SteriLUX · EverLUX® FilterCartridge TheEverLUX®polyethersulfone (PES) filter is designed for very high contaminant capacity, extended service life and high flow with low pressure

SteriLUX® Filter Cartridge

The SteriLUX®hydrophilic PVDF membrane filter is ideal for sterile filtration,

prefiltration and clarification of pharmaceutical and biological solutions.

It has been optimized to sterile filter pharmaceutical preparations, active

ingredients, biopharmaceuticals, vaccines, serum and blood products,

parenterals, ophthalmics, orals, topicals, protein solutions, salts, buffers,

diluents, growth media, cell and tissue culture media and media additives.

SteriLUX®also provides high performance filtration of bulk pharmaceutical

chemicals, cosmetics and toiletries, diagnostics, solvents and solvent/product

mixtures, reagents and high purity water. SteriLUX® filters can also be used

for particulate removal and bioburden reduction in aqueous liquid streams.

The SteriLUX®membrane is surface-modified to provide immediate and

permanent water-wettability. It also provides high flow rates and long service

life. It features extremely low binding of proteins and preservatives. Integrity

testable, SteriLUX® offers the highest assurance of product integrity and

filtration performance.

Meissner Technical Services (MTS) offers thecomprehensive technical and validation supportthat is essential to our pharmaceutical clients.

Based on ASTM F838-05 liquid bacterial challenge testing, SteriLUX® is a sterilizing grade filter. Its inert PVDF membrane

and polypropylene components provide wide chemical compatibility and thermal stability, enabling effective use in a broad

range of fluids and applications. The SteriLUX® filter is offered with absolute ratings of 0.1 μm, 0.2 μm, 0.4 μm and 0.6 μm.SteriLUX®can be used to filter aqueous solutions and many high surface tension chemicals and solvents.

Design Features

•Modified PVDF membrane for inherent water wettability

•Extremely low protein and preservative binding for maximum product recovery

•Extremely low extractables

•Highest flow rate of any PVDF membrane filter

Typical Applications

SteriLUX®has been optimized for the sterile filtration of critical fluids used in

pharmaceutical and biopharmaceutical manufacturing, including:

•Parenterals

•Antibiotics

•Vaccines

•Diagnostics

•Buffers

•Diluents

•Reagents

•Serum

•Tissue culture media

•Media additives

SteriLUX®can be used for the clarification and purification of:

•Deionized water

•Aqueous solvents

•Acids

•Bases

•Plating solutions

Within the food and beverage industry, SteriLUX® can be used for clarification and

stabilization of fluids, such as:

•Beer

•Wine

•Bottled water

SteriLUX®SEM

Product Specifications

Materials of Construction

Filter Media: Polyvinylidene fluoride(PVDF)

Upstream Support: Polypropylene

Downstream Support: Polypropylene

Core/Outer Guard: Polypropylene

End Caps: Polypropylene

Sealing Method: Thermal bonding

Gaskets/O-rings: Buna, EPR, polyethylene, silicone,

Teflon®, Teflon®over silicone,

Teflon®over Viton®

All materials of construction listed above are FDA approved

for food contact use per 21 CFR 177. Filters comply with

European Commission Directive 2002/72/EC and subsequent

amendments up to Commission Regulation (EU) no 10/2011.

SteriLUX® filters are manufactured in conformance to cGMP.

SteriLUX® filters meet the requirements as specified in the

current USP Class VI plastics, physicochemical, oxidizable

substances, and cytotoxicity tests. Bacterial endotoxin

levels in aqueous extracts of SteriLUX® filters are less than

0.5 EU/mL, as determined using the Limulus amebocyte

lysate (LAL) test. No binders, adhesives or surfactants are

used in the construction of SteriLUX® filters. SteriLUX®

filters are non-fiber-releasing as defined in 21 CFR 210.3(b)(6)

and 211.72

Filtration Ratings

Absolute Ratings (µm)

0.1 μm, 0.2 μm, 0.4 μm and 0.6 μm

Integrity Testing

Minimum Bubble Point, Water

0.1 μm 70 psi (4,8 bar)

0.2 μm 50 psi (3,4 bar)

0.4 μm 28 psi (1,9 bar)

0.6 μm 14 psi (1,0 bar)

Cartridge Dimensions (nominal)

Diameter: 2.75" (7 cm)

Lengths: 10", 20", 30", 40" (25 cm, 50 cm, 75 cm, 100 cm)

Bacterial Retention

ASTM F838-05 Challenge:

VTH/VMH

0.1 μm, 0.2 μm > 107cfu/cm2Brevundimonas diminuta and

meet the FDA definition of a sterilizing grade filter.

0.1 μm ≥ 104cfu/cm2Acholeplasma laidlawii

0.4 μm > 107cfu/cm2Serratia marcescens

0.6 μm > 107cfu/cm2Saccharomyces cerevisiae

Sterilization

Steam-in-place (SIP):

Saturated steam @ 121-135 ˚C, 30-60 minutes[15 psi (1 bar) to 30 psi (2 bar), 30-60 minutes]

Autoclave: 121-135 ˚C, 30-60 minutes

SteriLUX®cartridges are capable of repeated sterilization

cycles without loss of integrity. For applications requiring

autoclave/SIP, a stainless steel reinforcement ring must

be ordered. See “Reinforcement Ring Option” within the

Ordering Information.

Maximum Operating Temperatures & Pressures

∆p 80 psi @ 32 °F to 100 °F

(∆p 5,5 bar @ 0 °C to 38°C)

∆p 60 psi @ 150 °F

(∆p 4,1 bar @ 66 °C)

∆p 30 psi @ 180 °F

(∆p 2,1 bar @ 82 °C)

Typical Water Flow Rates per 10" Cartridge

L min-1

0 5 10 15 20 25 30 35

10

9 0.1 µm

0.2 µm

8 0.4 µm

0.6 µm

7

6

5

4

600

500

400

300

3 200

2

100

1

0 0

0 1 2 3 4 5 6 7 8 9 10

Flow Rate, gpm

InitialDifferentialPressure,psid

∆p(mbar)

-226 O-ring -222 O-ring -226 nO-Ring® -222 nO-Ring®

SteriLUX® Filter Cartridge

End Cap Configuration

External -226 O-rings withlocking tabs; open end forC6

and F6 SOE configurations

External -222 O-rings;openend for C2 and F2 SOE

configurations

External -226 nO-Ring® withlocking tabs; open end forC5


External -222 nO-Ring®, openend for C1 and F1 SOE

configurations

Flat Gasket Internal O-ring Button Cap Alignment Fin Recessed Cap

Flat Gasket; open end forGS

and GL DOE configurations

Internal O-ring; open end for

DN and DA DOE or RN andRA SOEconfigurations

Button Cap; closed endfor

C1, C2, C5 and C6 SOE

configurations

Alignment Fin; closed end for

F1, F2, F5 and F6 SOE

configurations

Recessed Cap; closed end for

RN and RA SOE configurations

Ordering Information

DOE = Double Open End

SOE = Single Open End

FilterGrade

AbsoluteRating (μm)

CartridgeLength

End CapConfiguration

ReinforcementRing Option

Seal Material(O-ring or Gasket)

VMH 0.2 3 F2 R

SIP applications

S

O-ring Seal

B = Buna

E = EPR

S = Silicone

T = Teflon®over silicone

V = Viton®

VLH = PVDF membrane;

not integrity tested

or flushed

(100 cm)F2 = SOE; -222 O-rings, fin end

C5 = SOE; -226 nO-Ring®, button cap end

C6 = SOE; -226 O-rings, button cap end

F5 = SOE; -226 nO-Ring®, fin end

F6 = SOE; -226 O-rings, fin end

DN = DOE; internal -120 O-rings

RN = SOE; internal -120 O-ring,

recessed cap end

DA = DOE; internal -213 O-rings

RA = SOE; internal -213 O-ring,

recessed cap end

X = Teflon®over Viton®

Gasket Seal

B = Buna

E = EPR

P = Polyethylene

S = Silicone

T = Teflon®

V = Viton®

Filter Grade Descriptions

VTH = This absolute, microbially rated filter meets full traceability requirements for the pharmaceutical industry. It is 100% integrity tested and flushed with DI

water during manufacture. Each VTH grade filter is shipped with a Certificate of Quality stating exact quality control criteria and test performance results. This is

a validatable product to meet the stringent requirements of the pharmaceutical industry.

VMH = This sterilizing grade filter is absolute, microbially rated and 100% integrity tested and flushed with DI water during manufacture. It is suited for critical

applications when regulatory documentation requirements are minimal. A Certificate of Conformance is available on a lot basis.

VLH = This filter is not 100% integrity tested or flushed with DI water during manufacture. It is offered as an economical prefilter or final filter when sterility

assurance and validation are not required.

Viton and Teflon are registered trademarks of E. I. du Pont de Nemours and Company

© 2013, 2003 Meissner Filtration Products, Inc. All rights reserved.

VMH 2.0

VTH = Certificated;

fully traceable

0.1 1 = 10"

(25 cm)

GS = DOE; flat gaskets

(9.75", 19.5", 29.25", 39" length filters)

(Blank) = Standard - no

reinforcement ring

PVDF membrane 0.2 2 = 20"

(50 cm)

GL = DOE; flat gaskets

(20", 30", 40" length filters) R = Reinforcement ring;

VMH = Standard 0.4 3 = 30" C1 = SOE; -222 nO-Ring®, button cap end required for autoclave/

PVDF membrane (75 cm) C2 = SOE; -222 O-rings, button cap end

0.6 4 = 40" F1 = SOE; -222 nO-Ring®, fin end

EverLUX® Filter Cartridge

The EverLUX® polyethersulfone (PES) f ilter is designed for very high contaminant capacity, ex tended

service life and high f low with low pressure drop in a wide range of biological f luids.

Opt im ized for ster ile f i lt rat ion, pref i lt rat ion and clar if icat ion applicat ions, the permanent ly

hydrophilic EverLUX® f ilt er of fers up to 2.5 t imes higher f low rates than other PES

membranes. It also offers except ional capacit y, low protein binding and absolutebacteria retent ion when f ilt ering moderate to high contaminant liquids.

The EverLUX® f ilt er incorporates the most technological ly advanced PES membrane

manufactured today. It is produced by a state-of-the art process, which creates a

unique, highly asymmet ric structure with the highest contaminant capacity of any

PES filter.

The membrane’s asymmetr ic structure ex tends its capacity and service life by withstanding

higher part icle loads and protein concentrat ions. Increased membrane thickness allows the

EverLUX® t o retain it s steril izing propert ies, while it s tapered pore st ructure allowsmore contaminant capacit y than even convent ional PES membranes.

The fast-f lowing, high-throughput, low-b ind ing and bacter ia-retent ive propert ies of the

EverLUX®PESmembrane make it avery reliable,cost -ef fect iveand t ime-saving filter.

De sig n Fe ature s and Be ne fits

• Unique, patented PES membrane offers very high f low rates

and except ional service life

• Chemical compat ibilit y across pH 1-14

• Low adsorpt ion, high transmission of proteins, act ive

ingredients and preservat ives

• Superior throughput in high contaminant f luids, including

growth media, serum and protein-containing solut ions

• Lower f ilt rat ion costs through increased service life and

contaminant -holding capacit y

• Permanent ly hydrophilic membrane

• Contains no binders, adhesives or other ex t raneous mater ials

• 100%integrit y tested during manufacture

• Biologically inert and non-toxic, the f ilt er meets FDA

requirements for food contact use and passes USPClass VI

Plast ics biological react ivit y tests

• Filters comply with European Commission Direct ive

2002/ 72/ EC and subsequent amendments up to 2008/ 39/ EC


EverLUX® f ilt ers are ideal for use in arange of low to high

contaminant liquids, including:

• Blood products

• Complex biologicals

• Serum

• Cell and t issue culturemedia

• Process intermediates

• Supernatants

• Vaccines

• Ophthalmics

• Buffers

Meissner Technical Services (MTS)

provides cl ients with completetechnical and validat ion support

for i ts manufactured products.

Product Specif icat ions


Filter Membrane: Polyethersu lfone (PES)

Upst ream Support : Polypropylene

Downst ream Support : Polypropylene

Core/ Outer Guard: PolypropyleneEnd Caps: Polypropylene


O-ring/ Gasket Seal: Buna, EPR, polyethylene, silicone,

Tef lon® over silicone, Tef lon® over Viton®

All materials of construct ion listed above are FDA approved

for food contact use per 21 CFR177. Filters comply

with European Commission Direct ive 2002/ 72/ EC and

subsequent amendments up to 2008/ 39/ EC.

EverLUX® f ilt ers are manufactured in conformance to

cGMP. EverLUX® f ilt ers meet the requirements as specif ied

in the current USP Class VI plast ics, physicochemical,

ox idizable substances, and cytotoxicit y tests. Bacterial

endotoxin levels in aqueous ext racts of EverLUX® f ilt ers

areless than 0.5 EU/ mL, asdetermined using theLimulus

amebocyte lysate (LAL) test . No binders, adhesives or

surfactants are used in the const ruct ion of EverLUX®

f ilt ers. EverLUX® f ilt ers are non-f iber-releasing as def ined

in 21 CFR 210.3(b)(6) and 211.72.

Filtration Ratings

Filter Grade: Absolute Rat ings (µm):

SMH 0.2, 0.4, 0.6

STW 0.2

SLH 0.2, 0.4, 0.6

SLW 0.2

SPH 0.1, 0.2, 0.4

Integrity Testing

Minimum Bubble Point , Water

SMH

0.2 µm 62 psi (4,3 bar)

0.4 µm 40 psi (2,8 bar)

0.6 µm 22 psi (1,5 bar)

Max imum Dif fusion Rate, Water

STW

0.2 µm 30 mL/ min per 10" @30 psi

(30 mL min-1 per 25 cm @ 2,07 bar)

EverLUX® SEM

2.5

2

1.5

1

0.5

0



Lengths: 10", 20", 30", 40"

(25 cm, 50 cm, 75 cm, 100 cm)

Bacterial Retention

ASTM F838-05 Challenge

SMH

0.4 µm > 107 cfu/ cm² Serratia marcescens

0.6 µm > 107 cfu/ cm² Saccharomyces cerevisiae

STW

0.2 µm > 10 7cfu/ cm² Brevundimonasdiminutaand meets

the FDA def init ion of a steril izing grade f ilter.

Sterilization


saturated steam @121-135 °C, 30-60 minutes

[15 psi (1bar) to 30 psi (2 bar), 30-60 minutes]

Autoclave: 121-135 °C, 30-60 minutes

EverLUX® cartr idges are capable of repeated steril izat ion

cycles without loss of integr ity. For applicat ions requiring

autoclave/ SIP, a stainless steel reinforcement ring mustbe ordered. See “Reinforcement Ring Opt ion” withinOrdering Information.

Maximum Operating Temperatures and Pressures

∆p 80 psi @32 °F to 100 °F

(∆p 5,5 bar @ 0 °C to 38 °C)

∆p 60 psi @ 150 °F

(∆p 4,1 bar @ 66 °C)

∆p 30 psi @ 180 °F

(∆p 2,1 bar @ 82 °C)

Typic a l Wa te r Flo w Ra te s pe r 10" C a rtridg e

Lm in -1

0 5 10 15 20 25 30 35

STW 0.2µm

0.2 µm

0.4 µm

0.6 µm

0 1 2 3 4 5 6 7 8 9 10

Flo w Ra te , g pm

160

140

120

100

80

60

40

20

0

Init

ial

Dif

fere

nti

al

Pre

ssu

re,

psid

p(m

ba

r)

- 226 O- ring - 222 O- ring - 226 nO- Ring - 222 nO- Ring

EverLUX® Filter Cartridge

End Cap Conf igurat ion

External -226 O-rings with

locking tabs; open end for C6


External -222 O-rings; open

end for C2 and F2 SOE

configurations

External -226 nO-Ring® with

locking tabs; open end for C5


External -222 nO-Ring®, open


configurations

Flat Gaske t Inte rnal O- ring Butto n C a p Alig nm e nt Fin Re c e sse d Cap

Flat Gasket; open end for GS



DN and DA DOE or RN and

RA SOE configurations

Button Cap; closed end for


configurations



configurations




DOE = Double Open EndSOE = Single Open End

FilterGrade


CartridgeLength

End CapC o nfig ura tio n



SMH 0.2 3 F2 R S

SMH

STW

SLH

SLW

SPH

0.2, 0.4, 0.6

0.2

0.2, 0.4, 0.6

0.2

0.1, 0.2, 0.4

1 = 10"

(25 cm)

2 = 20"

(50 cm)

3 = 30"

(75 cm)

4 = 40"

(100 cm)


(9.75", 19.5", 29.25", 39" length filters)


(20", 30", 40" length fil ters)

C1 = SOE; -222 nO-Ring®, but ton cap end

C2 = SOE; -222 O-rings, but ton cap end

F1 = SOE; -222 nO-Ring®, f in end

F2 = SOE; -222 O-rings, f in end






reinforcement ring

R = Reinforcement ring;

required for autoclave/

SIP applicat ions

O-ring Seal

B = Buna

E = EPR

S = Silicone

T = Teflon® over sil icone

V = Viton®

X = Teflon® over Viton®

Gasket Seal

B = Buna

E = EPR

P = Polyethylene

Grade Descriptions


RN = SOE; internal -120 O-rings,

recessed cap end


RA = SOE; internal -213 O-rings,

recessed cap end

S = Silicone

T = Teflon®

V = Viton®

SMH = This standard , sing le layer PES mem brane featu res a high ly asymm et ric pore st ructu re. It is 100%in tegr i t y tested and flushed during manufactu re. It is su ited fo r cr i t ical app licat ionswhen regulatory documentation requirements are minimal.

STW = This pharmaceut ical val idated , steri l iz ing grade fi l t er featu res two ser ial ly layered , high ly asymm et ric PES mem branes with the coarser upst ream layer op t imized fo r pref i l t rat ion. Thisfi l t er meet s fu l l t raceab i l i t y requ irement s fo r the pharmaceut ical indust ry. Each STW fi l t er is shipped with a Cer t i f icate of Qual i t y stat ing exact qual i t y con t rol cr i t er ia and test per fo rm ance resu lt s.

SLH = This sing le layer PES mem brane featu res a high ly asymm et ric pore st ructu re, bu t is no t 100%in tegri t y tested or flushed dur ingmanufacture. It is offered as an economical pre-filter or final f iler when sterilit y assurance is not required.

SLW = This fi l t er featu res two ser ial ly layered , highly asymm et ric PES mem branes with the coarser upst ream layer op t imized fo rpref i l t rat ion . This fi l t er is no t 100%in tegri t y tested or flushed dur ing manufactu re. It is of fered as an econom ical pre-f i l t er or finalf ilter that provides longer life in biological solut ions.SPH = This is an absolute, part iculate rated filter. It is 100%integrit y tested and DI flushed during manufacture.

Vit on and Tef lon ar e registered tradem ar ks of DuPont Dow Elastom er s L.L.C. & The DuPont Com pany© 2011, 2003 Meissner Filt ration Products, Inc.

STyLUX® Filter Cartridge

The STyLUX® filter cartridge is an absolute rated, pleated polyethersulfone (PES) membrane filter designed to provide greater

bacteria and particle removal at high flow rates and extremely low pressure drops. It offers the greatest assurance of filtration

performance, stability and service life for controlling contaminants in demanding environments.

The exceptional performance of STyLUX® is derived from its unique filtration media.

The filter media is made by a patented process which produces an asymmetric

polyethersulfone membrane that is inherently hydrophilic. The membrane is a highly

porous structure whose pore size decreases progressively through its depth. This

highly durable structure maintains consistent porosity and contaminant retention

throughout its operational life without shedding or unloading particles. This results

in a filter that provides absolute retention and

superior flow rates, cleanliness and throughputs,

even in severe process conditions.

For applications requiring Mycoplasma removal,

Meissner offers the STyLUX®SC0.1 filter. This sterilizing

grade filter provides 100% retention of Mycoplasma per modified ASTM F838 Challenge,

while delivering the highest reliability and security for the sterilization of serum, culture

media and other biological fluids.

All components of the STyLUX® filter cartridge comply with FDA regulations

for food contact use. A unique state-of-the-art process thermally bonds

the membrane and polypropylene support components to the cartridge end

caps. This provides an integral filter cartridge that has excellent chemical

compatibility and extremely low extractables in a wide range of fluids and

applications.

Features and Benefits

•Durable PES and PP components

STyLUX® is ideal for the clarification and cold sterilization of

beverages, including:

•Absolute ratings of 0.04, 0.1, 0.2, 0.4 and 0.6 μm

•Highly porous asymmetric membrane

•Mineral water

•Wine and wine coolers

•Soft drinks

•Draft beer

•Extremely high flow rates at low pressure drops

•Permanently hydrophilic membrane

•Integrity testable in water

The wide chemical resistance of PES and PP makes the

STyLUX® filter perfectly suited for the purification of chemicals

such as:

•Contains no binders, adhesives or other extraneous materials

•High thermal and hydrolytic stability

•Acids & bases

•Alcohols

•Aldehydes

•Resistant to oxidizing agents

•Rugged, thermally bonded construction

•Biologically inert and non-toxic

STyLUX® is designed for the removal of particulates, colloids

and microorganisms from a broad variety of pharmaceutical

and biological solutions, including:

•High protein transmission

•100% integrity tested during manufacture


STyLUX®meets the critical demand for contamination control in

the chemical, microelectronics, aerospace, food and beverage,

biologicals, veterinary, pharmaceutical and other industries.

STyLUX®may be used as either a prefilter or final filter. It offers

the greatest security for bulk and point-of-use filtration.

STyLUX® provides high quality filtration for a variety of ultrapure

water requirements, including:

•Deionized water

•High temperature water

•Chemically treated water

•Serum & blood-based products

•Tissue culture media

•Microbiological growth media

•Ophthalmics

•Oral and topical medications

•Diagnostics

•Protein solutions

•Antibiotics

•Vaccine preparations

0.04 µm

0.1 µm

0.2 µm

0.4 µm

0.6 µm




Filter Media: Polyethersulfone (PES)

Upstream Support: Polypropylene (PP)




Sealing Method: Thermal Bonding

O-ring/Gasket Seal: Buna, EPR, polyethylene, silicone,

Teflon®over silicone, Teflon®over Viton®


for food contact use per 21 CFR 177. Filters comply with

European Commission Directive 2002/72/EC and subsequent

amendments up to Commission Regulation (EU) no 10/2011.

STyLUX®filters are manufactured in conformance to cGMP.

STyLUX®filters meet the requirements as specified in the


substances, and cytotoxicity tests. Bacterial endotoxin levels

in aqueous extracts of STyLUX® filters are less than 0.5 EU/

mL, as determined using the Limulus amebocyte lysate (LAL)

test. No binders, adhesives or surfactants are used in the

construction of STyLUX® filters. STyLUX® filters are non-fiber-

releasing as defined in 21 CFR 210.3(b)(6) and211.72.

Filtration Ratings

Filter Grade: Absolute Ratings (µm):

SM, ST, SL 0.04, 0.1, 0.2, 0.4, 0.6

SP 0.04, 0.1, 0.2, 0.4

SC 0.1

Integrity Testing

Minimum Bubble Point, Water

Bacterial Retention

ASTM F838-05 Challenge:

SM/ST

0.04 μm, 0.1 μm, 0.2 μm > 107 cfu/cm2 Brevundimonas

diminuta and meet the FDA definition of a sterilizing grade filter.

0.04 μm > 107 cfu/cm2Acholeplasma laidlawii

0.1 μm ≥ 104cfu/cm2Acholeplasma laidlawii

0.4 μm > 107 cfu/cm2Serratia marcescens

0.6 μm > 107 cfu/cm2Saccharomyces cerevisiae

SC

0.1 μm > 107 cfu/cm2Brevundimonas diminuta and meets the

FDA definition of a sterilizing grade filter.

0.1 μm > 107 cfu/cm2Acholeplasma laidlawii

Sterilization


saturated steam @ 121-135 ˚C, 30-60 minutes[15 psi (1 bar) to 30 psi (2 bar), 30-60 minutes]


STyLUX®cartridges are capable of repeated sterilization cycles

without loss of integrity. For applications requiring autoclave/

SIP, a stainless steel reinforcement ring must be ordered.

See “Reinforcement Ring Option” on back page. (Membrane

must be wet prior to steam sterilization. Reference “Green

Docs” online for more information.)


Δp 80 psi @ 32 °F to 100 °F

(Δp 5,5 bar @ 0 °C to 38°C)

Δp 60 psi @ 150 °F

(Δp 4,1 bar @ 66 °C)

Δp 30 psi @ 180 °F

(Δp 2,1 bar @ 82 °C)


L min-1

0 5 10 15 20 25 30 35


Diameter: 2.75" (7 cm) 8

Lengths: 10", 20", 30", 40" 7

(25 cm, 50 cm, 75 cm, 100 cm)6

5

4

600

500

400

300

3 200

2

100

1

0 0

0 1 2 3 4 5 6 7 8 9 10

Flow Rate, gpm

∆p(mbar)

SM/ST0.04 µm 115 psi (7,9 bar)

0.1 µm

0.2 µm

0.4 µm

0.6 µm

80 psi

44 psi

32 psi

18 psi

(5,5 bar)

(3,0 bar)

(2,2 bar)

(1,2 bar)

SC

0.1 µm 110 psi (7,6 bar) 10

9


STyLUX® Filter Cartridge


External -226 O-rings withlocking tabs; open end forC6


External -222 O-rings;openend for C2 and F2 SOE

configurations

External -226 nO-Ring® withlocking tabs; open end forC5


External -222 nO-Ring®, openend for C1 and F1 SOE

configurations





DN and DA DOE or RN andRA SOEconfigurations



configurations



configurations






FilterGrade


CartridgeLength




SM 0.2 3 F2 R S

O-ring Seal

B = Buna

E = EPR

S = Silicone

T = Teflon®over silicone

V = Viton®

X = Teflon®over Viton®

Gasket Seal

B = Buna

E = EPR

P = Polyethylene

S = Silicone

T = Teflon®

V = Viton®

Grade Descriptions

SM = This sterilizing grade filter is absolute, microbially rated and 100% integrity tested and flushed with DI water during manufacture. It is suited for critical applications whenregulatory documentation requirements are minimal. A Certificate of Conformance is provided.

ST = This sterilizing grade, absolute microbially rated filter meets full traceability requirements for the pharmaceutical industry. It is 100% integrity tested and flushed with DI waterduring manufacture. Each ST grade filter is shipped with a Certificate of Quality that gives precise information on the quality, integrity and acceptance criteria of the filter. This is avalidatable product to meet the stringent requirements of the pharmaceutical industry.

SC0.1 = This is a sterilizing grade filter designed specifically for the 100% removal of Mycoplasma. It is 100% integrity tested and DI flushed during manufacture and it has the addedbenefit of certification that meets the critical needs of the pharmaceutical, biotechnology and related industries. Each SC0.1 filter comes with a Certificate of Quality that gives preciseinformation on the quality, integrity and acceptance criteria of the filter.

SL = This filter is not 100% integrity tested or flushed with DI water during manufacture. It is offered as an economicalprefilter or final filter when sterility assurance and validation are not required. A Certificate of Conformance is provided.

SP = This is an absolute, particulate rated filter. It is 100% integrity tested and DI flushed during manufacture.A Certificate of Conformance is provided.

SM 0.04, 0.1, 0.2, 1 = 10" GS = DOE; flat gaskets (Blank) = Standard -

0.4, 0.6 (25 cm) (9.75", 19.5", 29.25", 39" length filters) no reinforcement ring

2 = 20" GL = DOE; flat gaskets

ST 0.04, 0.1, 0.2, (50 cm) (20", 30", 40" length filters) R = Reinforcement ring;

0.4, 0.6 3 = 30"

(75 cm)

C1

C2

=

=

SOE; -222 nO-Ring®, button cap end

SOE; -222 O-rings, button cap end


SIP applications

SC 0.1 4 = 40" F1 = SOE; -222 nO-Ring®, fin end

SL 0.04, 0.1, 0.2,(100 cm)


0.4, 0.6 C5 = SOE; -226 nO-Ring®, button cap end


SP 0.04, 0.1, F5 = SOE; -226 nO-Ring®, fin end

0.2, 0.4 F6 = SOE; -226 O-rings, fin end



recessed cap end



recessed cap end

Steridyne®Filter Cartridge

Steridyne® f il ter cart ridges are hydrophobic, pleated, 0.2 µm absolute-rated PVDF membrane fil ters. In air andgas streams, they are virus retent ive and wil l remove contaminants to 0.01 µm. Offering high flow rates andbroad chemical compat ibil ity, the Steridyne® f il ter is ideal for the removal of part icles and microorganismsfrom gases in the pharmaceut ical, biologicals, chemical, and food and beverage industries. It is opt im ized forsterile tank vent ing, fermentat ion air and compressed air and gas f iltrat ion applicat ions.

The Steridyne® f il ter can also be used to fil ter many low surface tension chemicals and solvents.It is a sterilizing grade filter, based on ASTM F838-05 liquid bacterial challenge test ing.

The Steridyne® PVDF filter membrane is manufactured by Meissner ’s state-of -the-art process.All f il ter support components are polypropylene. Through a unique process, the membraneand polypropylenesupport componentsarethermally bonded to thecartridgeend caps.This produces an integral f il ter cart ridge with excellent mechanical st rength, wide chemicalcompat ibility and minimal extractables.

The Steridyne® f il ter ’s PVDF membrane is made without wet t ing agents, post treatmentsor other added materials. Steridyne® f iltersarecert if ied asnon-f iber-releasing. EachSteridyne® f il ter car t ridge is 100%integrity tested during manufacture. Each lot is tested forbacterial retent ion, according to ASTM methodology.

Fe a ture s a nd Be ne fits

• Inert , rugged PVDF membrane and polypropylenecomponentsof fer widechemical compat ibili tyand thermal strength in abroad rangeof f luidsand applicat ions

• Absolute 0.2 µm rated fil ter meets steril iz ing gradefil ter criteria per ASTM F838-05 methodology andis virus retent ive in air and gas applicat ions


Steridyne®meets theneed for crit ical contaminat ioncontrol in the pharmaceut ical, biologicals,biopharmaceut ical, bioprocessing, microelect ronics,chemical, food and beverage and other processindustries. It wil l remove part icles and microorganismsfrom awiderangeof process fluids. Typicalair and gasapplicat ions include:

• Contains no binders or adhesives for wide solventcompat ibili tywith extremely low extractables

• 100%integrity tested during manufacture to ensureproduct integrity, consistency and reliability

• Integrity testable for assured product integrity and

• Sterile tank vent ing

• Process gases

• Compressed air

• Fermentor inlet air and

off-gases

• Nitrogen and other

inert gases

• Bioreactor inlet and

out let air

ef fect iveness in operat ion

• Biologically iner t and non-tox ic, the fil ter meets FDArequirements for food contact useand passesUSPClass VI Plast ics biological react ivity tests

Steridyne® wets immediately in compat ible non-aqueousliquids. In aqueous liquids, the Steridyne® f il ter must bepre-wet by immersion in a low surface tension liquid(<35 dynes/ cm). Typical liquid applicat ions include:*

• Filters comply with European Commission Directive2002/ 72/ ECand subsequent amendments upto 2008/ 39/ EC

• Acids

• Alcohols

• Ant ibiot ic andsolvent mix tures

• Solvents

• Weak bases

* Not recomm ended for concent rated chlorinated hydrocarbon andketonesolut ions. Consult Meissner for chemical compat ibil it y.

Steridyne® SEM

0.2 µm

Product Specif icat ions


Filter Membrane: Polyvinylidene Fluoride (PVDF)

Upstream Support : Polypropylene

Downstream Support : Polypropylene

Core/ Outer Guard: Polypropylene



O-ring/ Gasket Seal: Buna, EPR, polyethylene, sil icone,Teflon® over silicone, Teflon® over Viton®

All materialsof construct ion listed aboveareFDAapproved for food contact use per 21 CFR 177.Fil ters comply with European Commission Directive2002/ 72/ ECand subsequent amendments upto 2008/ 39/ EC.

Steridyne® f il ters are manufactured in conformancetocGMP. Steridyne® f iltersmeet the requirementsas specif ied in the current USPClass VI plast ics,physicochemical, ox idizable substances, andcytotox icity tests. Bacterial endotox in levels inaqueous extracts of Steridyne® f il ters are less than0.5 EU/ mL, as determined using the Limulusamebocyte lysate (LAL)test . No binders, adhesivesorsurfactants are used in the construct ion of Steridyne®

f ilters. Steridyne® f ilters are non-f iber-releasing asdef ined in 21 CFR210.3(b)(6) and 211.72.

Filtration Rating (Absolute)

0.2 µm

Integrity Testing

Minimum Bubble Point , 60%IPA18 psi (1,2 bar)


Diameter: 2.75" (7 cm)Lengths: 10", 20", 30", 40"(25 cm, 50 cm, 75 cm, 100 cm)

Bacterial Retention

Steridyne® retains >107cfu/ cm2Brevundimonas

diminuta, qualifying it as a steril iz ing grade filter, perASTM F838-05 liquid challenge methodology.

Sterilization

Steam-in-place (SIP):saturated steam @121-135 °C, 30-60 minutes[15 psi (1 bar) to 30 psi (2 bar), 30-60 minutes]

Autoclave: 121-135 °C, 30-60 minutes

Steridyne®cartridges arecapable of repeatedsterilizat ion cycles without loss of integrity. Forapplicat ions requiring autoclave/ SIP, a stainlesssteel reinforcement ring must be ordered. See“Reinforcement Ring Opt ion” in Ordering Informat ion.


∆p 80 psi @32 °F to 100 °F(∆p 5,5 bar @0 °C to 38 °C)

∆p 60 psi @ 150 °F(∆p 4,1 bar @ 66 °C)

∆p 30 psi @ 180 °F(∆p 2,1 bar @ 82 °C)

Typic a l Wa te r Flo w Ra te s pe r 10" C a rtridg e

L m in- 1

0 10 20 306

5

4

3

2

1

0

400

350

300

250

200

150

100

50

0

2.0

1.8

1.6

1.4

1.2

1.0

0.8

0.6

0.4

0.2

0

Typic a l Air Flo w Ra te s pe r 10" C a rtridg e

Nm 3 hr- 1

0 20 40 60 80 100

0.2 µm

120

100

80

60

40

20

0

0 1 2 3 4 5 6 7 8 9 10

Flo w Ra te , g pm

0 10 20 30 40 50 60

Flo w Ra te , sc fm

∆p

(mb

ar)

Init

ial

Dif

fere

nti

al

Pre

ssu

re,

psid

∆p

(mb

ar)

Init

ial

Dif

fere

nti

al

Pre

ssu

re,

psid

- 226 O- ring - 222 O- ring - 226 nO- Ring - 222 nO- Ring

Steridyne®Filter Cartridge

End Cap Conf igurat ion


locking tabs; open end for C6and F6 SOE configurations

External -222 O-rings; open

end for C2 and F2 SOEconfigurations


locking tabs; open end for C5and F5 SOE configurations



Flat Gaske t Inte rnal O- ring Butto n C a p Alig nm e nt Fin Re c e sse d Cap

Flat Gasket; open end for GS




RA SOE configurations



configurations



configurations





FilterGrade


CartridgeLength

End CapC o nfig ura tio n



VMV 0.2 - 3 F2 R S

VMV

VTV

0.2

0.2

1 = 10"

(25 cm)

2 = 20"

(50 cm)

3 = 30"

(75 cm)

4 = 40"


(9.75", 19.5", 29.25", 39" length filters)


(20", 30", 40" length fil ters)





reinforcement ring



SIP applicat ions

O-ring Seal

B = Buna

E = EPR

S = Silicone

T = Teflon® over sil icone

V = Viton®

X = Teflon® over Viton®

l

Grade Descriptions

VMV = This ster i l izing grade fi l t er is abso lute, microb ial ly rated and 100%in tegr it y tested dur ing manufactu re. It is su ited for cr i t ical app licat ions when regu lato ry document at ion requ irement s areminimal. A Cert if icate of Conformance is available on a lot basis.

VTV = Th is abso lute, microb ial ly rated , ster i l izing grade fi l t er meet s fu l l t raceab i l i t y requ irem ent s fo r the pharmaceut ical indust ry. It is 100%in tegr it y tested dur ing manufactu re. Each VTV grade fi l t er issh ipped with a Cer t i f icate of Qual i t y stat ing exact qual i t y con t rol cri t er ia and test per fo rm ance resu lt s. This is a val idatab le product to meet the st r ingent requ irement s of the pharmaceut ical indust ry.

(100 cm) F2 = SOE; -222 O-rings, f in end

C5 = SOE; -226 nO-Ring®, but ton cap end Gasket Sea

C6 = SOE; -226 O-rings, but ton cap end B = Buna

F5 = SOE; -226 nO-Ring®, fin end E = EPR

F6 = SOE; -226 O-rings, f in end P = Polyethylene

DN = DOE; internal -120 O-rings S = Silicone

RN = SOE; internal -120 O-rings, T = Teflon®

DA =

recessed cap end

DOE; internal -213 O-rings

V = Viton®


recessed cap end

Chemdyne®Filter Cartridge

The Chemdyne® filter cartridge is an absolute rated, pleated membrane filter that is

constructed of 100% pure polypropylene. It provides maximum chemical compatibility,

performance and economy while controlling contaminants in critical processes.

Its pure polypropylene membrane is made by a patented process, which produces a

highly porous structure that is inherently hydrophobic. This uniform structure

maintains consistent porosity and particle retention throughout its operational life,

even after repeated in-line steam sterilization or autoclaving. A unique,

state-of-the-art process thermally bonds the filter and support components to the

cartridge end caps. This produces an integral filter cartridge with excellent

chemical compatibility and exceptionally low extractables levels.

Available in absolute retention ratings of 0.04, 0.1 and 0.2 micron, the Chemdyne® filter

offers a cost effective alternative to PTFE membrane filter cartridges. Constructed entirely of inert polypropylene, the

Chemdyne® filter offers similar chemical compatibility, reliability, and performance of PTFE membrane cartridges.


• 100% polypropylene components provide wide

chemical compatibility and permit use in a broad

range of fluids and applications

• Absolute ratings of 0.04, 0.1 and 0.2 micron deliver

precise particle retention at rated level

• Unique polypropylene membrane offers high flow

rates, long service life and is a cost effective

alternative to PTFEmembranes

• Inherently hydrophobic membrane provides a natural

barrier to water without the use of additives or

surface modifying agents which can leach or wash out

• Rugged, thermally bonded construction ensures

reliable integrity under severe process conditions and

withstands multiple sterilizations

• Contains no binders or adhesives for wide solvent

compatibility with extremely low extractables

• Fully integrity testable for assurance of product

integrity and effectiveness in operation

• 100% integrity tested by factory to guarantee

product reliability and consistency

• Biologically inert and non-toxic - Chemdyne®

meets FDA requirements for food contact use and

is biosafe in compliance with USP Class VI biological

reactivity tests


Chemdyne®meets the critical demand for contamination

control in the chemical, microelectronics, aerospace,

photonics, biologicals, pharmaceutical, cosmetics, and

other industries. The Chemdyne® cartridge is designed for

the removal of particulates, colloids and microorganisms

from solvents, corrosive chemicals and gases. It also

offers high security for bulk and point-of-use filtration.

Typical chemicals include:

• Acids

• Bases

• Alcohols

• Solvents

• Etchants

• Photoresists

• Photolithographic solutions

For aqueous solutions, the Chemdyne® filter must

be pre-wet by immersion in a suitable low surface

tension fluid.

The inherently hydrophobic Chemdyne® filter is ideal

for gas filtration applications which include:

• Compressed air

• Fermentation air

• Pressurized gases

• Tank ventilation




Filter Media: Polypropylene






O-ring/Gasket Seal: Buna, EPR,

polyethylene, silicone, Teflon® over silicone,

Viton®, Teflon® over Viton®

Filtration Ratings

Filter Grade: Absolute Ratings (µm):

PM 0.04, 0.1, 0.2

PT 0.2

Integrity Testing

Minimum Bubble Point, 60% IPA

0.04 µm 29 psi (2,0 bar)

0.1 µm 24 psi (1,7 bar)

0.2 µm 10 psi (0,7 bar)



Lengths: 10", 20", 30", 40"

(25 cm, 50 cm, 75 cm, 100 cm)

Bacterial Retention

ASTM F838-05 Challenge

0.1 µm, 0.2 µm > 107 cfu/cm2Brevundimonas diminuta

(0.1 µm, 0.2 µm meet the FDA definition

of a liquid rated sterilizing grade filter.)

Sterilization


saturated steam @ 121-135 ˚C, 30-60 minutes[15-30 psi (1-2 bar), 30-60 minutes]

Autoclave: 121-125 ˚C, 30-60 minutesChemdyne® cartridges are capable of repeated

sterilization cycles without loss of integrity.

For applications requiring autoclave/SIP, a

stainless steel reinforcement ring must be ordered.

See “Reinforcement Ring Option” on back page.

Maximum Operating Temperatures

and Pressures

80 psid @32°F to 100°F

(∆p 5,5 bar @ 0°C to 38°C)

60 psid @150°F

(∆p 4,1 bar @ 66°C)

30 psid @180°F

(∆p 2,1 bar @ 82°C)


L min-1

0 5 10 15 20 25 30 35

10

9

80.04 µm

0.1 µm

7 0.2 µm

6

5

4

3

2

1

600

500

400

300

200

100

3.0

2.5

2.0

1.5

1.0

0.5

Typical Air Flow Rates per 10" Cartridge

Nm3hr-1

0 20 40 60 80 100

0.04 µm

0.1 µm

0.2 µm

200

150

100

50

0 0

0 1 2 3 4 5 6 7 8 9 10

Flow Rate, gpm

0.0 0

0 10 20 30 40 50 60

Flow Rate, scfm

∆p(mbar)

∆p(mbar)


Chemdyne®Filter Cartridge


-226 O-ring -222 O-ring -226 nO-Ring -222 nO-Ring


locking tabs; open end forC6and F6 SOE configurations

External -222 O-rings;open


External -226 nO-Ring®with









RA SOEconfigurations



configurations



configurations



Ordering InformationDOE = Double Open End


FilterGrade

AbsoluteRating (µm)

CartridgeLength




PM 0.2 - 3 F2 R S

1 = 10"

(25 cm)

2 = 20"

(50 cm)

3 = 30"

(75 cm)

4 = 40"

(100 cm)


(9.75", 19.5", 29.25", 39" lengthfilters)


(20", 30", 40" length filters)



F1 = SOE; -222 nO-Ring®, fin end


(Blank) = Standard -

no reinforcement ring

R = Reinforcement

ring; required for

autoclave/SIP

applications

O-ring Seal

B= Buna

E= EPR

S= Silicone

T= Teflon ® over Silicone

V= Viton ®

X= Teflon ® over Viton®

C5 = SOE; -226 nO-Ring®, button cap end Gasket Seal

F5 = SOE; -226 nO-Ring®, fin end B= Buna





recessed cap end



recessed cap end

E= EPR

P= Polyethylene

S= Silicone

T= Teflon ®

V= Viton ®

Grade Descriptions

PM = This sterilizing grade filter is absolute, microbially rated and 100% integrity tested during manufacture. It is suited for critical applications when regulatory documentation

requirements are minimal. A Certificate of Conformance is available on a lot basis.

PT = This absolute, microbially rated, sterilizing grade filter meets full traceability requirements for the pharmaceutical industry. It is 100% integrity tested during manufacture.

Each PT grade filter is shipped with a Certificate of Quality stating exact quality control criteria and test performance results. This is a validatable product to meet the stringent

requirements of the pharmaceutical industry.

Viton and Teflon are registered trademarks of DuPont Dow Elastomers L.L.C. & The DuPont Company

© 2008, 2000, 1995 Meissner Filtration Products, Inc.

PM 0.04, 0.1, 0.2

PT 0.2

Protec® Filter Cartridge

The Protec® f i lter is a glass microf iber pref i lter optimized

to protect downstream sterile f ilters. The Protec®RF f i lter

contains a single layer of borosilicate glass f iber media in a

choice of absolute-rated 0.5 µm or 1 µm. The Protec®RM f i lter

is available in a choice of absolute-rated 0.2 µm, 0.3 µm or

0.5 µm and combines an outer layer of borosilicate glass f iber

media with an inner layer of Meissner’s proprietary hydrophilic

SteriLUX®PVDF membrane.

Protec® f i lters provide consistent submicron contaminant

removal, high dirt-holding capacity and high f low rates, while

removing colloids, aggregated and non-product proteins, lipids

and other particles. Protec®effectively protects downstream

membrane f ilters and equipment. These f i lter cartridges are

available in lengths of 10, 20, 30 and 40 inches.


•RF version can be specif ied in 0.5 µm and 1 µm

absolute-rated

•RM version can be specif ied in absolute-rated

0.2 µm, 0.3 µm and 0.5 µm

•High f low rates and excellent f i ltration economics

•High contaminant holding capacity provides a long

service life

•All-polypropylene support materials provide wide

chemical compatibility and permit use in a broad

range of f luids

•Protec®RM combines the retention performance

of a PVDF membrane with the high adsorption and

contaminant-holding capacity of a glass f iber media


Protec® f ilters are ideal for clarif ication, pref iltration

and bioburden reduction in a variety of applications.

•Biological liquids, including serum, plasma fractions

and other blood products

•Vaccines

•Tissue and cell culture media

•Protein solutions

•Fermentation media and feeds

•Cell removal from fermentation broths

•Pre-column chromatography

•Biopharmaceuticals

Product Specif ications


Filter Media

RF (single layer): Borosilicate glass microf iber

RM (double layer): Borosilicate glass microfiber

with SteriLUX®PVDF membrane




O-ring/Gasket Seal: Buna, EPR, polyethylene, silicone,

Tef lon®over silicone, Teflon®over Viton®


for food contact use per 21 CFR 177.

Protec® f i lters are manufactured in conformance to cGMP.

Protec® f i lters meet the requirements as specif ied in the


substances, and cytotoxicity tests. Protec® f ilters are non-

f iber-releasing as def ined in 21 CFR 210.3(b)(6) and 211.72.

Filtration Ratings

Filter Grade Absolute Particulate Ratings

RF 0.5 µm, 1 µm

RM 0.2 µm, 0.3 µm, 0.5 µm



Lengths: 10", 20", 30", 40"

(25 cm, 50 cm, 75 cm, 100 cm)

Typical Microbial Retention per cm2

Grade Rating Organism LRV

RF 0.5 µm Saccharomyces cerevisiae 6

RM 0.5 µm Serratia marcescens 5

Saccharomyces cerevisiae ≥7

RM 0.3 µm Serratia marcescens 6

RM 0.2 µm Serratia marcescens ≥7

Sterilization


Saturated steam @ 121-135 ˚C, 30-60 minutes

[15 psi (1 bar) to 30 psi (2 bar), 30-60 minutes]


For applications requiring autoclave/SIP, a stainless steel

reinforcement ring must be ordered. See “Reinforcement

Ring Option” within Ordering Information.


∆p 80 psi @ 32 °F to 100°F

(∆p 5,5 bar @ 0 °C to 38 °C)

∆p 60 psi @ 150 °F

(∆p 4,1 bar @ 66 °C)

∆p 30 psi @ 180 °F

(∆p 2,1 bar @ 82 °C)


L min-1

3.0

0 10 20 30

RM 0.2 µm

200

2.5

2.0

RM 0.3 µm

RM 0.5 µm

RF 0.5 µm

RF 1 µm

150

1.5 100

1.0

50

0.5

0.0 0

0 1 2 3 4 5 6 7 8 9 10

Flow Rate, gpm


∆p(mbar)


Protec® Filter Cartridge

End Cap Conf iguration

















configurations



configurations






FilterGrade


CartridgeLength




RM 0.2 3 F2 R S

RF = Borosilicate

glass microf iber media

(single layer)

RM = Borosilicate

glass microf iber media

(outer layer) combined

with a hydrophilic

PVDF membrane

(inner layer)

0.5, 1

0.2, 0.3, 0.5

1 = 10"

(25 cm)

2 = 20"

(50 cm)

3 = 30"

(75 cm)

4 = 40"

(100 cm)

GS = DOE; f lat gaskets

(9.75", 19.5", 29.25", 39" length f ilters)

GL = DOE; f lat gaskets

(20", 30", 40" length f i lters)











recessed cap end



recessed cap end


reinforcement ring



SIP applications

O-ring Seal

B = Buna

E = EPR

S = Silicone

T = Tef lon®over silicone

V = Viton®

X = Tef lon®over Viton®

Gasket Seal

B = Buna

E = EPR

P = Polyethylene

S = Silicone

T = Tef lon®

V = Viton®

ALpHA® Filter Cartridge

ALpHA® f ilter cartridges are absolute rated, pleated depth-type f i lters that are constructed of 100% polypropylene. ALpHA®

cartridges are high contaminant capacity f i lters that are available in absolute particle retention ratings from 0.45 to 70 micron.

The ALpHA® f ilter’s polypropylene media is made from a process which produces a self-bonded structure comprised of multiple

layers of successively f iner f ibers and smaller pores. This unique

construction results in a highly porous, tapered pore structure

with a controlled, absolute rated inner layer and several outer

pref i lter layers to substantially increase dirt holding capacity.

This f i lter matrix of decreasing pore size and remarkably high

void volume provides superior f low rates at low pressure drops

and high throughputs, while achieving submicron retentions,

high eff iciencies and extraordinary dirt holding capacities.

All components of the ALpHA® f i lter cartridge use FDA approved

polypropylene. By a unique, state-of-the-art process, the f i lter

media and its support structure are thermally bonded to the

end caps. This provides an integral f ilter cartridge, which has

excellent chemical compatibility and minimum extractables in a

wide range of f luids and applications. ALpHA® f i lter cartridges are

offered in a range of lengths and styles to allow service in most

standard f i lter housings.

Meissner Technical Services (MTS) provides clients with completetechnical and validation support for its manufactured products.

Features

•All-polypropylene construction

•Particle removal ratings from 0.45 to 70 µm

•Self-bonded f i lter media

•Tapered pore structure delivers high dirt

holding capacity

•Contains no binders, adhesives or surfactants

•Biologically inert and non-toxic

Benef its

Wide chemical compatibility for use in a broad range of f luids

Greater selection of optimum f ilter media for precise particle retention at

desired rating

Fixed pore structure, consistent particle removal, no migration of f i lter

media, non f iber releasing

Long f ilter service life, large throughputs, lower operating costs

Wide solvent compatibility, extremely low extractables, quickly rinses

to 18 meg-ohm

Meets FDA requirements for food contact and complies with European

Commission Directives; passes USP Class VI biological tests for plastics


ALpHA®polypropylene f ilter cartridges are ideal for applications where high quality f i ltration and economy are important. They may

be used as either pref i lters or as f inal f i lters. For selected applications, they are a low cost alternative to membrane f ilter cartridges.

•Water Purif ication

•Chemicals

•Solvents

•Biologicals

•Pharmaceuticals

•Ophthalmics

•Cosmetics

•Diagnostics

•Serum Products

•Food and Beverage

•Syrups

•Microelectronics

•Photonics

•Coatings

•Printing

•Metal Finishing

•Photovoltaics/Solar

•Petrochemicals

•Oil Well Production

•Compressed Air and Gasses

ALpHA®SEM

0.45 µm0.6 µm0.8 µm1.2 µm2.4 µm5 µm7 µm10 µm20 µm30 µm40 µm

Product Specif ications


Filter Media: Polypropylene






O-ring/Gasket Seal: Buna, EPR, polyethylene,

silicone, Tef lon®over silicone,

Tef lon®over Viton®

All materials of construction listed above are FDA

approved for food contact use per 21 CFR 177. Filters

comply with European Commission Directive

2002/72/EC and subsequent amendments up to

Commission Regulation (EU) No. 10/2011.

ALpHA® f ilters are manufactured in conformance

to cGMP. ALpHA® f i lters meet the requirements

as specif ied in the current USP Class VI plastics,

physicochemical, oxidizable substances, and

cytotoxicity tests. Bacterial endotoxin levels in

aqueous extracts of ALpHA® f i lters are less than

0.5 EU/mL, as determined using the Limulus

amebocyte lysate (LAL) test. No binders, adhesives

or surfactants are used in the construction of ALpHA®

f i lters. ALpHA® f i lters are non-f iber-releasing as

def ined in 21 CFR 210.3(b)(6) and 211.72.

Filtration Ratings

Absolute Pore Sizes (µm):

0.45, 0.6, 0.8, 1.2, 2.4, 5, 7,10, 20, 30, 40, 70



Lengths: 10", 20", 30", 40"

(25 cm, 50 cm, 75 cm, 100 cm)

Sterilization


Saturated steam @ 121-135 ˚C, 30-60 minutes[15 psi (1 bar) to 30 psi (2 bar), 30-60 minutes]


ALpHA®cartridges are capable of repeated sterilization

cycles without loss of integrity. For applications requiring

autoclave/SIP, a stainless steel reinforcement ring must be

ordered. See “Reinforcement Ring Option” on back page.


∆p 80 psi @ 32 °F to 100°F

(∆p 5,5 bar @ 0 °C to 38 °C)

∆p 60 psi @ 150 °F

(∆p 4,1 bar @ 66 °C)

∆p 30 psi @ 180 °F

(∆p 2,1 bar @ 82 °C)

The removal ratings given in the chart represent actual dynamic measurementsobtained from controlled laboratory tests using latex spheres in DI water at a flowrate of 2 gpm/10-inch element. The particle retention efficiencies were determinedusing a particle counter that accurately measured particles down to 0.3 µm.

Pore

Size

(µm)

Removal Rating in

Microns (µm) at % Efficiency

100% 99% 90%

0.45 0.45 0.40 < 0.30

0.6 0.6 0.56 0.38

0.8 0.8 0.72 0.50

1.2 1.2 1.1 0.7

2.4 2.4 2.3 2.0

5 5 4.5 3.0

7 7 6.5 5.0

10 10 9.5 7.5

20 20 19.0 12.0

30 30 26.0 16.0

40 40 35.0 28.0


L min -1

1.4

1.3

1.2

1.1

1.0

0.9

0.8

0.7

0.6

0.5

0.4

0.3

0.2

0.1

0.0

0 5 10 15 20 25 30 35

90

80

70

60

50

40

30

20

10

0

0 1 2 3 4 5 6 7 8 9 10

Flow Rate, gpm

∆p(mbar)



ALpHA® Filter Cartridge

End Cap Conf iguration


locking tabs; open end forC6




configurations


locking tabs; open end forC5




configurations









configurations



configurations





FilterMedia


CartridgeLength




MF 0.45 3 F2 R S

MF = 0.45 1 = 10" GS = DOE; flat gaskets (Blank) = Standard - no O-ring Seal

polypropylene 0.6 (25 cm) (9.75", 19.5", 29.25", 39" length f i lters) reinforcement ring B = Buna

microf iber 0.8 2 = 20" GL = DOE; flat gaskets E = EPR

1.2 (50 cm) (20", 30", 40" length f i lters) R = Reinforcement ring; S = Silicone

2.4 3 = 30" C1 = SOE; -222 nO-Ring®, button cap end required for autoclave/ T = Tef lon® over silicone

5 (75 cm) C2 = SOE; -222 O-rings, button cap end SIP applications V = Viton®

7 4 = 40" F1 = SOE; -222 nO-Ring®, f in end X = Teflon® over Viton®

10 (100 cm) F2 = SOE; -222 O-rings, fin end Gasket Seal

20 C5 = SOE; -226 nO-Ring®, button cap end B = Buna

30 C6 = SOE; -226 O-rings, button cap end E = EPR

40 F5 = SOE; -226 nO-Ring®, f in end P = Polyethylene

70 F6 = SOE; -226 O-rings, fin end S = Silicone

DN = DOE; internal -120 O-rings T = Tef lon®


recessed cap endV = Viton®



recessed cap end

Documents

SteriLUX · EverLUX® FilterCartridge TheEverLUX®polyethersulfone (PES) filter is designed for very high contaminant capacity, extended service life and high flow with low pressure