lubricants

equipment.

(95)

MAINTENANCE VERIFICATION

IQ-08

Ozone Generator

BY/DATE

PMP

PM program.

Spare Parts

equipment.

Lubricants

equipment.

(96)

MAINTENANCE VERIFICATION

IQ-08

Ozone Destructor

BY/DATE

PMP

PM program.

Spare Parts

equipment.

Lubricants

equipment.

(97)

MAINTENANCE VERIFICATION

IQ-08

6,000 Gal. Tank

BY/DATE

PMP

PM program.

Spare Parts

equipment.

Lubricants

equipment.

(98)

MAINTENANCE VERIFICATION

IQ-08

8,000 Gal. Tank

BY/DATE

PMP

PM program.

Spare Parts

equipment.

Lubricants

equipment.

(99)

MAINTENANCE VERIFICATION

IQ-08

BY/DATE

PMP

PM program.

Spare Parts

equipment.

Lubricants

equipment.

(100)

BY/DATE

PMP

PM program.

Spare Parts

equipment.

Lubricants

equipment.

(101)

BY/DATE

PMP

PM program.

Spare Parts

equipment.

Lubricants

equipment.

(102)

MAINTENANCE VERIFICATION

IQ-08

BY/DATE

PMP

PM program.

Spare Parts

equipment.

Lubricants

equipment.

(103)

MAINTENANCE VERIFICATION

IQ-08

Dual Reverse Osmosis unit

BY/DATE

PMP

PM program.

Spare Parts

equipment.

Lubricants

equipment.

(104)

MAINTENANCE VERIFICATION

IQ-08

De-gasification unit

BY/DATE

PMP

PM program.

Spare Parts

equipment.

Lubricants

equipment.

(105)

MAINTENANCE VERIFICATION

IQ-08

Dual Mixed Bed unit

BY/DATE

PMP

PM program.

Spare Parts

equipment.

Lubricants

equipment.

(106)

MAINTENANCE VERIFICATION

IQ-08

Microza “ultra filtration” filters

BY/DATE

PMP

PM program.

Spare Parts

equipment.

Lubricants

equipment.

IQ Purified Water

INSTALLATION QUALIFICATION PROTOCOL

For the

NEW PURIFIED WATER SYSTEM

Prepared by

TABLE OF CONTENTS

REVISION HISTORY

1.0 PURPOSE AND OBJECTIVE(S)

This protocol (___) intends to provide documented evidence that the new Purified Water System

was installed according to manufacturer’s specifications and ___ ___ requirements.

This Installation Qualification will provide documented evidence that all key aspects of the Purified

Water System equipment’s assembly and its auxiliary systems is as intended by manufacturer

design and in accordance to ___’s requirements.

At the end of the execution activities, a final report will be developed with a summary of the

executed tests results and the recommendation(s) necessary for the Installation Qualification.

Potential risks involved with the new Purified Water System installation when connected to the

manufacturing processes has already being evaluated by Risk Assessment PLS 0410.

2.0 BACKGROUND

In order to meet the new purified water utility demands at ___ I in ___ ___, ___ ___, a new purified

water system was purchased to replace the existing system. It is expected that this new purified

water system will increase the supply to up to 100 GPM. Additionally, it is intended to produce a

water quality that meets or exceeds current Purified Water USP and EP standards.

3.0 SCOPE

This protocol applies to the new equipment and auxiliary components that constitute the Purified

Water System, installed at ___ in ___ ___, ___ ___

4.0 REFERENCES

5.0 RESPONSABILITIES

5.1 Validation Specialist

• Prepare the documents that are applicable to the Validation exercise

• Coordinate efforts and resources, along with Facilities Dept., to perform the Validation

exercise

• Execute and collect the verification data for the Validation protocol

• Verify data against Acceptance Criteria and initiate deviation, as applicable

• Investigate, justify, and correct any deviation encountered during Validation execution

• Prepare validation Final Report

5.2 Quality Dept.

• Evaluate with the originator the extent of the validation required

• Review and approve documents for the validation exercise

• Review and approve validation activities for compliance and adherence to ___’s policies,

practices, and procedures

• Check that the collected data meets the acceptance criteria and that all the deviations (if

applicable) are properly resolved

• Once executed, review any deviations generated to confirm that investigation and

resolutions are complete

• Cooperate with Validation Specialist to investigate, justify, and correct any deviation

encountered during Validation execution

• Review and approve Final Report

• Maintain original validation documentation, except for drawings and equipment manuals

that will remain in the equipment information files

• Store the Validation Package in a designated filing area

5.3 Facility Dept.

• Review and approve documents for the validation exercise

• Coordinate efforts and resources to perform the validation activities

• Supply documentation and tools needed for the protocol execution

• Provide training in this protocol to all employees involved (internal and external) during the

execution of this protocol and ensure that all signatures are collected on Signature Log

Sheet

• Assist to document, investigate, justify, and correct any deviation encountered during the

IQ protocol execution

6.0 METHODOLOGY

6.1 Verification Data Sheet

All data resulting from test execution will be entered in Verification Data Sheets that will

pre-define the objective(s) to be attained with the verification, the procedure that will be followed

to reach such objective(s), the reference material to be used, and the criteria to evaluate as

to accept or not the testing results. All data entry will be properly signed and dated by the

executor in the “Performed By” and “Date” spaces. In cases where a Field Verification is

requested, a “Fail” condition will be applied to unverifiable information.

The comments/observations section included in each Data Collection Form will be used to

describe any additional information considered of importance for describing the validated

condition and/or discrepancies and resolution activities produced during the execution. The

comments/observations included must be signed or initialed and dated.

When the test execution is finished, a subject matter expert will sign and date on the

“Reviewed by” and “Date” spaces respectively, to state the completeness and correctness of

the data.

6.2 Deviation Report

The following deviations must be documented using the Deviation Report Form attached to

this protocol:

• Results invalidated and/or not in compliance with their pre-established Acceptance Criteria

• Testing procedure and/or sampling plan not followed or that could not be completed as

planned

was installed according to manufacturer’s specifications and _ _ requirements.

In order to meet the new purified water utility demands at _ I in _ _, _ ___, a new purified

Water System, installed at _ in _ _, _ ___

These deviations will be handled as per _ _ PR

who oversees the validation project in _ _, ___ PR, which in turn will open a deviation