Millipore Milliflex oasis User manual

SigmaAldrich.com

User Guide

Milliflex Oasis®system

Important:

For an animated interactive user guide, visit

SigmaAldrich.com/Milliflex-Oasis for a visual

understanding of the different operations.

The life science business of

Merck operates as MilliporeSigma

in the US and Canada.

Page 2 of 32

Notice

The information in this document is subject to change without notice and should not

be construed as a commitment by Merck KGaA, Darmstadt, Germany. Merck KGaA,

Darmstadt, Germany 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. In no event shall Merck KGaA, Darmstadt, Germany be liable for incidental

or consequential damages in connection with, or arising from, the use of this manual.

Table of Contents

Introduction 3

1. Components 4

1.1 Required items 4

1.2 Description of items 5

1.3 Touch switch 6

2. Hardware installation 7

3. Testing 9

3.1 Filtration units 9

3.2 Media plates 10

3.3 Testing 10

3.4 Waste 13

4. Cleaning & maintenance 14

4.1 Cleaning & maintenance table 14

4.2 Surface sanitizers and internal ow

sanitizers table 14

4.3 Filtration head cleaning 15

4.4 Pump surface cleaning 15

4.5 Pump rinsing 15

4.6 Filtration head external gasket cleaning 15

4.7 Pump internal ow sanitization 16

4.8 Filtration head complete cleaning 17

4.9 Filtration head gaskets and check valve

replacement 19

4.10 Sanitization kit gaskets and valve

replacement 19

5. Performance verication 20

6. Use of multiple pumps 21

6.1 Material needed 21

6.1.1 Two pumps connected 21

6.1.2 Three pumps connected 21

6.2 Installation 21

7. Culture media growth promotion test 24

8. Milliex®cassettes 25

9. System specications 27

10. Ordering information 28

11. Troubleshooting 30

12. Operator & equipment safety instructions 31

13. Technical assistance 31

Page 3 of 32

Introduction

The Milliex Oasis® system is a solution for the microbial testing of aqueous uids.

It is typically used in the pharmaceutical industry and provides an ecient method for

monitoring in-process samples, water, aqueous raw materials and nished products for

microbial limits testing.

It can also be used in the electronics industry to test bacterial levels in rinse water

following deionization for microelectronics and for drinking water and beverages including

beer, wine, fruit juice, soft drinks as well as their raw materials.

The Milliex Oasis® system for microbiological examination of aqueous uids is composed

of the Milliex Oasis® pump, the Milliex Oasis® single-use ltration unit and the Milliex

Oasis® single-use media plate. This system provides a convenient solution for increasing

the number of tests per hour while reducing the risk of false results.

Please refer to the ordering information section for details on the dierent items.

Page 4 of 32

1. Components

1.1 Required items

Three hardware item numbers are necessary to run the system:

1. Milliex Oasis® ltration pump (item MMSYSTMM1)

2. Milliex Oasis® power supply for one to three ltration pumps, specic to

dened regions:

•Australia: item MMPWRSPAU

•Brazil: item MMPWRSPBR

•China: item MMPWRSPCN

•Denmark: item MMPWRSPDK

•Europe: item MMPWRSPEU

•Switzerland: item MMPWRSPSZ

•India: item MMPWRSPIN

•UK: item MMPWRSPUK

•Japan: item MMPWRSPJP

•USA: item MMPWRSPUS

•South Africa: item MMPWRSPZA

3. Milliex Oasis® internal ow sanitization kit (item MMSANKIT1)

Optional: For higher throughput capability, it is possible to connect two or three

pumps together without additional power supplies. In this case, the Milliex

Oasis® electrical cable for connecting two pumps (item MMCABLEMM) is required

for each additional pump.

Consumables: please refer to the ordering information section for details on the

dierent items.

1. Filtration units

2. Culture media

3. Consumables for the Milliex Oasis® internal ow sanitization kit

Page 5 of 32

1.2 Description of items

The Milliex Oasis®pump package

(item MMSYSTMM1) contains

1. Pump body

2. Two ltration heads with their covers

3. Tubing for discarding the liquids

4. Accessory kit

5. Spare parts kit

The Milliex Oasis®power supply

package contains

1. Power supply

2. Power cable (region specic)

3. Two rubber fasteners

The Milliex Oasis® internal ow

sanitization kit (item MMSANKIT1)

package contains:

1. Stainless steel sanitization kit with

plug and gasket removal tool

2. Vacuum gauge

The Milliex Oasis® ltration unit

package contains:

1. Three bags of eight ltration units

The Milliex Oasis®media plate

package contains:

1. Six bags of eight media plates

The Milliex Oasis®consumable for

internal ow sanitization kit (item

MMSANSYFU) package contains:

1. Twenty-four plastic syringes for

dispensing the sanitizer

2. Twenty-four funnel assemblies for

rinsing with puried water

Figure 1: Milliex Oasis®pump (MMSYSTMM1)

package components

Figure 2: Milliex Oasis®power supply package

components

Figure 3: Milliex Oasis® internal ow sanitization kit

(MMSANKIT1) package components

Page 6 of 32

1.3 Touch switch

Color Meaning

White Steady: pump is ready for next handling step

Blinking: membrane dry out on-going

Blue Vacuum on

Green The sanitization kit is ready to use

Red No ltration head or ltration head is not

locked

Orange Blinking: synchronizing multiple pumps, wait

O No tension or standby

The switch is touch-sensitive. Use your

ngertip to activate it.

Touch the center of the switch without

touching the outer ring.

When the Milliex Oasis® pump is on

standby mode, it can be reactivated by

touching the space between the two

switches.

Note: If unused for thirty minutes, the

pump switches o. Touch the switch

once to power up.

Figure 4: INCORRECT – no activation if the nger

touches the outer ring

Figure 5: CORRECT nger position to start or stop

the pump

✓

✗

Page 7 of 32

2. Hardware installation

The pump must be installed on a horizontal

surface. Please make sure that your

working area is leveled to ensure good

sample volume readings.

• Take the pump body, pump heads and

tubing out of the package with care

• Take out the accessory bag and spare

part bag

Optional: the accessory bag contains

four stickers for customization/visual

identification; select your preferred sticker

and stick it carefully into the specific groove

on the pump.

Figure 6: pump sticker set up

• Clean the exterior of the pump and the

tubing using a wipe moistened with a

surface sanitizer listed in the cleaning &

maintenance section

• Place the pump in the working area

When using the Milliflex Oasis®system

under a horizontal laminar flow hood (LFH),

the front of the pump should be placed at

least at 160 mm (6.3 in.) from the front

edge of the LFH (see picture).

Figure 7: the front of the pump should be placed at

least at 160 mm (6.3 in.) from the front edge of a

horizontal LFH

• On the back of the pump, press the metal

latch and remove the white plug, then

connect the tubing

Figure 8: the metal latch must be pressed to

remove the white plug

• Place the other end of the tubing in a

liquid waste container

• Take the power supply out of its package

• Sanitize the power supply in the same

way as the pump

• Plug the DC power cord to one power port

situated at the back of the pump. Push

the connectors into the power port until a

click is heard

• Connect the free power cord to the power

supply

• Connect the other end of the power cord

to a properly grounded power outlet

Optional: attach the power supply outside

the working area with the two rubber

fasteners.

Figure 9: the power supply can be attached

outside the working area with the rubber

fasteners

Page 8 of 32

Optional: to arrange the tubing and

electrical cable in your working area, use

the Milliflex Oasis®guides for electrical

cable and tubing (item MMTUGUIDE).

Figure 10: use of Milliflex Oasis®guides for

electrical cable and tubing (item MMTUGUIDE)

•Sanitize the internal flow of the pump by

referring to the cleaning & maintenance

section

•Once the internal flow path sanitization

has been performed, take the two pump

heads out of their package and remove

the yellow covers

Optional: From the accessory bag, select

two colored rings, clean them using a wipe

and one of the sanitizers recommended in

the cleaning & maintenance section, then

install them on the pump heads.

Figure 11: colored ring installation — part 1

Figure 12: colored ring installation – part 2

•Clean the pump heads using a wipe

moistened with a surface sanitizer listed

in the cleaning & maintenance section

•Install the pump heads on the pump body

•Lock each pump head by turning

clockwise until the sign on the head is

aligned with the one on the pump body

Figure 13: the sign on a locked head is aligned

with the one on the pump body

The pump is ready for testing.

Page 9 of 32

3. Testing

The following components are needed

before starting your sample processing:

• Milliflex Oasis® pump installed following

the installation section

• Milliflex Oasis®filtration units

• Milliflex Oasis® media plates

• Samples to test

Ensure that the internal pump flow was

sanitized according to the cleaning &

maintenance section.

• Clean the exterior of the pump using a

wipe moistened with a surface sanitizer

listed in the cleaning & maintenance

section

3.1 Filtration units

Different types of filtration units are

available (see ordering information section)

Note: for testing samples with

antimicrobial activity, select filtration

units with low binding Durapore

membrane (item MMHVWP124 or item

MMHVWP224).

Note: Isopropyl myristate (IPM) is

not chemically compatible, therefore

samples containing IPM should not be

used.

• Open a box of filtration units and remove

the desired number of bags, each

containing a tray of eight filtration units

Note: you do not need a tool to open the

box of the filtration units. Grab one end

of the tape and pull it.

• Repeat the operation if more than one

box of filtration units is needed.

• Clean each bag using a wipe moistened

with one of the surface sanitizers listed in

the cleaning & maintenance section

Optional: if you need four filtration units

or less for your testing, open the bag at

the front of the safety cabinet, then pull

out only half of the tray, separate the tray

in two and place the “half-tray” in the

working area. Fold the bag to close it and

use the biggest part of the sticker situated

on the bag to secure its closure. The four

filtration units remaining in the bag can

be put aside for later usage. In this case

the bag can be opened by the sealed end,

which is achieved by pulling on each side of

the bag.

Figure 14: unused filtration unit storage

• Open a bag and remove the tray, then

place the tray near the pump

• Repeat the operation if more filtration

units are needed

Optional: to save space, trays can be

separated in two parts and stacked.

Figure 15: tray separated and stacked for space

saving

Note: Four stickers with traceability

information and 2D barcodes are present

on each bag. It is possible to detach the

stickers and stick them into a log book.

Page 10 of 32

3.2 Media plates

• Open a box of media and remove the

desired number of bags, each contains

eight media plates

• Repeat the operation if more than one

box of media plates is needed

• Clean each bag using a wipe moistened

with one of the surface sanitizers listed in

the cleaning & maintenance section

• Open the bag and place the media plates

on the working area

• Repeat the operation if more media

plates are needed

Note: The media plates must be at

ambient temperature for optimal growth

performance.

Optional: Four stickers, each with

traceability information and a 2D code,

are present on each bag. It is possible to

detach the stickers and stick them into a

log book.

3.3 Testing

When the pump is on standby mode,

the switch is not lit up. To power up the

Milliflex Oasis® pump, touch the front of the

pump between the two switches with your

fingertip.

Note: If starting a filtration without a

filtration unit placed on the filtration

head, you will hear a whistle noise, this

is due to a check valve found in each

pump head and is perfectly normal. If

the pump is started after having placed

a filtration unit on the pump head, this

noise will not be heard.

• Place the Milliflex Oasis®filtration unit

on the pump head, lining up one of the

unit’s frosted strips with the pump’s

colored background

Figure 16: filtration unit placement

• Open the filtration unit lid

• Pour the sample into the Milliflex Oasis®

filtration unit and flip down the lid without

locking it

Figure 17: CORRECT lid position on the LEFT SIDE

(unlocked lid)

• Touch the switch to start the filtration

Note: touch the switch three times within

one second to launch the filtration on

two filtration heads simultaneously.

• Open a media plate using both hands and

rest the cover back on the plate

• When the liquid is totally filtered,

touch the switch once more to stop the

filtration, the membrane dry-out will

automatically start

✓✗

Page 11 of 32

• When the dry-out cycle is finished, the

pump stops, and the switch light stops

blinking; firmly press the filtration unit lid

down to lock it

Figure 18: filtration unit lid firmly pressed down

with the palm to lock

• Tilt the filtration unit first, then remove it

from the pump head

Figure 19: Filtration unit tilted for removal

• Optional: inspect underneath the

membrane to verify that it has a convex

shape

Figure 20: checking of the membrane convex

shape

Note: a convex membrane shape shows

that there is no leakage or pass-through

(membrane and seal integrity). In

addition, it helps in removing bubbles

or folds between the membrane and the

agar after membrane transfer.

• Open the pre-opened media plate with

one hand

Note: Be careful not to touch the agar

while removing the media plate cover.

• Place the filtration unit on the media

plate

• Using the thumb and index finger of each

hand, push down the funnel’s lid edges

vertically ensuring a central contact

between the membrane and the agar.

Make sure the filtration unit is firmly

pressed down against the media plate.

Figure 21: optimal handling for pushing down the

filtration unit to the media plate

Note: pushing down the filtration unit

vertically with four fingers ensures that

the membrane has full contact with the

agar without forming folds or bubbles.

Page 12 of 32

• Open the filtration unit lid while

maintaining the base with the other hand

• With the same hand, now pinch the

funnel to separate it from the membrane

assembly

• Tilt the lid sideways to remove it

Figure 22: CORRECT filtration unit lid removal

Figure 23: INCORRECT filtration unit lid removal

• Place the lid onto the media plate/

membrane assembly and lock it

• Place the media plate upside down. It is

ready for incubation

Optional: empty filtration unit trays can be

used to transport and to incubate the media

plates/membrane assembly. When placing

media plates/membrane assemblies on the

trays, the lid tab must be positioned out of

the tray.

Figure 24: CORRECT media plate/membrane

assembly placement (lid tab outside the tray)

Figure 25: INCORRECT media plate/membrane

assembly placement (lid tab inside the tray)

Optional: Up to six media plates/membrane

assemblies can be stacked and locked.

Figure 26: up to six media plates assemblies can

be stacked together

• Remove the membrane support that

remains on the pump by twisting it

Figure 27: membrane support removal by twisting it

✓

✗

Page 13 of 32

Optional: it is possible to use an accessory

to remove the support, the Milliflex Oasis®

membrane support removal tool (item

MMSUPREMV).

Figure 28: membrane support removal with

removal tool — part 1

Figure 29: membrane support removal with

removal tool — part 2

Figure 30: membrane support removal with

removal tool — part 3

Note: If some filtered liquid remains in

the pump head, it is possible to remove

it with a dry, sterile wipe. Regardless of

the amount of liquid, it does not impact

the test results.

3.4 Waste

After use, the filtration units and membrane

supports can be stacked. Place one support

into a filtration unit and stack the second

filtration unit, then repeat the operation to

save space.

Figure 31: stacking of filtration units and

membrane supports for waste

Please refer to the waste management

document available on our website to

recycle the filtration unit material.

Page 14 of 32

4. Cleaning & Maintenance

4.1 Cleaning & Maintenance table

Component Action

First

installation

Before each

testing shift

After each

testing shift Monthly Yearly

Filtration head Cleaning x x x

Pump Surface cleaning xxx

Pump Internal ow

sanitization x x

Pump Rinsing If testing non-

water samples

Filtration head External gasket

cleaning

If testing non-

water samples

Filtration head Complete

cleaning x

Filtration head Spare parts

replacement x

Sanitization kit Spare parts

replacement x

Optional: Even if not mandatory, the filtration head including its components can be

autoclaved at 121 °C for 15 minutes or at 134 °C for 5 minutes.

4.2 Surface and internal flow sanitizers tables

Surface sanitizer tested: Active ingredients Suppliers Dilution

Ethanol (N°CAS 64-17-5 : 226 mg/g)

Chlorhexidine Digluconate (N°CAS 18472-51-0 : 0.64 mg/g)

Didecyldimethylammonium chloride (N°CAS 7173-51-5 : 0.53 mg/g), Excipients.

Consult our local