Capsule Filling Machine OQ

Operational Qualification Protocolfor the Capsule Filling Machine

Protocol No. EQ-

National Institute of HealthOperational Qualification Protocol

Equipment:Capsule Filling Machine

Protocol #: Date:16 March, 2010

Facility:National Institute of Health

Location:Building 10 Room 1N249Bethesda, MD 20892

Revision:Original

Title:Operational Qualification Protocol for the Capsule Filling Machine.Objective:The objective of this protocol is to document the satisfactory operation of the Capsule Filling Machine used for manufacturing at National Institute of Health

Written By: Michael MolloyTitle: Consultant

Signature:

Date:

Approved By: ______________________

Title: _____________________________

Signature:

Date:

Approved By: ______________________

Title: _____________________________

Signature:

Date:

Approved By: ______________________

Title: _____________________________

Signature:

Date:

Approved By: ______________________

Title: _____________________________

Signature:

Date:

Quality AssuranceApproved By: ______________________

Title: _____________________________

Signature:

Date:

Qualification Process

Solutions, Inc.

PROPRIETARY INFORMATION:Unauthorized Duplication Is Prohibited

DOCUMENT NUMBER DATE: 3/16/10 PAGE: 1 of 36

REVISION NUMBER 1

Author: Michael Molloy ______________________ Revision DATE: N/A

Operational Qualification

EQUIPMENT NAME: Capsule Filling Machine

OPERATIONAL QUALIFICATION

FOR THE

Capsule Filling Machine

INSTALLED

AT

NATIONAL INSTITUTE OF HEALTH

BUILDING 10 ROOM 1N249BETHESDA, MD 20892

QUALIFICATION PROCESS SOLUTIONS

13406 BLYTHENIA RD

PHOENIX, MD 21131

DOC. # OPERATIONAL QUALIFICATION PROTOCOL

Capsule Filling MachineNational Institute of Health, Building 10 Room 1n249

Bethesda MD 20892Page 2 of 36

TABLE OF CONTENTS

1.0 Purpose32.0 Scope 33.0 Equipment Description 34.0 Responsibilities 45.0 Reference Documents 46.0 Definitions 57.0 Test Function Number One: OQ Signature Verification List (Attachment #1) 58.0 Test Function Number Two: Test Equipment (Attachment #2) 59.0 Test Function Number Three: Procedure List (Attachment #3) 610.0 Test Function Number Four: Training Verification (Attachment #4) 611.0 Test Function Number Five: Operator Controls and Indicators (Attachment #5) 612.0 Test Function Number Six: Functional Verification (Attachment #6) 713.0 Test Function Number Seven: Alarms, Safeties and Interlocks (Attachment #7) 714.0 Test Function Number Eight: Sequence of Operations (Attachment #8) 715.0 Test Function Number Nine: Maximum / Minimum Values (Attachment #9) 716.0 Deviation Reporting Log (Attachment #10) 817.0 Operational Qualification Protocol Review (Attachment #11) 818.0 Summary Report Requirements 819.0 Attachment List10




1.0 Purpose

The objective of this protocol is to verify that the Capsule Filling Machine, 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 installed in the National Institute of Health, Building 10 room 1N249, Bethesda MD, 20892. This protocol is specific to the Capsule Filling Machine and related instrumentation and equipment. This protocol is specific to the Capsule Filling System, and related instrumentation and equipment, and does not address other facility, or facility related equipment and systems.

3.0 Equipment Description

The Capsule Filling Machine (Model : Zanasi 6F serial 35XXX) is a hard gelatine capsule filler, which is designed for filling liquids, powders, granular product, pellets and tablets. The filler is designed to accommodate capsules size 0,1,2,3 and 4. The output of the filler is adjustable with a maximum production rate of 6000-6120 capsules/hr dependant upon process selection.

The filler is an alternate movement capsule filling machine provided with a rotary stage that provides clockwise axis centered slip stick motion to transport capsules thru 8 process stages. The stages are:

1) Capsule feed (w/relative automatic selection via optional unit)2) Capsule orientation , positioning and opening (equipped w/ 8 stages)3) Capsule separation pre-filling4) Capsule product filling5) Unopened capsule selection (Automatic)6) Capsule alignment and closure7) Capsule ejection8) Capsule selection (automatic empty and partial fill segregation)

The capsule filling machine is comprised of the following major elements:

1) Base2) Motorization3) Moving Parts4) Protective hood5) Electric cabinet and control panel6) Size-change parts for process changeover7) Manual controls8) Powder feed unit9) Powder layer and leveling control10) Pellet or tablet dosing unit11) Powder or pellet dosing unit12) Defective capsule selection unit13) Capsule closing unit




14) Capsule selection unit15) Liquid dosing unit16) Central stage17) Emergency stop push button18) Electric extension plug

The following general parameters apply to the Zanasi 6F

1) Dimension: 2000mm W x 1670 mm H x 2140 mm L2) Weight 1050 kg3) Power 480 V – 1.5 kw4) Air

4.0 Responsibilities

4.1 Qualification Process Solutions, LLC.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 (SI)4.2.1 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 Drawing: 400024-00 Capsule Filling Machine Assembly 5.2 Drawing: 4400d010-37 Base Machine5.3 Drawing: 4401d011-28 Kinematic Motion Unit5.4 Drawing: 4402d012-11 Powder Unit5.5 Drawing: 4403d013-15 Manual Return Unit5.6 Drawing: 4404d014-05 Plate Unit5.7 Drawing: 4405d015-11 Capsule Feeding and Opening Unit5.8 Drawing: 4407d017-01 Powder Feeding Unit5.9 Drawing: 4408d018-07 Compression/Powder Ejection Unit5.10 Drawing: 4409d019-11 Reject Sorting Unit and Closing Counterplate5.11 Drawing: 4410d020-11 Capsule Ejection Unit5.12 Drawing: 4411d021-11 Cleaning Unit5.13 Drawing: 4005d002-03 Components Added to Basic Machine5.14 Drawing: 4002d004-07 Components Added to Basic Machine 5.15 Drawing: 4004d004-05 Components Added to Basic Machine5.16 Drawing: 4008d004-05 Components Added to Basic Machine5.17 Drawing: 4009d004-11 Components Added to Basic Machine5.18 Drawing: 4402d028-03 Components Added to Rotary Tank5.19 Drawing: 4410d090-12 Capsule Chute without SPC5.20 Drawing: 4005d141-06 Powder/Pellet Capsule Equipment Unit F15.21 Drawing: 4005d142-06 Powder/Pellet Capsule Equipment Unit F25.22 Drawing: 4005d143-06 Powder/Pellet Capsule Equipment Unit F3




5.23 Drawing: 4005d144-06 Powder/Pellet Capsule Equipment Unit F45.24 Drawing: 4005d146-06 Powder/Pellet Capsule Equipment Unit F05.25 Drawing: 4019d151-03 Powder Dosing Equipment F15.26 Drawing: 4019d152-03 Powder Dosing Equipment F25.27 Drawing: 4019d153-03 Powder Dosing Equipment F35.28 Drawing: 4019d154-03 Powder Dosing Equipment F45.29 Drawing: 4019d156-03 Powder Dosing Equipment F05.30 Drawing: 4440d363-02 Added Components without Weight Unit5.31 Drawing: 4428d364-37 Safety Hood5.32 Drawing: IE 44.68 Electrical Schematic5.33 Document: IE 44.68 Electrical Spare Part List5.34 Document: F-S22V1 Program Listing5.35 Drawing: 440C033 Compressed Air Plant5.36 Drawing: 440C039-01 Aspiration Air Plant5.37 Document: 35071M04 Installation & Operation Manual for the Capsule Filling Machine

including:MaintenanceSafety NoticesCE Conformity DocumentsTest Reports and Equipment Certs

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 CriteriaAll equipment required for execution shall be calibrated with copies of calibration records attached.

9.0 Test Function Number Three: Procedure List (Attachment #3)

9.1 ObjectiveTo verify the operating Standard Operating Procedures (SOP’s) provide adequate direction and control over the operation of the equipment.

9.2 Procedure9.2.1 Verify that the operational SOP provides personnel adequate direction and control

over the operation of the equipment. (The SOP’s used for execution may be in draft form.)

9.2.2 Complete the applicable attachment with a list of all applicable SOP’s. 9.2.3 Redline the SOP’s with an operator and validation personnel. Attach the redline copy

to this qualification protocol. 9.3 Acceptance Criteria

All associated SOP’s for operation and execution shall be reviewed and documented.

10.0 Test Function Number Four: Training Verification (Attachment #4)

10.1 ObjectiveTo document applicable personnel have received the required training for operation of the equipment.

10.2 Procedure10.2.1 Document all personnel executing this protocol that have been trained on the

approved/draft SOP for the equipment.10.2.2 List all SOP’s used during the execution of this protocol10.2.3 Complete required training forms in accordance with NIH’s training requirements.

10.3 Acceptance CriteriaTraining shall be performed on all SOP’s used during the execution of this qualification protocol.

11.0 Test Function Number Five: Operator Controls and Indicators (Attachment #5)

11.1 Objective To verify the controls and indicators operate as specified by manufacturer recommendations.

11.2 Procedure11.2.1 Manually operate the control switches listed in the applicable attachment.11.2.2 Visually verify and document the actual responses.11.2.3 Document any discrepancies in Attachment #10, Deviation Reporting Log. If any

variances/deviations are present, complete the appropriate deviation/variance form.11.3 Acceptance Criteria

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




12.0 Test Function Number Six: Functional Verification (Attachment #6)

12.1 Objective To verify and document the operation and functionality of the equipment.

12.2 Procedure12.2.1 Follow the procedures in the applicable attachments. 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. If any


All functional requirements must conform to the expected responses.

13.0 Test Function Number Seven: Alarms, Safeties and Interlocks (Attachment #7)

13.1 Objective To verify and document the operation and functionality of the alarms, safeties and interlocks.

13.2 Procedure13.2.1 Follow the procedures in the applicable attachments. 13.2.2 Visually verify and document the actual responses as pass or fail against the expected

results.13.2.3 Document all operational parameters used during execution. 13.2.4 Document any discrepancies in Attachment #10, Deviation Reporting Log. If any


All safeties and interlock requirements must conform to the expected responses.

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

14.1 ObjectiveTo verify and document the operational sequence of the system.

14.2 Procedure14.2.1 Execute the procedures in the order listed.14.2.2 Observe the expected operations and write “Pass” if the results were as expected, and

“Fail” if the expected operation did not take place. 14.2.3 Document any discrepancies in Attachment #10, Deviation Reporting Log. If any


The operating sequence occurs as expected.

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

15.1 ObjectiveTo verify the maximum and minimum allowable values of changeable setpoints.

15.2 Procedure 15.2.1 Display the changeable setpoint on the applicable attachment and test maximum and

minimum values.




15.2.2 Visually verify and document the actual results of the functions that appear on the operator interface.

15.2.3 Document any discrepancies in Attachment #10, Deviation Reporting Log. If any variances/deviations are present, complete the appropriate deviation/variance form.

15.3 Acceptance CriteriaThe actual results of the changeable setpoint limits shall conform to the expected responses.

16.0 Deviation Reporting Log (Attachment #10)

16.1 Objective: To document any deviation to the stated test procedure or acceptance criteria, and to evaluate the deviation relative to acceptability of the qualification study.

16.2 Procedure: 16.2.1 Document all deviations found during execution using the Deviation Report Form that

is with the Deviation Reporting Log. Make copies of the form for each logged Deviation.

16.2.2 Deviations caused by Out of Specification (OOS) Conditions. If during the evaluation of equipment parameters against specifications, the equipment fails to meet predetermined acceptance criteria, a formal deviation report investigates the cause. In these cases, the cause must be known prior to continuing the protocol execution since a true failure in equipment performance is likely to affect the completion of the protocol. The protocol deviation report determines 1) if the acceptance criteria are correct and current with user requirements and manufacturer's ratings, or 2) if there is an immediate and obvious explanation for the failure. If a true failure is documented, then appropriate root cause analysis and corrective actions ensue and are agreed to between the protocol executors and the department owners and QA. The protocol deviation report documents the conclusion to this investigation and any appropriate retesting and an impact assessment on the portions of the protocol executed prior to the documented failure.

16.2.3 Completed Deviation Report Forms are submitted to QA for signature acceptance.

17.0 Operational Qualification Protocol Review (Attachment #11)

17.1 Objective To document that this protocol has been reviewed for completeness as per Qualification Process Solutions, LLC Requirements.

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

18.0 Summary Report Requirements

18.1 Objective To provide an overview of the test results during the execution of this operational qualification.

18.2 Procedure18.2.1 Generate a final summary on completion of this protocol execution.

18.2.1.1 Compile a summary of the results obtained.18.2.1.2 Generate a conclusion, based on these results, of the acceptability of the

qualification results.




18.2.1.3 Include a statement of conformance to the specified acceptance criteria, evaluated in conjunction with the approved deviations and corrective actions taken.

18.2.1.4 Determination of acceptability of the protocol, as executed.18.2.2 Attach the completed, executed and approved protocol to the final report.18.2.3 Attached copies of all completed, approved Deviation Report and Corrective Action

Forms, where necessary.




19.0 Attachment List

Attachment #1 OQ Signature Verification List 11

Attachment #2 Test Equipment 12Attachment #3 Procedure List 13Attachment #4 Training Verification 14Attachment #5 Operator Controls and Indicators 15Attachment #6 Functional Verification 19Attachment #7 Alarms, Safeties and Interlocks 25Attachment #8 Sequence of Operation 31Attachment #9 Maximum / Minimum Values 33Attachment #10 Deviation Reporting Log 34Attachment #11 Operational Qualification Protocol Review 36




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

Yes/No

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 Capsule Filling Machine

Original Maintenance of the Capsule Filling Machine

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 Training Verification

List the Standard Operating Procedures (SOP) used to train personnel for operating the equipment.

SOP # Procedure TitleTraining

Documented (Y/N)

Initials/Date

Operation of the Capsule Filling Machine

Yes/No

Maintenance of the Capsule Filling Machine

Yes/No

Comments: ________________________________________________________________________

__________________________________________________________________________________

__________________________________________________________________________________

__________________________________________________________________________________

Acceptance Criteria: A list of written procedures that are used to train personnel to operate the equipment is provided above.


Reviewed by: __________________________________ Date: __________




Attachment #5 Operator Controls and Indicators

Press the control keys to verify that the equipment/system operations function as indicated. Note: document any failing results.

Device Expected Results Actual Results Pass/Fail Initials/Date

CONTROL PANEL SWITCHES and INDICATORS

Emergency Stop Button. Control Panel

Places equipment in safe mode when pressed. Red

_________ equipment in safe mode when pressed. Red

Pass/Fail

LED A.C. Power On

Indicates AC Power is on. LED Green.

Indicates AC Power ________ on. LED Green.

Pass/Fail

LED Feed Logic Control

Indicates Feed Logic is enabled. LED Green

Indicates Feed Logic ________ enabled. LED Green

Pass/Fail

LED Breakers Tripped

Indicates breakers have tripped. LED Red

Indicates breakers ________ tripped. LED Red

Pass/Fail

LED Handwheel Engaged

Indicates manual hand wheel is engaged. LED Red

Indicates manual hand wheel _________ engaged. LED Red

Pass/Fail

LED No Compressed Air

Indicates compressed air is not available. LED Red

Indicates compressed air ____________ available. LED Red

Pass/Fail

Vacuum Pump Off Pushbutton.

Shuts down vacuum pump when pressed. Red

___________ down vacuum pump when pressed. Red

Pass/Fail

Vacuum Pump Engaged Lamp

Indicates vacuum pump is operating. Lamp Green

Indicates vacuum pump __________ operating. Lamp Green

Pass/Fail

Vacuum Pump On Pushbutton.

Starts vacuum pump when pressed.

_________ vacuum pump when pressed.

Pass/Fail

LED No PowderIndicates no powder. LED Red

_________ no powder. LED Red

Pass/Fail

LED No CapsulesIndicates no capsules LED Red

_________ no capsules LED Red

Pass/Fail

LED No PelletsIndicates no Pellets LED Red

_________ no Pellets LED Red

Pass/Fail

Machine Motor Speed Reg. Potentiometer.

Rotating clockwise /counterclockwise increases/decreases motor speed

Rotating clockwise /counterclockwise __________/__________ motor speed

Pass/Fail

Machine Stop Stops the machine __________ the Pass/Fail




Pushbutton normally. Redmachine normally. Red

Machine Start Pushbutton

Starts the machine normally

____________ the machine normally

Pass/Fail

Lamp Machine Running

Indicates machine operating. Lamp Green

___________ machine operating. Lamp Green

Pass/Fail

LED No TabletsIndicates no tablets LED Red

___________ no tablets LED Red

Pass/Fail

LED Powder Mixer (MAN/AUTO) On

Indicates powder mixer is selected. LED Green

__________ powder mixer is selected. LED Green

Pass/Fail

Powder Mixer MAN/AUTO Selector

Selects either Manual or Auto Control

__________ either Manual or Auto Control

Pass/Fail

LED Powder Mixer Enabled

Indicates powder mixer on. LED Green

_________ powder mixer on. LED Green

Pass/Fail

Powder Loading Enable Selector

Enables Powder Loading

____________ Powder Loading

Pass/Fail

LED Max. Jog Runtime

Indicates JOG has exceeded Runtime. LED Red

Indicates JOG _________exceeded Runtime. LED Red

Pass/Fail

LED Tablet Unit Enabled

Indicates Tablet Unit Enabled. LED Green.

____________ Tablet Unit Enabled. LED Green.

Pass/Fail

Tablet Unit Enable Selector

Enables Tablet Selector

____________ Tablet Selector

Pass/Fail

Production CounterDisplays production counts

____________ production counts

Pass/Fail

Hour CounterLogs run time when machine is operating.

___________ run time when machine is operating.

Pass/Fail


___________ run time when machine is operating.

Pass/Fail

Hourly Production Counter

Logs run time when machine is operating

______________ run time when machine is operating

Pass/Fail





______________ run time when machine is operating.

Pass/Fail

Engage/Disengage Guards Selector

Engages / disengages guards

_____________ / _____________ guards

Pass/Fail

Guards Disengaged LED

Guards disabled LED Red

Guards ___________ LED Red

Pass/Fail

REAR PANEL SWITCHES and INDICATORS

Emergency Stop Button. Machine rear panel

Places equipment in safe mode when pressed.

_____________ equipment in safe mode when pressed.

Pass/Fail

Manual Control Handwheel

Engages/Disengages Mechanical Components

_____________/ _____________ Mechanical Components

Pass/Fail

SIDE PANEL SWITCHES and INDICATORS

Reset Capsules Produced

Resets the capsule counter

___________ the capsule counter

Pass/Fail

ELECTRICAL PANEL (Inside Door) SWITCHES and INDICATORS

Vacuum Bowl ON/OFF Selector

Enable/disable Vacuum Bowl

_____________/ _____________ Vacuum Bowl

Pass/Fail

Pellet Unit 1 ON/OFF

Enable/disable Pellet Unit 1

_____________/ _____________ Pellet Unit 1

Pass/Fail

Pellet Unit 2 ON/OFF

Enable/disable Pellet Unit 2

_____________/ _____________ Pellet Unit 2

Pass/Fail

Comments: ________________________________________________________________________




__________________________________________________________________________________

__________________________________________________________________________________

__________________________________________________________________________________

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


Reviewed by: __________________________________ Date: __________




Attachment #6 Functional Verification

Verify that the equipment/system operations function as indicated.

Input Address

Input Test Description Expected ResultsPass/Fail

Performed By/Date

I 00.00 Machine Start Push Button Energized(SB 5.17)

Lamp HL5.6 Green Machine starts

Machine Start Push Button Not Energized (SB 5.17)

Lamp HL5.6 off Machine stops

I 00.01Handwheel Detector Sensor Energized(BI 8.3)

LED E REDMachine won’t start

Handwheel DetectorSensor not Energized (BI 8.3)

LED E offMachine will start

I 00.02 Jog Button energized (XC5.15) Machine starts, after 20 sec LED Z Red

Jog Button de-energized (XC5.15) Machine stops

I 00.03Machine Start Relay Energized (KA8.6) LED B Green

Machine Start Relay De-energized (KA8.6) LED B off

I 00.04Guard MicroSwitchSwitch Energized (A 4A.9)

LED G offMachine will start

Guard MicroSwitchSwitch De-energized(A 4A.9)

LED G REDMachine wont start

I 00.05Mixer Auto/ManualSwitch energized (SA7.2) LED T Green

Mixer Auto/ManualSwitch de-energized (SA7.2) LED T off

I 00.06Emergency Push Button Button energized (SE 4A.4)

ESTOP Button RED, Machine stopped

Emergency Push ButtonButton de-energized (SE 4A.4) ESTOP Button off

Test Expected Result Pass/Fail Initial/DatePower Up the Equipment. Manually actuate the I/O by either simulating a condition or forcing a condition to activate the output. Verify the system I/O act accordingly.

I/O operates as expected






Input Address

Input Test Description Expected Results Pass/Fail

Performed By/Date

I 00.07Powder Min. Level Detector 2Sensor energized (BC8.10) LED L Red

Powder Min. Level Detector 2Sensor de-energized (BC8.10) LED L off

I 00.08Locked Inverter Signal energized (AR1.14)

LED D flashing RED

Locked Inverter Signal de-energized (AR1.14) LED D off

I 00.09Powder Charging AutoSwitch energized (SA7.14) LED V Green

Powder Charging Auto Switch de-energized (SA7.14) LED V off

I 00.10Powder Charging Manual Switch energized (SA7.14) LED X Green

Powder Charging Manual Switch de-energized (SA7.14) LED X off

I 00.11Powder Min. Level Detector 4Sensor energized (BC8.14) LED L Red

Powder Min. Level Detector 4Sensor de-energized (BC8.14) LED L off

I 01.00Stop PhaseSensor Energized (BI8.15)

LED D flashing RED

Stop Phase Sensor Energized De-energized (BI8.15) LED D off

I 01.01Capsule Minimum LevelSensor Energized (BC8.16)

LED M flashing RED, after 1 min. steady RED

Capsule Minimum Level Sensor Energized Not Energized (BC8.16)

LED M off

I 01.02JOG start Relay energized (KA5.13)

Machine starts while jog is pressed

JOG start Relay de-enegized (KA5.13)

Machine stops when jog is released

I 01.03Guards Control Key Switch energized (SA5.12)

LED G RED

Guards Control Key Switch de-energized (SA5.12)

LED G off








Input Address

Input Test Description Expected Results Pass/Fail

Performed By/Date

I 01.04 Program Stop On (SB5.17D1)Program initiated machine stop

Program Stop Off (SB5.17D1)Machine enabled normal

I 01.05Machine motor brake control Relay energized (AR1.14)

Machine brake engaged

Machine motor brake control Relay de-energized (AR1.14)

Machine brake dis-engaged

I 01.06 Mixer On/Off Switch energized (KT10.15)

LED T Green

Mixer On/Off Switch de-energized (KT10.15)

LED T off

I 01.07 Pellet Group 1 Selector Switch On (SA9.5)

Pellet Group 1 enabled.

Pellet Group 1Selector Switch Off (SA9.5)

Pellet Group 1 dis-abled.

I 01.08 Pellet Group 2 Selector Switch On (SA9.6)

Pellet Group 2 enabled.

Pellet Group 2 Selector Switch Off (SA9.6)

Pellet Group 2 dis-abled.

I 01.09 Pellet Group Sensor On (SA9.6)LED N Red no pellets

Pellet Group Sensor Off (SA9.6) LED N off

I 01.10Motor Overload Cutout energized (QM7.11)

LED D Red Machine stops

Motor Overload Cutout de-energized (QM7.11)

LED D off

I 01.11Air PressureSensor energized (SP9.9)

LED F off

Air Pressure Sensor de-energized (SP9.9)

LED F Red








Output Address

Output Test Description Expected ResultsPass/Fail

Performed By/Date

O10.00 Mixer Start (KA10.11)Mixer starts when bit is enabled.

O10.01 Machine Stop (KA10.12)Machine stops when bit is enabled.

O10.02 Remote Machine Start (KA10.13)Machine starts when bit is enabled.

O10.04 Mixer ON/OFF (KT10.15)

Mixer is on when bit is enabled. Mixer is off when bit is not enabled.








Procedure Expected Result Pass/Fail Initials/Date

Machine Start/Stop Sequence

1. With no dosing unit installed start pumps/aspirator. Press machine start pushbutton on control panel.2. While running push machine stop pushbutton.3. With unit running verify proper operation of the emergency stops provided on the machine and the control panel.

1. Machine starts and LED R illuminates green.

2. Machine stops

3. Machine stops immediately

Pass/Fail

Capsule Feed System

1. Manually fill hopper with capsules. No dosing units installed. Start pumps/aspirator. Initiate machine start.2. Verify capsule minimum level operates correctly by positioning sensor to simulate no capsules.3. Verify operation of the Sort/Unopened capsule system. Manually insert 4 unopened capsules in the feed channels. Operate the machine4. Adjust machine speed to 6000 Caps/hr

1. Capsules flow into the machine is initiated until stop pushbutton is pressed.

2. LED M is lit.

3. Closed capsules will be ejected into the unopened capsule container.

4. Verify machine is at minimum feed of 6000 caps/hr

Pass/Fail

Powder Feed System

1. Load upper powder hopper ¾ full. Turn the manual feed selector on the control panel.2. With tube full of powder calibrate capacitive sensor per IMA 35064M04 (Instruction manual)3. Utilize “Jog” to start and stop machine until product bowl is filled..4. Place feed selector in “auto” and observe powder coming out of dosators and a “tablet falls into capsule bottom. Adjust dosators in accordance with IMA 35064M04 (Instruction manual). 5. Adjust powder layer in accordance with IMA 35064M04 (Instruction manual).

1. Observe powder flow into lower powder hopper via plexiglass fill tube

2. Observe indicator light on capacitive sensor turns on.

3. Observe product bowl.

4. Confirm proper compactness and verify dosator piston projects .5mm from dosating unit.

5. Observe powder layer for proper height and homogeneity.

Pass/Fail




Pellet System

1. Install pellet unit 2 in the powder dosing unit station in accordance with IMA 35064M04 (Instruction manual). With the main switch on, use key lock and open the door guard and place selector switch C to on.2. After filling the hopper with product adjust the sensitivity of the pellet level sensors in accordance with IMA 35064M04 (Instruction manual).

1. Observe pellets filling dosators.

2. Observe no pellets LED N is Red when pellets are below this sensor.

Pass/Fail

Comments: _______________________________________________________________________



Reviewed by: __________________________________ Date: __________




Attachment #7 Alarms, Safeties and Interlocks

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


CONTROL PANEL


Push an emergency stop button while the machine is running.

Machine stops operations Pass/Fail

EMERGENCY STOP

LOW VOLTAGE Fault LED B




When machine is powered on LED B is green. Remove fuse from LV circuit .Low voltage transformer faults and LED B is off.

Low voltage fault LED indicates off Pass/Fail

When machine is powered on LED B and LED C are green. Remove fuse in DC PS circuit. DC power supply faults LED B is Green and LED C is off.

DC Power fault LED C indicates off. Pass/Fail

While operating and inverter faults LED D is on Remove fuse in Inverter circuit.

Machine inverter fault LED indicates flashing RED

Pass/Fail

While operating and motor overloads LED D is on Remove fuse in motor circuit.

Motor Overlaod fault LED indicates steady RED

Pass/Fail

DC POWER SUPPLY FAULT LED B AND LED C

MACHINE INVERTER FAULT LED D

MOTOR OVERLOAD FAULT LED D




With handwheel engaged LED E is on. Machine will not start

Handwheel engaged alarm LED E RED Pass/Fail

Adjust the main regulator to cut off the air supply while the machine is running..

Machine stops operations. LED F RED Pass/Fail

While operating powder mixer motor de-energize the motor. When stop limit (pre-set) is exceeded No Powder alarm is enabled.

No powder LED indicates RED Pass/Fail

INSUFFICIENT CAPSULE LEVEL ALARM LED M

HANDWHELL ENGAGED ALARM LED E

POWDER MIXER EXCEEDS LIMITS ALARM LED L

LOW PRESSURE ALARM LED F




With no or low capsule level and machine running LED will flash.

Insufficient capsule level LED M flashing RED

Pass/Fail

When capsule level is low for more than one minute machine stops and alarm LED changes from flashing to steady.

Insufficient capsule level Timeout LED M steady RED

Pass/Fail

With no or low pellet level and machine running LED will flash.

Insufficient pellet level LED N flashing RED

Pass/Fail

When pellet level is low for more than one minute machine stops and alarm LED changes from flashing to steady.

Insufficient pellet level Timeout LED N steady RED

Pass/Fail

INSUFFICIENT CAPSULE LEVEL TIMEOUT ALARM LED M

INSUFFICIENT PELLET LEVEL ALARM LED N

INSUFFICIENT PELLET LEVEL TIMEOUT ALARM LED N




With no or low tablet level and machine running LED will flash.

Insufficient tablet level LED S flashing RED

Pass/Fail

Placing powder Loading in manual causes LED to be on.

Powder Loading LED X steady GREEN Pass/Fail

Operate jog beyond 20 sec will cause LED Z to be on.

Maximum JOG time reached LED Z RED Pass/Fail

POWDER LOADING MANUAL ALARM LED X

INSUFFICIENT TABLET LEVEL ALARM LED S

MAXIMUN JOG RUNTIME ALARM LED Z




Disable Guards with keylock switch F. LED G is on.

Guards Disabled. LED G RED Pass/Fail

With machine running guards are opened. LED G is on.

Guards Opened. LED G RED Pass/Fail

Turning on tablet unit causes LED A to be on.

Tablet Unit On LED A GREEN Pass/Fail

Comments: _______________________________________________________________________



Reviewed by: __________________________________ Date: __________

GUARDS DISABLED ALARM LED G

TABLET UNIT RUNNING ALARM LED A

GUARDS OPENED ALARM LED G




Attachment #8 Sequence of Operation

Setup equipment to run with the appropriate operational parameters for a typical Production Cycle. Run equipment. Inspect cycle run data and verify it meets acceptance criteria.

Verify the sequence of operation of the pre-programmed cycle in Attachment #9.

Sequence Procedure Expected Results Pass/Fail Initials/Date

Power Up and System Operation

1Ensure that the machine is connected to a 115VAC power supply and compressed air supply.

Machine is connected to a 115VAC power supply and compressed air.

Pass/Fail

2Turn the main power switch to the "on" position.

The machine homes and the HMI boots.

Pass/Fail

3Manually load capsules into the capsule hopper

Machine is ready for Auto Mode operations.

Pass/Fail

4 Turn on suction systemMachine ready for capsule insertion

Pass/Fail

5Manually insert capsules into load position

Capsules ready for fill Pass/Fail

6Load the upper product hopper ¾ full with powder product

Powder ready for manual fill

Pass/Fail

7Load lower product hopper by placing selector to manual

Lower hopper filled with powder

Pass/Fail

8 Put power loading into automaticMachine ready for filling

9Press machine start (pushbutton Q) to begin filling operation. Operate at slow speed.

Machine automatically fills capsules.

Pass/Fail

10Press machine stop (pushbutton P) to stop filling operation. Operate at slow speed.

Machine stops Pass/Fail

11Conduct weight checks of filled capsules.

Capsules are within limits

Pass/Fail

12Restart machine and begin production.

Verify fill and feed rates for 10 minutes

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: __________




Attachment #8 Sequence of Operation

Setup equipment to run with the appropriate operational parameters for a typical Production Cycle. Run equipment. Inspect cycle run data and verify it meets acceptance criteria.

Verify the sequence of operation of the pre-programmed cycle in Attachment #9.

Sequence Procedure Expected Results Pass/Fail Initials/Date

Power Up and System Operation - Continued

13Repeat sequence of operations with handwheel in manual mode.

Verify Handwheel Engaged LED E is on RED.

Pass/Fail

14Repeat sequence of operations using Jog mode for 20 seconds.

Verify Max. Jog Runtime LED Z illuminates after 20 sec.

Pass/Fail

Power Off

15Stop machine operations by pressing pushbutton P

Machine operations stop. Pass/Fail

16Press each emergency stop while machine is running

Machine immediately stops Pass/Fail

17Turn machine off with main power switch

AC power LED B is off. Pass/Fail

Comments: ________________________________________________________________________



Reviewed by: __________________________________ Date: __________




Attachment #9 Maximum / Minimum Values

Change the system setpoints and verify the maximum and minimum values allowed. Note: document any failing results.

Setpoint Minimum Maximum Pass/Fail Initials/Date

Machine Speed 6000 cap/hr 12000 cap/hr Pass/Fail

Comments: ________________________________________________________________________

__________________________________________________________________________________

__________________________________________________________________________________

__________________________________________________________________________________



Reviewed by: __________________________________ Date: __________




Attachment #10 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

Comments: _______________________________________________________________________

_________________________________________________________________________________

_________________________________________________________________________________

Acceptance Criteria: A list of deviations resulting from the execution of this protocol shall be recorded.


Reviewed by: __________________________ Date: ____________




Protocol Deviation Report (Template)

Protocol # Protocol Section

Date Encountered: Page

Executor/Discovered By Step

Description of Deviation

Investigation / Findings

Statement of Impact

Resolution

ApprovalsRole Name (Print) Signature DateExecutor

Reviewer

NIH QA Officer




Attachment #11 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: _____________________