Rota 940 - Oq

“OPERATION QUALIFICATION
PROTOCOL (OQ)”
ROTA 940 PA
AMPOULE FILLING & SEALING MACHINE (A3)
FOR
PHARCO PHARMACEUTICAL INDUSTRIES
ROTA 940 PA (A3) MACHINE OPERATION
QUALIFICATION PROTOCOL (OQ)
Al kawthar St., building 6.
PROTOCOL (OQ)
31st km Alex-Cairodesertroad. Customer: PHARCO
Al-Amriya, Alexandria,Egypt.
Protocol no. : A02-OQ041-2014 Pharmaceutical industries Co.
Tel/Fax: +2-03-4499924
Mob. : +20-12-22208383 Date of issue: 1-10-2014 Customer ID: A02
E-mail:Greentk.info@gmail.com
1- Protocol approval
1.1 Protocol Prepared By: -
Name : Eng. Ahmed Bassiouny

Job Title : Validation & Qualification Engineer
Sign. I Date :
1.2 Protocol Reviewed By: -
Name : Eng. Dina Rabea

Job Title : Validation & Qualification Engineer
Sign. I Date :
1.3 Customer Approval for Documentation of the following Protocol: -
Name Job Title Sign. / Date
Eng. Samar Elroby Qualification Engineer
Eng. Karim Ramadan Mechanical Engineer
Eng. Yasser Dusuki Engineering Division Director
1.4 Personnel Responsible for Execution of Qualification Activities: -
Eng. Ahmed Bassiouny Validation & Qualification Engineer
Eng. Dina Rabea Validation & Qualification Engineer
1.5 Customer Approval for Execution of the following Protocol: -
Eng. Samar Elroby Qualification Engineer
Eng. Karim Ramadan Mechanical Engineer
Eng. Yasser Dusuki Engineering Division Director
ROTA 940 PA (A3) MACHINE OPERATION QUALIFICATION PROTOCOL (OQ) Page 1 of 38

PROTOCOL (OQ)
Tel/Fax: +2-03-4499924
2-Contents
Item No Content of Protocol Page No.
1 Protocol approval 1
2 Contents 2
3 Introduction 3
4 Overview 4
4.1 Scope 4
4.2 Testing Philosophy 4
4.3 Equipment Identification 5
5 Responsibility 6
5.1 GREEN TK company 6
5.2 PHARCO company 6
6 Procedure 7
7 Performing calibration 9
8 Associated documents 10
9 Definitions of terms used in OQ test result sheet 11
10 Test plan 12
11 Test Protocol 13
12 Operational qualification tests 14
13 Job Sheets 35
14 Non-conforming report 36
15 Operation qualification summary report 37
16 Attachment 38

PROTOCOL (OQ)
Tel/Fax: +2-03-4499924
3. Introduction
It is necessary to verify that ROTA 940 PA (A3) conformance to specification in its intended
operational environment.
This is considered at two levels:
Installation Qualification (IQ):
Has the ROTA 940 PA (A3) been built and configured to the agreed technical specification.
Operational Qualification (OQ):
Does the ROTA 940 PA (A3) perform to the agreed functional specification?
Purpose:
This document sets out the operational qualification tests recommended by engineering deviation to
verify the conformity of ROTA 940 PA (A3) to approved technical specification. This plan is design to
guide operational qualification.
The document includes a total package, which may be used to plan, manage, conduct, and document the
operational qualification to the standard required by regulatory bodies.

PROTOCOL (OQ)
Tel/Fax: +2-03-4499924
4 .Overview:-
4.1 Scope: -
The document covers Operation Qualification of the specific SARONGMACHINE, at the production
area.
All components and sub systems of ROTA 940 PA (A3) are included if exceeded in full, a
comprehensive validation of the ROTA 940 PA (A3) can be achieved, as required after initial
commissioning.
4.2Testing Philosophy: -
No testing can be completely exhaustive. The objectives of the test plan is to-achieve a reasonable
level of assurance on every component and sub- system of the ROTA 940 PA (A3) while giving
Particular emphasis to Critical Process Parameters.
All tests are designed to verify the system against unambiguous, documented, pre-determined
acceptance criteria. The protocols are designed to ensure that the testing follows clear, pre-
determined methods approved in advance.
All tests are designed to be conducted by properly authorized personnel, supported by relevant
documentation and test equipment.
Wherever possible the tests are designed to collect all the documentary evidence needed to
retrospectively audit the validity of the results. The procedures call for the test results to be formally
reviewed before being regarded as finally accepted.
As the tests are designed to produce documentary evidence of the results, they can be witnessed at
the review stage. It is left to the discretion of the customer to decide whether to also have the testing
independently witnessed at the time of testing.

PROTOCOL (OQ)
Tel/Fax: +2-03-4499924
4.3 Equipment Identification: -
Manufacture Rota Verpackungstechnik GmbH
Machine S.N. 81
Model R 940 PA
Location Production
Department Ampoules

PROTOCOL (OQ)
Tel/Fax: +2-03-4499924
5:- Responsibilities
Present paragraph identify responsibilities of various parts involved in Qualification
activities.
5.1:- GREEN TK Company
GREEN TK Company will be responsible for the following activities:
(1) Prepare the Qualification Protocol.

(2) To write and review the Qualification Protocol.
(3) To execute the Qualification activities.
(4) To check and collect results into appropriate data collection forms.
(5) To write and review the final Qualification Summery Reports;
Qualification certificate is attached.
5.2:- PHARCO Company
PHARCO Company will be responsible for the following activities:
(1) To manage the revision and the approval of the Qualification Protocol.
(2) To plan the execution of Qualification Protocol.
(3) To supply all necessary assistance to Qualification execution contractor for

the Qualification execution activities.
(4) To approve all qualification tests and the final Qualification Summery Reports.
(5) To manage amendments and deviations, if it is necessary.

PROTOCOL (OQ)
Tel/Fax: +2-03-4499924
6-Procedure
6.1 Preparing a test plan:
The designated ""test manager"" must complete the test plan by:-
1) Identifying all aspects of the Operational Qualification to be covered.
2) Reviewing the verification tests included in this document and ensuring that all OQ
requirements have been included.
3) Designing any "additional" tests needed to meet any OQ requirements not covered by this
standard set of tests, which.
Identifying any tests, which are not required for this machine because they are "Not applicable" or
documentary evidence of conformance already.
A qualified "test approver" who must sign of each protocol sheet as it is approved must approve the
method and acceptance criteria of all protocol in the finalized test plan in advance.
6.2 Conducting approved tests:
The authorized tester using the method section of its protocol must conduct each test. Should
the method be unsuitable then a variation must be documented and authorized by the "test approver"
and the protocol conducted as an additional test. Each test protocol includes statement of the accepted
criteria that must be achieved for the test to be passed. This may the combined result of many test
steps.
The results must be recorded as required by the result section.
Where the result confirm that the expected result has been achieved, the results table will allow for a
clear statement (Yes / Not) of this.
YES will always confirm a satisfactory result
NO will always denote non-conformance
Where the method required the use of a calibrated measuring instrument, the unique identity of the
instrument used must be recorded in the instrument reference section of the protocol and the
reference of the calibration certificate recorded in the document or printout reference section.

PROTOCOL (OQ)
Tel/Fax: +2-03-4499924
6.3 Conforming test compliance:
When the result show that all acceptance criteria have been satisfied. The tester must indicate, writing
YES in the compliance section at the end of each form, then sign and date the section.
Should any acceptance criteria remain not satisfied, the tester must write NO in the compliance
section, sign it not initial the test plan, fill the protocol sheet in the failed tests, and advise the "test
manager" the problem must be resolved and the repeated on a new protocol sheet.
6.4 Reviewing Passed Tests:
When each test has been satisfactory completed an authorized "test reviewer "must review the result
to verify that the test has been properly conducted by authorized personal, and signed off; all the
results are satisfactory; all the required supporting documentation has been identified, signed, dated
and retained. When satisfied that all is in order, the "test reviewer" must sign off the protocol sheet as
reviewed, file it in the reviewed tests, and initial the complete column in the test plan section 6.
6.5 Reviewing failed tests:
When a test has been failed, the "test reviewer" must assess its results or a reviewer group called by
the "test manager".
Three actions are possible:
1) Repeat the test, using a new protocol sheet.
2) Apply a change or modification to the equipment and repeat the test.
3) Abandon the test, and possibly others.
The review shall decide which course of action to take, and in the event of a change or modification,
decide the amount of subsequent re-testing to be done.
The results of this review must be documented in a non-conforming report.

PROTOCOL (OQ)
Tel/Fax: +2-03-4499924
7- Performing calibration
Performing calibration for all parts can be calibrated.

The calibration reports are attached.

PROTOCOL (OQ)
Tel/Fax: +2-03-4499924
8. Associated documents
The following documents have been used during preparation of the test result sheets:
• Wiring diagrams
• Layout
• Control Panel
 The following documents must be available for the tests:
• Operating manual
• Wiring diagram

PROTOCOL (OQ)
Tel/Fax: +2-03-4499924
9. Definition of terms used in OQ test result sheet

All assemblies required for production operation must be active in order to ensure that the OQ tests can be
performed in conformity with the test result sheets. The monitoring functions of the assemblies must be
active, too.
The packaging machine checks its assemblies and starts the referencing procedure if necessary.
The referencing procedure is started automatically after resetting of the faults.
The tests result sheets include some frequently recurring procedures, which will be explained in detail
below.
Term Procedure
All main power switches of the machine are OFF.
Machine switched off
Additional switches for optional devices, e.g. a separate 24 V
power supply are also OFF.
Turn off all main power switches of the machine.

Switch off
machine Turn off additional switches for optional devices, e.g. a separate 24
V power supply.
Turn on all main power switches of the machine.
Reset voltage control
Switch on machine Wait until the Touch Control has started up.
Log on to the Touch Control.
Reset faults
The message "Machine ready to start" appears in the status line.

Machine ready for
production
Production mode is selected.
Machine in production Machine runs in production mode.

PROTOCOL (OQ)
Tel/Fax: +2-03-4499924
10- Test plan

This section gives full available tests. Additional tests may be added at the test manager's discretion.
If the "test manager" assesses that earlier testing has given satisfactory evidence of functional
performance, he may choose to reduce or "Not required" the corresponding standard OQ test to be
done.
The tester must then initial each remaining test as it is completed with satisfactory result.
Test Version Initial

Test title Comments
ref. No. Not required Completed
OQ.1 1 Machine Control Panel - Completed No comment
OQ.2 1 Machine parts - Completed No comment

PROTOCOL (OQ)
Tel/Fax: +2-03-4499924
11- Test Protocols

Each test is specified by a protocol set out on one page in a consistent format:
Header Identify the machine's unique serial and customer

Test reference Unique identification of the test, with version number
Test title The name of the item to be tested
Purpose A brief statement of the aims of the test
The steps to be taken to conduct the test satisfactory including where
Method
appropriate any preparation, and documentation
The condition that must be met for the test to be passed failure to
Acceptance criteria
meet one or more acceptance criteria causes the test to fail
Test results A form for recording of test results
A section for recording any relevant supplementary comments.
Comments
In addition, where appropriate the protocols will include
A section for nothing the reference of any further documents that are
Document reference
needed as supportive evidence –e.g. printout, calibration certificates.
A section for recording the reference identities of any calibrated
Instrumentation identities
measuring instrumentation required.
Confirmation that an authorized "test approver" has formally
Approval signature
approved the test method before being used.
A section for a clear, unambiguous statement (Yes/No) As to whether
Compliance signature the test has been passed to be completed, signed and dated by the
authorized tester
A section for confirmation that the tests have been completed, an
Review signature
authorized "test reviewer" has formally reviewed the results.

PROTOCOL (OQ)
Tel/Fax: +2-03-4499924
12- Operational qualification tests
Test ref. Version No. Test title
OQ.12.01 1 Machine Control Panel

OQ.12.02 1 Machine parts

PROTOCOL (OQ)
Tel/Fax: +2-03-4499924
OQ.12.01 Machine Control Panel
OQ. Test No. 12.01.01 Mixing On Push Button
Test Criterion The machine detects if the Mixing On Push Button is

on to start the mixing operation
Pass/Fail
Expected Result 1  Machine is not running. Pass
2  Tension Pilot Lamp is extinguished Pass
Prerequisites :
Test Procedure Machine ready for production
1  Turn off the main electricity selector
2  Press Mixing On Push Button

PROTOCOL (OQ)
Tel/Fax: +2-03-4499924
OQ. Test No. 12.01.01Mixing On Push Button
 Switch on Main electricity selector
Remedy  Press Mixing On Push Button to start the mixer
 Tension Pilot Lamp is lighted up
Comment
Name Position Signature Date

Qualification
Done by: Ahmed Bassiouny 29-9-2014
Engineer
Qualification
Reviewed by: Dina Rabea 29-9-2014
Engineer
Approved by:

PROTOCOL (OQ)
Tel/Fax: +2-03-4499924
OQ. Test No. 12.01.02 Press emergency push button
The Machine detects if the emergency push button on

Test Criterion the control panel is not working.
Pass/Fail
 Machine cannot be started where
1 Pass
Expected Result ever you pressed
 Mixing Stop Pilot Lamp is lighted
2 Pass
up
Prerequisites :
1  Press Emergency push button
2  Start machine

PROTOCOL (OQ)
Tel/Fax: +2-03-4499924
OQ. Test No. 12.01.02 Press Emergency push button
Remedy  Release Emergency push button
 Press Reset push button

 Press Mixing on push button to start the mixer
operation
 Mixing Stop Pilot Lamp is extinguished
Comment

Qualification
Engineer
Qualification
Engineer
Approved by:

PROTOCOL (OQ)
Tel/Fax: +2-03-4499924
OQ. Test No. 12.01.03 Auxiliarsys Insertion Selector
Test Criterion The Machine detects if the Auxiliarsys Insertion

Selector is switched on then the mixer control panel is
supplied with electricity
Pass/Fail
Expected Result 1  Machine is not running Pass
2  All control panel items are off Pass
Prerequisites :
1  Switch off Auxiliarsys Insertion Selector
2  Press Mixing on push button to start the mixer

PROTOCOL (OQ)
Tel/Fax: +2-03-4499924
OQ. Test No. 12.01.03 Auxiliarsys Insertion Selector
 Switch on Auxiliarsys Insertion Selector
 Press Reset Push Button

 Press start Mixing on push button to start the
mixer operation
Comment

Qualification
Engineer
Qualification
Engineer
Approved by:

PROTOCOL (OQ)
Tel/Fax: +2-03-4499924
OQ. Test No. 12.01.04 Mixing Speed Potentiometer
Test Criterion The Machine detects if Mixing Speed Potentiometer

turned clockwise then the mixer speed will be increased
Pass/Fail
Expected Result
1  Mixer rotation speed increased Pass
 Digital speed indicator display the

2 Pass
increasing of the speed (RPM)
Prerequisites :
 Turn Mixing Speed Potentiometer clockwise to

1
increase the mixer speed rotation
2
operation

PROTOCOL (OQ)
Tel/Fax: +2-03-4499924
OQ. Test No. 12.01.04 Mixing Speed Potentiometer
 Adjust Mixing Speed Potentiometer according to

Remedy
the speed requirements for the patch
Comment

Qualification
Engineer
Qualification
Engineer
Approved by:

PROTOCOL (OQ)
Tel/Fax: +2-03-4499924
OQ. Test No. 12.01.05 Mixing Timer
The Machine detects if the Mixing Timer set to specific

Test Criterion time in (minutes) then the mixer will be operated until the
mixing timer countdown to (zero)
Pass/Fail
 Mixer is running until the mixing
1 Pass
timer countdown to (zero)
Expected Result
 Mixing End Pilot Lamp will be
2 lighted up when mixer stopped Pass
after the operation ended
Prerequisites :
1  Set the mixing timer to 10 (minutes)
2  Press mixing on push button

PROTOCOL (OQ)
Tel/Fax: +2-03-4499924
OQ. Test No. 12.01.05 Mixing Timer
 Adjust the mixing timer to the specific time for

Remedy the patch according to the requirements
Comment

Qualification
Engineer
Qualification
Engineer
Approved by:

PROTOCOL (OQ)
Tel/Fax: +2-03-4499924
12.02 Machine parts
OQ. Test No. 12.02.01 Vacuum Pump
To ensure that Vacuum Pump has started working

Test Criterion
Pass/Fail
1  The air line is off Pass

Expected Result
 The powder cannot be conveyed to
2 Pass
the mixer tank
Prerequisites :
1  Switch off vacuum pump switch
2  Press mixing on push button

PROTOCOL (OQ)
Tel/Fax: +2-03-4499924
OQ. Test No. 12.02.01 Vacuum Pump
Remedy  Press mixing off push button to stop the mixer
 Switch on vacuum pump switch to start filling the

mixing tank with powder
 Press mixing on push button
Comment

Qualification
Engineer
Qualification
Engineer
Approved by:

PROTOCOL (OQ)
Tel/Fax: +2-03-4499924
OQ. Test No. 12.02.02 Butterfly valve
To ensure that the Butterfly valve is working

Test Criterion
Pass/Fail
Expected Result  No powder will be conveyed due
1 to the opening of Butterfly valve Pass
gate
 Some powder will be conveyed
2 and discharged through the Pass
Butterfly valve gate
Prerequisites :
1  Open the Butterfly valve gate manually
2  Start the vacuum pump operation

PROTOCOL (OQ)
Tel/Fax: +2-03-4499924
OQ. Test No. 12.02.02 Butterfly valve
Remedy  Stop the vacuum pump
 Close the Butterfly valve gate

 Switch on the vacuum pump to fill the mixing
tank with powder (Patch)
Comment

Qualification
Engineer
Qualification
Engineer
Approved by:

PROTOCOL (OQ)
Tel/Fax: +2-03-4499924
OQ. Test No. 12.02.03 Safety Gate Sensor
The machine detects if the safety gate is opened then the

Test Criterion Safety Gate Sensor will send a signal to stop the mixer
immediately
Pass/Fail
1  The mixer is running Pass
Expected Result  The mixer will be stopped

2 immediately at any position when Pass
the safety gate is opened
 Mixing Stop Pilot Lamp is lighted
3 Pass
up
Prerequisites :
1  Press Mixing on push button to start the mixer
2  Open the safety gate

PROTOCOL (OQ)
Tel/Fax: +2-03-4499924
OQ. Test No. 12.02.03 Safety Gate Sensor
Remedy  Close the safety gate
 Press Reset push button
Comment

Qualification
Engineer
Qualification
Engineer
Approved by:

PROTOCOL (OQ)
Tel/Fax: +2-03-4499924
OQ. Test No. 12.02.04 Mixer Interlock Sensor
The machine detects if the machine is stopped then

Test Criterion the Mixer Interlock Sensor will activate the interlock
system to prevent the mixer rotation for safety
Pass/Fail
1  The mixer is running Pass
Expected Result  Then after press mixing off push

button, the mixer will be rotated by
2 inertia until stopping in vertical Pass
position but can be rotated easily
by the operator hand (manually)
Prerequisites :
 Disconnect the Mixer Interlock Sensor from the
1 main electricity panel
2  Press mixing on push button to start the mixer
 Then press Mixing off push button to stop the
3
mixer

PROTOCOL (OQ)
Tel/Fax: +2-03-4499924
OQ. Test No. 12.02.04 Mixer Interlock Sensor
 Reconnect the Mixer Interlock Sensor

 Press mixing on push button to start the mixer
Comment

Qualification
Engineer
Qualification
Engineer
Approved by:

PROTOCOL (OQ)
Tel/Fax: +2-03-4499924
OQ. Test No. 12.02.05 Positioning cam Proximity
Test Criterion The machine detects if the machine is running then

the Positioning cam Proximity will monitor the speed of
running
Pass/Fail
Expected Result
1  The machine running Pass
2  The speed indicator will be read Pass

(0.00 RPM)
Prerequisites :
 Disconnect the Positioning cam Proximity from
1 the main electricity panel
2  Press mixing on push button to start the mixer

PROTOCOL (OQ)
Tel/Fax: +2-03-4499924
OQ. Test No. 12.02.05 Positioning cam Proximity
 Reconnect Positioning cam Proximity
Remedy  Press mixing on push button to start the mixer

 Speed indicator will screen the current
rotation speed (RPM)
Comment

Qualification
Engineer
Qualification
Engineer
Approved by:

PROTOCOL (OQ)
Tel/Fax: +2-03-4499924
13- Job sheets
 The following tables list a series of possible faults which may be encountered
during normal machine operation.
 After resetting any mechanical faults remember to press the RESET pushbutton
and check the list of messages on the machine display.
 The following conditions must be observed in order to resolve the problems

listed below :
 When carrying out operations within the machine ,always remember to exercise
extreme caution as regards the surrounding devices , so as to avoid injury to
persons or damage to the machine
 Always ensure that all of the necessary checks or procedure have been completed
 Wear protective gloves
 Never leave objects ,such as wrenches inside the machine

PROTOCOL (OQ)
Tel/Fax: +2-03-4499924
14- Non-conforming Report
Test reference Test title

Observation
Person present
Name Signature Date
Follow up
Agreed corrective action
Date done backup evidence ref.

Qualification
Engineer
Qualification
Engineer
Approved by:

PROTOCOL (OQ)
Tel/Fax: +2-03-4499924
15- Summary Report

 All tests are done without any deviation.
Qualification
Engineer
Qualification
Engineer
Approved by:

PROTOCOL (OQ)
Tel/Fax: +2-03-4499924
16- Attachments
Attachment No. Description
Qualification
Engineer
Qualification
Engineer
Approved by:

Rota 940 - Oq

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“OPERATION QUALIFICATION

Name : Eng. Ahmed Bassiouny

Name : Eng. Dina Rabea

1.3 Customer Approval for Documentation of the following Protocol: -

Name Job Title Sign. / Date

Eng. Samar Elroby Qualification Engineer

Eng. Karim Ramadan Mechanical Engineer

Eng. Yasser Dusuki Engineering Division Director

1.4 Personnel Responsible for Execution of Qualification Activities: -

Name Job Title Sign. / Date

Eng. Ahmed Bassiouny Validation & Qualification Engineer

Eng. Dina Rabea Validation & Qualification Engineer

1.5 Customer Approval for Execution of the following Protocol: -

Name Job Title Sign. / Date

Eng. Samar Elroby Qualification Engineer

Eng. Karim Ramadan Mechanical Engineer

Eng. Yasser Dusuki Engineering Division Director

ROTA 940 PA (A3) MACHINE OPERATION QUALIFICATION PROTOCOL (OQ) Page 1 of 38

Item No Content of Protocol Page No.

ROTA 940 PA (A3) MACHINE OPERATION QUALIFICATION PROTOCOL (OQ) Page 2 of 38

This is considered at two levels:

Installation Qualification (IQ):

Operational Qualification (OQ):

ROTA 940 PA (A3) MACHINE OPERATION QUALIFICATION PROTOCOL (OQ) Page 3 of 38

ROTA 940 PA (A3) MACHINE OPERATION QUALIFICATION PROTOCOL (OQ) Page 4 of 38

4.3 Equipment Identification: -

Manufacture Rota Verpackungstechnik GmbH

ROTA 940 PA (A3) MACHINE OPERATION QUALIFICATION PROTOCOL (OQ) Page 5 of 38

5.1:- GREEN TK Company

GREEN TK Company will be responsible for the following activities:

(1) Prepare the Qualification Protocol.

5.2:- PHARCO Company

PHARCO Company will be responsible for the following activities:

(3) To supply all necessary assistance to Qualification execution contractor for

ROTA 940 PA (A3) MACHINE OPERATION QUALIFICATION PROTOCOL (OQ) Page 6 of 38

6.2 Conducting approved tests:

ROTA 940 PA (A3) MACHINE OPERATION QUALIFICATION PROTOCOL (OQ) Page 7 of 38

6.3 Conforming test compliance:

6.4 Reviewing Passed Tests:

6.5 Reviewing failed tests:

ROTA 940 PA (A3) MACHINE OPERATION QUALIFICATION PROTOCOL (OQ) Page 8 of 38

Performing calibration for all parts can be calibrated.

ROTA 940 PA (A3) MACHINE OPERATION QUALIFICATION PROTOCOL (OQ) Page 9 of 38

 The following documents must be available for the tests:

ROTA 940 PA (A3) MACHINE OPERATION QUALIFICATION PROTOCOL (OQ) Page 10 of 38

9. Definition of terms used in OQ test result sheet

Turn off all main power switches of the machine.

Turn on all main power switches of the machine.

Reset voltage control

Log on to the Touch Control.

The message "Machine ready to start" appears in the status line.

Machine in production Machine runs in production mode.

ROTA 940 PA (A3) MACHINE OPERATION QUALIFICATION PROTOCOL (OQ) Page 11 of 38

10- Test plan

Test Version Initial

OQ.2 1 Machine parts - Completed No comment

ROTA 940 PA (A3) MACHINE OPERATION QUALIFICATION PROTOCOL (OQ) Page 12 of 38

11- Test Protocols

Header Identify the machine's unique serial and customer

ROTA 940 PA (A3) MACHINE OPERATION QUALIFICATION PROTOCOL (OQ) Page 13 of 38

12- Operational qualification tests

Test ref. Version No. Test title

OQ.12.01 1 Machine Control Panel