Capsule Filling Machine OQ

Operational Qualification Protocol
for the Capsule Filling Machine

Protocol No. EQNational Institute of Health
Operational Qualification Protocol
Equipment:
Protocol #:
Date:
Capsule Filling Machine
Facility:
National Institute of Health
16 March, 2010
Location:
Building 10 Room 1N249
Bethesda, 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 Molloy
Title: Consultant
Approved By: ______________________

Title: _____________________________
Signature:
Signature:
Date:
Date:
Approved By: ______________________
Approved By: ______________________
Title: _____________________________
Title: _____________________________
Signature:
Signature:
Date:
Date:
Approved By: ______________________
Quality Assurance
Approved By: ______________________
Title: _____________________________
Title: _____________________________
Signature:
Signature:
Date:
Date:
Qualification
Process
Solutions, Inc.
DOCUMENT NUMBER
REVISION NUMBER 1
PROPRIETARY INFORMATION:
Unauthorized Duplication Is Prohibited
DATE: 3/16/10
Author: Michael Molloy ______________________
PAGE: 1 of 36
Revision DATE: N/A
Operational Qualification
EQUIPMENT NAME: Capsule Filling Machine
OPERATIONAL QUALIFICATION
FOR THE

INSTALLED
AT
NATIONAL INSTITUTE OF HEALTH

BUILDING 10 ROOM 1N249
BETHESDA, MD 20892
QUALIFICATION PROCESS SOLUTIONS

13406 BLYTHENIA RD
PHOENIX, MD 21131
DOC. #
OPERATIONAL QUALIFICATION PROTOCOL
National Institute of Health, Building 10 Room 1n249
Bethesda MD 20892
Page 2 of 36
TABLE OF CONTENTS
16 March, 2010....................................................................................................................................................2
Quality Assurance...................................................................................................................................2
1.0Purpose..............................................................................................................................................3
2.0Scope..................................................................................................................................................3
3.0Equipment Description.......................................................................................................................3
4.0Responsibilities..................................................................................................................................4
5.0Reference Documents........................................................................................................................4
6.0Definitions.........................................................................................................................................5
7.0Test Function Number One: OQ Signature Verification List (Attachment #1).................................5
8.0Test Function Number Two: Test Equipment (Attachment #2).........................................................5
9.0Test Function Number Three: Procedure List (Attachment #3).........................................................6
10.0Test Function Number Four: Training Verification (Attachment #4)..............................................6
11.0Test Function Number Five: Operator Controls and Indicators (Attachment #5)............................6
12.0Test Function Number Six: Functional Verification (Attachment #6).............................................7
13.0Test Function Number Seven: Alarms, Safeties and Interlocks (Attachment #7)............................7
14.0Test Function Number Eight: Sequence of Operations (Attachment #8).........................................7
15.0Test Function Number Nine: Maximum / Minimum Values (Attachment #9)................................7
16.0Deviation Reporting Log (Attachment #10).....................................................................................8
17.0Operational Qualification Protocol Review (Attachment #11).........................................................8
18.0Summary Report Requirements ......................................................................................................8
19.0Attachment List .............................................................................................................................10
Attachment #1 OQ Signature Verification List.....................................................................................11
Attachment #2 Test Equipment.............................................................................................................12
Attachment #3 Procedure List...............................................................................................................13
Attachment #4 Training Verification...................................................................................................14
Attachment #5 Operator Controls and Indicators.................................................................................15
Attachment #6 Functional Verification.................................................................................................19
Attachment #7 Alarms, Safeties and Interlocks.....................................................................................25
Attachment #8 Sequence of Operation..................................................................................................31
Attachment #9 Maximum / Minimum Values.......................................................................................33
Attachment #10 Deviation Reporting Log............................................................................................34
Attachment #11 Operational Qualification Protocol Review................................................................36
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Page 3 of 36
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 (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 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)
2)
3)
4)
5)
6)
7)
8)
Capsule feed (w/relative automatic selection via optional unit)

Capsule orientation , positioning and opening (equipped w/ 8 stages)
Capsule separation pre-filling
Capsule product filling
Unopened capsule selection (Automatic)
Capsule alignment and closure
Capsule ejection
Capsule selection (automatic empty and partial fill segregation)
The capsule filling machine is comprised of the following major elements:

1)
2)
3)
4)
5)
6)
7)
8)
9)
10)
11)
12)
13)
Base
Motorization
Moving Parts
Protective hood
Electric cabinet and control panel
Size-change parts for process changeover
Manual controls
Powder feed unit
Powder layer and leveling control
Pellet or tablet dosing unit
Powder or pellet dosing unit
Defective capsule selection unit
Capsule closing unit
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Page 4 of 36
14)
15)
16)
17)
18)
Capsule selection unit

Liquid dosing unit
Central stage
Emergency stop push button
Electric extension plug
The following general parameters apply to the Zanasi 6F

1)
2)
3)
4)
4.0
5.0
Dimension: 2000mm W x 1670 mm H x 2140 mm L

Weight 1050 kg
Power 480 V 1.5 kw
Air
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.
Reference Documents
5.1
5.2
5.3
5.4
5.5
5.6
5.7
5.8
5.9
5.10
5.11
5.12
5.13
5.14
5.15
5.16
5.17
5.18
5.19
5.20
5.21
5.22
Drawing:
Drawing:
Drawing:
Drawing:
Drawing:
Drawing:
Drawing:
Drawing:
Drawing:
Drawing:
Drawing:
Drawing:
Drawing:
Drawing:
Drawing:
Drawing:
Drawing:
Drawing:
Drawing:
Drawing:
Drawing:
Drawing:
400024-00
4400d010-37
4401d011-28
4402d012-11
4403d013-15
4404d014-05
4405d015-11
4407d017-01
4408d018-07
4409d019-11
4410d020-11
4411d021-11
4005d002-03
4002d004-07
4004d004-05
4008d004-05
4009d004-11
4402d028-03
4410d090-12
4005d141-06
4005d142-06
4005d143-06
Capsule Filling Machine Assembly

Base Machine
Kinematic Motion Unit
Powder Unit
Manual Return Unit
Plate Unit
Capsule Feeding and Opening Unit
Powder Feeding Unit
Compression/Powder Ejection Unit
Reject Sorting Unit and Closing Counterplate
Capsule Ejection Unit
Cleaning Unit
Components Added to Basic Machine
Components Added to Rotary Tank
Capsule Chute without SPC
Powder/Pellet Capsule Equipment Unit F1
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5.23
5.24
5.25
5.26
5.27
5.28
5.29
5.30
5.31
5.32
5.33
5.34
5.35
5.36
5.37
6.0
7.0
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.
Test Function Number One: OQ Signature Verification List (Attachment #1)

7.1
7.2
7.3
8.0
Drawing: 4005d144-06 Powder/Pellet Capsule Equipment Unit F4

Drawing: 4005d146-06 Powder/Pellet Capsule Equipment Unit F0
Drawing: 4019d151-03 Powder Dosing Equipment F1
Drawing: 4440d363-02 Added Components without Weight Unit
Drawing: 4428d364-37 Safety Hood
Drawing: IE 44.68 Electrical Schematic
Document: IE 44.68 Electrical Spare Part List
Document: F-S22V1 Program Listing
Drawing: 440C033 Compressed Air Plant
Drawing: 440C039-01 Aspiration Air Plant
Document: 35071M04 Installation & Operation Manual for the Capsule Filling Machine
including:
Maintenance
Safety Notices
CE Conformity Documents
Test Reports and Equipment Certs
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.
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.
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8.2.2
8.3
9.0
Test Function Number Three: Procedure List (Attachment #3)

9.1
9.2
9.3
10.0
Objective
To verify the operating Standard Operating Procedures (SOPs) provide adequate direction and
control over the operation of the equipment.
Procedure
9.2.1 Verify that the operational SOP provides personnel adequate direction and control
over the operation of the equipment. (The SOPs used for execution may be in draft
form.)
9.2.2 Complete the applicable attachment with a list of all applicable SOPs.
9.2.3 Redline the SOPs with an operator and validation personnel. Attach the redline copy
to this qualification protocol.
Acceptance Criteria
All associated SOPs for operation and execution shall be reviewed and documented.
Test Function Number Four: Training Verification (Attachment #4)

10.1
10.2
10.3
11.0
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
All equipment required for execution shall be calibrated with copies of calibration records
attached.
Objective
To document applicable personnel have received the required training for operation of the
equipment.
Procedure
10.2.1 Document all personnel executing this protocol that have been trained on the
approved/draft SOP for the equipment.
10.2.2 List all SOPs used during the execution of this protocol
10.2.3 Complete required training forms in accordance with NIHs training requirements.
Acceptance Criteria
Training shall be performed on all SOPs used during the execution of this qualification
protocol.
Test Function Number Five: Operator Controls and Indicators (Attachment #5)
11.1
11.2
11.3
Objective
To verify the controls and indicators operate as specified by manufacturer recommendations.
Procedure
11.2.1 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.
Acceptance Criteria
All operator controls and indicators tested shall conform to the expected response.
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12.0
Test Function Number Six: Functional Verification (Attachment #6)

12.1
12.2
12.3
13.0
Test Function Number Seven: Alarms, Safeties and Interlocks (Attachment #7)
13.1
13.2
13.3
14.0
Objective
To verify and document the operation and functionality of the alarms, safeties and interlocks.
Procedure
13.2.1 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.
Acceptance Criteria
All safeties and interlock requirements must conform to the expected responses.
Test Function Number Eight: Sequence of Operations (Attachment #8)

14.1
14.2
14.3
15.0
Objective
To verify and document the operation and functionality of the equipment.
Procedure
12.2.1 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.
Acceptance Criteria
All functional requirements must conform to the expected responses.
Objective
To verify and document the operational sequence of the system.
Procedure
14.2.1 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.
Acceptance Criteria
The operating sequence occurs as expected.
Test Function Number Nine: Maximum / Minimum Values (Attachment #9)

15.1
15.2
Objective
To verify the maximum and minimum allowable values of changeable setpoints.
Procedure
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15.3
16.0
17.0
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.
Operational Qualification Protocol Review (Attachment #11)

17.1
17.2
18.0
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.
Acceptance Criteria
The actual results of the changeable setpoint limits shall conform to the expected responses.
Objective
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.
Summary Report Requirements

18.1
18.2
Objective
To provide an overview of the test results during the execution of this operational
qualification.
Procedure
18.2.1 Generate a final summary on completion of this protocol execution.
18.2.1.1 Compile a summary of the results obtained.
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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.
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19.0
Attachment List
16 March, 2010....................................................................................................................................................2
Quality Assurance...................................................................................................................................2
1.0Purpose..............................................................................................................................................3
2.0Scope..................................................................................................................................................3
3.0Equipment Description.......................................................................................................................3
4.0Responsibilities..................................................................................................................................4
5.0Reference Documents........................................................................................................................4
6.0Definitions.........................................................................................................................................5
7.0Test Function Number One: OQ Signature Verification List (Attachment #1).................................5
8.0Test Function Number Two: Test Equipment (Attachment #2).........................................................5
9.0Test Function Number Three: Procedure List (Attachment #3).........................................................6
10.0Test Function Number Four: Training Verification (Attachment #4)..............................................6
11.0Test Function Number Five: Operator Controls and Indicators (Attachment #5)............................6
12.0Test Function Number Six: Functional Verification (Attachment #6).............................................7
13.0Test Function Number Seven: Alarms, Safeties and Interlocks (Attachment #7)............................7
14.0Test Function Number Eight: Sequence of Operations (Attachment #8).........................................7
15.0Test Function Number Nine: Maximum / Minimum Values (Attachment #9)................................7
16.0Deviation Reporting Log (Attachment #10).....................................................................................8
17.0Operational Qualification Protocol Review (Attachment #11).........................................................8
18.0Summary Report Requirements ......................................................................................................8
19.0Attachment List .............................................................................................................................10
Attachment #1 OQ Signature Verification List.....................................................................................11
Attachment #2 Test Equipment.............................................................................................................12
Attachment #3 Procedure List...............................................................................................................13
Attachment #4 Training Verification...................................................................................................14
Attachment #5 Operator Controls and Indicators.................................................................................15
Attachment #7 Alarms, Safeties and Interlocks.....................................................................................25
Attachment #9 Maximum / Minimum Values.......................................................................................33
Attachment #10 Deviation Reporting Log............................................................................................34
Attachment #11 Operational Qualification Protocol Review................................................................36
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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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Page 12 of 36
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
Cal
Due 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: __________
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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 #
Effective
Date
Procedure Title
Original
Operation of the Capsule Filling Machine
Original
Maintenance of the Capsule Filling Machine
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.
Reviewed by: __________________________________
Date: __________
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Attachment #4 Training Verification
List the Standard Operating Procedures (SOP) used to train personnel for operating the equipment.
SOP #
Procedure Title
Operation of the Capsule Filling
Machine
Maintenance of the Capsule Filling
Machine
Training
Documented
(Y/N)
Initials/Date
Yes/No
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: __________
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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
CONTROL PANEL SWITCHES and INDICATORS

Emergency Stop
Button. Control
Panel
Places equipment in
safe mode when
pressed. Red
LED A.C. Power

On
Indicates AC Power
is on. LED Green.
LED Feed Logic

Control
LED Breakers
Tripped
LED Handwheel
Engaged
LED No
Compressed Air
Vacuum Pump Off
Pushbutton.
Vacuum Pump
Engaged Lamp
Vacuum Pump On
Pushbutton.
LED No Powder
LED No Capsules
LED No Pellets
Machine Motor
Speed Reg.
Potentiometer.
Indicates Feed Logic

is enabled. LED
Green
Indicates breakers
have tripped. LED
Red
Indicates manual
hand wheel is
engaged. LED Red
Indicates compressed
air is not available.
LED Red
Shuts down vacuum
pump when pressed.
Red
Indicates vacuum
pump is operating.
Lamp Green
Starts vacuum pump
when pressed.
Indicates no powder.
LED Red
Indicates no capsules
LED Red
Indicates no Pellets
LED Red
Rotating clockwise
/counterclockwise
increases/decreases
motor speed
_________ equipment
in safe mode when
pressed. Red
Indicates AC Power
________ on. LED
Green.
Indicates Feed Logic
________ enabled.
LED Green
Indicates breakers
________ tripped.
LED Red
Indicates manual hand
wheel _________
engaged. LED Red
Indicates compressed
air ____________
available. LED Red
___________ down
vacuum pump when
pressed. Red
Indicates vacuum
pump __________
operating. Lamp
Green
_________ vacuum
pump when pressed.
_________ no
powder. LED Red
_________ no
capsules LED Red
_________ no Pellets
LED Red
Rotating clockwise
/counterclockwise
__________/
__________ motor
speed
Pass/Fail
Pass/Fail
Pass/Fail
Pass/Fail
Pass/Fail
Pass/Fail
Pass/Fail
Pass/Fail
Pass/Fail
Pass/Fail
Pass/Fail
Pass/Fail
Pass/Fail
Initials/Date
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Indicates powder
mixer on. LED Green
__________ the
machine normally.
Red
____________ the
machine normally
___________ machine
operating. Lamp
Green
___________ no
tablets LED Red
__________ powder
mixer is selected. LED
Green
__________ either
Manual or Auto
Control
_________ powder
mixer on. LED Green
Powder Loading
Enable Selector
Enables Powder
Loading
____________
Powder Loading
LED Max. Jog

Runtime
Indicates JOG has

exceeded Runtime.
LED Red
LED Tablet Unit

Enabled
Indicates Tablet Unit

Enabled. LED Green.
Indicates JOG
_________exceeded
Runtime. LED Red
____________ Tablet
Unit Enabled. LED
Green.
Tablet Unit Enable

Selector
Enables Tablet
Selector
____________ Tablet
Selector
Pass/Fail
Production Counter
Displays production
counts
____________
production counts
Pass/Fail
Hour Counter
Logs run time when

machine is operating.
Hour Counter
Logs run time when

Hourly Production
Counter
Logs run time when

machine is operating
Machine Stop
Pushbutton
Stops the machine

normally. Red
Machine Start
Pushbutton
Starts the machine

normally
Indicates machine
operating. Lamp
Green
Indicates no tablets
LED Red
Indicates powder
mixer is selected.
LED Green
Lamp Machine
Running
LED No Tablets
LED Powder Mixer
(MAN/AUTO) On
Powder Mixer
MAN/AUTO
Selector
LED Powder Mixer
Enabled
Selects either Manual

or Auto Control
___________ run time

when machine is
operating.
___________ run time
when machine is
operating.
______________ run
time when machine is
operating
Pass/Fail
Pass/Fail
Pass/Fail
Pass/Fail
Pass/Fail
Pass/Fail
Pass/Fail
Pass/Fail
Pass/Fail
Pass/Fail
Pass/Fail
Pass/Fail
Pass/Fail
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Hour Counter
Logs run time when

______________ 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.
Manual Control
Handwheel
Engages/Disengages
Mechanical
Components
_____________
equipment in safe
mode when pressed.
_____________/
_____________
Mechanical
Components
Pass/Fail
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
Pellet Unit 1
ON/OFF
Enable/disable Pellet
Unit 1
Pellet Unit 2
ON/OFF
Enable/disable Pellet
Unit 2
_____________/
_____________
Vacuum Bowl
_____________/
_____________ Pellet
Unit 1
_____________/
_____________ Pellet
Unit 2
Pass/Fail
Pass/Fail
Pass/Fail
Comments: ________________________________________________________________________
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__________________________________________________________________________________
__________________________________________________________________________________
__________________________________________________________________________________
Acceptance Criteria: The actual results are the same as the expected results or explained.
Reviewed by: __________________________________
Date: __________
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Attachment #6 Functional Verification
Verify that the equipment/system operations function as indicated.
Input
Address
I 00.00
I 00.01
Input Test Description

Machine Start
Push Button Energized(SB 5.17)
Machine Start
Push Button Not Energized (SB 5.17)
Handwheel Detector
Sensor Energized(BI 8.3)
Handwheel Detector
Sensor not Energized (BI 8.3)
I 00.02
I 00.03
I 00.04
I 00.05
I 00.06
Jog Button energized (XC5.15)

Jog Button de-energized (XC5.15)
Machine Start
Relay Energized (KA8.6)
Machine Start
Relay De-energized (KA8.6)
Guard MicroSwitch
Switch Energized (A 4A.9)
Guard MicroSwitch
Switch De-energized(A 4A.9)
Mixer Auto/Manual
Switch energized (SA7.2)
Mixer Auto/Manual
Switch de-energized (SA7.2)
Expected Results
Performed
By/Date
Lamp HL5.6 Green

Machine starts
Lamp HL5.6 off
Machine stops
LED E RED
Machine wont
start
LED E off
Machine will start
Machine starts,
after 20 sec LED Z
Red
Machine stops
LED B Green
LED B off
LED G off
Machine will start
LED G RED
Machine wont start
LED T Green
LED T off
Emergency Push Button

Button energized (SE 4A.4)
ESTOP Button
RED, Machine
stopped
Emergency Push Button

Button de-energized (SE 4A.4)
ESTOP Button off
Test
Power 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.
Pass/
Fail
Expected Result
I/O operates as
expected
Pass/Fail
Initial/Date
DOC. #
Bethesda MD 20892
Page 20 of 36
Input
Address
I 00.07
I 00.08
I 00.09
I 00.10
I 00.11
I 01.00
I 01.01

Powder Min. Level Detector 2
Sensor energized (BC8.10)
Sensor de-energized (BC8.10)
Locked Inverter
Signal energized (AR1.14)
Locked Inverter
Signal de-energized (AR1.14)
Powder Charging Auto
Powder Charging Auto
Powder Charging Manual
Powder Charging Manual
Sensor energized (BC8.14)
Sensor de-energized (BC8.14)
Stop Phase
Sensor Energized (BI8.15)
Stop Phase
Sensor Energized De-energized (BI8.15)
Capsule Minimum Level
Sensor Energized (BC8.16)
Capsule Minimum Level
Sensor Energized Not Energized (BC8.16)
I 01.02
JOG start
Relay energized (KA5.13)
JOG start
Relay de-enegized (KA5.13)
Expected Results
Pass/
Fail
Performed
By/Date
LED L Red
LED L off
LED D flashing
RED
LED D off
LED V Green
LED V off
LED X Green
LED X off
LED L Red
LED L off
LED D flashing
RED
LED D off
LED M flashing
RED, after 1 min.
steady RED
LED M off
Machine starts
while jog is pressed
Machine stops
when jog is
released
Guards Control
LED G RED
Key Switch energized (SA5.12)
Guards Control
LED G off
Key Switch de-energized (SA5.12)
Test
Expected Result
I/O operates as
expected
I 01.03
Pass/Fail
Initial/Date
DOC. #
Bethesda MD 20892
Page 21 of 36
Input
Address
I 01.04

Program Stop On (SB5.17D1)
Program Stop Off (SB5.17D1)
I 01.05
I 01.06
I 01.07
I 01.08
I 01.09
Machine motor brake control

Relay energized (AR1.14)
Machine motor brake control
Relay de-energized (AR1.14)
Mixer On/Off
Switch energized (KT10.15)
Mixer On/Off
Switch de-energized (KT10.15)
Pellet Group 1
Selector Switch On (SA9.5)
Pellet Group 1
Selector Switch Off (SA9.5)
Pellet Group 2
Selector Switch On (SA9.6)
Pellet Group 2
Selector Switch Off (SA9.6)
Pellet Group Sensor On (SA9.6)
Pellet Group Sensor Off (SA9.6)

Motor Overload
I 01.10
Cutout energized (QM7.11)
Motor Overload
Cutout de-energized (QM7.11)
Air Pressure
I 01.11
Sensor energized (SP9.9)
Air Pressure
Sensor de-energized (SP9.9)
Test
Expected Results
Pass/
Fail
Performed
By/Date
Program initiated
machine stop
Machine enabled
normal
Machine brake
engaged
Machine brake disengaged
LED T Green
LED T off
Pellet Group 1
enabled.
Pellet Group 1 disabled.
Pellet Group 2
enabled.
Pellet Group 2 disabled.
LED N Red no
pellets
LED N off
LED D Red
Machine stops
LED D off
LED F off
LED F Red
Expected Result
I/O operates as
expected
Pass/Fail
Initial/Date
DOC. #
Bethesda MD 20892
Page 22 of 36
Output
Address
Output Test Description
Expected Results
Pass/
Fail
Mixer starts
when bit is
enabled.
Machine stops
O10.01
Machine Stop (KA10.12)
when bit is
enabled.
Machine starts
O10.02
Remote Machine Start (KA10.13)
when bit is
enabled.
Mixer is on when
bit is enabled.
O10.04
Mixer ON/OFF (KT10.15)
Mixer is off when
bit is not enabled.
Test
Expected Result
Pass/Fail
I/O operates as
expected
O10.00
Performed
By/Date
Mixer Start (KA10.11)
Initial/Date
DOC. #
Bethesda MD 20892
Page 23 of 36
Procedure
Machine Start/Stop Sequence
Expected Result
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.
Capsule Feed System
1. Machine starts and LED R

illuminates green.
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 machine
4. Adjust machine speed to 6000 Caps/hr
1. Capsules flow into the machine

is initiated until stop pushbutton is
pressed.
2. Machine stops
Pass/Fail
Pass/Fail
3. Machine stops immediately
2. LED M is lit.
Pass/Fail
3. Closed capsules will be ejected

into the unopened capsule
container.
4. Verify machine is at minimum
feed of 6000 caps/hr
Powder Feed System

1. Load upper powder hopper 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.
Pass/Fail
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.
Initials/Date
DOC. #
Bethesda MD 20892
Page 24 of 36
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.
Pass/Fail
2. Observe no pellets LED N is Red
when pellets are below this sensor.
Comments: _______________________________________________________________________
Reviewed by: __________________________________
Date: __________
DOC. #
Bethesda MD 20892
Page 25 of 36
Attachment #7 Alarms, Safeties and Interlocks
Verify that the alarms, safeties and interlocks function as indicated.
Procedure
Expected Result
Pass/Fail
Initials/Date
Expected Result
Pass/Fail
Initials/Date
Machine stops operations
Pass/Fail
CONTROL PANEL
Procedure
EMERGENCY
STOP
Push an emergency stop button

while the machine is running.
LOW VOLTAGE
Fault LED B
DOC. #
Bethesda MD 20892
Page 26 of 36
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
DC Power fault LED C indicates off.
Pass/Fail
Machine inverter fault LED indicates

flashing RED
Pass/Fail
Motor Overlaod fault LED indicates

steady RED
Pass/Fail
DC POWER
SUPPLY FAULT
LED B AND LED C
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.
MACHINE
INVERTER FAULT
LED D
While operating and inverter faults

LED D is on Remove fuse in
Inverter circuit.
MOTOR
OVERLOAD
FAULT LED D
While operating and motor overloads

LED D is on Remove fuse in motor
circuit.
DOC. #
Bethesda MD 20892
Page 27 of 36
HANDWHELL
ENGAGED
ALARM LED E
With handwheel engaged LED E is

on. Machine will not start
Handwheel engaged alarm LED E RED
Pass/Fail
Machine stops operations. LED F RED
Pass/Fail
No powder LED indicates RED
Pass/Fail
LOW PRESSURE
ALARM LED F
Adjust the main regulator to cut off

the air supply while the machine is
running..
POWDER MIXER
EXCEEDS LIMITS
ALARM LED L
While operating powder mixer motor

de-energize the motor. When stop
limit (pre-set) is exceeded No
Powder alarm is enabled.
INSUFFICIENT
CAPSULE LEVEL
ALARM LED M
DOC. #
Bethesda MD 20892
Page 28 of 36
With no or low capsule level and

machine running LED will flash.
Insufficient capsule level LED M flashing

RED
Pass/Fail
Insufficient capsule level Timeout LED M

steady RED
Pass/Fail
Insufficient pellet level LED N flashing

RED
Pass/Fail
Insufficient pellet level Timeout LED N

steady RED
Pass/Fail
INSUFFICIENT
CAPSULE LEVEL
TIMEOUT ALARM
LED M
When capsule level is low for more

than one minute machine stops and
alarm LED changes from flashing to
steady.
INSUFFICIENT
PELLET LEVEL
ALARM LED N
With no or low pellet level and

INSUFFICIENT
PELLET LEVEL
TIMEOUT ALARM
LED N
When pellet level is low for more

than one minute machine stops and
alarm LED changes from flashing to
steady.
DOC. #
Bethesda MD 20892
Page 29 of 36
INSUFFICIENT
TABLET LEVEL
ALARM LED S
With no or low tablet level and

Insufficient tablet level LED S flashing

RED
Pass/Fail
Powder Loading LED X steady GREEN
Pass/Fail
Maximum JOG time reached LED Z RED
Pass/Fail
POWDER
LOADING
MANUAL ALARM
LED X
Placing powder Loading in manual

causes LED to be on.
MAXIMUN JOG
RUNTIME ALARM
LED Z
Operate jog beyond 20 sec will cause

LED Z to be on.
DOC. #
Bethesda MD 20892
Page 30 of 36
GUARDS
DISABLED
ALARM LED G
Disable Guards with keylock switch

F. LED G is on.
Guards Disabled. LED G RED
Pass/Fail
Guards Opened. LED G RED
Pass/Fail
Tablet Unit On LED A GREEN
Pass/Fail
GUARDS OPENED
ALARM LED G
With machine running guards are

opened. LED G is on.
TABLET UNIT
RUNNING
ALARM LED A
Turning on tablet unit causes LED

A to be on.
Comments: _______________________________________________________________________
Reviewed by: __________________________________
Date: __________
DOC. #
Bethesda MD 20892
Page 31 of 36
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

1
2
3
4
5
6
7
8
9
10
11
12
Ensure that the machine is connected

to a 115VAC power supply and
compressed air supply.
Turn the main power switch to the
"on" position.
Manually load capsules into the
capsule hopper
Turn on suction system
Manually insert capsules into load
position
Load the upper product hopper
full with powder product
Load lower product hopper by
placing selector to manual
Put power loading into automatic
Press machine start (pushbutton Q)
to begin filling operation. Operate at
slow speed.
Press machine stop (pushbutton P) to
stop filling operation. Operate at
slow speed.
Conduct weight checks of filled
capsules.
Restart machine and begin
production.
Machine is connected
to a 115VAC power
supply and compressed
air.
The machine homes
and the HMI boots.
Machine is ready for
Auto Mode operations.
Machine ready for
capsule insertion
Capsules ready for fill
Powder ready for
manual fill
Lower hopper filled
with powder
Machine ready for
filling
Pass/Fail
Pass/Fail
Pass/Fail
Pass/Fail
Pass/Fail
Pass/Fail
Pass/Fail
Machine automatically
fills capsules.
Pass/Fail
Machine stops
Pass/Fail
Capsules are within

limits
Verify fill and feed
rates for 10 minutes
Pass/Fail
Pass/Fail
Comments: ________________________________________________________________________
Reviewed by: __________________________________
Date: __________
DOC. #
Bethesda MD 20892
Page 32 of 36
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
Power Up and System Operation - Continued

Repeat sequence of
Verify Handwheel Engaged
13
operations with handwheel in
LED E is on RED.
manual mode.
Repeat sequence of
Verify Max. Jog Runtime LED Z
14
operations using Jog mode
illuminates after 20 sec.
for 20 seconds.
Power Off
Stop machine operations by
15
Machine operations stop.
pressing pushbutton P
Press each emergency stop
16
Machine immediately stops
while machine is running
Turn machine off with main
17
AC power LED B is off.
power switch
Initials/Date
Pass/Fail
Pass/Fail
Pass/Fail
Pass/Fail
Pass/Fail
Comments: ________________________________________________________________________
Reviewed by: __________________________________
Date: __________
DOC. #
Bethesda MD 20892
Page 33 of 36
Attachment #9 Maximum / Minimum Values
Change the system setpoints and verify the maximum and minimum values allowed. Note: document any
failing results.
Setpoint
Machine Speed
Minimum
Maximum
Pass/Fail
6000 cap/hr
12000 cap/hr
Pass/Fail
Initials/Date
Comments: ________________________________________________________________________
__________________________________________________________________________________
__________________________________________________________________________________
__________________________________________________________________________________
Reviewed by: __________________________________
Date: __________
DOC. #
Bethesda MD 20892
Page 34 of 36
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: ____________
DOC. #
Bethesda MD 20892
Page 35 of 36
Protocol Deviation Report (Template)
Protocol #
Protocol Section
Date Encountered:
Page
Executor/Discovered By
Step
Description of Deviation
Investigation / Findings
Statement of Impact
Resolution
Approvals
Role
Executor
Reviewer
NIH QA Officer
Name (Print)
Signature
Date
DOC. #
Bethesda MD 20892
Page 36 of 36
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: _____________________

Capsule Filling Machine OQ

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Operational Qualification Protocol

for the Capsule Filling Machine

Capsule Filling Machine

Approved By: ______________________

Approved By: ______________________

Approved By: ______________________

Author: Michael Molloy ______________________

Revision DATE: N/A

Capsule Filling Machine

NATIONAL INSTITUTE OF HEALTH

QUALIFICATION PROCESS SOLUTIONS

Capsule feed (w/relative automatic selection via optional unit)

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

Capsule selection unit

The following general parameters apply to the Zanasi 6F

Dimension: 2000mm W x 1670 mm H x 2140 mm L

Qualification Process Solutions, LLC.

National Institutes of Health (SI)

Capsule Filling Machine Assembly

Non-Critical Instrumentation Instrumentation provided for indication or convenience

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

Drawing: 4005d144-06 Powder/Pellet Capsule Equipment Unit F4

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

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

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

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

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

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

Deviation Reporting Log (Attachment #10)

Operational Qualification Protocol Review (Attachment #11)

Summary Report Requirements

Generate a conclusion, based on these results, of the acceptability of the

Operation of the Capsule Filling Machine

Maintenance of the Capsule Filling Machine

CONTROL PANEL SWITCHES and INDICATORS

LED A.C. Power

LED Feed Logic

Indicates Feed Logic

LED Max. Jog

Indicates JOG has

LED Tablet Unit

Indicates Tablet Unit

Tablet Unit Enable

Logs run time when

Logs run time when

Logs run time when

Stops the machine

Starts the machine

Selects either Manual

___________ run time

Logs run time when

Guards disabled LED

REAR PANEL SWITCHES and INDICATORS

SIDE PANEL SWITCHES and INDICATORS

Resets the capsule

ELECTRICAL PANEL (Inside Door) SWITCHES and INDICATORS

Input Test Description

Jog Button energized (XC5.15)

Lamp HL5.6 Green

Emergency Push Button

Emergency Push Button

ESTOP Button off

Input Test Description

Input Test Description