GIT-LCA Glove Integrity Tester Functional Test … SN 001 Functional Test...GIT-LCA Glove Integrity...

GIT-LCA Glove Integrity TesterFunctional Test Protocol

Software Version Applicable to this document:

PLC file name: GIT-LCA – PLC v2.1

OIT file name: GIT-LCA – OIT v2.1

Dynamic Design Pharma, Inc.

23332 Madero Road, Suite J

Mission Viejo, California 92691

June 8, 2007

GIT-LCA Glove Integrity Tester

Functional Test Protocol Date: June 8, 2007

This document contains information that is CONFIDENTIAL AND PROPRIETARY property of Dynamic Design Pharma. Any dissemination,distribution, or copying of this communication is strictly prohibited. Anyone receiving this document in error should immediately notify DynamicDesign Pharma and return this document to Dynamic Design Pharma, 23332 Madero Road, Suite J, Mission Viejo, California 92691.

CONFIDENTIALCOMPANY PROPRIETARY

TABLE OF CONTENTS

1. PURPOSE ............................................................................................................................................ 3

2. SYSTEM IDENTIFICATION............................................................................................................... 3

3. EXECUTION INSTRUCTIONS AND RESPONSIBILITIES .......................................................... 3

4. REFERENCES..................................................................................................................................... 3

5. TEST CASES ....................................................................................................................................... 5

6. PROTOCOL COMPLETION STATEMENT/SYSTEM RELEASE............................................. 28





1. PURPOSE

The purpose of this document is to test the functionality of the control system, electrical andsoftware, of the GIT-LCA Serial Number 001 glove Integrity tester. This protocol prepares thesystem for functional portion of the Factory Acceptance Testing.

Note: This document is not a software validation protocol. The software, PLC v1.0 and OIT v1.0,has been previously tested under Software Verification Protocol dated August 22, 2006 andexecuted on September 10, 2006. The current software version, PLC v2.1 and OIT v2.1, includemodifications that were documented under protocols SC-101 4-3-07 and SC-102 6-7-07.

The functional areas covered by this protocol are:

1) Analog Inputs and Outputs

2) Digital Inputs and Outputs

3) A/B channel selection

4) Security – Parameters Access Interlock

5) Security – Calibration Access Interlock

6) Leak Test Process

7) System Test Function

8) In-Situ Calibration Normal Sequence

9) Printing functions

Document any discrepancies in the “test notes” page of this protocol. Print additional copies, ifnecessary.

2. SYSTEM IDENTIFICATION

GIT-LCA glove integrity tester.

Ergoclean Gloveport interface.

3. EXECUTION INSTRUCTIONS AND RESPONSIBILITIES

The execution of this protocol will be conducted by a Quality Assurance or Engineeringrepresentative of Dynamic Design Pharma.

4. REFERENCES

GIT-LCA Glove Integrity Tester Specification





GIT-LCA Glove Integrity Tester Functional and Design Specification.

Functional Test Protocol - GIT-LCA Glove Integrity Tester Date: June 8, 2007

This document contains information that is CONFIDENTIAL AND PROPRIETARY property of Dynamic Design Pharma. Any dissemination, distribution, or copying of this communication is strictly prohibited.Anyone receiving this document in error should immediately notify Dynamic Design Pharma and return this document to Dynamic Design Pharma, 23332 Madero Road, Suite J, Mission Viejo, California 92691.


5. TEST CASES

5.1. TEST # 1 – ANALOG INPUT/OUTPUT

Test Purpose: This test confirms that the analog inputs and outputs are correctly connected and scaled.

Test Tools: Laptop connected to the PLC in monitor mode and voltmeter. System Test mode of operation.

Test Set up: Gloveport interface connected to the A port.

StepNo. Test Method Expected Result Actual Result

Pass /Fail

Initials/ Date

Comments /ExceptionReport #

1

Adjust the Up/Downarrows until the value of%AQ012 = 8000.Measure the voltage atthe %AQ12 terminal.Note the flow rate valuedisplay on the OIT.

The voltage at %AQ012 terminal is2.5VDC.

The flow rate value on the OITdisplay is 50 +/-1 Sccm.

Pass

Fail

2

Adjust the Up/Downarrows until the flow ratevalue displayed on theOIT is 50 Sccm. Note thevalue of %AI019.

%AI019 value is 8,000. Pass

Fail

3

Adjust the flow rate toachieve a pressurereading on the OIT of1,875 pa. Note the valueof %AI018.

%AI018 value is 16,000. Pass

Fail




5.2. TEST # 2 – DIGITAL INPUT/OUTPUT

Test Purpose: This test confirms that the digital inputs and outputs are correctly connected.

Test Tools: Laptop connected to the PLC in monitor mode.

Test Set up: None.


Pass /Fail

Initials/ Date


1

Actuate the Key Lock tothe Locked position andUnlocked position.Confirm On/Off statusfrom LEDs on PLC.

%I1 input is OFF in the Lockedposition.

%I1 input is ON in the Unlockedposition.

Pass

Fail

2 Force output %Q002 ONand then OFF.

The Inflate (K1) valve actuates (isenergized) when the output is ON.

Pass

Fail


The Deflate (K2) valve actuates (isenergized) when the output is ON.

Pass

Fail


The Vacuum/Pressure (K3), Flowdirection (K4) and Pressure Polarity(K5) valves actuate (are energized)when the output is ON.

Pass

Fail


The Beeper comes on when theoutput is ON.

Pass

Fail


The Pressure Inlet (K6) valveactuates (is energized) when theoutput is ON.

Pass

Fail





Pass /Fail

Initials/ Date



The Vacuum Outflow (K7) valveactuates (is energized) when theoutput is ON.

Pass

Fail


The Channel Select – Pressure (K8)and Channel Select – Flow (K9)valve actuate (are energized) whenthe output is ON.

Pass

Fail




5.3. TEST # 3 – A/B CHANNEL SELECTION AND POSITIVE/NEGATIVE PRESSURE MODE OF OPERATION

Test Purpose: This test covers the functionality of the A/B channels and the positive/negative pressure mode of operation. This test isconducted with the system in System Test mode.

Test Tools: Test device connected to A or B channel, as required by the test conducted

Test Set up: None


Pass /Fail

Initials/ Date


1From Home screen,depress the System Testbutton

The System Test screen comes on. Pass

Fail

2

Select the A channel andPositive pressure mode.

Depress the High FlowPlus button

Airflow comes out of one of the Achannel connectors.

No airflow comes out of either one ofthe two B channel connectors.

Pass

Fail

3

Select the B channel andPositive pressure mode.


Airflow comes out of one of the Bchannel connectors.

No airflow comes out of either one ofthe two A channel connectors.

Pass

Fail

4

Select the A channel andNegative pressure mode.


Air flows into one of the A channelconnectors (vacuum).

No airflow into either B channelconnectors.

Pass

Fail

5

Select the B channel andNegative pressure mode.


Air flows into one of the B channelconnectors (vacuum).

No air flow into either A channelconnectors.

Pass

Fail




5.4. TEST # 4 – SECURITY - PARAMETERS ACCESS INTERLOCK

Test Purpose: This test covers the functionality of the Parameters Access Interlock function.

Test Tools: None

Test Set up: No specific system set up is necessary.


Pass /Fail

Initials/ Date


1

Place the keylock in the“locked” position.

From Home screen,depress the Parametersbutton

Access Denied popup screen comeson.

Parameters printing icon is presentand is functional.

When “Exit” is pressed, the Homescreen returns active.

Pass

Fail

2

Place the keylock in the“unlocked” position.

From Home screen,depress the Parametersbutton

The Entry Confirmation popupscreen comes on. Pass

Fail

3 Depress the “No” button. The OIT displays the Home screen Pass

Fail

4 Depress the “Yes”button.

The OIT displays the ParameterManagement screen.

Pass

Fail

5Remove the key from thekeylock while in the“unlocked” position

The key cannot be removed from thekeylock

Pass

Fail




5.5. TEST # 5 – SECURITY - CALIBRATION ACCESS INTERLOCK

Test Purpose: This test covers the functionality of the Calibration Access Interlock function.

Test Tools: None



Pass /Fail

Initials/ Date


1

Place the keylock in the“locked” position.

From Home screen,depress the Calibrationbutton

Access Denied popup screen comeson.

When “Exit” is pressed, the Homescreen returns active.

Pass

Fail

2

Place the keylock in the“unlocked” position.

From Home screen,depress the Calibrationbutton

The Entry Confirmation popupscreen comes on. Pass

Fail

3 Depress the “No” button. The OIT displays the Home screen Pass

Fail

4 Depress the “Yes”button.

The OIT displays the SystemCalibration screen.

Pass

Fail

5Remove the key from thekeylock while in the“unlocked” position

The key cannot be removed from thekeylock

Pass

Fail




5.6. TEST # 6 – LEAK TEST PROCESS - PASSING TEST

Test Purpose: This test covers the functionality of the Leak Test Conclusion and test outcome determination.

Test Tools: Test device connected to A channel ports.

Test Set up: Program the A channel system parameters as follows:

5.6.1. Maximum pressure: 3500 pa5.6.2. Over-Pressure: 1100 pa.5.6.3. Threshold Pressure: 1000 pa.5.6.4. Maximum Flow: 60 Sccm5.6.5. Minimum Flow: 40 Sccm5.6.6. Inflate time: 60 Sec.5.6.7. Stabilization time: 30 Sec.5.6.8. Leak Test time: 60 Sec.5.6.9. Mode of operation: Positive Pressure5.6.10. Pressure Trending: Off


Pass /Fail

Initials/ Date

Comments/ Exception

Report #

1

Conduct a full cycle leaktest. Set up thegloveport interfacesimulator for a passingtest.

1. The OIT switches to the CycleResults screen

Pass

Fail

2

Take note of thefollowing:

1. The end pressure

2. The end flow

3. The total cycle time

1. The end pressure matches thevalue seen at the end of the testcycle

2. The flow matches the value seen atthe end of the test cycle

3. The time display matches the totaltime of the test cycle

Pass

Fail





Pass /Fail

Initials/ Date

Comments/ Exception

Report #

3 Cycle Results screendetails:

1. The channel display is: A

2. The test method display is “cycletime out”

Pass

Fail

4End pressure > 1000pa

(passing test)

1. The cycle result display is: PASS

2. The cycle results display is green incolor.

Pass

Fail

5

1. Depress the printericon

2. Enter “10” as theglove ID

3. Depress “Print”button

1. A print out is generated with thecorrect date

2. Glove ID matches the valueentered

3. Test outcome is: PASS

4. Active channel is: A

5. The end pressure, end flow andtotal cycle time values match thepreviously recorded values

6. Test method: Cycle Time Out




5.7. TEST # 7 – LEAK TEST PROCESS - FAILING TEST

Test Purpose: This test covers the functionality of the Leak Test Conclusion and test outcome determination.



5.7.1. Maximum pressure: 3500 pa5.7.2. Over-Pressure: 1100 pa.5.7.3. Threshold Pressure: 1000 pa.5.7.4. Maximum Flow: 60 Sccm5.7.5. Minimum Flow: 40 Sccm5.7.6. Inflate time: 60 Sec.5.7.7. Stabilization time: 30 Sec.5.7.8. Leak Test time: 60 Sec.5.7.9. Mode of operation: Positive Pressure5.7.10. Pressure Trending: Off


Pass /Fail

Initials/ Date

Comments/ Exception

Report #

1

Conduct a full cycle leaktest. Set up thegloveport interfacesimulator for a passingtest.


Pass

Fail

2


1. The end pressure

2. The end flow


1. The end pressure matches thevalue seen at the end of the testcycle

2. The flow matches the value seen atthe end of the test cycle

3. The time display matches the totaltime of the test cycle

Pass

Fail





Pass /Fail

Initials/ Date

Comments/ Exception

Report #

3 Cycle Results screendetails:

1. The channel display is: A

2. The test method display is “cycletime out”

Pass

Fail

4End pressure < 1000pa

(failing test)

1. The cycle result display is: FAIL

2. The cycle results display is red incolor.

Pass

Fail

5




1. A print out is generated with thecorrect date


3. Test outcome is: FAIL


5. The end pressure, end flow andtotal cycle time values match thepreviously recorded values

6. Test method: Cycle Time Out




5.8. TEST # 8 – LEAK TEST PROCESS WITH PRESSURE TRENDING (PASSING)

Test Purpose: This test covers the functionality of the Leak Test process with pressure trending.



5.8.1. Maximum pressure: 3500 pa5.8.2. Over-Pressure: 1100 pa.5.8.3. Threshold Pressure: 1000 pa.5.8.4. Maximum Flow: 60 Sccm5.8.5. Minimum Flow: 40 Sccm5.8.6. Inflate time: 60 Sec.5.8.7. Stabilization time: 30 Sec.5.8.8. Leak Test time: 180 Sec.5.8.9. Time before sampling: 30 Sec.5.8.10. Time between samples: 5 Sec.5.8.11. Number of samples: 105.8.12. Mode of operation: Positive Pressure5.8.13. Pressure Trending: On


Pass /Fail

Initials/ Date


1From Home screen,depress the CycleControl button

The Cycle Control screen comes on. Pass

Fail

2 If necessary, change theactive channel to A.

If the active channel display iscurrently B, it will change to A.

Pass

Fail

3

If necessary, adjust theflow arrow keys until theflow rate is approximately50 Sccm,

The flow rate will change up or downaccording to the arrow key that isdepressed.

Pass

Fail





Pass /Fail

Initials/ Date


4Depress the Start/Stopbutton to initiate thecycle.

1. The Pressure trendingindicator is: ON

2. The Pos. and Neg. value = 0

3. The Inflate phase takes place

4. The Stabilization phase takesplace

5. The phase count down timercounts down from 180

6. After a 30 second delay fromthe end of stabilization, thesystem enters the Leak Testphase

7. The OIT screen displays theTime Delay message.

Pass

Fail

5

The Leak test phaseprogresses. Pressure is> 1000 and steadilyclimbing.

1. Every 5 seconds, the POScount increases by 1

2. When the POS count reaches10, the Leak test phaseconcludes.

Pass

Fail

6 Allow the Leak Test cycleto conclude


Pass

Fail

7


1. The end pressure

2. The end flow


1. The end pressure matches thevalue seen at the end of thetest cycle

2. The flow matches the valueseen at the end of the testcycle

2. The time display matches thetotal time of the test cycle

Pass

Fail





Pass /Fail

Initials/ Date


8 Cycle Results screen1. The channel display is: A

2. The test method display is“pressure trend”

Pass

Fail

9End pressure > 1000paand positive trenddetected

1. The cycle result display is:PASS

2. The cycle results display isgreen in color.

Pass

Fail

10




1. A print out is generated withthe correct date


3. Test outcome is: PASS


5. The end pressure, end flowand total cycle time valuesmatch the previously recordedvalues

6. Test method: Pressure Trend

Pass

Fail




5.9. TEST # 9 – LEAK TEST PROCESS WITH PRESSURE TRENDING (FAILING)

Test Purpose: This test covers the functionality of the Leak Test process with pressure trending.


Test Set up: Program the A channel system parameters same as Test #24


Pass /Fail

Initials/ Date


1From Home screen,depress the CycleControl button

The Cycle Control screen comes on. Pass

Fail

2 If necessary, change theactive channel to A.

If the active channel display iscurrently B, it will change to A.

Pass

Fail

3

If necessary, adjust theflow arrow keys until theflow rate is approximately50 Sccm,

The flow rate will change up or downaccording to the arrow key that isdepressed.

Pass

Fail





Pass /Fail

Initials/ Date


4Depress the Start/Stopbutton to initiate thecycle.

1. The Pressure trending indicatoris: ON

2. The Pos. and Neg. value = 0

3. The Inflate phase takes place

4. The Stabilization phase takesplace

5. The phase count down timercounts down from 180.

6. After 30 seconds delay fromthe end of stabilization, thesystem enters the Leak Testphase.

7. The OIT Status Displaydisplays “Time Delay”.

Pass

Fail

5

The Leak test phaseprogresses. Pressure is< 1000 and steadilydropping.

1. Every 5 seconds, the NEG.count increases by 1

2. When the NEG. count reaches10, the Leak test phaseconcludes.

Pass

Fail

6 Allow the Leak Test cycleto conclude


Pass

Fail

7


1. The end pressure

2. The end flow

3. The total cycletime

1. The end pressure matches thevalue seen at the end of thetest cycle

2. The flow matches the valueseen at the end of the testcycle

3. The time display matches thetotal time of the test cycle

Pass

Fail





Pass /Fail

Initials/ Date


8 Cycle Results screen1. The channel display is: A

2. The test method display is“pressure trend”

Pass

Fail

9End pressure < 1000paand negative trenddetected

1. The cycle result display is:FAIL

2. The cycle results display is redin color.

Pass

Fail

10


2. Enter “25” for gloveID

3. Press “Print”



3. Test outcome is: FAIL


5. The end pressure, end flowand total cycle time valuesmatch the previously recordedvalues

6. Test method: Pressure Trend

Pass

Fail




5.10. TEST # 10 – SYSTEM TEST FUNCTION

Test Purpose: This test covers the functionality of the System Test function.

Test Tools: Test device



Pass /Fail

Initials/ Date


1From Home screen,depress the System Testbutton

The System Test screen comes on. Pass

Fail

2Time Elapsed valuedisplay functionality –Counting

The value of the timer is 0 uponentry into the screen and counts upat 1 second frequency continuouslywhile the screen is active.

Pass

Fail

3Time Elapsed valuedisplay functionality –Resetting

Upon depressing the Reset buttonthe value of the Time Elapseddisplay is reset to zero. The counterimmediately resumes counting at 1second frequency.

Pass

Fail

4

Connect the gloveportsimulator to the Achannel.

Select the A channel andpositive pressure

Actuate the High FlowPlus button

The Pressure PV display reflects arapid increase in internal pressure ofthe simulator.

Pass

Fail

5 Actuate the High FlowMinus button

The Pressure PV display reflects arapid decrease in internal pressureof the simulator

Pass

Fail





Pass /Fail

Initials/ Date


6

Allow the pressure tostabilize between the1000 and 2000 Pa.

Actuate the Low FlowPlus button

The Pressure PV display reflects aslow increase in internal pressure ofthe simulator

The Low Flow display increases invalue until it reaches 100.

Pass

Fail

7 Actuate the Low FlowMinus button

The Pressure PV display reflects aslow increase in internal pressure ofthe simulator

The Low Flow display decreasesuntil it reaches 0.

Pass

Fail

8

Actuate the Low Flowbuttons to set the flowrate at approximately50Sccm.

Allow the pressure tosettle.

Make note of the currentPressure, Flow Rate andTime Elapsed andactuate the printer icon.

The “Print System Test Results”screen comes on and shows the endof test Pressure, Flow Rate andTime Elapsed and the active channel(A channel).

Pass

Fail

9 Activate the “OK” button.



3. The end pressure, end flowand elapsed time values matchthe previously recorded values

4. System returns to the Homescreen

Pass

Fail

10Actuate the Key Lockswitch On/Off severaltimes.

Actuation of the Key Lock switch hasno impact on the System Testfunction.

Pass

Fail





Pass /Fail

Initials/ Date


11

Connect the gloveportsimulator to the Bchannel connections.

Change the activechannel selection to “B”.

Actuate the Low Flowbuttons to set the flowrate at approximately50Sccm.

Make note of the currentPressure, Flow Rate andTime Elapsed andactuate the printer icon.

The “Print System Test Results”screen comes on that shows the endof test Pressure, Flow Rate andTime Elapsed and the active channel(B channel).

Upon activation of the OK button, aprint out of the end of test valuesand the active channel (B channel) isproduced.

Pass

Fail

12

Connect the gloveportsimulator to the Achannel.

Select the A channel andpositive pressure

Actuate the High FlowPlus button

Allow the pressure toreach 3,750 pascals.

K2– Deflate (%Q3) valve actuates toprevent the pressure internal to thesimulator to increase above 3,750pa.

Pass

Fail




5.11. TEST # 11 – IN–SITU CALIBRATION – NORMAL SEQUENCE

Test Purpose: This test covers the functionality of the In-Situ calibration process sequence.

Test Tools: Test device.

Test Set up: Test device connected to the A ports, interlock key in the “unlocked” position.


Pass /Fail

Initials/ Date


1From Home screen,depress the Calibrationbutton

The System Calibration screencomes on.

Pass

Fail

2

Make note of the FixedOffset, the Incrementaloffset, Lower input valueand Upper input value.

Depress the “CalibrateSystem” button

The “Step1 – Low pressure factor”screen comes on.

Pass

Fail

3Open the valve of thetest device.

Press “Enter”

The P(pv) value is displayed in theappropriate window.

The “Time remaining” counter startscounting down to zero.

Make note of the pressure (pv) valuewhen the counter reaches zero.

When the counter reaches zero the“Step2 – High pressure factor”screen comes on.

Pass

Fail





Pass /Fail

Initials/ Date


4

Close the valve of thetest device.

Adjust the flow rate untilthe Flow(pv) reads 50.

Press “Enter”

The P(pv) value is displayed in theappropriate window.

The “Time remaining” counter startscounting down to zero.

Make note of the pressure (pv) valuewhen the counter reaches zero.

When the counter reaches zero the“Step3 – Calibration confirmation”screen comes on.

Pass

Fail

5

Make note of the FixedOffset, IncrementalOffset Current and Newvalues.

The current values displayed are thesame as the values previouslyrecorded.

Pass

Fail

6 Press the “Accept” buttonPop up window comes on: “You arechanging system calibration. Are yousure”

Pass

Fail

7 Press the “Yes” button. Pop up window comes on:“Calibration has been changed”

Pass

Fail

8 Press “Exit” button The Home screen comes on. Pass

Fail

9 Re-enter the calibrationscreen


The Fixed Offset, the Incrementaloffset, the Lower input value and theUpper input value match thepreviously recorded values.

Pass

Fail




5.12. TEST # 12 – PRINTING FUNCTION - IN–SITU CALIBRATION PARAMETERS

Test Purpose: This test covers the functionality of the calibration parameters printing.

Test Tools: None

Test Set up: None


Pass /Fail

Initials/ Date


1From Home screen,depress the Calibrationbutton


Pass

Fail

2

Make note of the FixedOffset, the Incrementaloffset, Lower input valueand Upper input value.

Depress the Printer icon

A print out of the calibrationparameters is generated.

The values printed match the valuesdisplayed on the screen.

Pass

Fail




5.13. TEST # 13 – PRINTING FUNCTIONS - PARAMETERS

Test Purpose: This test confirms the parameter data printed is complete and accurate

Test Tools: None

Test Set up: None.

Test Set up: None.


Pass /Fail

Initials/ Date


1

Place the key lock in the“unlocked” position

Enter the ParameterManagement screen anddepress the printer icon

A print out comes out

The print out header includes thecorrect date.

The print out lists all parameter IDlabels with the associatedprogrammed values.

Pass

Fail

2

Depress the “Overview”button from theparameters managementscreen.

The parameter list and theassociated values is displayed onthe OIT.

Pass

Fail

3Compare the printedvalues with the OITdisplayed values.

The id labels and associated valuesbetween the printed list and thedisplayed list match.

Pass

Fail




6. EXECUTION NOTES

TestNo. Notes




7. PROTOCOL COMPLETION STATEMENT/SYSTEM READINESS FOR FAT

All GIT-LCA Glove Integrity Tester functions have been tested per this protocol on ________________ and the system has met all acceptance criteria. Allexception conditions and other issues encountered during the test process have been corrected, as documented in the “notes” section of this document. Thesystem is ready for FAT testing.

Signed:___________________________ Time:__________ Date:____________

GIT-LCA Glove Integrity Tester Functional Test … SN 001 Functional Test...GIT-LCA Glove Integrity...

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Transcript of GIT-LCA Glove Integrity Tester Functional Test … SN 001 Functional Test...GIT-LCA Glove Integrity...