PQ Tablet Filler

Performance Qualification Protocol
Tablet Filler
Tetoros S.A Veterinary Company
Installation Qualification Protocol
Equipment:
Tablet Filler (IMA - Kilian)
Facility:
TETOROS S.A VETERINARY
COMPANY
Protocol #: 0014-2012-01
Date: 2/17/2012
Location:
10th km National Road
Athens - Lamia
Metamorfosi, Attiki 14451
Revision: None
Title:
Performance Qualification Protocol for Tablet Press
Objective:
The objective of this protocol is to document the performance of the Tablet Press
Written By:
Approved By:___________________________
Title:
Title:__________________________________
Signature:_______________________________
Signature:_______________________________
Date:___________________________________
Date:___________________________________
Approved By:___________________________
Approved By:___________________________
Title:__________________________________
Title:__________________________________
Signature:_______________________________
Signature:_______________________________
Date:___________________________________
Date:___________________________________
Documentation Number: 0014-2012-01

OPERATIONAL QUALIFICATION PROTOCOL
EQUIPMENT NAME: Tablet Filler
Page:3/41
Documentation Number:
0014-2012-01
Revision Number:
None
Date:
Page:
Revision Date:N/A
Operational Qualification
Equipment No.:____________________
PERFORMANCE QUALIFICATION
FOR THE
TABLET FILLER
INSTALLED
AT
TETOROS S.A
VETERINARY COMPANY
1.0
Purpose
The objective of this protocol is to verify that the Tablet Filler, 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 at the TETOROS VETERINARY COMPANY,10th km National Road Athens Lamia, Metamorfosi, Attiki. This
protocol is specific to the Tablet Filler. This protocol is limited to the Tablet Room. Connected equipment and utilities for this
system are not covered in this protocol; refer to specific equipment validations if applicable.
3.0
Equipment Description

Page:4/41
The Tablet Filler is a standalone die table and tablet press use for the formation of tablets. Operators load the machine with
powder and the machine operates automatically using electric power and suction air. The method of tablet forming is
accomplished in the following manner:
The die table guides the upper and lower punches into the punch reception bores. The die table rotates and thus forces the
punches to move in horizontal direction. The punch heads run in cam tracks which force them to move in vertical direction
during the rotation of the die table.
For filling the tablet die, the lower punch moves down in the die to its lowest position. The material to be pressed drops
down into the empty space. The final fill quantity is determined by the lower punch moving back into the fill compartment. At
the end of the fill unit, the material is smoothed out at the die edge. Behind the fillshoe, the upper punch moves down into
the die and thus closes the fill compartment.
The tablet press presses the tablet in two working steps. First upper and lower punches run in pairs between the
prepressure rollers. Here the distance between the punches decreases to the pre-set value. The tablet powder is pressed
into the remaining volume between the punches. By this processed, the material between the punches is de-aerated and
pre-pressed. Following the pressure rollers, this procedure is repeated with an even smaller distance between the punches
and thus with a higher pressure between the main pressure rollers. The final table is formed with its specified thickness.
Following the main pressure, the punches move apart and the lower punch pushes the finished tablet out of the die. With
the rotational movement of the die plate, the ejected tablet moves against the tablet scraper and drops from the die plate
into the chute.
The Tablet Filler is provided with the following specifications:
Variable Machine Speed: 5-50 rpm

Main Compression Force: 50 kN
Pitch Circle Diameter: 180 mm
Adjustable Speed: 4800 to 19200 tablets / hour
Handwheels for adjustments
Valve between product hopper and fill shoe

Stainless steel construction.
Variable speed motors
4.0
Responsibilities
4.1
Tetoros S.A
It is the responsibility of Tetoros S.A to write this protocol.
It is the responsibility of Tetoros S.A to execute this protocol.
Following the execution, Tetoros S.A will approve the final report
associated with this protocol, indicating the executed protocol was
completed correctly and all acceptance criteria were met.
4.1.1
4.1.2
4.1.3
5.0
Reference Documents
5.1
6.0
7.0
Operation and Maintenance Manuals
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.
6.2
Non-Critical Instrumentation - Instrumentation provided for indication or convenience purposes only.
6.3
Deviation - Any event (planned or unplanned) that has the potential to adversely impact product quality.
Deviations may or may not have the potential to impact operations and operational costs.
6.4
Variance - Any event (planned or unplanned) that has the potential to impact operations and operations costs and no
impact on product quality.
6.5
Change Control - A Change Control Request (CCR) shall be submitted in the event of nonconformity. Nonconformity is considered a failure in Tetoros S.A quality system.
Test Function Number One: OQ Signature Verification List (Attachment #1)

7.1
Objective
To 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
Page:5/41
Acceptance Criteria
Signatures from all personnel involved in execution of this protocol shall be present.
8.0
Test Function Number Two: Test Equipment (Attachment #2)

8.1
Objective
To verify and document all test equipment
8.2
8.3
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
Hellenic Accreditation System S.A. (E.SY.D) .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.
9.0
Test Function Number Three: Procedure List (Attachment #3)

9.1
Objective
To verify the operating Standard Operating Procedures (SOP's) provide adequate direction and control over the
operation of the equipment.
9.2
Procedure
9.2.1
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
9.3
Redline the SOP's with an operator and validation personnel. Attach the redline copy to this qualification
protocol.
Acceptance Criteria
All associated SOP's for operation and execution shall be reviewed and documented.
10.0 Test Function Number Four: Operator Controls and Indicators (Attachment #4)
10.1
Objective
To verify the controls and indicators operate as specified by manufacturer recommendations.
10.2
10.3
Procedure
10.2.1
Manually operate the control switches listed in the applicable
10.2.1
Visually verify and document the actual responses.
10.2.2
Document any discrepancies in Attachment #11, Deviation Reporting Log. If any variances/deviations are
present, complete the appropriate deviation/variance form.
attachment.
Acceptance Criteria
All operator controls and indicators tested shall conform to the expected response.
11.0
Test Function Number Five: Functional Verification (Attachment #5)

11.1
Objective
To verify and document the operation and functionality of the equipment.
11.2
Procedure
11.2.1
Follow the procedures in the applicable attachments.
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

Page:6/41
11.3 Acceptance Criteria

All functional requirements must conform to the expected responses.
12.0
Test Function Number Six: Operator Interface (Attachment #6)

12.1
Objective
To ensure proper communication between the batons and equipment.
12.2
12.3
Procedure
12.2.1
Display the operator batons listed on the applicable attachment.
12.2.2
Visually verify and document the actual results of the functions that appear on the operator interface.
12.2.3
Acceptance Criteria
The actual results of operator interface screens shall 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
13.3
Procedure
13.2.1
Follow the procedures in the applicable attachments.
13.2.1
Visually verify and document the actual responses as pass or fail against the expected results.
13.2.2
Document all operational parameters used during execution.
13.2.2
Acceptance Criteria
All safeties and interlock requirements must conform to the expected responses.
14.0
Test Function Number Eight: Sequence of Operations (Attachment #8)

14.1
Objective
To verify and document the operational sequence of the system.
14.2
14.3
Procedure
14.2.1
Execute the procedures in the order listed.
14.2.1
Observe the expected operations and write "Pass" if the results were as expected, and "Fail" if the expected
operation did not take place.
14.2.2
Acceptance Criteria
The operating sequence occurs as expected.
15.0
Test Function Number Nine: Maximum / Minimum Values (Attachment #9)

15.1
Objective
To verify the maximum and minimum allowable values of changeable set points.
15.2
15.3
Procedure
15.2.1
Display the changeable set point 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
Acceptance Criteria
The actual results of the changeable set point limits shall conform to the expected responses.

16.0
Page:7/41
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
16.3
17.0
Procedure
16.2.1
Document all deviations found during execution.
16.2.2
Complete the Deviation/Variance Form immediately upon any observed deviations.
16.2.3
Route the deviation form for review and approval from Quality Assurance (QA), prior to final approval of this
protocol.
Acceptance Criteria
16.3.1
All deviations shall be property documented on the Deviation/Variance Form.
16.3.2
All deviation reports and corrective action forms, if necessary, shall be approved prior to final approval of
this qualification protocol.
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
Procedure
Complete 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
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.
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
necessary.
Action Forms, where

19.0
Page:8/41
Attachment List
Attachment #1 OQ Signature Verification List............................................................................................................................... 9

Attachment #4 Operator Controls and Indicators........................................................................................................................ 12
Attachment #5 Functional Verification......................................................................................................................................... 13
Attachment #6 Operator Interface............................................................................................................................................... 14
Attachment #7 Alarms, Safeties and Interlocks...........................................................................................................................28
Attachment #8 Sequence of Operation....................................................................................................................................... 29
Attachment # 10 Deviation Reporting Log................................................................................................................................... 31
Attachment #11 Operational Qualification Protocol Review
.....33

Page:9/41
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
Signature
Name
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
Manufacture
r
ID#
Page:10/41
Certified/
Serial # Calibrate
d
Cal.
Cal
Initials/ Date
Date Due 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.
( ) Yes
)No
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 #
Operation of the Tablet Filler
Procedure Title
Effective
Initials/Date
Date

Page:11/41
Maintenance of the Tablet Filler
Comments:_________________________________________________________________________________________________________________
___________________________________________________________________________________________________________________________
___________________________________________________________________________________________________________________________
____________________________________________________________________________________________
Acceptance Criteria: A list of written procedures that are used to operate the equipment is provided above.
attach a copy to the executed protocol.
( ) Yes
)No
Reviewed by:_____________________________________________
Date:_________________________
If procedures are in draft form,
STANDARD OPERATING PROCEDURE

Title: OPERATION OF THE KILIAN TABLET PRESS
Effective Date
Approvals
SOP Number
Supersedes / Date:
Name
Page 1 of 3
Signature
Date
Originated by:
Dept Approval:
OA Approval:
1.0
TABLE OF CONTENTS
1.0 TABLE OF CONTENTS.....................................................................1
2.0 RELATED SOPS................................................................................1
3.0 PURPOSE.........................................................................................1
4.0 SCOPE..............................................................................................1
5.0 RESPONSIBILITY..............................................................................1
6.0 SAFETY...........................................................................................2
7.0 PROCEDURE...........................................................2
8.0 DOCUMENTATION............................................................................3
9.0 REVISION HISTORY..........................................................................3
2.0
RELATED SOPS
2.1
Maintenance of the Kilian Tablet Press
3.0
PURPOSE
The purpose of this procedure is to provide directions to an operator for the making of tablets.
Machine maintenance, clean up, disassembly, and set-up are not a part of this SOP.
4.0
SCOPE
This SOP applies to employees that work in laboratory or cGMP area and may operate the
tablet maker.
5.0
RESPONSIBILITY
5.1
Title: OPERATION OF
PRESSIMA TABLET PRESS
6.0
Department Supervisors and above are accountable for providing training. All training
must be documented and filed.
THE
KILIANSOP Number
Effective Date:
Supersedes / Date:
Page 2 of 3
Originator / date
Approved by / date
QA Approval /date
SAFETY
6.1
There are a few areas where it is possible to make settings or to use the machine in a way that
could damage the machine.
6.2
The machine is heavy. During any disassembly operation take care to avoid injury due to
gravitational displacement of the equipment.
7.0
PROCEDURE
Page 14 of33
7.1
The machine is operated (on off jog) from the Work page. If the machine has been set up properly with
powder, the soft button "START" will cause the machine to make tablets.
7.2
Speed of the main drive in rpm.
7.3
The Basic settings can be calculated and compaction force should be calculated to prevent damaging the
fitted punches.
7.4
The calculated values are a guide only. To obtain final values, during setup, adjust the values
for filling and wall dimension as required. The following dependencies apply:
7.5
Changing the filling has a direct impact on the tablet weight.
7.6
Changing the wall dimension directly influences the tablet hardness (for constant filling level).
7.7
During production, the speed is controlled by the drive speeds.
7.8
Remove sample tablets at regular intervals and measure them. If the tablet samples are not
OK, correct the values set on the machine.
7.9
Batch change:
7.9.1 Stop the machine at the end of a batch with the stop soft button.
7.9.2 Label the batch
7.9.3 Clean the machines compression chamber.
7.9.4 Set up the machine for the next batch.
7.9.5 Restart.
Title: OPERATION OF THE KILIAN PRESSIMA TABLET PRESS
7.10
SOP Number
Effective Date:
Supersedes / Date:
Page 3 of 3
Originator / date
Approved by / date
QA Approval /date
Product change:
7.10.1 Stop the machine.

7.10.2 Record the final values if the product is to be produced again at some later
time.
7.10.3 Empty the material hopper and the filling shoe.

7.10.4 Clean the machine completely.
7.10.5
If required, change the tools.
7.10.6 Set up the machine for the new product.

7.10.7 Start the tablet press.
8.0
DOCUMENTATION
There is a manual that goes into more detail about assembly and disassembly of the
machine.
9.0
REVISION HISTORY
9.1
This is a NEW procedure.
STANDARD OPERATING PROCEDURE

Title: MAINTENANCE OF THE KILIAN TABLET PRESS
Effective Date
Approvals
Supersedes / Date:
Name
Signature
SOP Number
Page 1 of 4
Date
Originated by:
Dept Approval:
OA Approval:
1.0
TABLE OF CONTENTS
1.0 TABLE OF CONTENTS............................................................................1
2.0 RELATED SOPS......................................................................................1
3.0 PURPOSE................................................................................................1
4.0 SCOPE.....................................................................................................1
5.0 RESPONSIBILITY....................................................................................1
6.0 SAFETY..................................................................................................2
7.0 PROCEDURE......................................................................................... 2
8.0 DOCUMENTATION...................................................................................4
9.0 REVISION HISTORY.................................................................................4
2.0
RELATED SOPS
2.1
Operation of the Kilian Pressima Tablet Press
3.0
PURPOSE
The purpose of this procedure is to provide general directions for maintenance
and cleaning of the tablet press.
4.0
SCOPE
This SOP applies to maintenance employees that work in laboratory or cGMP
area and may maintain or clean the tablet press.
5.0
RESPONSIBILITY
5.1 Department Supervisors and above are accountable for providing training.
All training must be documented and filed.
Title: MAINTENANCE
KILIAN TABLET PRESS
OF
THESOP
Number:
Effective Date:
Supersedes / Date:
Page 2 of 4
Originator/date
Approved by / date
OA Approval /date
6.0
SAFETY
7.0
6.1
There are a few areas where it is possible to make settings or to use the
machine in a way that could damage the machine.
6.2
The machine is heavy. During any disassembly operation take care to

avoid injury due to gravitational displacement of the equipment.
PROCEDURE
7.1
A primary maintenance item is the disassembly and cleaning of the

machine after use. Additional detail related to disassembly of the
machine is available in the manual.
7.2
For cleaning apply:
7.2.1
only lint free cloth which does not damage the surfaces
of the compression chamber or cause any reaction with
the press material
7.2.2
only light cleaning agents (pH value between 7-8, free from
chlorine chloride). The surfaces can be damaged if you use
detergents with a pH value" 91
7.2.3
no solvent-based, scouring or abrasive cleaning agents.
7.2.4
no steam jets (high-pressure cleaner). The high pressure and hot

steam damage the seals.
7.2.4
no compressed air
7.2.5
no water for cleaning the die table
7.2.6
Generally proceed as follows:
7.2.7.1
Vacuum the compression chamber to remove product

residues
7.2.7.2
Clean the compression chamber using cloth and

detergents
7.2.7.3
Remove oil and product residues on connections and

union joints; after cleaning check these for leaks,
damage or loose connections.
SOP Number:
Effective Date:
Supersedes / Date:
Page 3 of4
Originator/date
Approved by / date
QA Approval /date
7.2.7
For minor cleaning proceed as follows:
7.2.8.1
Remove the material hopper - vacuum away product

debris. Use a soft cloth and lint free wipes to clean it
with a appropriate solvent (water). Use an appropriate

procedure to clean away any solvents. Do a final rinse in
WFI. Dry the hopper thoroughly before introducing any
new product powders.
7.2.8.2
Clean all contact parts using a procedure like that

described above.
7.2.8.3
Remove tablet chute and tablet scraper
7.2.8.4
Remove the product scraper
7.2.8.5
Empty the fill shoe, dismantle and clean it.
7.2.8.6
Remove the upper punches and clean the guides
7.2.8.7
Clean the compression chamber
7.2.8.8
Clean the suction
7.2.8
For major cleaning proceed as follows:
7.2.9
Execute all steps of the minor cleaning and in addition:
7.2.10.1
Remove the lower punches and clean the guides
7.2.10.2
Remove the dies and clean the bores of the dies

carefully with the cleaning scraper
7.2.10.3
Clean the die table with alcohol.
7.2.10.4
Detail instructions for disassembly are in the manual.
SOP Number:
Effective Date:
Supersedes / Date:
Page 4 of 4
Originator/date
Approved by / date
OA Approval / date
7.2.10 Lubrication:
Components
Upper main pressure
Time Interval
every 50 hours of operation
Lubricant
Grease
Lower main pressure
Grease
Upper pre-pressure
Grease
Shaft bearing
Grease
Upper pressure roller
before every operating cycle
Oil
Lower pressure roller
Oil
Upper punch
Oil
Lower punch
Oil
8.0
DOCUMENTATION
There is a manual that goes into more detail about assembly and disassembly
of the machine.
9.0 REVISION HISTORY

9.1
This is a NEW procedure.

Page:20/41
Attachment #4 Operator Controls and Indicators
Press the control keys to verify that the equipment/system operations function as indicated.
failing results.
Device
Main switch
Function
Expected Results
When switched to ON
When switched to ON
equipment is powered.
equipment______
When switched to OFF
powered. When switched
Note: document any
Pass/Fail Initials/Date
Pass / Fail
equipment is not powered. to OFF

equipment______powered
.
Filling hand wheel
By using the hand wheel,
the fill height is adjusted.
the Fill height is adjusted.
When the height is
When the height is
increased, the weight is
increased, the weight
Pass / Fail
increased. When the height is__________. When the

is decreased, the weight is height is decreased, the
decreased.
weight
is_______________
Die table hand
wheel
the die table turns.
the die table___________
Pass / Fail
Comments:__________________________________________________________________________________________________
___________________________________________________________________________________________________________
___________________________________________________________________________________________________________

Page:21/41
___________________________________________________________________________________________________________
________________________________
Acceptance Criteria: The actual results are the same as the expected results or explained.
( ) Yes
) No
Reviewed by:_____________________________________________
Date:_________________________

Page:23/41
Attachment #5 Functional Verification

Verify that the equipment/system operations function as indicated.
Procedure
Expected Results
HARDNESS VERIFICATION
Record settings
Set machine to one set of settings,
Record hardness values on data
record settings, run machine, pull 30
sheet.
Pass/Fail
Initials/ Date
Pass / Fail
samples and record hardness values.

WEIGHT VERIFICATION
Record settings
Set the machine to one set of settings,
Record weight values on data
sheet.
samples and record weight values.
Values are within 5% of each
Pass / Fail
other.
DIMENSIONAL VERIFICATION
Record settings
Set the machine to one set of settings,
Record weight values on data
sheet.
Pass / Fail
samples and record dimensional values. Values are within 5% of each

other.
SUCTION STATION
When the system runs, the suction Pass / Fail
Run system and observe operation of
station removes dust from tablets
suction station.
that pass the station.
HOPPER
Butterfly valve stops flow of
Powder is filled in the hopper for
product into machine.
dispensing into the machine. Run
When the machine operates
machine and observe operation.
automatically, powder flows from
Operate butterfly valve.
hopper into fillshoe
DISCHARGE STATION
When the system runs, tablets are Pass / Fail
Run system and observe operation of
discharged from the machine
discharge station.
down the discharge chute.
Pass / Fail
Comments:_________________________________________________________________________________________________________________
___________________________________________________________________________________________________________________________

Page:24/41
___________________________________________________________________________________________________________________________
____________________________________________________________________________________________
( ) Yes
) No
Reviewed by:_____________________________________________
Date:_________________________

Attachment #5 Functional Verification

Machine settings:
Filling Depth:____________________
Compression:___________________
Page:25/41

Hardness
Weight (g)
Diameter
(mm)
Thickness (mm)
Page:26/41

Page:
Attachment #7 Alarms, Safeties and Interlocks

Verify that the alarms, safeties and interlocks function as indicated.
Alarm
Function
Expected Results
Actual Results
Emergency stop
Emergency
When equipment is
When equipment is
push button
shutdown of tablet operating, pressing
operating, pressing
press
Initials/Date
button stops equipment. button__________

equipment
General System
Alarm
Indicates an alarm When a system alarm is When a system alarm

has occurred.
received, an error
is received, an error
message is displayed.
message is________
Comments:__________________________________________________________________________________________________
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
_____________________________
Acceptance Criteria: The actual results are the same as the expected

( ) Yes
) No
Page:
Reviewed
Date:________________________
by:_____________________________________________
Page 29 of 33
Attachment #8 Sequence of Operation

Setup system to run with the appropriate operational procedures. Run system. Inspect system and verify it meets acceptance criteria.

Sequence
1
Procedure
Expected Operation
Switching on mains switch.

Adjust the compaction force
Page:32/41
The lamps on the control

panel light up.
Pass/Fail
Initials/ Date
Pass / Fail
Set basic tablet press
using a ratchet screwdriver on settings are established.
Pass / Fail
top of the tablet press.

Measure the tablet weight and The table press is adapted
3
tablet hardness and adjust the to the product.

values for filling and wall
Pass / Fail
dimensions as required.
4
Fill hopper with powder, start
Press runs. Tablets are
the tablet press.
produced and discharged.
Stop the tablet press and
System shutdown
place the main switch to off
Pass / Fail
Pass / Fail
position.
Comments:_________________________________________________________________________________________________________________
___________________________________________________________________________________________________________________________
___________________________________________________________________________________________________________________________
____________________________________________________________________________________________
Acceptance Criteria: All test methods shall pass the expected
( ) Yes
) No
Reviewed by:_____________________________________________
Date:_______________________
Page 29 of 33

Page:
Attachment #9 Maximum / Minimum Values

Change the system set points and verify the maximum and minimum values allowed. Note: document any Tailing results.
Changeable Setpoint
Pressure roller block
Specified
Actual Maximum
Maximum /
/ Minimum Value
Minimum Value
Pass/Fail
0 kN
Pass / Fail
50 kN
Pass / Fail
0 mm
Pass / Fail
17 mm
Pass / Fail
Main compression - Distance
0 mm
Pass / Fail
sensor
AS-FOUND mm
Pass / Fail
Main motor - Speed sensor
0 rpm
Pass / Fail
AS-FOUND rpm
Pass / Fail
0 rpm
Pass / Fail
AS-FOUND rpm
Pass / Fail
Filling depth
Fillshoe drive - Speed sensor
Initials/Date
Comments:_____________________________________________________________________________________________________
______________________________________________________________________________________________________________
______________________________________________________________________________________________________________
______________________________________________

( ) Yes
) No
Page:

Reviewed by:_____________________________________________
Page:
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
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.

( ) Yes
Page:
) No
Reviewed by:_____________________________________________
Date:_______________________
Protocol #
Protocol Section
Date Encountered:
Page
Executor/Discovered
By
Step
Description of Deviation

Investigation / Findings
Statement of Impact
Resolution
Page:

Page:
Approvals
Role
Name
Signature
Date
Executor
Reviewer
QA Officer
Attachment #11 Operational Qualification Protocol Review

Qualification Process Solutions, Tetoros S.A 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:___________________________________________
Page:40/41
Date: ________________________
TETOROS S.A VETERINARY COMPANY DOCUMENT REVIEW APPROVAL:
Approved By:
Approved By:
Title:___________________________________
Title:________________________________
Signature:_______________________________
Signature:___________________________
Date:___________________________________
Date:________________________________

PQ Tablet Filler

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Performance Qualification Protocol

Documentation Number: 0014-2012-01

Documentation Number: 0014-2012-01

The Tablet Filler is provided with the following specifications:

Variable Machine Speed: 5-50 rpm

Valve between product hopper and fill shoe

Operation and Maintenance Manuals

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

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

Documentation Number: 0014-2012-01

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

Complete a list of all the instruments required for conducting OQ testing.

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

Manually operate the control switches listed in the applicable

Visually verify and document the actual responses.

Test Function Number Five: Functional Verification (Attachment #5)

Follow the procedures in the applicable attachments.

Document all operational parameters used during execution.

Documentation Number: 0014-2012-01

11.3 Acceptance Criteria

Test Function Number Six: Operator Interface (Attachment #6)

Display the operator batons listed on the applicable attachment.

Follow the procedures in the applicable attachments.

Document all operational parameters used during execution.

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

Execute the procedures in the order listed.

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

Documentation Number: 0014-2012-01

Deviation Reporting Log (Attachment #10)

Document all deviations found during execution.

Complete the Deviation/Variance Form immediately upon any observed deviations.

All deviations shall be property documented on the Deviation/Variance Form.

Operational Qualification Protocol Review (Attachment #11)

Summary Report Requirements

18.2.1 Generate a final summary on completion of this protocol execution.

Compile a summary of the results obtained.

Include a statement of conformance to the specified acceptance criteria, evaluated in

Determination of acceptability of the protocol, as executed.

Attached copies of all completed, approved Deviation Report and Corrective

Action Forms, where

Documentation Number: 0014-2012-01

Attachment #1 OQ Signature Verification List............................................................................................................................... 9

Documentation Number: 0014-2012-01

Attachment #1 OQ Signature Verification List

Meets Acceptance Criteria?

Attachment #2 Test Equipment

Documentation Number: 0014-2012-01

Meets Acceptance Criteria?

Attachment #3 Procedure List

SOP Number SOP Revision #

Operation of the Tablet Filler

Documentation Number: 0014-2012-01

Maintenance of the Tablet Filler

Meets Acceptance Criteria?

If procedures are in draft form,

STANDARD OPERATING PROCEDURE

Maintenance of the Kilian Tablet Press

Speed of the main drive in rpm.

Changing the filling has a direct impact on the tablet weight.

During production, the speed is controlled by the drive speeds.

Title: OPERATION OF THE KILIAN PRESSIMA TABLET PRESS

7.10.1 Stop the machine.

7.10.3 Empty the material hopper and the filling shoe.