IQ OQ PQ Overview
Brief:
Correct functionality and performance of scientific apparatus to obtain reliable and accurate analytical data therefore instrument qualification should be a part of any good analytical practice
The contents of the qualification workbook are as follows.
- Installation Qualification (IQ) for performing and documenting the installation in a location selected by the user.
- Operational qualification (OQ) for testing of the equipment in the position selected by the user, to ensure that it meets the performance specification dictated by waters instrument LTD.
- Performance Qualification (PQ) for testing that the instrument consistently performs as required for the intended application
01. Installation Qualification
Instrument Series: | Waters® 1500 Series
1525 BINARY PUMP |
Equipment Code: | |
Instrument Description: | The Waters 1500 Series HPLC Pumps combine the most important aspects of eluent
delivery for HPLC: high precision, reliability, smooth eluent flow, and proven performance. pumps perform their intended functions equally well: The 1525 Binary HPLC Pump achieves reproducible, binary gradient delivery with exceptionally smooth concurrent-stream blending. pumps are controlled by the Waters empower HPLC system software. |
Manufacturer: | Waters
34 Maple Street Milford, MA 01757 |
Service Contact: | If you encounter any problems replacing parts contact Waters
Technical Service at (800) 252-4752, U.S. and Canadian customers only. Other customers, call your local Waters subsidiary or Technical Service Representative or call Waters corporate headquarters at (508) 478-2000 (U.S.A.). |
Serial Number: | |
Condition When Received: | |
New | |
Used | |
Reconditioned | |
Date Received: |
Installation Qualification
Instrument Specification
Fluid-Handling Components in the Waters 1525 Pump
Instrument Parameter | Specified Range | Acceptable |
Gradient mixer
|
Combines eluents together and helps to increase homogeneity. Also adds a desired delay volume to the system. | |
Draw-off valve
|
Enables you to attach a syringe and draw eluent through the eluent reservoir line into the pump for priming. | |
Reference valve
|
Directs flow from the pumps to waste for purging, or through
the injector, the column, and the rest of the system. |
|
Reference valve waste
line |
Routes flow from the reference valve to the waste container. | |
Drip tray | Catches fluid leaks. | |
Seal wash holes | Allow you to flush and clean the plunger seals. | |
Pump head assembly | Draws in and delivers eluent. | |
Pulse dampeners
|
Dampens operating pressure fluctuations. It is located on the
left side of the unit under the mixer and behind the shroud. |
|
Inlet manifold
|
Provides the connection for eluent inlet tubing and routes
eluent to the inlet check valve on each pump head. |
|
Pressure transducer
|
Senses operating pressure and convert values to electronic
signals for monitoring. |
|
Pump outlet | Routes eluent to the injector, column, and detector. | |
1500 Series
Manual Injector |
Enables a manual sample injection. Generates an inject start
to the detector. |
|
Manual injector valve
waste lines |
Drains fluid overflow from the syringe to the waste container. | |
Inlet and outlet check
valve assemblies |
Maintain flow direction by opening in one direction only.
|
|
Plunger indicator rods | Show the position of each pump head plunger. | |
Comments:
Product for Research, pharmaceutical Quality Control Analysis. |
Installation Qualification
Environment and Siting
Has the instrument been adequately acclimatized since transport or storage?
YES NO |
||
Parameters | Specified Range | Conditions Met |
Ambient Temperature | 4 to 40 °C (39 to 104 °F) | |
Maximum Relative Humidity | 20 to 80%, noncondensing | |
Bench space
|
Width: 17 in. (43 cm) including bottle holder
[24” (61 cm) with 1500 Series Column Heater] Depth: 24 in. (61 cm) Height: 17 in. (43 cm) |
|
Vibration | Negligible | |
Clearance
|
At least 6 in. (15 cm) at rear for ventilation and
cable connections |
|
Static electricity
|
Negligible | |
Input voltage and
frequency
|
Grounded ac, 120/240 Vac, 50/60 Hz, single phase |
|
Electromagnetic fields | No nearby source of electromagnetic noise, such
as arcing relays or electric motors |
|
Power requirement | 200 VA for pump
150 VA for column heater |
|
Comments:
|
Installation Qualification
Instrument Delivery and Documentation
Unpack the instrument carefully. Are any items missing against the Packing List?
Yes q No q
If yes, state missing items:_______________________________________ |
Is there any damage to the instrument or accessories?
Yes q No q
If yes: Description of damage: _______________________________________
Corrective action: ___________________________________________
The manufacturer informed: Yes q No q |
Is all standard documentation included?
Present Missing
Operator Manual (OM) q q
Certificate of conformity q q
Quick start guide q q
Warranty card q q
|
Is all additional documentation included?
Requested Present Missing Not Requested Calibration Certificate q q q
Service Manual (SM) q q q
Performance Qualification (PQ) q q q |
Installation Qualification
Instrument Safety
Manufacturer’s Safety Recommendations:
To prevent injury, always observe good laboratory practices when you handle eluents, change tubing, or operate the 1500 Series HPLC Pump. Know the physical and chemical properties of the eluents. Refer to the Material Safety Data Sheets for the eluents in use. always observe safe laboratory practices when you operate your system.
To avoid the possible eye injury or cuts, handle the plunger with care. Wear safety glasses and use the plunger insertion tool. Be aware that the pieces of a broken plunger are very sharp.
To avoid possible electric shock, do not remove the cover. The interior of the pump does not contain user-serviceable parts.
To avoid having an eluent leak from a pump outlet, position each eluent reservoir below its corresponding pump inlet until the outlet is connected to the system.
To avoid high-temperature hazards, always allow adequate time to cool the system before you perform maintenance or troubleshooting. Wear protective clothing whenever you open the sample compartment or the analysis compartment.
To prevent eluent from leaking out of the pump outlet, make sure you position the eluent reservoir below the pump inlet manifold before you disconnect the pump outlet fitting.
|
Comments:
|
Installation Qualification
Assembly and Installation
Installation Procedure: |
Yes | No |
Unpacking and setting up the Pump | | |
Making Electrical Connections | | |
IEEE-488 connector Connects the pump to a PCI busLAC/E-card in the empower
workstation. |
| |
Making Fluidic Connections | | |
Connect the Inject Start Signal (1500 Series Manual Injector) | | |
Making Eluent Supply Connections | | |
Install the Bottle Holder | | |
Connect the Pump Inlet | | |
Connect to an Eluent Reservoir | | |
Comments: |
Installation Qualification
|
Summary Report
Instrument:
Waters 1525 BINARY HPLC PUMP |
Manufacturer:
Waters Instruments |
|||
Assessment of Complete Installation Qualification:
No Deviations Deviations (List below) |
||||
Deviation |
Impact on Operation
|
Justification for Acceptance |
||
Successful completion of the preceding activities and checks indicates that this instrument has been satisfactorily delivered and installed. The instrument has passed the Installation Qualification procedure and may now be submitted for Operational Qualification. | ||||
IQ Completed By:
|
Date : | |||
Deviations Approved By:
|
Date: | |||
IQ Approved By:
|
Date : | |||
02. Operational Qualification:
During the OQ testing, the actual operating parameters of the equipment are checked.
Operational tests are specific to the type of equipment and its function. Several prerequisites must be met before the OQ is performed: completion of the IQ; verification that deficiencies have been resolved and that the protocol has been updated and approved; verification of the availability of OQ support utilities; verification that all calibrations have been completed; identification of test equipment; and verification of the current calibration status.
Safety information
eluents. Refer to the Material Safety Data Sheets for the eluents you use.
affect the column are gradual such as flow or pressure. |
||||
Safety Test | Pass | Fail | Date | Signed |
Earth Bonding | | |
|
|
Insulation Resistance | | |||
Comments: |
Operational Qualification
Pump Preparation Recommendations
Status
|
Prime1 |
Purge* |
Equilibrate* |
Initiating operation | | | |
Changing eluent | | | |
Adding fresh eluent | | | |
Changing columns | | | |
The system has been idle for some time | | | |
Eluent Guidelines
Use methanol to prime a new pump, or one that has been stored for an extended period. |
Yes | No | |
|
|||
Use an intermediate solvent when you change between eluents that are not
miscible. |
|||
To prevent air from being drawn into the pump, keep the eluent level in the reservoir at least four inches (10 cm) higher than the inlet manifold. Do not place eluent reservoirs on top of a Waters® 1500 Series Pump. | |||
Comments (including discrepancies):
Power on the pump and other chromatographic system devices before you power on the empower work station.
|
Operational Qualification
Functional Test | Acceptance Criteria
|
Pass | Fail |
Power on a 1500 Series Pump | To power on the pump, find the power switch on the left side panel and set it to the 1 (ON) position. | | |
Preparing the Pump | Follow pump preparation recommendations. | | |
Priming and Purging the Pump |
Priming and purging the pump ensure proper pump operation. |
| |
Purging the Injector and Detector
|
To purge the injector and the 486 detector
1. Run the empower software. 2. Follow the on-screen instructions. |
| |
Equilibrating the System | Equilibrate your HPLC system | | |
Powering Off the Pump
|
To power off the pump:
1. If you have been using buffers, purge the buffer from the pump and other HPLC system components with HPLC-grade water. If the pump will be idle for more than one day, purge with a methanol/water solution to prevent the growth of microorganisms. 2. If the pump is running, powering off the pump will stop the flow immediately. Since abrupt flow changes may damage columns, it is advisable to ramp flow to zero with a Empower shutdown method, which is created by the user. 3. Turn the power switch to the O (OFF) position. |
| |
Comments:
Before Equilibrating Make sure the eluent is filtered and degassed. |
Operational Qualification
Calibration
Calibration of the pump (Flow rate)
Flow rate adjusted to 1.0 ml/min. | Observed weight in gm. | Limit in ml/min. | |||
1 | 2 | Mean wt. / min | Mean Vol. / min | ||
Pump-A | |||||
Weight of beaker + water after 10 min. (W2) |
44.9288gm |
44.9279gm | 9.9177gm | 0.99177 | 0.99 to 1.01 |
Weight of beaker (W1) |
35.0106gm
|
35.0107gm | |||
(W2 – W1) / 10 |
0.99182
|
0.99172 | |||
Pump-B | |||||
Weight of beaker + water after 10 min. (W2) |
44.9189gm
|
44.9178gm | 9.90625 | 0.990625 | 0.99 to 1.01 |
Weight of beaker (W1) |
35.0117gm
|
35.0125gm | |||
(W2 – W1) / 10 |
0.99072 |
0.99053 | |||
Pressure drop test:
|
|||||
Remarks : |
Operational Qualification
Training
Date Instrument Released for Use: | |||
Trained Operators |
Read Operator Manual |
Practical Training |
Authorizing Signature |
| | ||
| | ||
| | ||
| | ||
Comments:
|
Operational Qualification
|
Summary Report
Instrument:
Waters 1525 BINARY HPLC PUMP |
Manufacturer:
Waters Instruments |
|||
Assessment of Complete Installation Qualification:
No Deviations Deviations (List below) |
||||
Deviation |
Impact on Operation
|
Justification for Acceptance |
||
Successful completion of the preceding activities and checks indicates that this instrument is operating satisfactorily following delivery and installation. The instrument has passed the Operational Qualification procedure and may now be released for use. | ||||
OQ Completed By: | Date : | |||
Deviations Approved By: | Date: | |||
OQ Approved By: | Date : | |||
03. Performance Qualification
Triggering Factor for Performance Qualification
PQ Trigger(s): Recalibration Routine Maintenance
Functional Tests
|
Recalibration
Recalibration Step | Suggested Frequency
|
Not Done | OK | Not OK |
Calibration Of Pump (Flow Rate) |
Annually
|
| | |
Pressure drop test: |
Annually
|
| | |
Comments: |
Performance Qualification
Functional Test | Acceptance Criteria | Pass | Fail |
Power on a 1500 Series Pump
|
To power on the pump, find the power switch on the left side panel and set it to the 1 (ON)
position. |
| |
Preparing the Pump | Follow pump preparation recommendations. | | |
Priming and Purging the Pump | Priming and purging the pump ensure proper pump operation. | | |
Purging the Injector and Detector
|
To purge the injector and the 486 detector
1. Run the empower software. 2. Follow the on-screen instructions. |
| |
Equilibrating the System | Equilibrate your HPLC system | | |
Powering Off the Pump
|
To power off the pump:
1. If you have been using buffers, purge the buffer from the pump and other HPLC system components with HPLC-grade water. If the pump will be idle for more than one day, purge with a methanol/water solution to prevent the growth of microorganisms. 2. If the pump is running, powering off the pump will stop the flow immediately. Since abrupt flow changes may damage columns, it is advisable to ramp flow to zero with a Empower shutdown method, which is created by the user. 3. Turn the power switch to the O (OFF) position.
|
| |
Comments:
Before Equilibrating Make sure the eluent is filtered and degassed.
|
Performance Qualification
Routine Maintenance
Diagnostic Tests
Regular diagnostic tests can help you to track system performance and prevent or identify
potential problems before they interfere with operation. Two tests are:
- Retention time stability test
- Ramp-and-decay test
Routine Maintenance | Scheduled Frequency | |
Replacing and Cleaning Plunger Seals and Plungers | six months
|
|
Replacing Check Valves | 1year | |
Replacing a Draw-Off Valve | 1year | |
Replacing Fuses | 1year |
Performance Qualification
Safety Tests
the appropriate type and rating.
glasses and use the plunger insertion tool. Be aware that the pieces of a broken plunger are very sharp. |
|||||
Safety Tests | Not Done | Pass | Fail | Date | signed |
Earth Bonding
|
| | | ||
Insulation Resistance
|
| | | ||
Comments: |
Performance Qualification
Post Fault Rectification
Is this PQ directly following a fault rectification? Yes No
If yes:
Description of fault: _______________________________________________ ________________________________________________________________ ________________________________________________________________
Rectification: ____________________________________________________ ________________________________________________________________ ________________________________________________________________
Date rectified: ___________________________________________________
Fault rectified by:
User Specialised Engineer Return to Manufacturer
Any measures advised to prevent reoccurrence: ________________________ ________________________________________________________________ ________________________________________________________________ ________________________________________________________________
|
Performance Qualification
|
Summary Report
Instrument:
Waters 1525 BINARY HPLC PUMP |
Manufacturer:
Waters Instruments |
|||
Assessment of Complete Installation Qualification:
No Deviations Deviations (List below)
|
||||
Deviation |
Impact on Operation |
Justification for Acceptance |
||
Successful completion of the preceding activities and tests indicates that this instrument is operating satisfactorily following recalibration, maintenance, or functional checks. The instrument has passed the Performance Qualification procedure and may now be returned to use.
|
||||
PQ Completed By: | Date : | |||
Deviations Approved By:
|
Date: | |||
PQ Approved By:
|
Date : | |||