Millipore Milliflex Plus User Manual

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User Guide

Milliex® Plus

VHP Resistant Pump

The life science business of Merck KGaA, Darmstadt, Germany operates as MilliporeSigma in the U.S. and Canada.

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1. Notice

The information in this document is subject to change without notice and should not be construed as a commitment by Millipore SAS. Millipore SAS assumes no responsibility for any errors that may appear in this document. This manual is believed to be complete and accurate at the time of publication.

2. Application

The VHP Resistant Milliex® PLUS Pump is designed to perform ltrations of samples inside an isolator. The pump is compatible with the isolator environment. The housing and the external parts are VHP resistant.

3. Operator and Equipment safety

All employees who will operate and/or be near the Milliex® Plus Pump VHP must comply with the following:

• Read and understand the user guide of the pump before using this pump. Failure to follow operating instructions could result in user injury or damage to the instrument.

• Read and understand all maintenance instructions in this user guide before performing maintenance on the pump. Failure to follow instructions could result in user injury or damage to the instrument.

• Any alteration of the pump from factory specication may cause unsafe conditions, and will void the product warranty.

• Any attempt to use the pump in a manner not specied in this user guide may result in damage to the instrument, operator injury, and will void the product warranty.

• Do not attempt to open and repair the pump. Service should be performed by trained and authorized personnel only.

• Place the pump on a clean, at, stable, horizontal surface, away from any source of excessive heat and close to an easily accessible, properly grounded power supply outlet.

• The Milliex® Plus Pump VHP must be installed and used in a clean and dry area.

• The product is not intended to be used in explosive atmosphere.

• Do not expose the power supply to liquid. If this happens, immediately switch o and disconnect the pump from the power outlet, wipe up the liquid.

• Use only accessories and replacement parts designed for the pump. Using accessories not designed for the pump could result in user injury or damage to the instrument.

• When ltrating hazardous liquids, wear and use proper protective clothing and equipment for the handling and the disposal of the liquid to be ltrated.

• The system power cord is the main system disconnecting device, and must be easily accessible at all times.

• To avoid damaging the power cord or the outlet, it is recommended that you pull on the plug and not on the cord to unplug the system from a wall outlet or an electrical connector.

• Make sure the power cord is not a tripping hazard. Make sure that it is not gripped too tightly at the plug, the outlet or the point where it is connected to the system.

• Before use, check that the hoses are not unplugged, folded, or damaged.

• In case of skin contact with the ltrated liquid, refer to the safety datasheet of the ltrated liquid for rst aid measures.

• Dispose the ltrated liquids according to local regulations.

• Do not use the Milliex® Plus Pump VHP to ltrate

ammable products.

• Before cleaning, shut down the Milliex® Plus Pump VHP and switch o and disconnect the power supply from power source.

• Use only the power supply (model FRA072-S24-4) designed for the pump.

• The power supply must be connected to the earthing system.

• The electrical installation must comply with local standards, power supply voltage: 100–240 Volt AC, 50–60 Hz.

• Use an electrical surge protector to prevent damage to the system.

• Milliex® Plus Pump VHP System is designed for indoor use only.

• Use and storage temperatures

– The Milliex® Plus Pump VHP and/or its accessories must be kept away from any heat source. Do not expose the system to direct sunlight or to temper atures outside the ranges of values are given below. – Use and storage temperatures are given below:

System operation System storage Altitude

10 to 40 °C 0 to 40 °C < 2000 m

– Maximum relative humidity (storage and operation) 80% at temperatures up to 31 °C, then linear decrease to 50% RH at 40 °C.

• System dismantling—WEEE directive:

In accordance with to the European Union Directive 2012/19/EC on Waste Electric and Electronic Equipment (WEEE), the presence of this logo on the product indicates that it should not be disposed of in the normal waste stream but collected separately.

Go to millipore.com/weee for details on how to ensure proper treatment of the product in dierent countries.

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4. System description

A. VHP Pump (MXPPLUVHP)

The Milliex® Plus VHP pump is composed of the following elements:

• The pump body

• The pump head with its protective cover (MXPHEAVHP)

• A lead to protect the pump when the pump head is not in place (to be used for assembling the pumps

with the manifold tray)

VHP Resistant Pump Head

Pump Head Mounting Post

Control Panel and Display

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Pump Body

The pump comes with the following documents:

• User Guide PF12640

• Certicate of conformity for the pump (MXPPLUVHPCOQ) and the pump head (MXPHEAVHPCOQ)

Note: The VHP resistant pump (MXPPLUVHP) is compatible with the VHP resistant pump head (MXPHEAVHP) only. These items are designed for use with Milliex® ltration devices only.

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B. Manifold tray for VHP pumps (MXPTRAY03V2)

The manifold tray is used to assemble the pumps together.

C. Milliex® Plus pump VHP Hub kit (MXPHUBKIT)

The VHP Hub kit is composed of:

• Some components for the electrical parts: electrical hub, cables set and power supply

• Some components for the uidic parts: uidic hub and tubes set

MXPFHUVHP

Milliflex

fluidic hub

VHP compatible

MXTUBVHP—VHP tubes set for Milliflex fluidic hub

MXPELEHUB

Milliflex hub VHP compatible

electrical

MXPELCVHP—VHP cables set for Milliflex electrical hub

MXPP0WVHP Electrical hub power supply (with 1 power cord Eur —1 power cord US)

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D. Supply set for one VHP Pump (MXPSPL001)

The supply set is composed of:

• A power supply

• A uidic tube

5. System installation

A. Single pump system

Connect the supply set (uidic tube and power cable) to the VHP pump as follows:

Then place the system in the isolator.

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B. Three pump system

When using a three pump system, it is strongly recommended to assemble the pumps on the Manifold tray, and to use the Hub kit for the electrical and uidic connections.

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It is recommended to assemble the pumps together before placing the system in the isolator. The use of the tray facilitates the transfer of the assembled system to the isolator.

Caution: when assembled, the system is heavy (14.3 kg without the heads). Make sure you can handle the system to transfer to the isolator.

1. Assembly of the 3 pumps on the tray

Do not place the pump head at this stage.

• Put the pump lead on each pump to protect them through the assembly step.

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• Reverse the 3 pumps: the keypad should be facing the operator and the pumps should be aligned to enable assembly with the tray

VHP Resistant

• Put in place the tray

VHP Resistant

• Fix each pump one by one to the tray using the fast screw

VHP Resistant

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• Once the 3 pumps are assembled on the tray, connect the electric cables and uidic tubes to each pump

VHP Resistant

Detail of the electrical connection:

• Once all the connections are in place, reverse the whole system using the manifold tray. Take care not to crush the uidic tubes and electric cables while reversing the system.

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VHP Resistant

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2. Hub installation

The VHP Compatible Milliex® PLUS Pump Hub is used to connect the uidic tubes and electrical cables from up to three Milliex® PLUS pumps.

• Fluid Line Connections

Push the Milliex® PLUS Pump uid line connectors into the uid hub until a click is heard. Install the other end of the tubing onto the pumps.

Insert the output tubing onto the stainless steel connector.

To disconnect the uid lines, push on the button and pull the connector.

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• Electrical Connection

Push the Milliex® PLUS Pump electrical cables into the electrical hub until a click is heard. Connect the other end of the cables onto the pumps.

Connect the power supply to the electrical hub and tighten the connector.

To disconnect the electrical cables from the hub, pull the cables out of the hub.

• Connecting the Hubs

The uid and electrical hubs may be connected or disconnected by sliding them together.

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• Decontamination

The hubs must be cleaned after each use. To decontaminate the uid line hub and the tubing, use the sanitizing mode of the Milliex® PLUS Pump (refer to the Milliex® PLUS Pump User Guide). The external parts of both hubs may be sprayed with an alcohol solution or a standard laboratory surface decontamination solution.

Hang the hubs inside the isolator during the decontamination cycle as shown below.

3. Pump head installation

• Push in the latch on the side of the pump head.

• Place the pump head onto the mounting post, with the latch to the left, as you face

the pump, as shown.

• Turn the pump head until it drops down and is fully in contact with the mounting post. The latch is automatically released and locks the head in place. The latch should be positioned on the left side of the pump assembly, when the head is locked in place.

NOTE: The pump head should be autoclaved before the rst use, as described in the Maintenance section.

Latch

Mounting Post

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4. Typical installation

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Caution: the pump will not be VHP resistant if the O-ring or any screws are removed. The pump head must remain in place on the pump during VHP cycle to maintain VHP resistance. The white cover delivered with the pump head does NOT ensure VHP resistance of the pump.

6. Controls and display

A. Keypad

Display

Arrow buttons (scroll through

Keypad control

C button (cancel or return to previous level)

selections)

OK button (accept or go to next level)

Power ON/OFF button

START button

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B. Control functions menu

POWER ON

Milliﬂex® PLUS

Serial N: xxx

Manual Tare

Sampling Manual Volume OFF

Sanitizing

Conﬁguration Buzzer Buzzer ON

Remove expandable

press start

Place expandable

press start

Validation

See paragraph

8.B

See paragraph

8.D

Buzzer OFF

Weight

calibration

Time

veriﬁcation

For maintenance

only

For maintenance

only

nber of cycle since

last calib: xx

nber of total

cycle: xx

Calibration date:

DD MM YY

Expendable

key number

Export

conﬁguration

Software

V1.01 VHP

Vacuum

veriﬁcation

Enter code

or press C

Connect printer

and press start

For maintenance

only

For maintenance

only

For maintenance

only

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7. Initial Power-up

At installation, the steps described above (Hardware Installation) should have been performed, as applicable, before conguration.

1. Switch the pump on by pressing the ON/OFF button on the keypad. The display shows the

following for a few seconds: Milliex® PLUS SERIAL N:

2. The following display appears: Manual

3. Press OK. The display will show: Tare

4. Press OK. The display shows: Remove expendable—press start

5. Remove anything on the pump head (e.g., cover or disposable) and press START.

The display shows: measuring..... please wait......

6. After a few seconds, the display will revert to the display manual testing. (Additional information on

the Tare procedure may be found in the Preparation for Testing section.)

8. Operation

A. Preparation for Testing

We recommend that the pump head be autoclaved before the rst use and after each workday. See the Maintenance section.

Whenever the pump head is removed, the Tare cycle must be run (see below).

It is also recommended to sanitize the pump interior before the rst use and after each workday, and if the pump is unused for more than a day. See Sanitizing below, in this section.

1. Install the pump head, as described in the Installation section. Run the Tare cycle, as described below.

2. To prepare for testing, switch on the pump, by pressing the ON/OFF button on the keypad.

For a few seconds, the display shows: Milliex® PLUS Serial N:

After the power-up display, the Main Program Screen for the previously selected program is displayed. For example: Manual

B. Tare

The Tare procedure adjusts the measurement system in the pump for the positioning and removing of the Milliex® funnels

1. When the display shows Tare, press OK. The display shows: Remove expendable. Press Start

2. Remove anything on the pump head (e.g., cover or disposable) and press START. The display shows:

Measuring… Please wait…

After a few seconds, the display returns to the Main Program Screen for the previously-selected program.

C. Sample Processing

1. Position a tray of Milliex® 100 funnels with the Millipore name facing the operator.

2. Remove a funnel from its packaging tray. A notch in the tray is uncovered: this will facilitate picking

up the spacer.

3. Use sterile forceps to place the aseptic spacer on the pump head. Firmly press the funnel onto the pump head.

NOTE: Make sure that the base of the funnel is ush with the top of the pump head lter support.

4. Remove the cover from the funnel, while maintaining the funnel in position with the other hand.

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5. Pour a sample into the funnel, using the graduations to reach the required volume. When the required volume has

been reached, stop pouring. Leave the cover tilted on top of the funnel, but not closed, during the next two steps.

6. Press START to start the pump.

7. Operate the pump until the sample has been ltered, then press START to dry out the pump head.

Wait for the pump to stop.

8. Remove the white/opalescent cover from the solid cassette or the paper cover from the liquid cassette.

9. Remove the funnel from the pump head and reinstall the funnel cover.

10. Inspect the underside of the membrane, to verify membrane integrity. When viewed from beneath the funnel,

the membrane should have a convex shape.

11. Place the funnel base down over (and the lter membrane onto) the exposed medium cassette. The membrane

should be fully in contact with the medium.

12. Assure and secure membrane contact with the medium, by pressing slowly and rmly on the cover with the

thumb and forenger of each hand.

13. Press down on the top of the funnel with the palm of one hand. Start with a rm vertical pressure and

gradually increase your hand pressure until the funnel breaks o. The funnel will shear o at the groove on the unit. NOTE: If the working position is uncomfortable, e.g., in a vertical laminar ow hood with the shield in a low position, then the funnel may be broken in two steps, thus requiring less strength. Press slightly to one side of the funnel rst, until a “snap” is heard, then press on the opposite side of the funnel until a second “snap” is heard.

14. After the funnel section has broken o, remove the cover from the funnel and place it on top of the lter

cassette assembly.

15. Incubate upside down.

16. Wipe the pump head with an aseptic wipe.

D. Sanitizing

The pump interior should be sanitized before its rst use, after each workday and if unused for more than a day. The Sanitizing cycle enables the user to sanitize the interior surfaces of the pump, according to a xed regimen.

See the Specications section for information on acceptable sanitizing agents.

The pump head can be autoclaved.

See the Maintenance section for autoclaving specications and for recommendations on cleaning the pump exterior.

In the Sanitizing cycle, the pump automatically circulates a quantity of sanitizing agent through the interior of the uid-handling mechanism; pauses for ten minutes, while the interior surfaces are still wetted with the agent; circulates the rest of the agent through the pump; and then circulates multiple rinses. The user is prompted to add the appropriate liquid when required, at each stage. A drying cycle completes the process. The Milliex® HA (mixed cellulose esters membrane) funnel should be used for sanitization with any recommended agent except for solutions containing alcohol, where the Milliex® HV (PVDF membrane) is required. If the agent and the membrane used are not compatible, remove the membrane from the funnel before sanitizing.

CAUTION

Install the exhaust tubing and waste receptacle higher than the pump, to prevent sanitizing agent being siphoned out of the pump during the ten minutes of contact time.

1. At the Main Program Screen, press OK, to enter the Main Menu. The display shows: Tare

2. Press the down arrow until the display shows: Sanitizing

3. Press OK. The display shows: Put expendable—press start

4. Place an aseptic spacer and a Milliex® 100 funnel, without its cover, on the pump head and press START.

The display shows: Fill 100 mL of Agent press start

5. Fill the funnel with 100 mL of sanitizing agent and press START. The pump starts and the display shows: Sanitizing

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6. The pump should pull 25 to 75 mL of agent through (ltration during ve seconds); pause for ten minutes,

and then pull the remaining liquid through. A bar graph at the bottom of the display shows the progress of this operation.

7. After the pump has emptied the funnel, it runs a drying cycle and then the display shows: Fill 100 mL of

Water press start

8. Fill the funnel with 100 mL of sterile water and press START. The display shows: Rinsing

9. The pump empties the funnel and runs a drying cycle. Then the display shows: Fill 100 mL of Water press start

10. Fill the funnel with 100 mL of sterile water and press START. The rinsing cycle is performed as before.

11. Then the display prompts for the funnel to be lled again, for each rinse, for a total of four rinses. When the

fourth rinse has been completed, the display shows: Sanitizing nished—Press start

12. Press START. Remove the funnel and discard it. The display shows: Sanitizing

13. Press C button to go back to the display manual testing. Remove the residual liquid on the Milliex® Head.

9. Maintenance

A. Autoclaving

Autoclave the pump head before the rst use and after the last use each day. Autoclave at 121 °C for 30 minutes, or at 134 °C for 10 minutes.

B. Sanitizing

After each workday, or when the pump is unused for more than a day, sanitize the pump interior, using the automated procedure provided in Sanitizing.

Sanitizing agents:

• Bleach 250 ppm

• Peraceticacid 0.125%

• Quaternary ammonium

C. Exterior Cleaning

The exterior surface can be cleaned with a soft cloth, moistened with alcoholic solution or a standard laboratory surface alcohol decontamination solution

D. Calibration

Must be performed by our authorized internal Technician.

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10. System Specications

Materials of Construction

Dimensions

Electrical

Vacuum

Flow rate

TimeAccuracy

OperationalRequirements

Regulatory Information

Housing Stainless steel 316 L

Key pad Polyester

Screen window Polyester with coating

Drying valve o-ring Viton® elastomer

Liquid pump housing Polypropylene

Liquid pump membrane PTFE

Liquid pump valve Viton elastomer

Pump head Stainless steel 316 L with local Teon® coating

Fluidic connections Polyamide

Fluidic tubing Silicone

Pump head cover Polyacetal

Seal (O-ring between pump and pump head) EPDM

Bottom plate seal Silicone

Single 3 head system

Width 170 mm 585 mm

Depth 265 mm 265 mm

Height without head 162 mm 167 mm

Height with head 170 mm 175 mm

Weight without head 4.4 kg 14.3 kg

Weight with head 5.2 kg 16.8 kg

Power supply input 100–240 V — 50–60 Hz — 1.8 A

Power supply output 24 V VDC—3.0 A

Pump input 24 VDC

Pump power 25 VA

Electrical Hub 24 VDC/75 VA

≥ 0.4 bar (11.8 inches of Hg)

7 to 16 seconds for 100 mL of Milli-Q® grade sterile water ltered through a Milliex® MXHAWG124 funnel

± 2 seconds in 5 minutes

Temperature 10 °C to 40 °C (50 °F to 104 °F)

Relative humidity See chapter 3—Operator and Equipment Safety

Altitude < 2,000 Meters (6,561 feet)

Pollution degree II

Main supply voltage ± 10% of the nominal voltage

Transient over voltages Over voltage category II

Millipore SAS certies that the VHP Resistant Milliex® PLUS pump is designed and

manufactured in application of:

2014/30/EU Relating to electromagnetic compatibility

2014/35/EU Relating to electrical equipment designed for use within certain voltage

2011/65/EU Relating to the restriction of the use of certain hazardous substances (ROHS) in electrical and electronic equipment

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11. Ordering Information

Catalogue No. Description Qty./Pk

MXPPLUVHP Milliex® PLUS Pump VHP Resistant 1

MXPHEAVHP Milliex® PLUS Pump Head VHP Resistant 1

MXPFHUVHP Milliex® Fluidic Hub VHP Compatible 1

MXPELEHUB Milliex® Electrical Hub VHP compatible 1

MXPTUBVHP VHP tubes set for Milliex® Fluidic Hub 3

MXPELCVHP VHP Cables set for Milliex® Electrical Hub 3

MXPP0WVHP Electrical Hub Power Supply 1

MXPTRAY03V2 Milliex® VHP Tray for 3 Pumps 1

MXPSPL001 Supply set for one Milliex® PLUS Pump VHP 1

FTPF01866 Power cord for Europe

FTPF02471 Power cord for North America, Central America Brazil Mexico

SIMCABLE1 Power cord for United Kigdom, Ireland, Malaysia, Singapore, Hong Kong

SIMCABLE2 Power cord for Denmark

SIMCABLE3 Power cord for India, South Africa

SIMCABLE4 Power cord for Switzerland

SIMCABLE7 Power cord for Japan

SIMCABLE8 Power cord for Australia, China, New Zealand, Argentina

SIMCABLE9 Power cord for Italy

Kits information

Kit No./Description Components Qty

MXPHUBKIT

Milliex® Plus Pump VHP Hub kit

MXPVHPKIT

Milliex® VHP 3 heads kit

MXPFHUVHP 1

MXPELEHUB 1

MXPTUBVHP 1

MXPELCVHP 1

MXPP0WVHP 1

MXPPLUVHP 3

MXPTRAY03V2 1

MXPFHUVHP 1

MXPELEHUB 1

MXPTUBVHP 1

MXPELCVHP 1

MXPP0WVHP 1

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12. SymbolsReferenced

The presence of this logo on the product signies the compliance of VHP Resistant Milliex® PLUS Pump with the following European Union directives:

2014/30/EU relating to electromagnetic compatibility

2014/35/EU relating to electrical equipment designed for use within certain voltage limits

2011/65/EU relating to the Restriction of the use of certain Hazardous Substances (RoHS) in electrical and electronic equipment

In accordance to the European Union Directive 2012/19/EC on Waste Electric and Electronic Equipment, the presence of this logo on the product indicates that it should not be disposed of in the normal waste stream, but should be collected separately.

LPS

Go to Millipore.com/weee for details on how to ensure proper treatment of the in dierent countries.

Indicates that the output voltage and current are limited.

Direct current (DC).

Alternate current (AC).

Hazard Hot surface.

Possible high-voltage hazard.

Do not disassemble.

13. Standard Warranty

The applicable warranty for the products listed in this publication may be found at Millipore.com/terms (“Terms & Conditions of Sale”).

Manufacturer

Millipore SAS 39 Route Industrielle de la Hardt 67120 Molsheim, France

Technical Assistance

For more information, please visit Millipore.com/oces for up-to-date worldwide contact information

© 2019 Merck KGaA, Darmstadt, Germany and/or its aliates. All Rights Reserved. The vibrant M, Millipore, Milliex, Sigma-Aldrich, and Milli-Q are trademarks of Merck KGaA, Darmstadt, Germany or its aliates. All other trademarks are the property of their respective owners. Detailed information on trademarks is available via publicly accessible resources.

PF12640 – Rev D

2017 - 08235

01/2019