Validation VialWasher OQ NIH

Operational Qualification ProtocolVial Washer

National Institutes of HealthOperational 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 1C166A5ABethesda, 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 BeatyTitle: Qualification Process Solutions

Signature:

Date:

Approved By: ______________________

Title: _____________________________

Signature:

Date:

Approved By: ______________________

Title: _____________________________

Signature:

Date:

Approved By: ______________________

Title: _____________________________

Signature:

Date:

Qualification Process

Solutions, Inc.

PROPRIETARY INFORMATION:Unauthorized Duplication Is Prohibited

DOCUMENT NUMBER E-0001-2009-01 DATE: 2/8/2010 Page 1 of 29

REVISION NUMBER None

Author: Narlin Beaty ______________________ Revision Date: None

Operational Qualification

EQUIPMENT NAME: Vial Washer Equipment No: ________________

OPERATIONAL QUALIFICATION

FOR THE

VIAL WASHER

INSTALLED

AT

NATIONAL INSTITUTES OF HEALTH

BUILDING 10BETHESDA, MD 20892

QUALIFICATION PROCESS SOLUTIONS

13406 BLYTHENIA RD

PHOENIX, MD 21131

DOC # E-0001-2009-01OPERATIONAL QUALIFICATION PROTOCOL

VIAL WASHERNational Institute of Health, Building 10

Bethesda MD 20892Page 2 of 29

TABLE OF CONTENTS1.0 Purpose32.0 Scope 33.0 Equipment Description 34.0 Responsibilities 35.0 Reference Documents 36.0 Definitions 47.0 Test Function Number One: OQ Signature Verification List (Attachment #1) 48.0 Test Function Number Two: Test Equipment (Attachment #2) 44.0 Test Function Number Three: Procedure List (Attachment #3) 59.0 Test Function Number Four: Operator Controls and Indicators (Attachment #4) 510.0 Test Function Number Five: Operator Interface (Attachment #5) 511.0 Test Function Number Six: Functional Verification (Attachment #6) 512.0 Test Function Number Seven: Alarms, Safeties and Interlocks (Attachment #7) 613.0 Test Function Number Eight: Sequence of Operations (Attachment #8) 614.0 Test Function Number Nine: Maximum / Minimum Values (Attachment #9) 615.0 Deviation Reporting Log (Attachment #10) 716.0 Operational Qualification Protocol Review (Attachment #11) 717.0 Summary Report Requirements 718.0 Attachment List8




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 (cGMP’s).

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.

4.2 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.

5.0 Reference Documents

5.1 Cozzoli Vial Washer O&M5.2 Reference drawings




Title Drawing Number DateBasic Machine – SS 320479 2 Jun 2005GW24 Floor Plan FP-1221 22 Apr 2002

Frame Assy 320478 2 Jun 2005Basin and Basin Cover

Assy318893 19 Apr 2002

Inside/Outside Wash Assy – Burkert Valves

320507 8 Jul 2005

Drain Assy 318894 19 Apr 2002Spray Nozzle Assy 308976 20 May 1987

Electrical Schematic (3 drawings)

901690 06 Oct 2006

Pneumatic Schematic 901689 27 Sept 2006Flow Schematic (8.5 x

11”)901688 27 Sept 2006

5.3 Vendor certifications

6.0 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).

6.2 Non-Critical Instrumentation – Instrumentation provided for indication or convenience purposes only.

7.0 Test Function Number One: OQ Signature Verification List (Attachment #1)

7.1 ObjectiveTo identify and document all personnel involved in executing this protocol.

7.2 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.

7.3 Acceptance CriteriaSignatures from all personnel involved in execution of this protocol shall be present.

8.0 Test Function Number Two: Test Equipment (Attachment #2)

8.1 Objective To verify and document all test equipment

8.2 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.

8.3 Acceptance Criteria




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 ObjectiveThe objective of this test function is The objective of this test function is to verify that the Standard Operating Procedures (SOP’s) necessary for proper operation of the equipment have been identified and that when drafted have been attached to this qualification.

8.5 Procedure8.5.1 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 SOP’s. 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.8.6 Acceptance Criteria

All associated SOP’s for operation and maintenance shall be listed.

9.0 Test Function Number Four: Operator Controls and Indicators (Attachment #4)

9.1 Objective The objective of this test function is to verify that the controls and indicators operate as specified by vendor recommendations.

9.2 Procedure9.2.1 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.9.3 Acceptance Criteria

All operator controls and indicators tested shall conform to the expected response.

10.0 Test Function Number Five: Operator Interface (Attachment #5)

10.1 ObjectiveThe objective of this test function is to ensure proper communication between the operator interface, PLC, and equipment.

10.2 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.

10.3 Acceptance CriteriaThe actual results of operator interface screens shall conform to the expected responses.

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.




11.2 Procedure11.2.1 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.

11.3 Acceptance CriteriaAll 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 Objective The objective of this test function is to verify and document the operation and functionality of the alarms, safeties and interlocks.

12.2 Procedure12.2.1 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.

12.3 Acceptance CriteriaAll safeties and interlock requirements must conform to the expected responses.

13.0 Test Function Number Eight: Sequence of Operations (Attachment #8)

13.1 ObjectiveThe objective of this test function is to verify and document the operational sequence of the system.

13.2 Procedure13.2.1 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.

13.3 Acceptance CriteriaThe operating sequence occurs as expected.

14.0 Test Function Number Nine: Maximum / Minimum Values (Attachment #9)

14.1 ObjectiveThe objective of this test function is to verify the maximum and minimum allowable values of changeable setpoints.

14.2 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.




14.2.3 Document any discrepancies in Attachment #10, Deviation Reporting Log. 14.3 Acceptance Criteria

The actual results of the changeable setpoint limits shall conform to the expected responses.

15.0 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.

15.2 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. 15.3 Acceptance Criteria

15.3.1 All deviations shall be properly documented on Attachment 11 and subsequent attached pages.

16.0 Operational Qualification Protocol Review (Attachment #11)

16.1 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.

16.2 ProcedureComplete attachment with name, title, signature and date.

17.0 Summary Report Requirements

17.1 Objective The objective of this test function is to provide an overview of the test results during the execution of this operational qualification.

17.2 Procedure17.2.1 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.




18.0 Attachment List

Attachment #1 OQ Signature Verification List 9

Attachment #2 Test Equipment 10Attachment #3 Procedure List 11Attachment #4 Operator Controls and Indicators 12Attachment #5 Operator Interface 13Attachment #6 Functional Verification 23Attachment #7 Alarms, Safeties and Interlocks 24Attachment #8 Sequence of Operation 25Attachment #9 Deviation Reporting Log 28Attachment #10 Operational Qualification Protocol Review 29




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 TitleDepartment/

Company NameSignature 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: __________




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

Manufacturer ID# Serial #Certified/ Calibrated

Cal.Date

CalDue Date

Initials/Date

RiboflavinYes/No

Ultra-violet light Yes/No

Yes/No

Yes/No

Yes/No

Yes/No

Yes/No

Yes/No

Yes/No

Comments: ______________________________________________________________________________

_______________________________________________________________________________________

_______________________________________________________________________________________

_______________________________________________________________________________________

Acceptance Criteria: All test equipment required for execution shall be calibrated with copies of calibration records attached.


Reviewed by: _____________________________________ Date: __________




Attachment #3 Procedure List

List the Standard Operating Procedures (SOP) that are required for execution of this protocol.

SOP Number

SOP Revision #

Procedure TitleEffective

DateInitials/Date

Original Operation of the Vial Washer

Original Maintenance of the Vial Washer

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.


Reviewed by: __________________________________ Date: __________




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 Function Expected Results Pass/Fail Initials/Date Vial washer power on/off switch

Turns power on to the vial washer

Power comes on

Comments: ________________________________________________________________________

__________________________________________________________________________________

__________________________________________________________________________________

__________________________________________________________________________________

Acceptance Criteria: The actual results are the same as the expected results or explained.


Reviewed by: __________________________________ Date: __________




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 Expected Results Pass/Fail Initials/Date

This is the OIT opening screen. After powering up this screen appears. Pass/Fail

Comments: ________________________________________________________________________



Reviewed by: __________________________________ Date: __________




Attachment #5 Operator Interface (continued)


Panelview Display

Screen 2 - Main Screen: The screen below will appear after pressing F1 from the First Screen.


This screen permits access to all of the other screens.

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

Pass/Fail

Comments: ________________________________________________________________________



Reviewed by: __________________________________ Date: __________






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.


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

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

Comments: ________________________________________________________________________



Reviewed by: __________________________________ Date: __________






Panelview Display

Screen 4 – Memory Recall: The screen below will appear after pressing F2 Recall from the Main Screen..


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

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

Comments: ________________________________________________________________________



Reviewed by: __________________________________ Date: __________






Panelview Display

Screen 5 - Purge: The screen below will appear after pressing F3 Purge from the Main Screen.


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

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

Comments: ________________________________________________________________________



Reviewed by: __________________________________ Date: __________






Panelview Display

Screen 6 – Alarm History: The screen below will appear after pressing F4 Alarm from the Main Screen.


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

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

Comments: ________________________________________________________________________



Reviewed by: __________________________________ Date: __________






Panelview Display

Screen 7 – Password Edit: The screen below will appear after pressing F5 Pass.


This screen enables the password to be changed.

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

Comments: ________________________________________________________________________



Reviewed by: __________________________________ Date: __________






Panelview Display

Screen 8 - Password: The screen below will appear when the F1 Edit key is pressed on the Main Screen.


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

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

Comments: ________________________________________________________________________



Reviewed by: __________________________________ Date: __________






Panelview Display

Screen 9 – Password Error: The screen below will appear if an incorrect password has been entered.


This screen indicates that an incorrect password has been entered.

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

Comments: ________________________________________________________________________



Reviewed by: __________________________________ Date: __________






Panelview Display

Alarm Banner: The screen below will appear when an alarm condition occurs. The message may be different from that shown.


This screen displays current alarms.

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

Pass/Fail

Comments: ________________________________________________________________________



Reviewed by: __________________________________ Date: __________




Attachment #6 Functional Verification

Verify that the equipment/system operations function as indicated.

Procedure Expected Result Pass/Fail Initials/Date

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.

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

Pass/Fail

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.

Test results in the visual absence of riboflavin for all vial sizes.

Pass/Fail

Comments: _______________________________________________________________________



Reviewed by: __________________________________ Date: __________




Attachment #7 Alarms, Safeties and Interlocks

Verify that the alarms, safeties and interlocks function as indicated.

Procedure Expected Result Pass/Fail Initials/Date

Low Pressure On WFI

While running a wash cycle, the equipment loses air pressure.

An alarm message appears on the display screen.

Pass/Fail

High Pressure On WFIAn alarm message appears on the display screen.

Pass/Fail

Low Pressure On Inlet 3

While running a wash cycle, the equipment loses air pressure.

An alarm message appears on the display screen.

Pass/Fail

High Pressure On Inlet 3An alarm message appears on the display screen.

Pass/Fail

Comments: _______________________________________________________________________

_________________________________________________________________________________

_________________________________________________________________________________



Reviewed by: __________________________________ Date: __________




Attachment #8 Sequence of Operation

Verify the sequence of operation.

Sequence Procedure Expected Results Pass/Fail Initials/Date

Power Up and System Operation

1Ensure that the machine powered.

Machine is powered. Pass/Fail

2 Verify air is on. Air pressure is on. Pass/Fail

3Turn the red power switch, on the lower control panel door, to the “I” position.

Power is on to the machine. Pass/Fail

4

Turn the power switch ON and press F1 to initialize PanelView, as prompted by display text.

The PanelView display comes on and shows the First Screen.

Pass/Fail

Normal Wash Sequence

5Using flip trays load vials into vial washer, close lid.

Vials are loaded and lid is closed.

Pass/Fail

6From the PanelView select F2 Recall.

The Recall screen appears, showing the current recipe number.

Pass/Fail

7 Press F5 DoneThe display returns to Main Screen

Pass/Fail

8Press the “Start” push-button to start the wash cycle.

PanelView display indicates valve operation, step timing, and alarm states. When run is finished, the display will light with “COMPLETE” message.

Pass/Fail

9 Remove vials. Vials appear visually clean. Pass/Fail

Comments: ________________________________________________________________________

___________________________________________________________________________________



Reviewed by: __________________________________ Date: __________




Attachment #8 Sequence of Operation (continued)



Liquid Purge Sequence

10 Press F3 to select Purge.The PanelView display shows the Purge Screen.

Pass/Fail

11 Press F1 to select Water.The display shows Purge Water Lines

Pass/Fail

12Enter values between 1 and 99 seconds for the Purge Time Set and the Remaining Duration.

Time values are entered.

Pass/Fail

13Press the start pushbutton to run the purge cycle.

The purge cycle operates. Upon completion, the display returns to Main Screen.

Pass/Fail

Comments: ________________________________________________________________________

_________________________________________________________________________________

_________________________________________________________________________________

_________________________________________________________________________________

_________________________________________________________________________________



Reviewed by: __________________________________ Date: __________




Attachment #8 Sequence of Operation (continued)



Air Purge Sequence

14 Press F3 to select Purge.The PanelView display shows the Purge Screen.

Pass/Fail

15 Press F2 to select Air.The display shows Purge Air Lines

Pass/Fail

16Enter values between 1 and 99 seconds for the Purge Time Set and the Remaining Duration.

Time values are entered.

Pass/Fail

17Press the start pushbutton to run the purge cycle.

The purge cycle operates. Upon completion, the display returns to Main Screen.

Pass/Fail

Comments: ________________________________________________________________________

_________________________________________________________________________________

_________________________________________________________________________________

_________________________________________________________________________________

_________________________________________________________________________________



Reviewed by: __________________________________ Date: __________




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) Initials & Date

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.


Reviewed by: __________________________________ Date: __________




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: ________________________________________ Date: _____________________

NIH Document Review Approvals:

Approved By: ______________________

Title: _____________________________

Signature:

Date:

Approved By: ______________________

Title: _____________________________

Signature:

Date:

Validation VialWasher OQ NIH

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