Machine Type: 630DuN

INSTALLATION AND OPERATION Serial Number:

170516-
QUALIFICATION PROTOCOL 113870

INSTALLATION AND OPERATION QUALIFICATION

for the

Watson-Marlow
630DuN

July 2017

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1. 630DuN IQ/OQ test protocol approval form

COMPANY TITLE Name Signature Date

Watson-Marlow
Fluid Technology Product Manager Tony Barrass 19/07/17
Group
Chiesi
Farmaceutica
LTDA
Customer:

Project
Approved by:
Engineering

Validation

System owner

Quality
Assurance

REVIEW HISTORY
Revision Date Comment Prepared by
First issue for the 630DuN IP66 pump
01 Tony Barrass
model

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CONTENTS

1. 630DUN IQ/OQ TEST PROTOCOL APPROVAL FORM .................................................. 2

2. OBJECTIVE............................................................................................................................... 4
3. SCOPE ........................................................................................................................................ 4
4. INSTALLATION QUALIFICATION ..................................................................................... 5
4.1. INSTALLATION ACCEPTANCE CRITERIA .................................................................... 5
4.2. INSTALLATION QUALIFICATION PROCEDURE ........................................................... 5
4.3. EQUIPMENT DESCRIPTION .......................................................................................... 5
5. DOCUMENTATION VERIFICATION .................................................................................. 6
6. HARDWARE VERIFICATION .............................................................................................. 7
7. SOFTWARE VERIFICATION ................................................................................................ 9
8. SAFETY VERIFICATION ..................................................................................................... 10
9. EQUIPMENT INSTALLATION VERIFICATION DATA SHEET.................................. 11
10. OPERATION QUALIFICATION ..................................................................................... 12
OPERATION ACCEPTANCE CRITERIA ...................................................................................... 12
10.1. KeypadTest ................................................................................................................... 13
10.2. Power Failure ................................................................................................................ 15
10.3. MemoDose Test ............................................................................................................ 16
10.4. External Control Signal Test .......................................................................................... 17
10.5. Calibration Test ............................................................................................................. 18
11. EQUIPMENT OPERATION VERIFICATION DATA SHEET .................................... 19
12. APPENDIX I: FUNCTION KEY TEST HELP SHEETS. .............................................. 20
13. 630DUN IQ/OQ TEST APPROVAL FORM .................................................................... 30
14. APPENDIX II: DEVIATION TRACKING SHEET ........................................................ 31

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2. OBJECTIVE

The objective of this protocol is to qualify the 630DuN peristaltic pump from Watson-
Marlow Pumps Group.
This Installation and Operation Qualification protocol (IQ/OQ) will define the scope,
methods and documentation that will be used to establish that 630DuN is installed in
accordance with the manufacturer's specification.
The operation qualification part of this protocol will define the scope and methods that will
be used to establish that 630DuN operates as specified and described by the
manufacturer.

3. SCOPE
The IQ/OQ protocol documents installation and operation of the 630DuN. The scope is
limited to verifying the installation according to the manufacturer’s specifications and
verifying that the 630DuN operates as specified by manufacturer.

The 630DuN functionality is tested under individual test criteria, e.g. memo dose and flow
calibration, verifying the software's ability to perform consistently and accurately.

The scope is limited to the pump drive only and does not include the different pumpheads
and tubing options that can be fitted to the 630DuN peristaltic pump.

Any deviations will be recorded on the deviation tracking sheet in Appendix II.

Reference Documents:

630DuN Operating Manual

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4. INSTALLATION QUALIFICATION
4.1. INSTALLATION ACCEPTANCE CRITERIA

The following acceptance criteria will be used to demonstrate that the 630DuN is installed
as per the manufacturer's specification.

INSTALLATION ACCEPTANCE CRITERIA

Section
Parameter Criteria
No
Documentation Documentation necessary for work is available 5

Hardware Verification Hardware is installed as described by manufacturer 6

Software is installed in the 630DuN and works as
Software Verification 7
required
Verifies that the safety features designed into the
Safety Verification 8
630DuN work as intended

4.2. INSTALLATION QUALIFICATION PROCEDURE

The following verifications will confirm that the installation of the 630DuN peristaltic pump
has been undertaken in accordance with Good Engineering Practice.

During execution, any deviations identified must be recorded in a Deviation Tracking

Sheet, Appendix II.

4.3. EQUIPMENT DESCRIPTION

General system overview:

The 630DuN is a peristaltic pump designed to meter or dose liquids by using the
peristaltic principle.
630DuN accepts external input signals and can therefore be activated by external
equipment.
630DuN maintains a closed fluid path from the product reservoir to the end of the fluid
system. As the complete tube assembly can be replaced at the end of each production,
all risk of cross contamination is eliminated.
Tubing change can be completed in less than one minute.

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5. DOCUMENTATION VERIFICATION

The following documentation is required.

Documents Available Comments Checked By

(Yes/No) (Initials)
Operator’s Manual for
630DuN

Comments:

Performed by: Initials: Date:

Reviewed by: Initials: Date:

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6. HARDWARE VERIFICATION

Verify that the 630DuN peristaltic pump has been installed according to the manufacturer's
specifications.

If the information cannot be determined by inspection then the data stated in the manual
should be entered.

Equipment Description Verified by

Model Number 630DuN
Serial Number 170516-113870
Power Supply 230 V
Equipment Feature Details present (Y/N) Verified by
Pumphead and tubing:

…………………………………………

…………………………………………

9-key interface with display

Mains

Product and serial number labels

630N IP66 watertight module

Comments:

Performed by: Initials: Date:

Reviewed by: Initials: Date:

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Equipment Feature Feature present (Y/N) Verified by

Warning labels. The following labels
should be present.
Top face of the 630N Module and
rear face of the pump (when the
630N module has been removed).
Labels are adjacent to the fuseholder

Top face of a 620R, 620RE or

620RE4 pumphead. Top face of the
adaptor cover of a 620L or 620LG
pumphead

Comments:

Performed by: Initials: Date:

Reviewed by: Initials: Date:

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7. SOFTWARE VERIFICATION

Remove the 630N module (section 11 of the Operating Manual) and check that the pumps'
voltage selector switch is set to the required supply voltage. Replace the 630N module,
ensuring that the sealing strip is properly seated. Connect the 630DuN peristaltic pump to
a power supply and verify the following, for first-time switch on.

Software Verification Data Sheet

Yes/No
Description Performed by
(Deviation No.)
Ensure the pumphead is fitted to the 630DuN
Load the tubing
Turn on the 630DuN
Check that the display is lit
Choose the language
(The language selection screen is displayed
for first-time switch on only)
Check the manual mode main screen appears
(See Section 14 of the Operating Manual)
Note the software versions shown by 630DuN
(see section 22.6)
Press MAX for the prime function
The pumphead begins to run continuously at
the maximum allowed speed
Repeat

Comments:

Performed by: Initials: Date:

Reviewed by: Initials: Date:

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8. SAFETY VERIFICATION

Verify the features below. If not applicable write, NA.

Electrical Hazards

Applicable: YES  NO 
All wiring is properly shielded: YES  NO 
Mains cable is properly grounded: YES  NO 

Physical Environmental

Applicable: YES  NO 
Sharp edges are protected: YES  NO 
Warning and precautionary signs where appropriate: YES  NO 
Moving parts are protected: YES  NO 

Ergonomic Design

Applicable: YES  NO 
Ergonomic risks evaluated,
YES  NO 
operators can access all areas of equipment :
Adequate operator visibility: YES  NO 

Comments:

Performed by: Initials: Date:

Reviewed by: Initials: Date:

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9. EQUIPMENT INSTALLATION VERIFICATION DATA SHEET

Equipment Installation Verification

Yes/No
Description Performed by
(Deviation No.)

Unit is securely installed

The 630DuN appears with no scratches or

blemishes
630DuN IP66 watertight module is present
and correctly fitted

Power is connected to the equipment

Pumphead and tubing are present

Software is installed in the 630DuN

Comments:

Performed by: Initials: Date:

Reviewed by: Initials: Date:

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10. OPERATION QUALIFICATION

OPERATION ACCEPTANCE CRITERIA

The following acceptance criteria will be used to demonstrate that the 630DuN functions
according to the manufacturer's specification:

OPERATION ACCEPTANCE CRITERIA

Test No. Parameter Criteria

All keys on 630DuN work according to the
10.1 Keypad Test
manufacturers specification
To establish evidence that the 630DuN maintains the set
parameters when a power failure occurs and that the
10.2 Power Failure
630DuN starts in a controlled manner (Ensure that Auto-
restart is not enabled)
630DuN allows a repeat-dose of a precise volume of
fluid (MemoDose)

Establishes evidence that input signals can be received

by the 630DuN and that the 630DuN reacts to the
10.3-10.5 Operation Checks signals. An external device such as a footswitch can be
used to stimulate the activation

630DuN can perform calibration of a target volume of

fluid

Performed by: Initials: Date:

Reviewed by: Initials: Date:

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10.1. KeypadTest 630DuN

Purpose:

To verify that all keys on the 630DuN keypad can be activated and the functions related
to keys respond and appear on the display

Reference Documents:

630DuN Operating Manual

Procedure:

Obtain the latest version of the operating manual

Turn on the 630DuN

1. Following the directions contained in the operating manual, enter Manual Mode and
check that all keys on the keypad function correctly (Section 16 and 17 of the
Operating Manual)
2. Where values can be inserted, input the values
3. Where values cannot be inserted, verify existence/access of function

Acceptance Criteria:

1. All keys work and can be accessed

2. Values can be inserted
3. Values over or under defined limits cannot be inserted

Acceptance Criteria Met: YES NO DEV no:

Comments:

Attachments:

Performed by: Initials: Date:

Reviewed by: Initials: Date:

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10.1 Keypad Test continued 630UN

Pass /Fail
Key Action Reaction Performed by:
(Dev No.)
START
MAX
STOP
UP (˄)
DOWN (˅)
DIRECTION
HOME
MENU
INFO
MEMODOSE

Performed by: Initials: Date:

Reviewed by: Initials: Date:

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10.2. Power Failure 630DuN

Purpose:

To ensure that the 630DuN restarts in a controlled manner when mains power is
restored following a power failure (if not in auto-restart mode). 630DuN retains the start-
up defaults.

Reference Documents:

630DuN Operating manual

Procedure:

Obtain the relevant version of the operating manual.

Enter General Settings (see section 22.2 of the Operating Manual). Ensure that Auto-
restart is not operational. Set your chosen flow units, enter the pumphead type, tube
size and tube material for your installed peristaltic tubing. Set the pump to Manual Mode
and set a desired flow rate (see section 16 of the Operating Manual)
Start pumping by pushing START
1. Disconnect the power to the 630DuN and wait for 1 minute
2. Reconnect the power supply. Check the start-up defaults

Acceptance Criteria:

1. The 630DuN peristaltic pump displays the Watson-Marlow start-up screen for
approx. 3 seconds and then displays the Manual mode home screen. The pump
does not run
2. The 630DuN has retained the set parameters

Before interrupting power supply After reconnecting Power

Speed Speed
Direction Direction
Acceptance Criteria Met: YES NO DEV no:
Comments:

Attachments:

Performed by: Initials: Date:

Reviewed by: Initials: Date:

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10.3. MemoDose Test OPERATION CHECKS 630UN

Purpose:

To ensure that the 630DuN peristaltic pump operates with MemoDose

Reference Documents:

630DuN Operating Manual

Procedures:

Obtain the relevant version of the operating manual.

Load the tubing into the pumphead as described in the manual
Prime the tubes with water
Follow the MemoDose procedure in the Operating Manual (see section 21)

1.1 Dispense a master dose

1.2 Repeat the dose
2.1 Manually enter a master dose
2.2 Repeat the dose

Acceptance Criteria

 The 630DuN has dispensed a master dose

 The master dose can also be entered manually
 The 630DuN has repeated the master dose

Acceptance Criteria Met: YES NO DEV no:

Comments:

Attachments:

Performed by: Initials: Date:

Reviewed by: Initials: Date:

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10.4. External Control Signal Test 630DuN

Purpose:

To confirm that the 630DuN delivers the set dose in MemoDose while under control of an
external device
Reference Documents:

630DuN Operating manual

Procedure:

Obtain the relevant version of the operating manual

Connect an activation device to the pump, such as a footswitch, for MemoDose triggering (see
section 13.6 of the Operating Manual)
Select MemoDose (section 20 of the Operating Manual)
Set the master dose manually using the procedure described in section 21.4

Activate the external device (such as a footswitch) to trigger a repeat dose

Repeat the remote activation of MemoDose

Acceptance Criteria:

The 630DuN delivers accurate repeat doses under control of an external device

Acceptance Criteria Met: YES NO DEV no:

Comments:

Attachments:

Performed by: Initials: Date:

Reviewed by: Initials: Date:

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10.5. Calibration Test OPERATION CHECKS 630DuN

Purpose:

To confirm that the 630DuN operates within calibration when dosing

Reference Documents:

630DuN Operating Manual

Procedure:

Obtain the relevant version of the operating manual

Load the tubing into the pumphead as described in the operating manual
Prime the tubes with water
Follow the Calibration procedure in the Operating Manual (see section 18)

1. Perform the calibration

2. Repeat the calibration
3. Perform a measured dose to confirm the accuracy of the calibration

Acceptance Criteria:

 The 630DuN performs a calibration dose

 The 630DuN then delivers an accurate dose

Acceptance Criteria Met: YES NO DEV no:

Comments:

Attachments:

Performed by: Initials: Date:

Reviewed by: Initials: Date:

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11. EQUIPMENT OPERATION VERIFICATION DATA SHEET

Equipment Operation Verification

Yes/No Performed
(Deviation No.) by

All keys on 630DuN function

The 630DuN reacts in appropriate manner to power

failure

The 630DuN can perform MemoDose

The 630DuN can be operated from a remote

activation device

The 630DuN can perform calibration

Comments:

Performed by: Initials: Date:

Reviewed by: Initials: Date:

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12. Appendix I: Function key test help sheets.

Keypad function Function Description

START Starts the pump at the speed and direction shown on the display

Input Actual/Reaction Expected Pass/Fail

Comments:

Performed by: Initials: Date:

Reviewed by: Initials: Date:

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Keypad function Function Description:

When pressed, the MAX key operates the pump at the maximum
MAX speed allowed
When released it returns the pump to the previous state

Input Actual/Reaction Expected Pass/Fail

Comments:

Performed by: Initials: Date:

Reviewed by: Initials: Date:

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Keypad Function Function Description

Has no effect if the pump is not running
STOP If the pump is running, pressing STOP stops the pump

Input Actual/Reaction Expected Pass/Fail

Comments:

Performed by: Initials: Date:

Reviewed by: Initials: Date:

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Keypad Function Function Description

Increases the speed shown on the display in minimums steps of
0.1rpm or other steps as preselected in in the Scrolling section of the
UP (˄) Set-up menu
If the pump is then started, it will run at the new speed
If the pump is running while the UP key is pressed, the pump will run
at the new speed immediately

Input Actual/Reaction Expected Pass/Fail

Comments:

Performed by: Initials: Date:

Reviewed by: Initials: Date:

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Keypad Function Function Description

Decreases the speed shown on the display in minimums steps of
0.1rpm or other steps as preselected in the Scrolling section of the
Set-up menu
DOWN (˅) If the pump is then started, it will run at the new speed
If the pump is running while the DOWN key is pressed, the pump will
run at the new speed immediately
The minimum speed possible is 0.1rpm

Input Actual/Reaction Expected Pass/Fail

Comments:

Performed by: Initials: Date:

Reviewed by: Initials: Date:

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Keypad Function Function Description

Toggles the direction of rotation and this is shown on the display
DIRECTION If the pump is then started, it will rotate in the new direction
If the pump is running while the DIRECTION key is pressed, the
pump will rotate in the new direction immediately. The direction arrow
on the display changes direction of rotation to match the rotor

Input Actual/Reaction Expected Pass/Fail

Comments:

Performed by: Initials: Date:

Reviewed by: Initials: Date:

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Keypad Function Function Description

Takes you back to the ‘Home/Start’ screen.
The function depends on the active screen when the home button is
HOME
pressed.

From the following menu locations, pressing the home button should
return the user back to the ‘Home/start’ display screen.
SECURITY MENU;
GENERAL SETTINGS MENU;
CHANGE MODE MENU;
CONTROL SETTINGS MENU;
HELP & ADVICE MENU

If the INFO button is pressed to display pump info, pressing the

HOME button should NOT change screens

Input Actual/Reaction Expected Pass/Fail

Comments:

Performed by: Initials: Date:

Reviewed by: Initials: Date:

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Keypad Function Function Description

Take you to the MAIN MENU screen from where a range of settings
MENU and control modes can be selected.

Pressing the key below the ‘MENU’ text from the start screen should
take the user to the ‘MAIN MENU’ screen.

Pressing the key below the ‘MENU’ text when in any of the INFO
mode screens should take user back to the ‘MAIN MENU’ screen.

Input Actual/Reaction Expected Pass/Fail

Comments:

Performed by: Initials: Date:

Reviewed by: Initials: Date:

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Keypad Function Function Description

Displays pump operating and configuration parameters.
INFO Screens displayed are dependent on the configured control mode.

In ‘Manual Mode’ – pressing info button once will change display to

show pump operating and configuration parameters. Info will
disappear and be replaced by EXIT option.

In ‘Analog Mode’
First press of INFO button changes display to Analog response
profile.
Second press of INFO button changes display to pump operating and
configuration parameters.
Third press of INFO button changes display to Analog profile display.
Fourth press of button (now displaying EXIT) returns user to
‘Home/Start’ page.

Input Actual/Reaction Expected Pass/Fail

Comments:

Performed by: Initials: Date:

Reviewed by: Initials: Date:

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Keypad Function Function Description

MEMODOSE When pressed, the MemoDose function is displayed

Input Actual/Reaction Expected Pass/Fail

Comments:

Performed by: Initials: Date:

Reviewed by: Initials: Date:

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13. 630DuN IQ/OQ Test Approval Form

COMPANY TITLE Name Signature Date

Customer

Project
Approved by:
Engineering
Validation

System owner

Quality
Assurance

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14. APPENDIX II: DEVIATION TRACKING SHEET

Page 1 of _

The following deviations have been found during execution of this protocol.

Approved by
Deviation Deviation description
Resolution Initials/
No. Initial / Date
Date

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