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Operational Qualification Protocol Vial Washer National Institutes of Health Operational Qualification Protocol Equipment:

Vial Washer

Protocol #: E-0001-2009-01

Date: 2/8/2010

Facility: National Institutes of Health

Location: 9000 Rockville Pike Building 10 Room 1C166A5A Bethesda, MD 20892

Revision: None

Title: Operational Qualification Protocol for the Vial Washer. Objective: The objective of this protocol is to document the satisfactory operation of the vial washer used for manufacturing at National Institutes of Health, Inc. Written By: Narlin Beaty Title: Qualification Process Solutions Signature: Signature: Date: Date: Approved By: ______________________ Title: _____________________________ Signature: Date: Approved By: ______________________ Title: _____________________________ Signature: Date: Approved By: ______________________ Title: _____________________________

Qualification Process Solutions, Inc. DOCUMENT NUMBER E-0001-2009-01 REVISION NUMBER None Author: Narlin Beaty ______________________

PROPRIETARY INFORMATION: Unauthorized Duplication Is Prohibited DATE: 2/8/2010 Revision Date: None

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Operational Qualification
EQUIPMENT NAME: Vial Washer

Equipment No: ________________

OPERATIONAL QUALIFICATION
FOR THE

VIAL WASHER

INSTALLED AT

NATIONAL INSTITUTES OF HEALTH BUILDING 10 BETHESDA, MD 20892

QUALIFICATION PROCESS SOLUTIONS 13406 BLYTHENIA RD PHOENIX, MD 21131

DOC # E-0001-2009-01 OPERATIONAL QUALIFICATION PROTOCOL VIAL WASHER National Institute of Health, Building 10 Bethesda MD 20892

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TABLE OF CONTENTS 1.0 Purpose..............................................................................................................................................3 2.0 Scope.................................................................................................................................................3 3.0 Equipment Description......................................................................................................................3 4.0 Responsibilities.................................................................................................................................3 5.0 Reference Documents.......................................................................................................................3 6.0 Definitions........................................................................................................................................4 7.0 Test Function Number One: OQ Signature Verification List (Attachment #1)................................4 8.0 Test Function Number Two: Test Equipment (Attachment #2)........................................................4 4.0 Test Function Number Three: Procedure List (Attachment #3)........................................................5 9.0 Test Function Number Four: Operator Controls and Indicators (Attachment #4)............................5 10.0 Test Function Number Five: Operator Interface (Attachment #5)..................................................5 11.0 Test Function Number Six: Functional Verification (Attachment #6)............................................5 12.0 Test Function Number Seven: Alarms, Safeties and Interlocks (Attachment #7)...........................6 13.0 Test Function Number Eight: Sequence of Operations (Attachment #8)........................................6 14.0 Test Function Number Nine: Maximum / Minimum Values (Attachment #9)...............................6 15.0 Deviation Reporting Log (Attachment #10)....................................................................................7 16.0 Operational Qualification Protocol Review (Attachment #11)........................................................7 17.0 Summary Report Requirements......................................................................................................7 18.0 Attachment List ..............................................................................................................................8 Attachment #1 OQ Signature Verification List......................................................................................9 Attachment #2 Test Equipment............................................................................................................10 Attachment #3 Procedure List..............................................................................................................11 Attachment #4 Operator Controls and Indicators................................................................................12 Attachment #5 Operator Interface .......................................................................................................13 Attachment #6 Functional Verification...............................................................................................23 Attachment #7 Alarms, Safeties and Interlocks....................................................................................24 Attachment #8 Sequence of Operation.................................................................................................25 Attachment #9 Deviation Reporting Log.............................................................................................28 Attachment #10 Operational Qualification Protocol Review...............................................................29

DOC # E-0001-2009-01 OPERATIONAL QUALIFICATION PROTOCOL VIAL WASHER National Institute of Health, Building 10 Bethesda MD 20892

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1.0

Purpose The objective of this protocol is The objective of this test function is to verify that the Vial Washer, described in Section 3.0, operates in accordance to manufacturers specification, and in accordance with Current Good Manufacturing Practices (cGMPs).

2.0

Scope This Operational Qualification pertains to the verification of the operation of the equipment described in Section 3.0 of this protocol, to be installed in the Clean Prep Room at National Institutes of Health, 9000 Rockville Pike Building 10 Pharmacy, Bethesda, MD 20892. This protocol is specific to the Vial Washer and related instrumentation and equipment. This protocol is limited to the sterile manufacturing space. Connected equipment and utilities for this system are not covered in this protocol; refer to specific equipment validations if applicable.

3.0

Equipment Description The vial washing system consists of a batch washer, and vial plate sets for individual vial sizes, used to wash vials prior to dry heat depyrogenation. Wash media surfaces are constructed of 316 stainless steel, and the base frame is aluminum with 304 stainless steel exterior surfaces. Plastic wrapped vial packages are received and logged. The vial packages are placed onto flip trays and the plastic is removed while retaining the packaging pattern. An additional set of trays are used to flip and place the vial pack into the vial washer. The vial washer is equipped with a single spray nozzle per vial. An operator initiates a washing cycle through a PanelView Display and the vials are washed with an alternating series of Water For Injection and Pure Steam. Washed vials are then removed and transferred to trays for dry heat depyrogenation. The machine is password protected. As delivered, the default password is 2040 (ancillary document gives current password as 1111 and backdoor password as 1357).

4.0

Responsibilities 4.1 Qualification Process Solutions, LLC (QPS) 4.1.1 It is the responsibility of QPS to write this protocol. 4.1.2 It is the responsibility of QPS to execute this protocol. National Institutes of Health, Inc. (NIH) Following the execution, NIH will approve the final report associated with this protocol, indicating the executed protocol was completed correctly and all acceptance criteria were met.

4.2

5.0

Reference Documents 5.1 5.2 Cozzoli Vial Washer O&M Reference drawings

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5.3 6.0

Title Basic Machine SS GW24 Floor Plan Frame Assy Basin and Basin Cover Assy Inside/Outside Wash Assy Burkert Valves Drain Assy Spray Nozzle Assy Electrical Schematic (3 drawings) Pneumatic Schematic Flow Schematic (8.5 x 11) Vendor certifications

Drawing Number 320479 FP-1221 320478 318893 320507 318894 308976 901690 901689 901688

Date 2 Jun 2005 22 Apr 2002 2 Jun 2005 19 Apr 2002 8 Jul 2005 19 Apr 2002 20 May 1987 06 Oct 2006 27 Sept 2006 27 Sept 2006

Definitions 6.1 Critical Instrumentation Critical instruments are defined as those whose performance will affect the operation of the system and/or the quality attributes of the processed materials. Critical instruments are calibrated and certified using standards that are traceable to NIST (National Institutes of Standards and Testing). Non-Critical Instrumentation Instrumentation provided for indication or convenience purposes only.

6.2 7.0

Test Function Number One: OQ Signature Verification List (Attachment #1) 7.1 7.2 7.3 Objective To identify and document all personnel involved in executing this protocol. Procedure Verify that each person who executes this protocol signs Attachment #1. Each person must be identified by name, title, company, signature, initials and date on the attached form. Acceptance Criteria Signatures from all personnel involved in execution of this protocol shall be present.

8.0

Test Function Number Two: Test Equipment (Attachment #2) 8.1 8.2 Objective To verify and document all test equipment Procedure 8.2.1 Complete a list of all the instruments required for conducting OQ testing. 8.2.2 Verify that the test equipment/instruments are calibrated and the reference standards are traceable to National Institute for Standards and Technology (NIST) or other approved standard. 8.2.3 Complete the applicable attachment, indicating the equipment description, ID/serial number, calibration date, re-calibration date. Acceptance Criteria

8.3

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All test equipment required for execution shall be calibrated with copies of calibration records attached. 4.0 Test Function Number Three: Procedure List (Attachment #3) 8.4 Objective The objective of this test function is The objective of this test function is to verify that the Standard Operating Procedures (SOPs) necessary for proper operation of the equipment have been identified and that when drafted have been attached to this qualification. Procedure 8.5.1 List and attach SOPs needed for the operation and/or maintenance of this equipment. 8.5.2 Complete the applicable attachment with a list of all applicable SOPs. 8.5.3 If SOPs have been drafted for this equipment, or SOPs are already approved and in place, then attach copies of the SOPs. Acceptance Criteria All associated SOPs for operation and maintenance shall be listed.

8.5

8.6 9.0

Test Function Number Four: Operator Controls and Indicators (Attachment #4) 9.1 9.2 Objective The objective of this test function is to verify that the controls and indicators operate as specified by vendor recommendations. Procedure 9.2.1 Operate the control switches listed in the attachment. 9.2.2 Visually verify and document the actual equipment response. 9.2.3 Document any discrepancies in Attachment #10, Deviation Reporting Log. If any variances/deviations are present, complete the appropriate deviation/variance form. Acceptance Criteria All operator controls and indicators tested shall conform to the expected response.

9.3 10.0

Test Function Number Five: Operator Interface (Attachment #5) 10.1 10.2 Objective The objective of this test function is to ensure proper communication between the operator interface, PLC, and equipment. Procedure 10.2.1 Display the operator interface screen listed on the attachment. 10.2.2 Visually verify and document the actual results of the functions that appear on the operator interface. 10.2.3 Document any discrepancies in Attachment #10, Deviation Reporting Log. Acceptance Criteria The actual results of operator interface screens shall conform to the expected responses.

10.3 11.0

Test Function Number Six: Functional Verification (Attachment #6) 11.1 Objective The objective of this test function is to verify and document the operation and functionality of the equipment.

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11.2

11.3

Procedure 11.2.1 Follow the procedures in the attachment. 11.2.2 Visually verify and document the actual responses as pass or fail against the expected results. 11.2.3 Document all operational parameters used during execution. 11.2.4 Document any discrepancies in Attachment #10, Deviation Reporting Log. Acceptance Criteria All functional requirements must conform to the expected responses, be explained, or treated as a deviation.

12.0

Test Function Number Seven: Alarms, Safeties and Interlocks (Attachment #7) 12.1 12.2 Objective The objective of this test function is to verify and document the operation and functionality of the alarms, safeties and interlocks. Procedure 12.2.1 Follow the procedures in the attachment. 12.2.2 Visually verify and document the actual responses as pass or fail against the expected results. 12.2.3 Document all operational parameters used during execution. 12.2.4 Document any discrepancies in Attachment #10, Deviation Reporting Log. Acceptance Criteria All safeties and interlock requirements must conform to the expected responses.

12.3 13.0

Test Function Number Eight: Sequence of Operations (Attachment #8) 13.1 13.2 Objective The objective of this test function is to verify and document the operational sequence of the system. Procedure 13.2.1 Execute the procedures in the order listed. 13.2.2 Observe the expected operations and write Pass if the results were as expected, and Fail if the expected operation did not take place. 13.2.3 Document any discrepancies in Attachment #10, Deviation Reporting Log. Acceptance Criteria The operating sequence occurs as expected.

13.3 14.0

Test Function Number Nine: Maximum / Minimum Values (Attachment #9) 14.1 14.2 Objective The objective of this test function is to verify the maximum and minimum allowable values of changeable setpoints. Procedure 14.2.1 Display the changeable setpoint on the attachment and test maximum and minimum values. 14.2.2 Visually verify and document the actual results of the functions that appear on the operator interface.

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14.3 15.0

14.2.3 Document any discrepancies in Attachment #10, Deviation Reporting Log. Acceptance Criteria The actual results of the changeable setpoint limits shall conform to the expected responses.

Deviation Reporting Log (Attachment #10) 15.1 Objective The objective of this test function is to document any deviation to the stated test procedure or acceptance criteria, and to evaluate the deviation relative to acceptability of the qualification study. Procedure 15.2.1 Document all deviations found during execution. 15.2.2 Use additional pages as needed to discuss and explain any deviations. 15.2.3 Initial review (Protocol Review) should be completed once all deviations have been satisfactorily addressed. 15.2.4 Prior to NIH approval of the document the deviation form shall be reviewed and approved internally by NIH personnel. Acceptance Criteria 15.3.1 All deviations shall be properly documented on Attachment 11 and subsequent attached pages.

15.2

15.3

16.0

Operational Qualification Protocol Review (Attachment #11) 16.1 16.2 Objective The objective of this test function is to document that this protocol has been reviewed for completeness as per Qualification Process Solutions, LLC Requirements. Procedure Complete attachment with name, title, signature and date.

17.0

Summary Report Requirements 17.1 17.2 Objective The objective of this test function is to provide an overview of the test results during the execution of this operational qualification. Procedure 17.2.1 Generate a final summary on completion of this protocol execution. 17.2.1.1 Compile a summary of the results obtained. 17.2.1.2 Generate a conclusion regarding the acceptability of the qualification results. 17.2.1.3 Include a statement of conformance to the specified acceptance criteria for each test function. Specifically comment on any deviations and corrective actions taken. 17.2.1.4 Determine the overall executed protocol acceptability. 17.2.2 Attach the completed, executed and approved protocol to the final report.

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18.0

Attachment List 1.0 Purpose..............................................................................................................................................3 2.0 Scope.................................................................................................................................................3 3.0 Equipment Description......................................................................................................................3 4.0 Responsibilities.................................................................................................................................3 5.0 Reference Documents.......................................................................................................................3 6.0 Definitions........................................................................................................................................4 7.0 Test Function Number One: OQ Signature Verification List (Attachment #1)................................4 8.0 Test Function Number Two: Test Equipment (Attachment #2)........................................................4 4.0 Test Function Number Three: Procedure List (Attachment #3)........................................................5 9.0 Test Function Number Four: Operator Controls and Indicators (Attachment #4)............................5 10.0 Test Function Number Five: Operator Interface (Attachment #5)..................................................5 11.0 Test Function Number Six: Functional Verification (Attachment #6)............................................5 12.0 Test Function Number Seven: Alarms, Safeties and Interlocks (Attachment #7)...........................6 13.0 Test Function Number Eight: Sequence of Operations (Attachment #8)........................................6 14.0 Test Function Number Nine: Maximum / Minimum Values (Attachment #9)...............................6 15.0 Deviation Reporting Log (Attachment #10)....................................................................................7 16.0 Operational Qualification Protocol Review (Attachment #11)........................................................7 17.0 Summary Report Requirements......................................................................................................7 18.0 Attachment List ..............................................................................................................................8 Attachment #1 OQ Signature Verification List......................................................................................9 Attachment #2 Test Equipment............................................................................................................10 Attachment #3 Procedure List..............................................................................................................11 Attachment #4 Operator Controls and Indicators................................................................................12 Attachment #5 Operator Interface .......................................................................................................13 Attachment #6 Functional Verification...............................................................................................23 Attachment #7 Alarms, Safeties and Interlocks....................................................................................24 Attachment #8 Sequence of Operation.................................................................................................25 Attachment #9 Deviation Reporting Log.............................................................................................28 Attachment #10 Operational Qualification Protocol Review...............................................................29

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Attachment #1 OQ Signature Verification List This section identifies the personnel conducting the Operational Qualification. Each person who will be executing this protocol shall complete an entry on the page. Print Name Title Department/ Company Name Signature Initials Date

Comments: ________________________________________________________________________ __________________________________________________________________________________ __________________________________________________________________________________ __________________________________________________________________________________ Acceptance Criteria: Signatures from all personnel involved in execution of this protocol shall be present. Meets Acceptance Criteria? ( ) Yes ( ) No Reviewed by: __________________________________ Date: __________

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Attachment #2 Test Equipment This attachment identifies the instruments, equipment, and materials that are not part of the equipment or system being qualified, but are used in this qualification. Equipment Description Riboflavin Ultra-violet light Manufacturer ID# Serial # Certified/ Calibrated Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Cal. Date Cal Due Date Initials/ Date

Comments: ______________________________________________________________________________ _______________________________________________________________________________________ _______________________________________________________________________________________ _______________________________________________________________________________________ Acceptance Criteria: All test equipment required for execution shall be calibrated with copies of calibration records attached. Meets Acceptance Criteria? ( ) Yes ( ) No Reviewed by: _____________________________________ Date: __________

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Attachment #3 Procedure List List the Standard Operating Procedures (SOP) that are required for execution of this protocol. SOP Number SOP Revision # Original Original Procedure Title Operation of the Vial Washer Maintenance of the Vial Washer Effective Date Initials/Date

Comments: ________________________________________________________________________ __________________________________________________________________________________ __________________________________________________________________________________ __________________________________________________________________________________ Acceptance Criteria: A list of written procedures that are used to operate the equipment is provided above. If procedures are in draft form, attach a copy to the executed protocol. Meets Acceptance Criteria? ( ) Yes ( ) No Reviewed by: __________________________________ Date: __________

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Attachment #4 Operator Controls and Indicators Press the control keys The objective of this test function is to verify that the equipment/system operations function as indicated. Note: document any failing results. Device
Vial washer power on/off switch

Function
Turns power on to the vial washer

Expected Results
Power comes on

Pass/Fail

Initials/Date

Comments: ________________________________________________________________________ __________________________________________________________________________________ __________________________________________________________________________________ __________________________________________________________________________________ Acceptance Criteria: The actual results are the same as the expected results or explained. Meets Acceptance Criteria? ( ) Yes ( ) No Reviewed by: __________________________________ Date: __________

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Attachment #5 Operator Interface Verify that the OIT screen and sub-screens are as expected. Note: Document any failing results. Panelview Display Screen 1 - First Screen: The OIT screen below will appear after powering up the vial washer. Values need not be as shown.

Function This is the OIT opening screen.

Expected Results After powering up this screen appears.

Pass/Fail Pass/Fail

Initials/Date

Comments: ________________________________________________________________________ Acceptance Criteria: The actual results are the same as the expected results or explained. Meets Acceptance Criteria? ( ) Yes ( ) No Reviewed by: __________________________________ Date: __________

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Attachment #5 Operator Interface (continued) Verify that the OIT screen and sub-screens are as expected. Note: Document any failing results. Panelview Display Screen 2 - Main Screen: The screen below will appear after pressing F1 from the First Screen.

Function This screen permits access to all of the other screens.

Expected Results The screen displays as shown. Other screens can be accessed by pressing the appropriate function key.

Pass/Fail Pass/Fail

Initials/Date

Comments: ________________________________________________________________________ Acceptance Criteria: The actual results are the same as the expected results or explained. Meets Acceptance Criteria? ( ) Yes ( ) No Reviewed by: __________________________________ Date: __________

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Attachment #5 Operator Interface (continued) Verify that the OIT screen and sub-screens are as expected. Note: Document any failing results. Panelview Display Screen 3 Edit Recipe: The screen below will appear after pressing F1 Edit from the Main Screen, entering the correct password on the Password screen, and pressing F5 Done on the Password Screen.

Function

Expected Results The screen displays as shown, though values may be different. Entry of the correct password activates the Edit mode. The program can be edited using the F1 through F10 keys and the numeric key pad. Pressing the F5 Done key returns the display to the Main screen.

Pass/Fail

Initials/Date

This screen displays recipe parameters and permits editing with the use of a password.

Pass/Fail

Comments: ________________________________________________________________________ Acceptance Criteria: The actual results are the same as the expected results or explained. Meets Acceptance Criteria? ( ) Yes ( ) No Reviewed by: __________________________________ Date: __________

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Attachment #5 Operator Interface (continued) Verify that the OIT screen and sub-screens are as expected. Note: Document any failing results. Panelview Display Screen 4 Memory Recall: The screen below will appear after pressing F2 Recall from the Main Screen. .

Function This screen displays the current recipe number and permits the selection of a new recipe.

Expected Results The screen displays as shown. A new recipe number can be selected using the numeric key pad. When the desired recipe is selected, pressing the F5 Done key returns the display to the Main screen.

Pass/Fail

Initials/Date

Pass/Fail

Comments: ________________________________________________________________________ Acceptance Criteria: The actual results are the same as the expected results or explained. Meets Acceptance Criteria? ( ) Yes ( ) No Reviewed by: __________________________________ Date: __________

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Attachment #5 Operator Interface (continued) Verify that the OIT screen and sub-screens are as expected. Note: Document any failing results. Panelview Display Screen 5 - Purge: The screen below will appear after pressing F3 Purge from the Main Screen.

Function This screen permits the air and water lines to be flushed.

Expected Results The screen displays as shown. Purge time (up to 99 seconds) can be entered and air or liquid flush can be selected. Pressing F5 Done returns the display to the Main Screen.

Pass/Fail

Initials/Date

Pass/Fail

Comments: ________________________________________________________________________ Acceptance Criteria: The actual results are the same as the expected results or explained. Meets Acceptance Criteria? ( ) Yes ( ) No Reviewed by: __________________________________ Date: __________

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Attachment #5 Operator Interface (continued) Verify that the OIT screen and sub-screens are as expected. Note: Document any failing results. Panelview Display Screen 6 Alarm History: The screen below will appear after pressing F4 Alarm from the Main Screen.

Function This screen displays the alarm history and permits alarms to be acknowledged and cleared..

Expected Results The screen displays as shown. All the alarms shown can be acknowledged and cleared. Pressing F5 Done returns the display to the Main Screen.

Pass/Fail Pass/Fail

Initials/Date

Comments: ________________________________________________________________________ Acceptance Criteria: The actual results are the same as the expected results or explained. Meets Acceptance Criteria? ( ) Yes ( ) No Reviewed by: __________________________________ Date: __________

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Attachment #5 Operator Interface (continued) Verify that the OIT screen and sub-screens are as expected. Note: Document any failing results. Panelview Display Screen 7 Password Edit: The screen below will appear after pressing F5 Pass.

Function This screen enables the password to be changed.

Expected Results The screen displays as shown. Entering the current password activates the password edit mode. A new password can be entered using the number key pad. Pressing F5 Done returns the display to the Main Screen.

Pass/Fail

Initials/Date

Pass/Fail

Comments: ________________________________________________________________________ Acceptance Criteria: The actual results are the same as the expected results or explained. Meets Acceptance Criteria? ( ) Yes ( ) No Reviewed by: __________________________________ Date: __________

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Attachment #5 Operator Interface (continued) Verify that the OIT screen and sub-screens are as expected. Note: Document any failing results. Panelview Display Screen 8 - Password: The screen below will appear when the F1 Edit key is pressed on the Main Screen.

Function This screen enables a password to be entered to activate the .program edit mode.

Expected Results The screen displays as shown. After entering the correct password and pressing the F5 Done key, the display goes to the Edit Recipe Screen.

Pass/Fail Pass/Fail

Initials/Date

Comments: ________________________________________________________________________ Acceptance Criteria: The actual results are the same as the expected results or explained. Meets Acceptance Criteria? ( ) Yes ( ) No Reviewed by: __________________________________ Date: __________

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Attachment #5 Operator Interface (continued) Verify that the OIT screen and sub-screens are as expected. Note: Document any failing results. Panelview Display Screen 9 Password Error: The screen below will appear if an incorrect password has been entered.

Function This screen indicates that an incorrect password has been entered.

Expected Results The screen displays as shown when an incorrect password is entered. Pressing the F5 Done key returns the display to the Password Screen.

Pass/Fail Pass/Fail

Initials/Date

Comments: ________________________________________________________________________ Acceptance Criteria: The actual results are the same as the expected results or explained. Meets Acceptance Criteria? ( ) Yes ( ) No Reviewed by: __________________________________ Date: __________

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Attachment #5 Operator Interface (continued) Verify that the OIT screen and sub-screens are as expected. Note: Document any failing results. Panelview Display Alarm Banner: The screen below will appear when an alarm condition occurs. The message may be different from that shown.

Function
This screen displays current alarms.

Expected Results The screen displays as shown with the current alarm condition listed. Pressing F1 acknowledges the alarm. Pressing F2 clears the alarm.

Pass/Fail Pass/Fail

Initials/Date

Comments: ________________________________________________________________________ Acceptance Criteria: The actual results are the same as the expected results or explained. Meets Acceptance Criteria? ( ) Yes ( ) No Reviewed by: __________________________________ Date: __________

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Attachment #6 Functional Verification Verify that the equipment/system operations function as indicated. Procedure Material Handling Use flip trays and load vials into washer. Wash vials. Remove vials and transfer them onto depyrogenation trays. Repeat test for each vial size. Washing Verification Spray vials with riboflavin solution. Verify presence using black light. Load vials into washer run wash cycle. Inspect vials with black light. Repeat test for each vial size. Comments: _______________________________________________________________________ Acceptance Criteria: The actual results are the same as the expected results or explained. Meets Acceptance Criteria? ( ) Yes ( ) No Reviewed by: __________________________________ Date: __________ Test results in the visual absence of riboflavin for all vial sizes. Expected Result Pass/Fail Initials/Date

Vial packs fit into flip trays. Vials fit into vial holders. Vials transfer into depyrogenation trays correctly.

Pass/Fail

Pass/Fail

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Attachment #7 Alarms, Safeties and Interlocks Verify that the alarms, safeties and interlocks function as indicated. Procedure Low Pressure On WFI While running a wash cycle, the equipment loses air pressure. High Pressure On WFI Low Pressure On Inlet 3 While running a wash cycle, the equipment loses air pressure. High Pressure On Inlet 3 An alarm message appears on the display screen. An alarm message appears on the display screen. Pass/Fail Expected Result An alarm message appears on the display screen. An alarm message appears on the display screen. Pass/Fail Pass/Fail Pass/Fail Pass/Fail Initials/Date

Comments: _______________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ Acceptance Criteria: The actual results are the same as the expected results or explained. Meets Acceptance Criteria? ( ) Yes ( ) No Reviewed by: __________________________________ Date: __________

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Attachment #8 Sequence of Operation Verify the sequence of operation. Sequence Procedure Expected Results Machine is powered. Air pressure is on. Power is on to the machine. The PanelView display comes on and shows the First Screen. Vials are loaded and lid is closed. The Recall screen appears, showing the current recipe number. The display returns to Main Screen PanelView display indicates valve operation, step timing, and alarm states. When run is finished, the display will light with COMPLETE message. Vials appear visually clean. Pass/Fail Pass/Fail Pass/Fail Pass/Fail Initials/Date

Power Up and System Operation Ensure that the machine 1 powered. 2 Verify air is on. Turn the red power switch, on 3 the lower control panel door, to the I position. Turn the power switch ON and press F1 to initialize PanelView, 4 as prompted by display text. Normal Wash Sequence Using flip trays load vials into 5 vial washer, close lid. 6 7 From the PanelView select F2 Recall. Press F5 Done

Pass/Fail

Pass/Fail Pass/Fail Pass/Fail

Press the Start push-button to start the wash cycle.

Pass/Fail

Remove vials.

Pass/Fail

Comments: ________________________________________________________________________ ___________________________________________________________________________________ Acceptance Criteria: The actual results are the same as the expected results or explained. Meets Acceptance Criteria? ( ) Yes ( ) No Reviewed by: __________________________________ Date: __________

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Attachment #8 Sequence of Operation (continued) Verify the sequence of operation. Sequence Liquid Purge Sequence 10 11 12 Press F3 to select Purge. Press F1 to select Water. Enter values between 1 and 99 seconds for the Purge Time Set and the Remaining Duration. Press the start pushbutton to run the purge cycle. The PanelView display shows the Purge Screen. The display shows Purge Water Lines Time values are entered. The purge cycle operates. Upon completion, the display returns to Main Screen. Pass/Fail Pass/Fail Pass/Fail Procedure Expected Results Pass/Fail Initials/Date

13

Pass/Fail

Comments: ________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ Acceptance Criteria: The actual results are the same as the expected results or explained. Meets Acceptance Criteria? ( ) Yes ( ) No Reviewed by: __________________________________ Date: __________

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Attachment #8 Sequence of Operation (continued) Verify the sequence of operation. Sequence Air Purge Sequence 14 15 16 Press F3 to select Purge. Press F2 to select Air. Enter values between 1 and 99 seconds for the Purge Time Set and the Remaining Duration. Press the start pushbutton to run the purge cycle. The PanelView display shows the Purge Screen. The display shows Purge Air Lines Time values are entered. The purge cycle operates. Upon completion, the display returns to Main Screen. Pass/Fail Pass/Fail Pass/Fail Procedure Expected Results Pass/Fail Initials/Date

17

Pass/Fail

Comments: ________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ Acceptance Criteria: The actual results are the same as the expected results or explained. Meets Acceptance Criteria? ( ) Yes ( ) No Reviewed by: __________________________________ Date: __________

DOC # E-0001-2009-01 OPERATIONAL QUALIFICATION PROTOCOL VIAL WASHER National Institute of Health, Building 10 Bethesda MD 20892

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Attachment #9 Deviation Reporting Log Document all deviations found during execution. Note: Make additional copies of this attachment as necessary. DEVIATION LOG Deviation Number Description Resolved (Y/N) Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Comments: _______________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ Acceptance Criteria: A list of deviations resulting from the execution of this protocol shall be recorded. Meets Acceptance Criteria? ( ) Yes ( ) No Reviewed by: __________________________________ Date: __________ Initials & Date

DOC # E-0001-2009-01 OPERATIONAL QUALIFICATION PROTOCOL VIAL WASHER National Institute of Health, Building 10 Bethesda MD 20892

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Attachment #10 Operational Qualification Protocol Review Qualification Process Solutions, LLC signature below verifies this Operational Qualification protocol has been reviewed, for completeness and for accuracy of calculations. A separate final report will be written and attached to this protocol. The final report will discuss any deviations, conclusions, and/or recommendations resulting from the execution of the protocol.

Name (print):_____________________________________ Company (print): __________________________________ Title: ____________________________________________ Signature: ________________________________________ NIH Document Review Approvals: Date: _____________________

Approved By: ______________________ Title: _____________________________ Signature: Date:

Approved By: ______________________ Title: _____________________________ Signature: Date:

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