Qualification of Laboratory Equipment’s

1525 BINARY PUMP

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.

34 Maple Street

Milford, MA 01757

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.).

the injector, the column, and the rest of the system.

line

left side of the unit under the mixer and behind the shroud.

eluent to the inlet check valve on each pump head.

signals for monitoring.

Manual Injector

to the detector.

waste lines

valve assemblies

Product for Research, pharmaceutical Quality Control Analysis.

YES                                 NO   

[24” (61 cm) with 1500 Series Column

Heater]

Depth: 24 in. (61 cm)

Height: 17 in. (43 cm)

cable connections

frequency

Grounded ac, 120/240 Vac, 50/60 Hz, single phase

as arcing relays or electric motors

150 VA for column heater



Yes                      q     No                            q

If yes, state missing items:_______________________________________

Yes                      q     No                            q

If yes:   Description of damage: _______________________________________

Corrective action: ___________________________________________

The manufacturer informed:                   Yes    q   No   q

                                                                                    Present            Missing

Operator Manual (OM)                                                    q      q

Certificate of conformity                                                   q      q

Quick start guide                                                              q      q

Warranty card                                                                  q      q

Requested

Present        Missing       Not Requested

Calibration Certificate                                   q     q       q

Service Manual (SM)                                    q     q       q

Performance Qualification (PQ)                    q     q       q

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.      

Installation Procedure:                                     

workstation.

Waters 1525 BINARY HPLC PUMP

Waters Instruments

No Deviations                                              Deviations           (List below)

Deviation

Impact on Operation

Justification for Acceptance

• To avoid chemical hazards, observe safe laboratory practices when you handle

eluents. Refer to the Material Safety Data Sheets for the eluents you use.      

• To avoid damaging the column, make sure any changes to conditions that

affect the column are gradual such as flow or pressure.     

Status

Prime1

Purge*

Equilibrate*

Use methanol to prime a new pump, or one that has been stored for an extended period.

miscible.

Power on the pump and other chromatographic system devices before you power

on the empower work station.

Priming and purging the pump ensure proper pump operation.

1. Run the empower software.

2. Follow the on-screen instructions.

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.

Before Equilibrating

Make sure the eluent is filtered and degassed.

44.9288gm

35.0106gm

0.99182

44.9189gm

35.0117gm

0.99072

Pressure drop test:

• Proper functioning check valve
• No leak from the pump

Trained Operators

Read Operator Manual

Practical Training

Authorizing Signature

Waters 1525 BINARY HPLC PUMP

Waters Instruments

No Deviations                                              Deviations           (List below)

Deviation

Impact on Operation

Justification for Acceptance

PQ Trigger(s):

Recalibration                                       Routine Maintenance    

Functional Tests            

Calibration Of Pump (Flow Rate)

Annually

Annually

position.

1. Run the empower software.

2. Follow the on-screen instructions.

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.

Before Equilibrating

Make sure the eluent is filtered and degassed.

• For continued protection against fire hazard, replace fuses with those of the

the appropriate type and rating.

• To avoid 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.

Earth Bonding

Insulation Resistance

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: ________________________

________________________________________________________________

________________________________________________________________

________________________________________________________________

Waters 1525 BINARY HPLC PUMP

Waters Instruments

No Deviations                                              Deviations           (List below)

Deviation

Impact on Operation

Justification for Acceptance