SAT-S & D System

Site Acceptance Test (SAT) Project no.
: CWI 147 TERAPIA-RANBAXY
CWI147_SAT_REV0_PWS & LOOP CONTROL
Revision: R0 Page 1 of 23
Author Title Validation engineer Name Mr.Abhijit Thete

Firstname Lastname
Company Christ Nishotech
Sign / Date
Approved by Title Project Manager Name Mr.Yogesh Bendre

Firstname Lastname
Company Christ Nishotech
Sign / Date
Project leader
Mr.Bhavik Bhatti
Firstname Lastname
Christ Nishotech
Project leader
Firstname Lastname
TERAPIA-RANBAXI
QA
Firstname Lastname
TERAPIA-RANBAXI
Revision history Revision 0 Change First issue Date 12.03.07 Initials MC
Site Acceptance Test (SAT) Project no.: CWI 147 TERAPIA-RANBAXY
CONTENTS
1.0 SAT Plan................................................................................................................3
1.1 Introduction................................................................................................................. 3 1.2 Abbreviation................................................................................................................ 3 1.3 Purpose of the tests...................................................................................................3 1.4 Object Description......................................................................................................3 1.5 Performance................................................................................................................ 3 1.5.1 Responsibilities......................................................................................................3 1.5.2 Good Testing Practice...........................................................................................4 1.5.3 How to fill in the tests /inspections.........................................................................4 1.5.4 Deviation handling.................................................................................................5 1.6 Acceptance criteria.....................................................................................................5 1.7 SAT Results................................................................................................................5
2.0 Tests.......................................................................................................................5
2.1 Mechanical & Documentation Inspection.................................................................6 2.1.1 P&ID...................................................................................................................... 6 2.1.2 Components.......................................................................................................... 7 2.1.3 Air gap to drain......................................................................................................8 2.2 Hardware Acceptance Tests (IQ)...............................................................................9 2.2.1 Main Switch........................................................................................................... 9 2.2.2 Hardware operating environment.........................................................................10 2.3 System Acceptance Tests (OQ)...............................................................................11 2.3.1 Software Version.................................................................................................11 2.3.2 Back-up............................................................................................................... 12 2.4 Operation tests (OQ)................................................................................................13 2.4.1 Leak Test............................................................................................................. 13 2.4.2 Operation of UV 301.1.1......................................................................................14 2.4.2 Operation of UV 301.1.2......................................................................................15 2.4.3 Operation, Purified water system in normal mode................................................16 2.4.4 Sanitisation PW storage & loop control................................................................17 2.4.5 System Parameters.............................................................................................18 2.4.6 Water Quality.......................................................................................................19 2.4.7 Deviation list........................................................................................................ 20 ........................................................................................................................................ 22
3.0 SAT Report..........................................................................................................22

3.1 Purpose of the report...............................................................................................22 3.2 Deviations................................................................................................................. 22 3.3 Retests....................................................................................................................... 22 3.4Final Approval............................................................................................................ 23
Handover of the water treatment system...............................................................23
1.0 SAT Plan

1.1 Introduction
The SAT for Purified water Storage & loop control system shall show that the system is installed and operates 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 IQ N/A OQ P&ID SAT PWS Good Testing Practice Installation Qualification Not Applicable Operation Qualification Process & Instrumentation Diagram Site Acceptance Test Purified Water System
1.3 Purpose of the tests

To test, inspect and show that the PW storage & loop control system is installed correctly according to design specifications.
1.4 Object Description

Product Function Manufacturer Project no. Year of manufacture : Purified water Storage & loop control system. : Storage & Distribution of Purified water. : Christ Nishotech Water Systems Pvt. Ltd. : CWI 147 : 2007
1.5 Performance
The tester shall first read this SAT Plan section, then perform the tests and finally fill in the Report in the end of this document. The performance of the specific Site Acceptance Tests is described for each test in the test sheets.
1.5.1 Responsibilities
The person who performs the tests (Tester) is responsible for the execution of the tests. The tester confirms with his/her initials that the test is performed correctly. A second person, (witness) checks if
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 corrections in 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 marked as N/A (not applicable). Attachments such as P&ID and component list shall be marked with the name of the SAT test, and date 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 also be a result table here. Fill then in the actual value and Pass or Fail. Description Ex) Temperature at TT270.6.3 Required value > 80C Actual value Result (Pass /Fail)
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 acceptance criteria. 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 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: Name (readable in block letters) Signature / Date
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 write Fail 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, write N/A in the sections below. Needed document(s) / equipment The P&ID Acceptance criteria All valves, instruments and components shall be located according to the P&ID and be marked with the correct P&ID number. Pass /Fail + Deviation no. Comment
Tester, Date /Initials Witness, Date /Initials
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 the specifications. 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. Needed document(s) / equipment Component List Acceptance criteria All valves, instruments and components shall be in accordance with the specifications in the Component List. Pass /Fail + Deviation no. Comment
Tester, Date /Initials
Witness, Date /Initials
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 Needed document(s) / equipment Measuring device. Acceptance criteria There shall be an open outlet from the drain pipe to the drain system that is > 5cm Pass /Fail + Deviation no. Comment
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 then ON again. Needed document(s) / equipment The Functional Logics, Section special logic. Acceptance criteria The system shall start up in step 1 ready. Pass /Fail + Deviation no. Comment
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 shall not exceed 40C. Needed document(s) / equipment Temperature instrument. Acceptance criteria For control cabinets without built in ventilation shall the temperature inside the control cabinet not exceed 40C. Pass /Fail + Deviation no. Comment
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: Needed document(s) / equipment HMI & Programming tools Acceptance criteria The version of the HMI shall be written above in the Test procedure square. Pass /Fail + Deviation no. Comment
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 the Back-up disc or CD-Rom. Check that the back-up disc is marked correctly with version and date. Needed document(s) / equipment 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. Pass /Fail + Deviation no. Comment
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. UV 2. Storage Tank 3. Pump Let the system run for 1hour. Check the plant connections and the components by visual inspection. Needed document(s) / equipment N/A Acceptance criteria No leaks shall be present in the system. Pass /Fail + Deviation no. Comment
Name of test
2.4.2 Operation of UV 301.1.1

Test procedure Check that the plant is in the operation step. 1 2 3 During operation check working of hour meter During operation check working of intensity meter Check operation of UV as per control logic.
Needed document(s) / equipment Control logic. Acceptance criteria 1. Hour meter indicate working hours. 2. Intensity >= 1.6 milliwatt/cm2 Pass /Fail + Deviation no. Comment
Name of test
2.4.2 Operation of UV 301.1.2

Test procedure Check that the plant is in the operation step. 4 5 6 During operation check working of hour meter During operation check working of intensity meter Check operation of UV as per control logic.
Needed document(s) / equipment Control logic. Acceptance criteria 3. Hour meter indicate working hours. 4. Intensity >= 1.6 milliwatt/cm2 Pass /Fail + Deviation no. Comment
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. Needed document(s) / equipment Operating manuals, Control logic. Acceptance criteria System is operating as per the steps mentioned in control logic. Pass /Fail + Deviation no.
Comment
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 the Sanitisation 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 temperature logs 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 record the result in the table below. Start the counting when the temperature is reached and measure during 6 0 minutes. Needed document(s) / equipment S & D operating instruction, section Sanitisation. The Functional Logics Acceptance criteria
Description
Required value The Sanitisation shall proceed acc to the N/A Functional Logics Temperature at TE 301.1.5 at start 80C Temperature at TE 301.1.5 after 10 min Temperature at TE 301.1.5 after 20 min Temperature at TE 301.1.5 after 30 min Temperature at TE 301.1.5 after 40 min Temperature at TE 301.1.5 after 50 min Temperature at TE 301.1.5 after 60 min Pass / Fail + Deviation nos Comment 80C 80C 80C 80C 80C 80C
Actual value Result (Pass / Fail) N/A
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. Needed document(s) / equipment The Instrumentation List (Functional Logic) Acceptance criteria Pass /Fail + Deviation no.
Comment
Name of test
2.4.6 Water Quality

Test procedure Check the conductivity at V301.1.18 Check the TOC value at sample V301.1.18 (analysis by customer) Check the microbiological situation at sample V301.1.18 (analysis by customer) Needed document(s) / equipment N/A Acceptance criteria Description Conductivity Required 1.3 s/cm @25C Actual Result (Pass /Fail)
TOC Microbiological situation Pass /Fail + Deviation no.
<500 ppb <100 cfu/ml
Comment
2.4.7 Deviation list
Description
Noted by: (Date/Sign.)
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. 2.1 2.1.1 2.1.2 2.1.3 2.2 2.2.1 2.2.2 2.3 2.3.1 2.3.2 2.4 2.4.1 2.4.2 2.4.3 2.4.4 2.4.5 2.4.6 2.4.7 Test name Mechanical & Documentation inspections (IQ) P&ID Components Air gap to drain Hardware Acceptance Tests (IQ) Main switch Hardware, operating environment System Acceptance Tests (OQ) Software version Back-up Operation tests (OQ) Leak test Operation of UV Operation of Purified water system in normal mode Sanitization PW storage & loop control System Parameters Water Quality Deviation list Test Completed (Yes /No)
3.4 Final Approval

To be signed by SAT participants. The unit is approved for Operation Title Name Company Sign / Date
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. Title Name Company
CHRIST-NISHOTECH
Sign / Date
CHRIST-NISHOTECH
TERAPIA-RANBAXI
TERAPIA-RANBAXI

SAT-S &amp; D System

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Site Acceptance Test (SAT) Project no.

: CWI 147 TERAPIA-RANBAXY

CWI147_SAT_REV0_PWS & LOOP CONTROL

Author Title Validation engineer Name Mr.Abhijit Thete

Company Christ Nishotech

Approved by Title Project Manager Name Mr.Yogesh Bendre

Company Christ Nishotech

Revision history Revision 0 Change First issue Date 12.03.07 Initials MC

Site Acceptance Test (SAT) Project no.: CWI 147 TERAPIA-RANBAXY

CWI147_SAT_REV0_PWS & LOOP CONTROL

3.0 SAT Report..........................................................................................................22

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

Site Acceptance Test (SAT) Project no.: CWI 147 TERAPIA-RANBAXY

CWI147_SAT_REV0_PWS & LOOP CONTROL

1.0 SAT Plan

1.3 Purpose of the tests

1.4 Object Description

Site Acceptance Test (SAT) Project no.: CWI 147 TERAPIA-RANBAXY

CWI147_SAT_REV0_PWS & LOOP CONTROL

1.5.2 Good Testing Practice

Ex) Installation 20/01/04 Initials

1.5.3 How to fill in the tests /inspections

Site Acceptance Test (SAT) Project no.: CWI 147 TERAPIA-RANBAXY

CWI147_SAT_REV0_PWS & LOOP CONTROL

1.5.4 Deviation handling

1.6 Acceptance criteria

1.7 SAT Results

Site Acceptance Test (SAT) Project no.: CWI 147 TERAPIA-RANBAXY

CWI147_SAT_REV0_PWS & LOOP CONTROL

Control Logics, revisions:

2.1 Mechanical & Documentation Inspection

Tester, Date /Initials Witness, Date /Initials

Site Acceptance Test (SAT) Project no.: CWI 147 TERAPIA-RANBAXY

CWI147_SAT_REV0_PWS & LOOP CONTROL

Tester, Date /Initials

Site Acceptance Test (SAT) Project no.: CWI 147 TERAPIA-RANBAXY

CWI147_SAT_REV0_PWS & LOOP CONTROL

Witness, Date /Initials

2.1.3 Air gap to drain

Tester, Date /Initials

Site Acceptance Test (SAT) Project no.: CWI 147 TERAPIA-RANBAXY

CWI147_SAT_REV0_PWS & LOOP CONTROL

Witness, Date /Initials

2.2 Hardware Acceptance Tests (IQ)

2.2.1 Main Switch

Tester, Date /Initials Witness, Date /Initials

Site Acceptance Test (SAT) Project no.: CWI 147 TERAPIA-RANBAXY

CWI147_SAT_REV0_PWS & LOOP CONTROL

2.2.2 Hardware operating environment

Tester, Date /Initials Witness, Date /Initials

Site Acceptance Test (SAT) Project no.: CWI 147 TERAPIA-RANBAXY

CWI147_SAT_REV0_PWS & LOOP CONTROL

2.3 System Acceptance Tests (OQ)

2.3.1 Software Version

Tester, Date /Initials

Site Acceptance Test (SAT) Project no.: CWI 147 TERAPIA-RANBAXY

CWI147_SAT_REV0_PWS & LOOP CONTROL

Witness, Date /Initials

Tester, Date /Initials Witness, Date /Initials

Site Acceptance Test (SAT) Project no.: CWI 147 TERAPIA-RANBAXY

CWI147_SAT_REV0_PWS & LOOP CONTROL

2.4 Operation tests (OQ)

2.4.1 Leak Test

Site Acceptance Test (SAT) Project no.: CWI 147 TERAPIA-RANBAXY

SAT-S & D System

SAT-S & D System