SAT-S & D System

7/30/2019 SAT-S & D System

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Site Acceptance Test(SAT)

CWI147_SAT_REV0_PWS & LOOP CONTROL

Project no.: CWI 147 Revision: R0

TERAPIA-RANBAXY Page 1 of 23

Author

Title Name Company Sign / Date

Validation engineer Mr.Abhijit Thete

Firstname Lastname

Christ Nishotech

Approved by


Project Manager Mr.Yogesh Bendre

Firstname Lastname

Christ Nishotech

Project leader Mr.Bhavik Bhatti

Firstname Lastname

Christ Nishotech

Project leader

Firstname Lastname

TERAPIA-RANBAXI

QA

Firstname Lastname

TERAPIA-RANBAXI

Revision history

Revision Change Date Initials

0 First issue 12.03.07 MC


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CONTENTS

1.0 SAT Plan................................................................................................................31.1 Introduction.................................................................................................................31.2 Abbreviation................................................................................................................31.3 Purpose of the tests................................................................................................... 31.4 Object Description......................................................................................................31.5 Performance................................................................................................................3

1.5.1 Responsibilities......................................................................................................31.5.2 Good Testing Practice...........................................................................................41.5.3 How to fill in the tests /inspections.........................................................................41.5.4 Deviation handling.................................................................................................5

1.6 Acceptance criteria.....................................................................................................51.7 SAT Results................................................................................................................ 5

2.0 Tests.......................................................................................................................52.1 Mechanical & Documentation Inspection.................................................................6

2.1.1 P&ID...................................................................................................................... 62.1.2 Components..........................................................................................................72.1.3 Air gap to drain...................................................................................................... 8

2.2 Hardware Acceptance Tests (IQ)...............................................................................92.2.1 Main Switch........................................................................................................... 92.2.2 Hardware operating environment.........................................................................10

2.3 System Acceptance Tests (OQ)...............................................................................112.3.1 Software Version................................................................................................. 112.3.2 Back-up............................................................................................................... 12

2.4 Operation tests (OQ)................................................................................................ 132.4.1 Leak Test.............................................................................................................132.4.2 Operation of UV 301.1.1......................................................................................142.4.2 Operation of UV 301.1.2......................................................................................152.4.3 Operation, Purified water system in normal mode................................................162.4.4 Sanitisation PW storage & loop control................................................................17

2.4.5 System Parameters.............................................................................................182.4.6 Water Quality.......................................................................................................192.4.7 Deviation list........................................................................................................ 20

........................................................................................................................................ 22

3.0 SAT Report..........................................................................................................223.1 Purpose of the report...............................................................................................223.2 Deviations................................................................................................................. 223.3 Retests.......................................................................................................................223.4Final Approval............................................................................................................23

Handover of the water treatment system...............................................................23


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1.0 SAT Plan

1.1 Introduction

The SAT for Purified water Storage & loop control system shall show that the system is installed andoperates in accordance with the design specifications. The SAT is divided into four test sections:

Mechanical & Documentation Inspections (IQ).

Hardware Acceptance Tests (IQ)

Software Acceptance Tests (OQ)

Operation Test (OQ)

1.2 Abbreviation

GTP Good Testing PracticeIQ Installation QualificationN/A Not ApplicableOQ Operation QualificationP&ID Process & Instrumentation DiagramSAT Site Acceptance Test

PWS Purified Water System

1.3 Purpose of the tests

To test, inspect and show that the PW storage & loop control system is installed correctly accordingto design specifications.

1.4 Object Description

Product : Purified water Storage & loop control system.Function : Storage & Distribution of Purified water.Manufacturer : Christ Nishotech Water Systems Pvt. Ltd.Project no. : CWI 147

Year of manufacture : 2007

1.5 Performance

The tester shall first read this SAT Plan section, then perform the tests and finally fill in the Report inthe end of this document. The performance of the specific Site Acceptance Tests is described foreach test in the test sheets.

1.5.1 ResponsibilitiesThe person who performs the tests (Tester) is responsible for the execution of the tests. The testerconfirms with his/her initials that the test is performed correctly. A second person, (witness) checks if


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the test was correctly performed and that the result was in accordance with the acceptance criteria

and if not, that a deviation report is filled in.

1.5.2 Good Testing Practice

A (archive resistance) blue pen shall be used for the SAT tests and for approvals. For the correctionsin the attached design documents (such as the P&ID or the circuit diagram) a red pen will be used.Correction fluid and other correction techniques that obscure the original entry should not be used.Spelling mistakes and other changes shall be corrected as follows:

Ex) Installation 20/01/04 Initials

Deviations are recorded and traceable. Fields in a test, that are not filled out, shall be clearly markedas N/A (not applicable).Attachments such as P&ID and component list shall be marked with the name of the SAT test, anddate and initials of the tester. This shall be written on the front page.

Ex) Attachment to SAT 2.1.2 P&ID 20/01/04 Initials

When the SAT is performed are the documents reviewed for correctness and completeness before

the SAT Report section is filled in.

1.5.3 How to fill in the tests /inspections

Inspection name

Inspection procedure

Needed document(s) / equipment

Acceptance criteria

OK / Deviation no

1)Date

2)

Initials

3)

Witnessed by

4)

1) The acceptance criteria is specified in this square and if values are to be recorded there will alsobe a result table here. Fill then in the actual value and Pass or Fail.

Description Required value Actual value Result (Pass /Fail)

Ex) Temperature atTT270.6.3

> 80C


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2) If the acceptance criteria is fulfilled Pass is written in this square. If not, Fail and deviation

number(s) are written, and a deviation report is filled in. (See deviation handling)3) Comment. This field are used for instance for explanation, or relevant information. For deviations,

a deviation report will be filled in.

4) Date of the execution of the test /inspection and initials of the tester.

5) To be signed by the customer if present during the SAT. Otherwise N/A will be written.

1.5.4 Deviation handling

A Deviation report regarding SAT is filled in if the result of a test is not according to the acceptancecriteria. It could be more than one deviation report per test, and then all numbers have to be filled in,on the test sheet.

1.6 Acceptance criteria

The acceptance criteria for each Site Acceptance Test are specified in the test sheets.

1.7 SAT Results

The result of the SAT will be concluded in the SAT Report section.

2.0 Tests

Signature list for test /inspection personnel

Company Name

(readable in block letters)

Signature / Date

Christ Nishotech

Christ Nishotech

TERAPIA-RANBAXI

TERAPIA-RANBAXI

Attachments to this Site acceptance test

(To be filled in on the day for SAT start)

P&ID no. And revision:

Component List, revision:

Circuit diagram, revision:


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Control Logics, revisions:

2.1 Mechanical & Documentation Inspection

Name of test

2.1.1 P&ID

Test procedure

Check that the Purified Water System is built according to the P&ID and that the items are marked with

the correct P&ID numbers.

Write, Pass at the valve /instrument /component on the P&ID if both criteria are fulfilled. If not writeFail and the deviation number in the drawing.

Sign & date the P&ID.

Attach the used P&ID to this document.

Parts inspected during FAT will not be re-inspected. If all items are already checked during FAT, writeN/A in the sections below.


The P&ID

Acceptance criteria

All valves, instruments and components shall be located according to the P&ID and be marked with thecorrect P&ID number.

Pass /Fail + Deviation no.

Comment

Tester, Date /Initials

Witness, Date /Initials


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Name of test

2.1.2 Components

Test procedure

Check that valves, instruments and components in the Component List are in accordance with the

description in the List.

Write, Pass at the valve /instrument /component in the list, if the item is in compliance with thespecifications. If not write Fail and the deviation number in the list.

Sign & date in the bottom of each page.

Attach the used Component List to this document.


Component List

Acceptance criteria

All valves, instruments and components shall be in accordance with the specifications in the ComponentList.


Comment



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Name of test

2.1.3 Air gap to drain

Test procedure

Check by visual inspection that the pipe to drain leaves an air gap to the drainage


Measuring device.

Acceptance criteria

There shall be an open outlet from the drain pipe to the drain system that is > 5cm


Comment



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2.2 Hardware Acceptance Tests (IQ)

Name of test

2.2.1 Main Switch

Test procedure

Check that the system turns on in step ready when the main switch has been set to OFF and thenON again.


The Functional Logics, Section special logic.

Acceptance criteria

The system shall start up in step 1 ready.


Comment




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Name of test

2.2.2 Hardware operating environment

Test procedure

Measure the temperature in the Control cabinet. The temperature for the control cabinet equipment shallnot exceed 40C.


Temperature instrument.

Acceptance criteria

For control cabinets without built in ventilation shall the temperature inside the control cabinet notexceed 40C.


Comment




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2.3 System Acceptance Tests (OQ)

Name of test

2.3.1 Software Version

Test procedure

Check the version of the HMI shown in the system menu.Write the version of the HMI:HMI version at SAT:


HMI & Programming tools

Acceptance criteria

The version of the HMI shall be written above in the Test procedure square.


Comment



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Name of test

2.3.2 Back-up

Test procedure

Make a comparison of the version of the loaded software for HMI, and the program version of theBack-up disc or CD-Rom.

Check that the back-up disc is marked correctly with version and date.


Back-up disc (or CD-Rom), the downloaded program, programming software and lap-top.

Acceptance criteria

There shall not be any differences in code between the HMI program on the floppy disk and CPU.Parameters could differ.The disc /CD-Rom shall be marked with the correct version and date.


Comment




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2.4 Operation tests (OQ)

Name of test

2.4.1 Leak Test

Test procedure

Put the Purified Water System into Normal (Auto) mode.During operation, the operating pressure is present at the following components:

1. UV2. Storage Tank3. Pump

Let the system run for 1hour.Check the plant connections and the components by visual inspection.


N/A

Acceptance criteria

No leaks shall be present in the system.


Comment


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Name of test

2.4.2 Operation of UV 301.1.1

Test procedure

Check that the plant is in the operation step.

1 During operation check working of hour meter2 During operation check working of intensity meter3 Check operation of UV as per control logic.


Control logic.

Acceptance criteria

1. Hour meter indicate working hours.

2. Intensity >= 1.6 milliwatt/cm2


Comment


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Name of test

2.4.2 Operation of UV 301.1.2

Test procedure

Check that the plant is in the operation step.

4 During operation check working of hour meter5 During operation check working of intensity meter6 Check operation of UV as per control logic.


Control logic.

Acceptance criteria

3. Hour meter indicate working hours.

4. Intensity >= 1.6 milliwatt/cm2


Comment


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Name of test

2.4.3 Operation, Purified water system in normal mode

Test procedure

1. Check the operation of PW System in normal auto mode.


Operating manuals, Control logic.

Acceptance criteriaSystem is operating as per the steps mentioned in control logic.


Comment


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Name of test

2.4.4 Sanitisation PW storage & loop control

Test procedure

Check that the program steps are executed as described in the Functional description. Carry out theSanitisation as specified in the Operating Instructions.Check that the necessary sanitising temperature is reached and maintained for the entire period.

Check that the necessary sanitising temperature is reached and maintained by saving the temperaturelogs printout from the recorder.If there is no recorder for the system, check the temperature value for TE 301.1.5 in the HMI and recordthe result in the table below. Start the counting when the temperature is reached and measure during6 0 minutes.


S & D operating instruction, section Sanitisation. The Functional Logics

Acceptance criteria


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Description Required

value

Actual value Result (Pass / Fail)

The Sanitisation shall proceed acc to theFunctional Logics

N/A N/A

Temperature at TE 301.1.5 at start 80C

Temperature at TE 301.1.5 after 10 min 80C






Pass / Fail + Deviation nos

Comment

Tester, Date / Initials

Witness, Date / Initials

Name of test

2.4.5 System Parameters

Test procedure

Run the system in operation mode.

Fill in the Instrumentation list for all parameters and set points.


The Instrumentation List (Functional Logic)

Acceptance criteria



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Comment



Name of test

2.4.6 Water Quality

Test procedure

Check the conductivity at V301.1.18Check the TOC value at sample V301.1.18 (analysis by customer)Check the microbiological situation at sample V301.1.18 (analysis by customer)


N/A

Acceptance criteria

Description Required Actual Result (Pass /Fail)

Conductivity 1.3 s/cm @25C


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TOC


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3.0 SAT Report

3.1 Purpose of the report

To conclude the performed Site Acceptance Test of the PW storage & loop control system system.

3.2 Deviations

The deviations shall be measured until, Date: _______

Deviation summary

Total amount of attached deviations:

3.3 Retests

All tests shall be completed at end of SAT.

No. Test name Test Completed

2.1 Mechanical & Documentation inspections (IQ) (Yes /No)2.1.1 P&ID

2.1.2 Components

2.1.3 Air gap to drain

2.2 Hardware Acceptance Tests (IQ)

2.2.1 Main switch

2.2.2 Hardware, operating environment

2.3 System Acceptance Tests (OQ)

2.3.1 Software version

2.3.2 Back-up

2.4 Operation tests (OQ)

2.4.1 Leak test

2.4.2 Operation of UV

2.4.3 Operation of Purified water system in normal mode2.4.4 Sanitization PW storage & loop control

2.4.5 System Parameters

2.4.6 Water Quality

2.4.7 Deviation list


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3.4 Final Approval

To be signed by SAT participants.

The unit is approved for Operation


Christ Nishotech

Christ Nishotech

TERAPIA-RANBAXI

TERAPIA-RANBAXI

Handover of the water treatment system

To be signed by the SAT participants.

The system is approved for hand-over.


CHRIST-NISHOTECH

CHRIST-NISHOTECH

TERAPIA-RANBAXI

TERAPIA-RANBAXI

SAT-S & D System

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