Professional Documents
Culture Documents
for the
Watson-Marlow
630DuN
July 2017
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
CONTENTS
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:
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.
Section
Parameter Criteria
No
Documentation Documentation necessary for work is available 5
The following verifications will confirm that the installation of the 630DuN peristaltic pump
has been undertaken in accordance with Good Engineering Practice.
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.
5. DOCUMENTATION VERIFICATION
Comments:
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.
…………………………………………
…………………………………………
Mains
Comments:
Comments:
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.
Comments:
8. SAFETY VERIFICATION
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:
Comments:
The following acceptance criteria will be used to demonstrate that the 630DuN functions
according to the manufacturer's specification:
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:
Procedure:
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:
Attachments:
Pass /Fail
Key Action Reaction Performed by:
(Dev No.)
START
MAX
STOP
UP (˄)
DOWN (˅)
DIRECTION
HOME
MENU
INFO
MEMODOSE
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:
Procedure:
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
Attachments:
Reference Documents:
Procedures:
Acceptance Criteria
Attachments:
To confirm that the 630DuN delivers the set dose in MemoDose while under control of an
external device
Reference Documents:
Procedure:
Acceptance Criteria:
The 630DuN delivers accurate repeat doses under control of an external device
Comments:
Attachments:
Reference Documents:
Procedure:
Acceptance Criteria:
Attachments:
Comments:
Comments:
Comments:
Comments:
Comments:
Comments:
Comments:
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
Comments:
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.
Comments:
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.
Comments:
Comments:
Customer
Project
Approved by:
Engineering
Validation
System owner
Quality
Assurance
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