OPERATING AND MAINTENANCE INSTRUCTIONS



1 Machine Description:

The DPI Testing System is designed to carry out a series of testing protocols on components of the DPI device. The equipment tests four (4) parts that form the assembly of the DPI device. See Drawing 2-1for a top view of the equipment.

The equipment is designed to handle three (3) dose configurations:

• 100 µg – 7-, 14-, 30-, 60- and 120-count doses

• 200 µg – 7-, 14-, 30-, 60- and 120-count doses

• 400 µg – 7-, 14-, 30-, and 60-count doses

The equipment is designed to perform the following five (5) tests:

1. Dose hole alignment of lower subassembly

2. Snap force of the lower to upper subassembly

3. Insertion force of the dry desiccant into the overcap

4. Counter function with overcap (partial) and application and removal torque

5. Counter function with overcap (complete) and application and removal torque.

2 Parts of the Machine:

The DPI Testing System consists of four (4) independent testing stations:

• Station 1 – Dose Hole Alignment Test

• Station 2 – Snap Force Test

• Station 3 – Insertion Force Test

• Station 4 – Counter and Torque Test

[pic]

Drawing 2-1 - Dry Powder Inhaler Testing System

1 Station 1 – Dose Hole Alignment

The primary function of Station 1 (Picture 2-1) is to check the lower subassembly’s dose hole size and alignment.

The Dose Hole Alignment Station includes the following components: lower subassembly, one (1) vision camera with light, a servo motor, a vision camera, and two (2) pneumatic cylinders.

2 Station 2 – Snap Force

The function of Station 2 (Picture 2-2) is to measure the force required to snap the upper subassembly to the lower subassembly.

The Snap Force Station includes the following components: lower subassembly, upper subassembly, and a servo press.

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Picture 2-2 - Snap Force

1. The operator manually places an upper subassembly onto a lower subassembly, aligning the parts properly.

2. These parts are then placed in the single tooling fixture (as shown in Picture 2-2).

3. The operator rotates the combined assembly until the window is in line with notch on nest.

4. A test is initiated by pressing one of the opto start buttons.

5. The light curtain is reset. The green light-stack light turns on solid.

6. A force-measuring servo press lowers a ram and snaps the upper subassembly and lower subassembly together. The peak force to snap the two parts together is recorded.

7. The green light-stack light turns off, indicating the operator must remove the part.

8. The operator places successfully tested parts back on the part tray. Rejected parts are placed in the reject bin.

3 Station 3 – Insertion Force

The primary function of Station 3 (Picture 2-3) is to measure the force required to snap the desiccant cartridge into the overcap.

The Insertion Force Station includes the following components: overcap, desiccant cartridge, and a servo press.

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Picture 2-3 - Insertion Force

1. The operator manually places a desiccant cartridge and overcap onto a single tooling fixture.

2. A test is initiated by pressing one of the opto start buttons.

3. The light curtain is reset. The green light-stack light turns on solid.

4. A force-measuring servo press lowers a ram and snaps the desiccant cartridge and overcap together. The peak force to snap the two parts together is recorded.

5. The green light-stack light turns off, indicating the operator must remove the part.

6. The operator places successfully tested parts on to a part tray. Rejected parts are placed in the reject bin.

3 Control Description

1 Machine Control

Allen-Bradley ControlLogix platform of programmable logic controllers (PLCs) and associated equipment are used on this machine. This platform was developed to integrate logic and motion; therefore, it was the preferred choice as the PLC for this machine.

Each test station has independent controls and light curtain guards. Therefore, they can be run independently.

Vision inspection and Optical Character Recognition is achieved by using Cognex In-Sight model 5100 camera systems.

2 Data Collection Computer

The machine server is a server member of the Schering-Plough domain server. It is mounted inside a lockable console.

All test results are stored on the machine server in a Microsoft SQL server database. When testing is completed on a particular lot, the database is archived to Schering-Plough’s secure server. Even if this data is successfully archived, it remains on the local server for 90 days before it is deleted.

3 Human-Machine Interface (HMI)

Allen-Bradley RSView software (Supervisory Edition) running on Dell workstations serves as the operator interface to the equipment. This includes the following functions:

• Manual buttons to initiate individual machine motions for testing and setup

• Diagnostics to alert the operator to problems that may prevent the machine from running/starting

• Disable and abort automatic cycles

• Printing of reports

• Calibration and maintenance alerts

Operation and Controls

1 Operator Interface Overview

Dell workstations with touchscreen monitors are the Human Machine Interface (HMI). These HMIs are used for machine control and adjustments.

The touchscreen monitors are mounted on ERGOTRON arms, which allow for horizontal, vertical, and swivel adjustment.

Operation of the DPI Testing System is controlled by RSView ME software via the Dell workstations with touchscreens and function control pushbuttons. The HMI includes screens that are used for station status displays, manual actions, station setup, and alarm handling. The HMI system on the DPI Testing System is based on Rockwell’s RSView Supervisory Edition Client.

RSView Supervisory Edition Server handles the system level user interface via a Windows-based PC.

2 HMI Overview:

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Picture 3-2 - Human Machine Interface

Screens appear as an integrated entity on the HMI. Each HMI screen is constructed of a base screen overlaid with the selected screen. The base screen contains elements that are present on all screens and serves the purpose of maintaining consistent presentation of common information, format, and function. The selected screen contains information related to its topic.

|IMPORTANT: After entering any numeric data on the HMI screen, always press the enter key. Data is not accepted until the enter key is pressed. |

1 Navigation Buttons

All screens on the HMI have navigation capability to go to another screen via touchscreen buttons located on the footer of each screen.

2 Common Features and Screens Between All HMIs

1 Header

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Screen 3-1 – Header

The header remains visible at the top of the RSView SE display screens at all times. The header contains the following information:

• Operator who is logged in

• Filename of the test data

• RIC number and description of product being tested (RIC number is Schering-Plough’s internal part number)

• Current time and date

2 Electronic Signature Comment Screen

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Screen 3-2 – Electronic Signature Comment Screen

Accept pushbutton: Pressing this pushbutton will accept information entered.

Cancel pushbutton: Pressing this pushbutton will exit out of this screen.

Information displayed on screen or information to enter:

Operation: Operation that is being done and recorded

Comments: Enter reason for operation to be completed

User name: Enter user name of person making change.

Password: Enter user’s password.

3 Alarms Screen

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Screen 3-3 – Alarms

Information displayed on screen:

Alarm Date: Displays the date the alarm occurred.

Alarm Time: Displays the time the alarm occurred.

Description: Displays the description of the alarm. See alarm section for more detail.

Statements in Yellow signify warning message.

Statements in Red signify alarm message.

4 Operator Login Screen

[pic]

Screen 3-4 – Operator Login Screen

USER: dpiadmin1

Password: dpiadmin1

OK pushbutton: Pressing this pushbutton will accept information entered.

Cancel pushbutton: Pressing this pushbutton will exit out of this screen.

Information displayed on screen:

User name: Enter user name of person to use the station.

Password: Enter user’s password.

5 Press Console*

Important

This screen is only used for troubleshooting. Person operating the press using this screen must follow defined procedure or damage to the machine will occur. See troubleshooting section for more information.

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Screen 3-5 – Press Console

B1 pushbutton: Pressing this pushbutton will slowly jog press’s crosshead up.

B2 pushbutton: Pressing this pushbutton will slowly jog press’s crosshead down.

B3 pushbutton: Pressing this pushbutton will quickly jog press’s crosshead down.

B4 pushbutton: Pressing this pushbutton will quickly jog press’s crosshead up.

B5 pushbutton: Pressing this pushbutton will redefine zero. IT IS EXTREMELY IMPORTANT THAT THIS BUTTON IS NEVER PRESSED. SERVE HARM WILL BE DONE TO STATION’S PROGRAM.

3 Station 2 – Snap Force Screens

1 Snap Force Screen Footer

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Screen 3-14 – Snap Force Screen Footer

The footer remains visible at the bottom of the RSView SE display screens at all times. Pressing a touchscreen button will switch to that screen to perform a task, view information, or print a screen.

alarms pushbutton: Pressing this pushbutton takes the operator to the Alarm screen.

alarm reset pushbutton: Pressing this pushbutton clears all current alarms.

sf test status pushbutton: Pressing this pushbutton takes the operator to the Snap Force Test Station screen.

login pushbutton: Pressing this pushbutton takes the operator to the Login screen. (Shown if logged out)

logout pushbutton: Pressing this pushbutton will logout the operator. (Shown if logged in)

print screen pushbutton: Pressing this pushbutton will print the current screen to the printer located in the Printer/Server Cart, located near Station 4.

2 Snap Force Test Station Screen

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Screen 3-15 – Snap Force Test Station Screen

datum test pushbutton: Pressing this pushbutton will define zero for the press.

return to zero pushbutton: Pressing this pushbutton will move ram to zero position.

abort test pushbutton: Pressing this pushbutton will abort current test and reset the station.

acknowledge pushbutton: Pressing this pushbutton will acknowledge the failure. (Appears when there is a failure)

disregard this test pushbutton: Pressing this pushbutton will discard results of last tested part. (Appears when there is a failure)

Set Limit pushbutton: Pressing this button will bring up the Electronic Signature screen. This is required to make changes to the limits of the test. (Requires a supervisor, engineer or administrator level password to change)

verify press force pushbutton: Pressing this pushbutton will verify station’s load cell (see the verification procedure).

press calibrated pushbutton: Pressing this pushbutton will reset the time counter monitoring the calibration of station. (Requires engineer or administrator level password) When logged in as an operator or supervisor, press calibrated pushbutton will not be visible. Blue text stating “Last Calibrated” will be displayed in its place.

press verified pushbutton: Pressing this pushbutton will reset the time counter monitoring the verification of station.

Admin Access hmi pushbutton: Pressing this pushbutton will launch Windows Explorer. (Requires administrator level password)

Start Press Console pushbutton: Pressing this pushbutton will launch Press Console Interface. Only used for troubleshooting. (Requires administrator level password)

Information displayed or settings to set on screen:

Lower Subassembly: Displays the RIC # and MI # of the lower subassembly being tested.

Upper Subassembly: Displays the RIC # and MI # of the upper subassembly being tested.

Test Status: Will display messages pertaining to the station and light stack:

• Ready to Run (Flashing green on light stack)

• Running (Steady green on light stack)

• Alarms Active (Steady amber on light stack)

Status: Displays statistics of current test.

Snap Force: Displays result of last tested assembly.

Snap Force Test: Displays status of press, either running or completed.

USL Acceptable: Applies to the first 100 parts tested for a given filename. The following equation is used determine if the lot passes:

M + (K2 * D) ( A

Where:

• M = Mean force of the 100 tested parts

• K2 = USL Factor

• D = Standard deviation of the 100 tested parts

• A = Max Force

If it is determined that the first 100 parts have failed, run additional units based upon the DPI Sampling Plan for Snap Force.

LSL Acceptable: Applies to the first 100 parts tested for a given filename. The following equation is used determine if the lot passes:

M + (K1 * D) ( B

Where:

• M = Mean force of the 100 tested parts

• K1 = LSL Factor

• D = Standard deviation of the 100 tested parts

• B = Min Force

If it is determined that the first 100 parts have failed, run additional units based upon the DPI Sampling Plan for Snap Force.

Date under Press Calibrated Pushbutton: Displayed last calibration date of station.

Date under Press Verified Pushbutton: Displayed last verified date of station.

Additional Components: Displays the MI# and RIC# of the other components involved in the test.

Snap Force Setpoints:

Max Force: Enter the maximum allowable force to pass the test. (Requires a supervisor, engineer or administrator level password)

Min Force: Enter the minimum allowable force to pass the test. (Requires a supervisor, engineer or administrator level password)

USL Factor (K2): The value is preset to 1.51. This value is used to determine is lot is acceptable or not. (Requires a supervisor, engineer or administrator level password to change)

LSL Factor (K1): The value is preset to 2.18. This value is used to determine is lot is acceptable or not. (Requires a supervisor, engineer or administrator level password to change)

Display: Displays the last graph recorded by the station

Power Not Reset Start Test or Press Alarm Reset: Message will appear when light curtain is broken and station is disabled.

4 Station 3 – Insertion Force Screens

1 Insertion Force Screen Footer

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Screen 3-16 – Insertion Force Screen Footer

The footer remains visible at the bottom of the RSView SE display screens at all times. Pressing a touchscreen button will switch to that screen to perform a task, view information, or print a screen.

alarms pushbutton: Pressing this pushbutton takes the operator to the Alarm screen.

alarm reset pushbutton: Pressing this pushbutton clears all current alarms.

if test status pushbutton: Pressing this pushbutton takes the operator to the Insertion Force Test Station screen.

login pushbutton: Pressing this pushbutton takes the operator to the Login screen. (Shown if logged out)

logout pushbutton: Pressing this pushbutton will logout the operator. (Shown if logged in)

print screen pushbutton: Pressing this pushbutton will print the current screen to the printer located in the Printer/Server Cart, locate near Station 4.

2 Insertion Force Test Station Screen

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Screen 3-17 – Insertion Force Test Station Screen

datum test pushbutton: Pressing this pushbutton will define zero for the press.

return to zero pushbutton: Pressing this pushbutton will move ram to zero position.

abort test pushbutton: Pressing this pushbutton will abort current test and reset the station.

acknowledge pushbutton: Pressing this pushbutton will acknowledge the failure. (Appears when there is a failure)

disregard this test pushbutton: Pressing this pushbutton will discard results of last tested part. (Appears when there is a failure)

Set Limit pushbutton: Pressing this button will bring up the Electronic Signature screen. This is required to make changes to the limits of the test. (Requires a supervisor, engineer or administrator level password to change)

verify press force pushbutton: Pressing this pushbutton will verify station’s load cell (see the verification procedure).

press calibrated pushbutton: Pressing this pushbutton will reset the time counter monitoring the calibration of station. (Requires engineer or administrator level password) When logged in as an operator or supervisor, press calibrated pushbutton will not be visible. Blue text stating “Last Calibrated” will be displayed in its place.

press verified pushbutton: Pressing this pushbutton will reset the time counter monitoring the verification of station.

Admin Access hmi pushbutton: Pressing this pushbutton will launch Windows Explorer. (Requires administrator level password)

Start Press Console pushbutton: Pressing this pushbutton will launch Press Console Interface. Only used for troubleshooting. (Requires administrator level password)

Information displayed or settings to set on screen:

Test Status: Will display messages pertaining to the station and light stack:

• Ready to Run (Flashing green on light stack)

• Running (Steady green on light stack)

• Alarms Active (Steady amber on light stack)

Status: Displays statistics of current test.

Insertion Force: Displays result of last tested assembly.

Insertion Force Test: Displays status of press, either running or completed.

Date under Press Calibrated Pushbutton: Displayed last calibration date of station.

Date under Press Verified Pushbutton: Displayed last verified date of station.

Additional Components: Displays the MI# and RIC# of the other components involved in the test.

Insertion Force Setpoints:

Max Force: Enter the maximum allowable force to pass the test. (Requires a supervisor, engineer or administrator level password)

Min Force: Enter the minimum allowable force to pass the test. (Requires a supervisor, engineer or administrator level password)

Display: Displays the last graph recorded by the station

Power Not Reset Start Test or Press Alarm Reset: Message will appear when light curtain is broken and station is disabled.

3 Station 2 – Snap Force

1 General Information:

The Snap Force Station uses a load cell to measure the force required to snap the upper assembly onto the lower assembly.

2 Starting Conditions

a. System power up has been completed.

b. Operator has logged into station as an engineer or administrator.

3 Special Tools

1. Snap Force Verification Tool (Part Number 04-1835-A022) (Picture 4-4)

2. Sensotec Instrument (Part Number P0152708)

3. Snap Force Set-up Tool (Part Number 04-1835-0211) (Picture 4-4)

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Picture 4-4 - Snap Force Tools

4 Set-up Procedure

1. Place Set-up Tool into nest (Picture 4-5).

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Picture 4-5 - Set-up Tool in Nest

2. Press alarm reset pushbutton to energize the station.

3. On Snap Force Test Station screen, press datum test pushbutton. The ram will slowly move down and tap the tool and return to a set position. It is very important that the light curtain is not broken during this move because zero will be incorrectly defined.

4. Once ram has stopped moving, wait for 10 seconds and then press return to zero pushbutton. The ram will move back and forth around the arrows.

5. Visually verify ram is aligned with arrows (Picture 4-6).

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Picture 4-6 - Press Ram Starting Position

6. Remove Set-up tool from nest.

5 Verification Procedure

1. Place Verification Tool into nest (Picture 4-7). Run tool’s wire to either side of the tray stop, hooking wire under shoulder bolt (Picture 4-8).

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Picture 4-7 – Snap Force Verification Tool In Nest

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Picture 4-8 – Snap Force Verification Tool Wire Run

2. Verify that the Snap Force Verification Tool is plugged into Channel 1 of the Sensotec Instrument (Picture 4-9).

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Picture 4-9 - Sensotec Instrument Interface

3. Plug Sensotec Instrument into outlet and turn on.

4. Turn Sensotec Instrument to Channel 1.

5. Press tare pushbutton on Sensotec Instrument.

6. On Snap Force Test Station screen, press alarm reset pushbutton to energized the station.

7. Press verify press force pushbutton to perform test. The ram of the press will lower and hold, creating a force on the tool.

8. Wait 20 seconds for the ram to settle in to its position.

9. Read value from Snap Force Test Station screen.

10. Compare to value read from HMI screen to value shown on Sensotec Instrument.

11. If value is +/- 1.0 lb, press return to zero pushbutton to return the ram to the home position. If value read is out of the accepted range, consult maintenance.

12. Press press verified pushbutton to complete the test and reset verification timer.

13. Remove Verification Tool from nest.

6 Calibration Procedure

To calibrate the Chatillon press, follow the steps in section 11 (specifically section 11.4) of the “Service Manual for the Plus Series of Materials Testing Machines” (Part # 01/3126).

Use the Sensotec Instrument and Verification Tool listed in section 4.2.3 to measure the applied force on the Chatillon crossarm.

4 Station 3 – Insertion Force

1 General Information

The Insertion Force Station uses a load cell to measure the force required to snap the upper assembly onto the lower assembly.

2 Starting Conditions

a. System power up has been completed.

b. Operator has logged into station as an engineer or administrator.

3 Special Tools

1. Insertion Force Verification Tool (Part Number 04-1835-A032) (Picture 4-10)

2. Sensotec Instrument (Part Number P0152708)

3. Insertion Force Set-up Tool (Part Number 04-1835-0305) (Picture 4-10)

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Picture 4-10 - Insertion Force Tools

4 Set-up Procedure

1. Place Set-up Tool into nest (Picture 4-11).

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Picture 4-11 - Set-up Tool in Nest

2. Press alarm reset pushbutton to energize the station.

3. On Snap Force Test Station screen, press datum test pushbutton. The ram will slowly move down and tap the tool and return to a set position. It is very important that the light curtain is not broken during this move because zero will be incorrectly defined.

4. Once ram has stopped moving, wait for 10 seconds and then press return to zero pushbutton. The ram will move back and forth around the arrows.

5. Verify ram is aligned with arrows (Picture 4-12).

[pic]

Picture 4-12 - Press Ram Starting Position

6. Remove Set-up tool from nest.

5 Verification Procedure

1. Place Verification Tool into nest (Picture 4-13). Run tool’s wire to either side of the tray stop, hooking wire under shoulder bolt (Picture 4-14).

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Picture 4-13 – Insertion Force Verification Tool In Nest

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Picture 4-14 – Insertion Force Verification Tool Wire Run

2. Verify that the Insertion Force Verification Tool is plugged into Channel 3 of the Sensotec Instrument (Picture 4-15).

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Picture 4-15 - Sensotec Instrument Interface

3. Plug Sensotec Instrument into outlet and turn on.

4. Turn Sensotec Instrument to Channel 3.

5. Press tare pushbutton on Sensotec Instrument.

6. On Insertion Force Test Station screen, press alarm reset pushbutton to energized the station

7. Press verify press force pushbutton to perform test. The ram of the press will lower and hold, creating a force on the tool.

8. Wait 20 seconds for the ram to settle in to its position.

9. Read value from Insertion Force Test Station screen.

10. Compare to value read from HMI screen to value shown on Sensotec Instrument.

11. If value is +/- 2.0 lb, press return to zero pushbutton to return the ram to the home position. If value read is out of the accepted range, consult maintenance.

12. Press press verified pushbutton to complete the test and reset verification timer.

13. Remove Verification Tool from nest.

6 Calibration Procedure

To calibrate the Chatillon press, follow the steps in section 11 (specifically section 11.4) of the “Service Manual for the Plus Series of Materials Testing Machines” (Part # 01/3126).

Use the Sensotec Instrument and Verification Tool listed in section 4.3.3 to measure the applied force on the Chatillon crossarm.

7 Snap Force

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8 Insertion Force

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Station 2 – Snap Force Test

Station 3 – Insertion Force Test

Station 1 – Dose Hole Alignment Test

Station 4 – Counter and Torque Test

Printer and Server Stand

Electrical Cabinet

Part Alignment Notch

Header

Movable Arm

Touchscreen

Footer

Keyboard

and Mouse

Tray Folds Up When Not Needed

B6

B5

B4

B1

B2

B3

Verification Tool

04-1835-A022

Set-up Tool

04-1835-0211

Shoulder Bolt

ON/OFF Switch

Channel 1

Verification Tool

04-1835-A032

Set-up Tool

04-1835-0305

Shoulder Bolt

ON/OFF Switch

Channel 3

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