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BiopharmaceuticalFiltration Solutions

Lauter Filter.

Located in Hangzhou, 's plant covers a 2production workshop area of 6000 m , with 3000

2m area meeting the GMP requirements for 2 5manufacturing of medical devices, 600 m 10 -

2class cleaning room and 2400 m cleaning room.

We have more than twenty lines for the

production of microporous membranes and

pleated filter cartridges, advanced inspection

tools and equipments, as well as professional

R&D Center and Validation Center. All the

membrane products are manufactured in

ISO9001:2008 certified facility with the help of

trained manpower meeting or exceeding

industry standards.

COMPANY INTRODUCTION

icrofiltration is a well nown filtration leader,started from 1 , who focus on research and

de elopment o E lon, PES, PVDF, PTFE membrane, with pore size ranging from 0.03 μm to 10

μm, as well as design and production of arious pleated filter cartridges, s ringe filters and capsule

filters. pro ides professional assistances to li uid and ga ir filtration solutions for

customers around the world in biopharmaceutical, medical, foo e erage, microelectronic,

chemistr , water treatment and laborator pplications.

n biopharmaceutical industr , products

are used in highl egulated industries for critical

applications such as sterile filtration of

pharmaceutical and biopharmaceutical

process fluids, sterilit esting of aseptic drug

products, anal tical sample preparation, new

drug de elopment and so on.

has been ma ing great efforts to impro e

th ualit anagement s stem during the

process of obtaining the production certificates

and registration e help to deli er an e er

increasing portfolio of inno ati e products with

uni ue performance ad antages.

1 www.lauterfilter.com

Lauter

Lauter

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Lauter

CONTENTS

COMPANY INTRODUCTION

CONTENTS

Lauter Membrane Technologies

Quality Assurance

Validation Service

Customer Support

Facilitie ater

el ultur edia Preparation

Small Volume Parenteral SVP

arge Volume Parenteral VP

Plasma Fractionation

phthalmic Solutions

Filter Cartridges

PS ow E tractable an onger Ser ic ife Filte artridge with Doubl a er PE embrane

13

1

1

1

1

3

1

3

Filter Housings

Connections

1

3

PS T ighl s mmetric PES Filter artridge fo igher Throughput Demands

PS V PES Filte artridge for Sterile

Filtration o igh Viscous Pharmac PS Singl a e drophilic PES Filter artridge for Final Filtration of Pharmac

PSD Doubl a e drophilic PES

Filte artridge for E tremelDemanding of Sterilizing Filtration PT drophobic PTFE Filter artridge wit roa hemica ompatibilit

PT drophobic PTFE Filter artridge for Sterilizing Filtration o ir as

P drophili lon Filter artridge for Sterile Filtration of

Facilitie ate P PT drophilic PTFE Filter artridge for Sol ent Filtration

P F lass Fiber Filte artridge

for Prefiltration of Viscous Pharmac nd Vaccines

drophili lo embrane

drophilic PE embrane

drophili embrane

drophobic PTF embrane

drophobic PVD embrane

Stainless Steel Filter ousing for Sanitar i uid

Filtration

Series

Stainless Steel Filter ousing fo as ir Filtration

Series

Sanitar isc olderSeries Filter

T Titanium Filte ousingSeries

Sanitar n lin i uid an as Filte ousing

Series

Chemical compatibility Guide

10

11

1

31

33

3

3

3

P drophili E Filter artridge for Prefiltration o iologicals

PV drophobic PVDF Filter artridge wit ow Protei inding

PP Th ost Economical PP

Filte artridge for Prefiltration PPF Th ost Efficient multi la er

PP Filte artridge for Prefiltration P P bsolute PP Filte artridge

fo cti e Pharmaceutica ngredients

1

3

3

3

3

3

Applications

Membranes

TP Tri lam apsule Filter for

Small Volum igh Value added Pharmac

os ar apsule Filter for Small Volum igh Value added Pharmac

P 1 P apsule Filter for Small Volum igh Value added Pharmac

F P φ 0 Filte nit®Easiprep φ

S ringe Filterφ13 φ 0/φ /φ33

3

1

Capsule Filters &Syring Filters

www.lauterfilter.com

Membrane Technologies

brings more than 26 years

experience in membrane technology to the

biopharmaceutical, medical, laboratory, food

& beverage, microelectronic and chemical

applications. And we have been continuously

working to provide customized filtration solutions

with high quality.

3

of


membrane products are well designed with built-in quality assurance. We introduce the most stringent Quality

Management System covering careful selection of raw material, validated manufacturing process, quality control

and assurance and so on. All this is to ensure consistently offer high quality products for our customers.

Qu al i t y A s s u r ance

4

ISO Certified

Complete Traceability

Certificate of Products

Deep Characterization and Certification

Lauter


I n t egr i t y T es tConfirm the correlation of integrity test values which

were gotten under both standard and process fluid

conditions.

B act er i al Chal l enge T es tAccording to ASTM F838 methodology, testify bacterial

retention capability of membrane or filter at a minimum 7 2concentration of 10 cfu/cm of filter surface area,

under simulated process conditions.

Chem i cal Com pat i bi l i t yEnsure the compatibility of filter and process fluid.

Ensure the reliability of filter in process condition.

Provide supportive data for filter selection.

E x t r act abl esDetermine all the chemical components that migrate

from membranes or filters into a drug product or process

fluid in proper solvents in worst case. It indicates

maximum possibility of chemical components migrating

from membranes or filters.

Ads or pt i onMeasure the adsorption ability of filter media in fluid

filtration process.

Mu l t i - u s e Val i dat i onConfirm retention capacity of cartridges in normal

process or simulated conditions after multiple uses.

F i l t er C l ean i ng

Provide the filter cleaning method for the specific fluid

filtration.

Sterilizing filtration for pharmaceutical liquids is indispensable and critically important in aseptic manufacturing. It is the

process of removing bioburden, particles and bacterial endotoxins from a fluid stream without adversely affecting drug

product quality. With years of experiences in pharmaceutical research, more details and supportive data were found

that the sterilizing filtration is a high risk process, whose risk is next only to that of sterilizing making and filling. Only if it gets

through with validation, we could be sure of the compatibility, extractables/leacheables and adsorption, then to confirm the

reliability of sterilizing filtration. Besides, GMP, FDA and PDA described the requirements for sterilizing filtration validation

under specific conditions.

can offer validation services, designed to the unique needs of each customer's fluid and set of process conditions,

and help to prepare normative documents to achieve regulatory compliance. These include the following items:

Validation Service

5

Lauter


has always been working to support your

applications and welcomes the opportunity to assist

you in the education of your staff.

Cu s t om er S u ppor t

Cu s t om i z ed F i l t r at i on S ol u t i onsWe offer customized solutions for complex

filtration problems. And we will help you in finding

suitable solutions with minimizing filtration cost.

F i l t r at i on S y s t em D es i gn offers technical support for your selection of

filter materials, cartridge length, filter housing and

performing throughput studies to optimize filter sizing

with cost-effective filtration system.

I n s t al l at i on and Oper at i on T r ai n i ng filtration specialists are available to assist

customers with theory training and hands-on

installation and operation training.

T echn i cal S em i nar sTechnical seminars at customer’s location are

organized to help the users better understand

standard operation procedures of products, thus

to improve the performance and to extend the

service life of products. Besides, technical exchanges

can also be helpful for users to select the optimized

solutions for their applications.

6

offers an extensive range of support including

validation, filtration education, installation training,

and other experience sharing that customers need.

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Cells used to produce therapeutic proteins should have a precise nutritional balance to support their reproduction and growth. These nutrients are provided by culture media, which must be sterile. Final sterilizing filtration should assure the removal of bacteria and mycoplasma from culture media containing animal derived components.Culture media are then stored in a fermentation vessel or bioreactor after bulk preparation and sterilizing filtration. Prefilters are used to remove most particulate and colloidal contaminants from culture media in order to extend the service life of final sterilizing filters.

7

Cell Culture Media Preparation

� Prefiltration

Remove colloids, lipids and particles

� Sterilizing filtration

Remove bacteria and mycoplasma

Prefiltration should remove particulate and colloidal contaminants effectively and not hinder the bypass of important

components.

Prefilters must have high flow rates and consistent high throughputs in order to finish the separating process timely and

economically. Furthermore, the filtration system should be compatible with differences, resulting from batch to batch component variability.

Filtration Step Recommendation

Prefiltration LPM, LPGF

Sterile venting LPTA

Final filtration LPS, LPSD, LPSL

Prefiltration Sterile Filtration Sterile Holding Tank Final Filtration Bioreactor Fermentor

SterileVenting SterileVenting

Mix Tank

Media Powder

WFI

Separation Goals

Application Requirements

Recommendation


8

Facilities Water

Pharmaceutical grade water is defined as feed water common to process systems such as washers, autoclavesor WFI systems. Since water source varies widely in quality, only appropriate filtration systems can ensure the production to be effective, safe and successful.Filtration is just one step of the manufacturing process of pharmaceutical grade water. Other steps may result in the increasing of particles, for both resin and activated carbon beds could produce powder.

Separation Goals Prefiltration

Remove colloidal and particulate contaminants to extend the service life of final filters.

Final Filtration

Remove particles, microorganisms and endotoxins to meet the requirements of FDA and other international standards.

Application RequirementsPrefilters must remove most particulate and colloidal contaminants effectively, and have high dirt-holding

capacity, and keep high flow rates and high throughputs.

Final filters must remove microorganisms and endotoxins, and keep high flow rates and high throughputs.


Prefiltration LPP, LPM, LPGF


Final filtration LPSLPNN for removing endotoxins

Filters with positive charge have limited capacity of removing endotoxins. Once the capacity is saturated, they lose this ability of removing endotoxins. Series connection of two filters is the solution, monitoring the endotoxins between the two filters. When endotoxins exist in the downstream of the first f ilter, the second filter should replace the first one in its position. This can make full use of filters and ensure reliable retention rate. Replacement of filters with no charge depends on pre-setting limitation index such as maximum differential pressure, minimum flow rate and maximum life time.

Recommendation

Prefiltration Sterile Filtration Final FiltrationCompression

Air

Point of Use

Prefiltration Sterile Filtration Sterile Holding Tank Final Filtration

SterileVenting

Water

EndotoxinRemoval

Point of Use


Large Volume Parenterals (LVP)

arge Volume Parenteral VPs re single unit doses more tha 0 cc. Prefiltration is used for remo ing particles to e tend the ser ice life of fina sterilizing iltration. Final filters are used for reducing bioburden or sterile filtration prior to terminal sterilization. Th olume o VPs is usuall ens of thousands of liters, and multiple filling lines ma e wor ing at the same time. ngredients in t pica VP solutions include water, de tros fro 0 , amino acid, salts an er iscous total

parenteral nutritio TP . Prefilters are used to reduce particles for salt solutions, and to remo e hard particles for de trose solutions before final sterilizing filtratio it s another option to reduce bioburden b sing 0. μm filters

9

� Prefiltration

emo e colloidal and particulate contaminants to e tend the ser ice life of downstream sterilizing filters

� Final filtration

educe bioburden prior to terminal sterilizatio 0. μm Sterile filtration prior to terminal sterilizatio 0. μm

VP filters must pro ide consistent high flow rates to ensure the accurac nd consistenc f filling.

Since t pica VP filling process is operated under high differential pressure and high flow rates, filters must ha e superior

mechanical strength and be reliable and robust.

The cost o VP filters must be economical.

Prefilters and sterilizing filters must bear multiple c cles of steam in place sterilization or hot water sanitization.

Filtration Step ecommendation

Prefiltration PP PPF

Steril enting PT

Final filtration PS

Separation Goals


Recommendation

PrefiltrationSterile

olding Tan

Final Filtration

SterileVenting

i an

Powder

F

Filling utocla e Pac agingioburdeneduction


10

Small Volume Parenterals (SVP)

Smal olume parenteral SVP nclud arious traditional and bioengineered drugs. These drugs are usuall ac aged in smal ial less tha 0 ml , pre filled s ringes and ampoules, or made in l ophilized powder ots of SVPs need aseptic processing for their lac f heat stabilit .Sterilizing filtration is used after s nthesis or before filling nd it can add the sterilit ssurance if sterilizing filtration is used at both locations. Prefilters should be used to reduce bioburden and particles, which would clog final filters prematurel .

Prefiltrationemo e colloidal and particulate contaminants to e tend the ser ice life of downstream sterilizing filters

Final filtration Pro ide a sterile filtrate meeting the re uirements of current regulator

Separation Goals

Final sterilizing filters should remo e bacteria without altering the effects of drug products. Therefore, these filters

should ha e low adsorption of acti e pharmaceutical ingredien P , low e tractables, be non p rogenic and integrit estable, and be sterile or can be sterilized.

Prefilters and final filters should ha e enough flow rates. Final filters in the filling machine must ha e strong structures

to pre ent media fle ing during pulsed flow filling processing, which will result in particle release, drips or other dispense problems.

Filtration Step ecommendation

Prefiltration PP P

Steril enting PT

Final filtration PS PSD


Recommendation

Prefiltrationi an

SterileVenting

cti ePharmacetical

ngredients

Filling utocla e Pac agingFinal Filtration

therFormulation

ngredients


Ophthalmic preparations, ranging from contact lens cleaning and storing solutions to washing solutions in eye surgery and eye treatment products, must meet the rigid regulatory requirements and product specifications. The major component of most ophthalmic solutions is water. Furthermore, there maybe salts such as NaCl, preventatives, vaseline for the production of ointments and gel polymer used for lubricants. Heat-sensitive ophthalmic solutions can be sterilized by sterilizing filtration or by adding sterilized components into pre-sterilized bulk solutions.

Ophthalmis Solutions

● Prefiltration Reduce particles and bioburden prior to sterilizing filtration

● Sterilizing filtration Keep reliable retention of microorganisms for a long time

● Filters must provide consistent high flow rates and be robust to satisfy mass manufacturing processes.

● Sterilizing filters must keep reliable retention of microorganisms for a long time.

● Filters must have no adsorption or binding of preservatives in product manufacturing.


Prefiltration LPP, LPM, LPGF


Final filtration LPS, LPSD, LPSHV

Separation Goals


Recommendation

PrefiltrationSterile Holding Tank

Final Filtration

SterileVenting

Mix Tank

Ingredients

WFI

FillingSterile Filtration


12


Human plasma contains lots of valuable therapeutic proteins, such as albumin, a variety of immunoglobulins, V�

ófactors, fibrous proteins and other proteins. The process of extracting and purifying these proteins is called plasma fractionation. Plasma fractionation is accomplished by a series of extracting and purifying such proteins. Foreigners in plasma can result in instability of products and clogging of downstream filters. Therefore, prefilters are necessary for classification and removing impurities prior to chromatography and ultrafiltration. Final filters are used for the sterilizing filtration of heat-sensitive proteins.

● Prefiltration Remove colloids, aggregates, non-targeted proteins, lipids and particles to protect sterilizing filters or chromatography column prior to downstream purification.

● Sterilizing filtration Control the microorganism level during the manufacturing process. Final sterile filling (referred to SVPs)

● Prefiltration must remove contaminants and have no retention of target products.

● Filters must have consistent high flow rates and high throughputs for the sake of time and cost.

● Filters should not contaminate feeding liquids, especially metals such as aluminum.


Prefiltration LPM, LPGF, LPPF


Final filtration LPS, LPSD, LPSHV

Separation Goals

Recommendation


ClarificationPrecipitation

Plasma

PrefiltrationVirus Inactivation

SterileVenting

Concentration Final Filtration


L P S L

LPSL filter cartridges are specially designed for sterilizing filtration of plasma fractionation, lyophilized powder and vaccines. They are featuring extremely low extractables with no more than 10mg/10”, longer service life with 40

cycles of SIP. These filters can powerfully ensure final product quality.

Appl icat ion

● Plasma Fractionation

● Lyophilized Powder

● Vaccines

S peci f icat ion

Support

Core, Cage and Drainage

End Caps

O-rings/Gasket

Sealing Technology

D im en s ion s

F i l t r at ion A r ea

µ

Membrane

Thermal Bonding, No Adhesives

Silicone/EPDM/Viton

PP (222/226 with encapsulated stainless steel reinforcing ring)

PP

PP

Double Layer Hydrophilic PES

Diameter

Length5 inch, 10 inch, 20 inch, 30 inch40 inch

70mm

≥ ( ) per 10-inch cartridge2 20.46m 4.9ft

0.45+0.22

Forward: 4.2 bar @ 23� ; 1.5 bar @ 85�

Double layer hydrophilic PES Membrane

Low protein binding

Extensive drug compatibility for critical applications

Extremely low extractables

Cartridges produced in a controlled

environment

Manufactured according to ISO9001 certified

Quality Management System

Water bubble point≥ 3500 mbar (50 psig)

Air diffusion ≤ 30ml/min/10”@2.8bar

Low Extractable and Longer Service Life Filter Cartridge with Double Layer PES Membrane


≤ 10 mg per autoclaved 10-inch cartridge after 24-h soak in purified water at controlled room temperature.

Meets the requirements of Chinese Pharmacopoeia 2010, Volume , appendix C.

Meets the criteria for a “non-fiber releasing” filter as defined in 21 CFR 210.3 (b) (6).

Component materials meet GB/T 14233.2<2005> of Chinese National Standard for Safety Tests.

Passed the bacterial challenge testing using Brevundimonas diminuta(ATCC19146) at a minimum challenge concentration of

71 x 10 CFU/cm .

< 500 ppb after a water flush of 60 liters per 10-inch cartridge.

40 steam-in-place sterilization or autoclave cycles of 30 min at 123 .

Meets the criteria of Chinese Pharmacopoeia 2010, volume for purified water.

< 0.25 EU/ml as determined by the LAL test.

2

14

Biop

harm

ac

eutic

al

SL PES

【】【】

05

10

20

30

40 40inch

30inch

20inch

10inch

A

B

C

D

222/Fin

222/Flat

226/Fin

226/Flat

DOEE

【】

5inch

【】【】

PP with stainlesssteel endcapB

【】S

E

V

Silicone

LP D42 C 1 0 BS

【】

EPDM

Viton

【】

D42 (0.45+0.22)μm

【】【】

SL

【】【【

@

10

Water Flow Rate(L/min/10")

Diff

eren

tial P

ress

ure(

mba

r)

(0.22+0.45)μ

0

50

100

150

200

250

300

20 30 40 50

PP with stainlesssteel liningC

PPA

A: PP <60 ℃ (140℉)B: PP with stainless steel lined end cap <85℃ (185℉)C: PP with stainless steel lining <95℃ (203℉)

L P S H T Highly Asymmetric PES Filter Cartridge for Higher Throughput Demands

LPSHT filter cartridges are integrity testable membrane filters, specially developed for terminal filtration needing highthroughputs, such as cell culture media, large volumeparenterals and vaccines applications. They are characterized by a unique highly asymmetric, hydrophilic polyethersulfone membrane, offering higher throughputs, low protein adsorption and superior microbiological safety.

Appl icat ion● Cell Culture Medium

● Large Volume Parenterals

● Vaccines

Specification

Support


End Caps

O-rings/Gasket

Sealing Technology

D im en s ion s


µ

Membrane


Silicone/EPDM/Viton


PP

PP

Highly Asymmetric Hydrophilic PES

Diameter

Length5 inch, 10 inch, 20 inch, 30 inch, 40 inch

68mm

2≥ (5.7ft ) per 10-inch cartridge20.53m

0.1, 0.22, 0.45, 0.65, 0.8, 1.2, 3.0

Forward: 4.2 bar @ 23 ; 1.5 bar @ 85

0.1 μm≥ 3800 mbar (55 psig)

0.22 m≥ 3400 mbar (49 psig)

0.45 m≥ 2300 mbar (33 psig)

Highly asymmetric, hydrophilic polyethersulfone

membrane

Absolute bacteria retention

Long service life and high flow rates


environment




16

SHT PES

【】【】

05

10

20

30

40 40inch

30inch

20inch

10inch

A

B

C

D

222/Fin

222/Flat

226/Fin

226/Flat

DOEE

【】

5inch

【】【】【】S

E

V

Silicone

LP 022 C 1 0 BS

【】

EPDM

Viton

【】

010

022

045

065

080

120

0.1 m

0.22 m

0.45 m

0.65 m

0.8 m

300

1.2 m

3.0 m

【】【】

SHT

【】【【


Meets the requirements of Chinese Pharmacopoeia 2010, Volume Ⅱ, appendix Ⅸ C.




7 21 x 10 CFU/cm .


15 steam-in-place sterilization or autoclave cycles of 30 min at 123 ℃.

Meets the criteria of Chinese Pharmacopoeia 2010, volume Ⅱ for purified water.


Biop

harm

ac

eutic

al

@

10


Diff

eren

tial P

ress

ure(

mba

r) 0.1m

0

50

100

150

200

250

300

20 30 40 50

0.22 m

0.45 m



PPA


L P S H V PES Filter Cartridge for Sterile Filtration of High Viscous Pharmacy

LPSHV filter cartridges are designed for terminal filtration, specially for high viscosity liquids in biopharmaceutical industry,such as ophthalmic solutions, parenterals and vaccines. Because of high dirt holding capacity and low protein adsorption performance, these filters have longer service life for high viscosity pharmacy filtration.

Appl icat ion

Ophthalmic Solution

Parenterals with High Viscosity(Large Volume

Parenterals, Small Volume Parenterals)

Vaccines

S peci f icat ion

Support


End Caps

O-rings/Gasket

Sealing Technology

D im en s ion s


µ

Membrane


Silicone/EPDM/Viton


PP

PP

Hydrophilic PES

Diameter


68mm

≥ per 10-inch cartridge2 20.53m (5.7ft )

0.1, 0.22, 0.45, 0.65, 0.8, 1.2, 3.0

Forward: 4.2 bar @ 23 ; 1.5 bar @ 85 ℃ ℃

0.1 μm≥ 3800 mbar (55 psig)

0.22 m≥ 3400 mbar (49 psig)

0.45 m≥ 2300 mbar (33 psig)

Low protein binding




environment




18

SHV PES

【】【】

05

10

20

30

40 40inch

30inch

20inch

10inch

A

B

C

D

222/Fin

222/Flat

226/Fin

226/Flat

DOEE

【】

5inch

【】【】【】S

E

V

Silicone

LP 022 C 1 0 BS

【】

EPDM

Viton

【】

010

022

045

065

080

120

0.1 m

0.22 m

0.45 m

0.65 m

0.8 m

300

1.2 m

3.0 m

【】【】

SHV

【】【【

Biop

harm

ac

eutic

alPP with stainless

steel endcapB


PPA

@

10

6 0 0 cp Fluid Flow Rate(L/min/10")

Diff

eren

tial P

ress

ure(

mba

r) 0.1m

0

100

200

300

400

500

600

20 30 40 50

0.22m

0.45m

µ µ






71 x 10 CFU/ .2cm






L P S Single Layer Hydrophilic PES Filter Cartridge for Final Filtration of Pharmacy

LPS filter cartridges are integrity testable membrane filters specially developed for sterilizing filtration in biopharmaceutical industry. They are characterized by a unique asymmetric, hydrophilic polyethersulfone membrane, offering high throughputs, low protein adsorption and superior microbiological safety.

Appl icat ion

● Active Pharmaceutical Ingredient

● Cell Culture Medium

● Ophthalmic Solution

S peci f icat ion

Support


End Caps

O-rings/Gasket

Sealing Technology

D im en s ion s


µ

Membrane


Silicone/EPDM/Viton


PP

PP

Single Layer Hydrophilic PES

Diameter


68mm


0.1, 0.22, 0.45, 0.65, 0.8, 1.2, 3.0

Forward: 4.2 bar @ 23 ; 1.5 bar @ 85℃ ℃

0.1 μm≥ 3800 mbar (55 psig)

0.22 m≥ 3400 mbar (49 psig)

0.45 m≥ 2300 mbar (33 psig)

Low protein binding




environment




Parenterals(Large Volume Parenterals, Small

Volume Parenterals)

Lyophilized Powder

Vaccines


20

S PES

【】【】

05

10

20

30

40 40inch

30inch

20inch

10inch

A

B

C

D

222/Fin

222/Flat

226/Fin

226/Flat

DOEE

【】

5inch

【】【】【】S

E

V

Silicone

LP 022 C 1 0 BS

【】

EPDM

Viton

【】

010

022

045

065

080

120

0.1 m

0.22 m

0.45 m

0.65 m

0.8 m

300

1.2 m

3.0 m

【】【】

S

【】【【

Biop

harm

ac

eutic

alPP with stainless

steel endcapB


PPA

@

10


Diff

eren

tial P

ress

ure(

mba

r) 0.22m

0

50

100

150

200

250

300

20 30 40 50

0.45 m0.65 m

1.2 m

µ µ






71 x 10 CFU/ .2cm






L P S D

LPSD filter cartridges are characterized by a unique highly asymmetric, double-layer hydrophilic polyethersulfone membrane, specially designed for extremely demanding of sterilizing filtration in biopharmaceutical industry. These filters can powerfully ensure products meeting the rigid requirements of current regulatory.

Appl i cat i on● Cell Culture Medium

● Ophthalmic Solution

● Plasma Fractionation

● Parenterals(Large Volume Parenterals, Small

Volume Parenterals)

● Lyophilized Powder

● Vaccines

S peci f i cat i on

Support


End Caps

O-rings/Gasket

Sealing Technology

D i m ens i ons

F i l t r at i on A r ea

μ

Membrane


Silicone/EPDM/Viton


PP

PP

Double Layer Hydrophilic PES

Diameter

Length5 inch, 10 inch, 20 inch, 30 inch, 40inch

68mm

≥ 0.44 per 10-inch cartridge2 2m (4.8ft )

0.22+0.1, 0.22+0.22, 0.45+0.22

Forward: 4.2 bar @ 23 ; 1.5 bar @ 85 ℃ ℃

0. μm .1 μm≥ 000 mba sig

0. μm . μm≥ 3 00 mba 3 psig

0. μm . μm≥3 00 mba 0 psig

● Double la er h drophilic PES membrane

● ow protein binding and e tensi e drug

compatibilit or critical applications

● ntegrit estable

artridges produced in a controlled

en ironment

anufactured according t S 001 certified

ualit anagement S stem

Doubl a e drophilic PES Filte artridge for E tremel emanding of Sterilizing Filtration


22

S PES

【】【】

0

10

0

30 30inch

0inch

10inch

D

Fin

Flat

Fin

Flat

D EE

【】

inch

【】【】【】S

E

V

Silicone

P D 1 0 S

【】

EPD

Viton

【】

D 1

D

D

0. 0.1μm

0. 0. μm

0. 0. μm

【】【】

S

【】【【

iop

harm

ac

eutic

alPP with stainless

steel endcap

PP with stainlesssteel lining

PP

@

10


Diff

eren

tial P

ress

ure(

mba

r)

(0.2

2+0.

1)m

0

50

100

150

200

250

300

20 30 40 50

(0.22

+0.22)

m

(0.45+0.22) m

μ μ

≤ 0 mg per autocla ed 10 inch cartridge afte h soa n purified water at controlled room temperature.

eets the re uirements o hinese Pharmacopoeia 010, Volume Ⅱ, appendi Ⅸ .

eets the criteria fo non fiber releasing ilter as defined i F 10. b .

omponent materials mee T 1 33. 00 f hines ational Standard for Safet ests.

Passed the bacterial challenge testing using Brevundimonas diminuta T 1 1 t a minimum challenge concentration of

0 F .cm

00 ppb after a water flush o 0 liters per 10 inch cartridge.

1 team in place sterilization or autocla e c cles of 30 min at 1 3 ℃.

eets the criteria o hinese Pharmacopoei 010, olume Ⅱ for purified water.

. ml as determined b h est.

: PP < 0 ℃ (1 0℉): PP with stainless steel lined end cap < ℃ (1 ℉): PP with stainless steel lining < ℃ ( 03℉)

0 0inch

L P T Hydrophobic PTFE Filter Cartridge with Broad Chemical Compatibility

LPT filter cartridges are characterized by permanently hydrophobic PTFE membrane, specially developed for sterile filtration of Active Pharmaceutical Ingredients production. They are integrity testable, providing high throughputs, broad chemical compatibility and high flow rates. Due to their hydrophobic characteristic, they must be pre-wetted with ethanol or IPA before the filtration of aqueous solutions.

F eat u r es a n d B en ef i t s

● Broad chemical compatibility

● High throughputs and superior flow rates

● 100% integrity testable prior to release

Qu al i t y


environment



S peci f icat ion

Support


End Caps

O-rings/Gasket

Sealing Technology

D im en s ion s


µ

Membrane


EPDM/Viton/Silicone


PP

PP

Hydrophobic PTFE

Diameter


68mm


0.05 0.1, 0.22, 0.45, 1.0,3.0, , 5.0, 10

Forward: 4.2 bar @ 23 ℃; 1.5 bar @ 85 ℃

0.1 μm≥ 1000 mbar (14.5 psig)

0.22 m≥ 900 mbar (13 psig)

0.45 m≥ 300 mbar (4.35 psig)

Organic solvent filtration

Filtration for harsh chemicals and HPLC mobile

phases that destroy other membrane materials

Sterile filtration for aqueous media

Filtration for strongly corrosive or oxidizing solutions


24

T HydrophobicPTFE

【】【】

05

10

20

30

40 40inch

30inch

20inch

10inch

A

B

C

D

222/Fin

222/Flat

226/Fin

226/Flat

DOEE

【】

5inch

【】【】【】S

E

V

Silicone

LP 022 C 1 0 BE

【】

EPDM

Viton

【】

010

022

045

100

300

500

0.1 m

0.22 m

0.45 m

1.0 m

3.0 m

01K

5.0 m

10 m

【】【】

T

【】【【

Biop

harm

ac

eutic

al

Notes : T hey mus t be pre-wetted with ethanol or I PA before the fi ltration of aqueous s olutions .

005 0.05 m



PPA

@

10


Diff

eren

tial P

ress

ure(

mba

r)

0.1

m

0

50

100

150

200

250

300

20 30 40 50

0.22

m

0.45m

µ µ






71 x 10 CFU/ .2cm






LPTA filter cartridges are featured by permanently hydrophobic PTFE membrane, specially designed for sterile venting and gas application in biopharmaceutical industry. They are integrity testable, offering the highest process security, high throughputs, extreme humidity and stringent in-line steam sterilizations


High flow rates and low pressure drop

High strength, long service life and cost-effective

100% integrity testable prior to release

Have a particulate removal rating of 0.01 m in gases

and a microbial removal rating of 0.22 μm in liquids

μ

Qu al i t y


environment



S peci f icat ion

Support


End Caps

O-rings/Gasket

Sealing Technology

D im en s ion s


µ

℃

Membrane


Silicone/EPDM/Viton


PP

PP

Double-layer Polytetrafluoroethylene (PTFE)

Diameter


68mm


0.01

Forward: 4.2 bar @ 23 ℃; 1.5 bar @ 85 ℃

Bubble point≥ 1100 mbar with 60/40% IPA/water(15.95 psig)

HydroCorr (water intrusion test)≤ 0.75mL/min per 10-inch cartridge with water at 2620mbar

Hydrophobic PTFE Filter Cartridge for Sterilizing Filtration of Air/Gas

Sterile venting of vessels and carboys

Autoclave vacuum break lines

Fermentation air applications

Sterile process gases

Bioreactor inlet and outlet gas filtration

Sterile filtration of CO2


TA HydrophobicPTFE for air

【】【】

05

10

20

30

40 40inch

30inch

20inch

10inch

A

B

C

D

222/Fin

222/Flat

226/Fin

226/Flat

DOEE

【】

5inch

LP 001 C 1 0

【】【】【】

TA

【】【【






001 0.01μm

26

【】【】【】S

E

V

Silicone

BS

【】

EPDM

Viton


Biop

harm

ac

eutic

al


71 x 10 CFU/ .2cm



PPA

@

303Nitrogen Flow Rate(m /h/10")

Diff

eren

tial P

ress

ure(

mba

r)

0 bar outlet pressure

0

50

100

150

200

250

300

60 90 120 150

2 bar outlet pressure



L P NN Hydrophilic Nylon Filter Cartridge for Sterile Filtration of Facilities Water & API

LPNN filter cartridges are characterized by hydrophilic Nylon membrane, providing high throughputs, low extractables and good mechanical strength, widely used for sterile filtration in Active Pharmaceutical Ingredients production and facilities water, for removing particles, microorganisms and endotoxins to meet the requirements of FDA and other international standards.

F eat u r es a n d B en ef i t s● Low extractables and high absorption

● High throughputs and superior flow rates


Qu al i t y


environment



S peci f icat ion

Support


End Caps

O-rings/Gasket

Sealing Technology

D im en s ion s


µ

Membrane


Silicone/EPDM/Viton


PP

PP

Hydrophilic Nylon

Diameter


68mm


0.1, 0.22, 0.45, 0.65, 1.0, 3.0, 5.0

Forward: 4.2 bar @ 23 ; 1.5 bar @ 85 ℃ ℃

0.22 m≥ 2800 mbar (40.6 psig)

0.45 m≥ 1200 mbar (17.4 psig)

Facilities water

Active pharmaceutical ingredients

28

NN Nylon

【】【】

05

10

20

30

40 40inch

30inch

20inch

10inch

A

B

C

D

222/Fin

222/Flat

226/Fin

226/Flat

DOEE

【】

5inch

【】【】【】S

E

V

Silicone

LP 022 C 1 0 BE

【】

EPDM

Viton

【】

010

022

045

100

300

500

0.1 m

0.22 m

0.45 m

1.0 m

3.0 m

5.0 m

【】【】

NN

【】【【

Biop

harm

ac

eutic

al

065 0.65 m



PPA

@

10


Diff

eren

tial P

ress

ure(

mba

r)

0.45

m

0

50

100

150

200

250

300

20 30 40 50

0.22

m

1.0 m3.0 m

µ µ






71 x 10 CFU/ .2cm






L P T L Hydrophilic PTFE Filter Cartridge for Solvent Filtration

LPTL filter cartridges are characterized by hydrophilic PTFE membrane and polypropylene components for broad applications, widely used in Active Pharmaceutical Ingredients production in a variety of solvent filtration.



● No need of pre-wetting


Qu al i t y


environment



S peci f icat ion

Support


End Caps

O-rings/Gasket

Sealing Technology

D im en s ion s


µ

Membrane


Viton/EPDM/Silicone


PP

PP

Hydrophilic Polytetrafluoroethylene (PTFE)

Diameter


68mm


0.1, 0.22, 0.45, 1.0

Forward: 4.2 bar @ 23℃; 1.5 bar @ 85℃

0.1 m≥1100 mbar (16 psig)

0.22 m≥ 900 mbar (13 psig)

Organic solvent filtration

Filtration for harsh chemicals

Sterile filtration for aqueous media

Filtration for strongly corrosive or oxidizing solutions


30

【】【】

05

10

20

30

40 40inch

30inch

20inch

10inch

A

B

C

D

222/Fin

222/Flat

226/Fin

226/Flat

DOEE

【】

5inch

【】【】【】S

E

V

Silicone

LP 022 C 1 0 BE

【】

EPDM

Viton

【】

010

022

045

100

0.1 m

0.22 m

0.45 m

1.0 m

【】【】

TL

【】【【

Biop

harm

ac

eutic

al

TL HydrophilicPTFE



PPA

@

10


Diff

eren

tial P

ress

ure(

mba

r)

0.1

m

0

50

100

150

200

250

300

20 30 40 50

0.22

m

0.45m

μ μ






71 x 10 CFU/ .2cm






www.anowfilter.com31

L P M Hydrophilic MCE Filter Cartridge for Prefiltration of Biologicals

LPM filter cartridges are characterized by high-performance, hydrophilic mixed cellulose esters membrane, offering high flow rates, low protein adsorption and superior microbiological safety. These filters are designed to reduce costs and are especially suited for prefiltration of vaccines and plasma fractionation production.

F e a t u r e s a n d B e n e f i t s

● Low protein binding

● Superior throughputs and cost-effective

● High retention efficiency for more critical

degrees of prefiltration

Q u a l i t y


environment



S p e c i f i c a t i o n

Support


End Caps

O-rings/Gasket

Sealing Technology

D i m e n s i o n s

F i l t r a t i o n A r e a

μ

Membrane


Silicone/EPDM/Viton


PP

PP

Hydrophilic MCE

Diameter


68mm


0.1, 0.22, 0.45, 0.65, 1.0, 3.0, 5.0

Forward: 4.2 bar @ 23 ; 1.5 bar @ 85 ℃ ℃

Vaccines


0.22 m≥1000 mbar (14.5 psig)

0.45 m≥ 500 mbar (7.25 psig)


32

M MCE

【】【】

05

10

20

30

40 40inch

30inch

20inch

10inch

A

B

C

D

222/Fin

222/Flat

226/Fin

226/Flat

DOEE

【】

5inch

【】【】【】S

E

V

Silicone

LP 045 C 1 0 BS

【】

EPDM

Viton

【】

010

022

045

100

300

500

0.1 m

0.22 m

0.45 m

1.0 m

3.0 m

5.0 m

【】【】

M

【】【【

Biop

harm

ac

eutic

al

065 0.65 m



PPA

@

10


Diff

eren

tial P

ress

ure(

mba

r)

0.1m

0

50

100

150

200

250

300

20 30 40 50

0.22

m0.45 m

μ μ






71 x 10 CFU/ .2cm






L P V Hydrophobic PVDF Filter Cartridge with Low Protein Binding

LPV filter cartridges are characterized by hydrophobic PVDF membrane and polypropylene components, featuring lowestprotein binding. Due to these characterizes, they are ideal for sterile filtration of biologicals, chemical intermediates and organic solvents.

F eat u r es a nd B enef i t s● Minimum protein binding and low extractables


● Superior throughputs and high flow rates


Qu al i t y


environment



S peci f i cat i on

Support


End Caps

O-rings/Gasket

Sealing Technology

D i m ens i ons


μ

Membrane


Silicone/Viton/EPDM


PP

PP

Hydrophobic PVDF

Diameter


68mm


0.1, 0.22, 0.45, 0.65, 1.0, 3.0, 5.0

Forward: 4.2 bar @ 23℃; 1.5 bar @ 85℃

0.1 m≥ 400 mbar (5.8 psig)

0.22 m≥ 300 mbar (4.35 psig)

Biologicals

Chemical intermediates

Organic solvents


34

【】【】

05

10

20

30

40 40inch

30inch

20inch

10inch

A

B

C

D

222/Fin

222/Flat

226/Fin

226/Flat

DOEE

【】

5inch

【】【】【】S

E

V

Silicone

LP 045 C 1 0 BE

【】

EPDM

Viton

【】

010

022

045

100

0.1 m

0.22 m

0.45 m

1.0 m

【】【】

V

【】【【

Biop

harm

ac

eutic

al

V HydrophobicPVDF



PPA

300 3.0 m

500 5.0 m

065 0.65 m

2


Diff

eren

tial P

ress

ure(

mba

r) 0.1m

0

50

100

150

200

250

300

4 6 8 10

0.22 m0.45 m

μ μ






71 x 10 CFU/ .2cm






LPP filter cartridges are constructed of polypropylene fine fiber, featuring high flow rates and high dirt holding capacity. They are the most economical and efficient prefilters in biopharmaceutical industry, removing most particulate and colloidal contaminants. These filters can be personalized according to your specific fluids and processes, such as pore size and other characteristics, improving filtration efficiency and reducing filtration costs.


● Superior dirt-holding capacity

● High flow rates


Qu al i t y


environment



Speci f icat ion

Support


End Caps

O-rings/Gasket

Sealing Technology

D im en s ion s


µ

Filter Media


Silicone/EPDM/Viton

PP

PP

PP

PP

Diameter


68mm


0.1, 0.22, 0.45, 0.65, 1.0, 3.0, 5.0, 10, 20

Forward: 4.2 bar @ 23℃; 1.5 bar @ 85℃

The Most Economical PP Filter Cartridge for Prefiltration

Active Pharmaceutical Ingredient

Cell Culture Medium

Ophthalmic Solution


Volume Parenterals)

Lyophilized Powder

Vaccines



P PP

【】【】

05

10

20

30

40 40inch

30inch

20inch

10inch

A

B

C

D

222/Fin

222/Flat

226/Fin

226/Flat

DOEE

【】

5inch

LP 100 C 1 0

【】【】【】

P

【】【【



Support steam-in-place sterilization or autoclave at 123℃.


【】【】【】S

E

V

Silicone

AS

【】

EPDM

Viton


≥ 80

Biop

harm

ac

eutic

al


010

022

045

100

300

500

0.1μm

0.22μm

0.45μm

1.0μm

3.0μm

5.0μm

065 0.65μm

01K

02K

10μm

20μm



PPA

@

10


Diff

eren

tial P

ress

ure(

mba

r) 3.0 m

0

50

100

150

200

250

300

20 30 40 50

0.22 m0.45 m

1.0 m



LPPF filter cartridges are constructed of multilayer polypropylene, featuring high flow rates, broad chemical compatibility and high dirt holding capacity. These filters are ideal for prefiltration in biopharmaceutical industry, removing particulate and colloidal contaminants. And these cartridges can be personalized according to your specific filtration fluids and processes, improving filtration efficiency and reducing filtration costs.



● Reliable retention of particulates


Qu al i t y


environment



S peci f icat ion

Support


End Caps

O-rings/Gasket

Sealing Technology

D im en s ion s


µ

Filter Media


Silicone/EPDM/Viton

PP

PP

PP

Multi-layer PP

Diameter


68mm

2 20.2~0.3 m (2.1~3.2 ft ) per 10-inch element

0.5, 1.0, 3.0, 5.0, 10, 20

Forward: 4.2 bar @ 23 ℃; 1.5 bar @ 85 ℃

The Most Efficient multi-layer PP Filter Cartridge for Prefiltration

Active Pharmaceutical Ingredients

Cell Culture Medium

Ophthalmic Solution


Volume Parenterals)

Lyophilized Powder

Vaccines



PF Multi-layer PP

【】【】

05

10

20

30

40 40inch

30inch

20inch

10inch

A

B

C

D

222/Fin

222/Flat

226/Fin

226/Flat

DOEE

【】

5inch

LP 100 C 1 0

【】【】【】

PF

【】【【





【】【】【】S

E

V

Silicone

AS

【】

EPDM

Viton


≥ 90

Biop

harm

ac

eutic

al


100

300

500

1.0μm

3.0μm

5.0μm

050 0.5μm

01K

02K

10μm

20μm



PPA

@

10


Diff

eren

tial P

ress

ure(

mba

r)

0.5m

0

50

100

150

200

250

300

20 30 40 50

1.0m

3.0m

5.0m



LPAP absolute filter cartridges are constructed of polypropylene fine fiber, featuring high flow rates, high dirt holding capacity and reliable particle removal efficiency. Due to their features, they are the most economical and efficient prefilter cartridges, ideal for the wide range of classification and prefiltration in Biopharmaceutical Industry, especially in Active Pharmaceutical Ingredients Manufacturing.

F eat u r es a nd B enef i t s● Superior dirt-holding capacity


● Low extractables and low protein binding


Qu al i t y


environment



S peci f i cat i on

Support


End Caps

O-rings/Gasket

Sealing Technology

D i m ens i ons


μ

Filter Media


Silicone/EPDM/Viton

PP

PP

PP

Absolute PP

Diameter


68mm

2 20.2~0.3 m (2.1~3.2 ft ) per 10-inch element

0.5, 1.0, 3.0, 5.0, 10, 20

Forward: 4.2 bar @ 23 ℃; 1.5 bar @ 85℃

Absolute PP Filter Cartridge for Active Pharmaceutical Ingredients

parenterals, organic solvents, DIW

Clarification

Prefiltration for air & gas

Prefiltration for chemical intermediates, biologicals,


AP PP

【】【】

05

10

20

30

40 40inch

30inch

20inch

10inch

A

B

C

D

222/Fin

222/Flat

226/Fin

226/Flat

DOEE

【】

5inch

LP 100 C 1 0

【】【】【】

AP

【】【【

40

【】【】【】S

E

V

Silicone

AS

【】

EPDM

Viton

Biop

harm

ac

eutic

al

100

300

500

1.0μm

3.0μm

5.0μm

050 0.5μm

01K

02K

10μm

20μm






≥ 95




PPA

@

10


Diff

eren

tial P

ress

ure(

mba

r)

0.5m

0

50

100

150

200

250

300

20 30 40 50

1.0m

3.0m



LFGF filter cartridges are adsorption depth filters, designed for removing colloidal and viscous contaminants in vaccines and culture media. Featured by high dirt holding capacity and excellent particle retention ability, these filters can effectively protect the final cartridges to extend the service life.


● High throughputs and high adsorption



Qu al i t y


environment



S peci f icat ion

Support


End Caps

O-rings/Gasket

Sealing Technology

D im en s ion s


µ

Filter Media


Silicone/EPDM/Viton

PP

PP

PP

Glass Fiber

Diameter


68mm

≥ 0.37 per 10-inch element2 2m (4.0ft )

0.45, 1.0, 3.0, 5.0

Forward: 4.2 bar @ 23 ; 1.5 bar @ 85 ℃ ℃

Vaccines

Culture Media

Colloidal and viscous liquids

Glass Fiber Filter Cartridge for Prefiltration of Viscous Pharmacy and Vaccines


GF Glass Fiber

【】【】

05

10

20

30

40 40inch

30inch

20inch

10inch

A

B

C

D

222/Fin

222/Flat

226/Fin

226/Flat

DOEE

【】

5inch

LP 045 C 1 0

【】【】【】

GF

【】【【





【】【】【】S

E

V

Silicone

AS

【】

EPDM

Viton


≥ 95

Biop

harm

ac

eutic

al


100

300

500

1.0μm

3.0μm

5.0μm

045 0.45μm



PPA

@

10


Diff

eren

tial P

ress

ure(

mba

r)

0.45 m

0

50

100

150

200

250

300

20 30 40 50

1.0 m



CTP Tri-Clamp capsule filters are designed to provide smart, disposable and safe filtration for small capacity liquids of lyophilized powder and other pharmacy. These disposable filters can help eliminate cleaning problems and extra validation costs. The T-style configuration isideal for operation. 100% integrity testable prior to release ensures high quality products.


● Eco-friendly and cost-effective

● Smart, disposable and safe

● Low hold-up volume

● Good resistance to pressure

Qu al i t y


environment



S peci f icat ion

Support & Housing

Sealing Technology


µ

Filter Media


PP

PES/Nylon/PTFE/PP/GF/PVDF/MCE

≥ 0.2 2 2m (2.2ft )

Please refer to Ordering Information.

Liquid: 3.5 bar @ 23℃ and 3.0 bar @ 60℃

Tri-Clamp Capsule Filter for Small Volume & High Value-added Pharmacy

Air&Gas: 3.0 bar @ 23℃ and 2.5 bar @ 60℃

. 0 1 µ m , 0 .1 µ m , 0 .2 2 µ m P E S / P T F E

Passed the bacterial challenge testing using Brevundimonas diminuta(ATCC19146) at a minimum challenge concentration

7 2of 1 x 10 CFU/cm .

S

3 autoclave cycles of 30 min at 123 ℃; steam-in-place sterilization not recommended.

For more information on specification, please refer to cartridges with the same membrane.


m

S PES FS

FE

5inch

CTP 010 FS 5S

Biop

harm

ac

eutic

al

010

022

0.1μm

0.22μm

001 0.01( for air)

μm

NN Nylon

TL HydrophilicPTFE

TA HydrophobicPTFE for Air

T HydrophobicPTFE

P PP

GF Glass Fiber

V HydrophobicPVDF

100 1.0μm

045 0.45μm

300 3.0μm

5

207

82.5

5

1"TC

mm

Inlet/Outlet: Tri-clampVent&Drain: Silicone

Inlet/Outlet: Tri-clampVent&Drain: EPDM

500 5.0μm

M MCE

T F 2

300

250

200

150

100

50

0 0.4 0.8 1.2 1.6 2.0

Diff

eren

tial P

ress

ure(

mba

r)

( / )

300

250

200

150

100

50

0 0.5 1.0 1.5 2.0 2.5

Diff

eren

tial P

ress

ure(

mba

r)

( / )

P P P T FE

. μ

.μ

.μ

.μ

. μ. μ


CHP Hose Barb capsule filters are designed to provide smart, disposable and safe filtration for small volume liquid and high value-added liquid of lyophilized powder and other pharmacy. Disposable filters can help eliminate cleaning problems and extra validation costs. 100% integrity testable prior to release ensures high quality products.


● Eco-friendly and cost-effective

● Smart, disposable and safe

● Low hold-up volume

● Good resistance to pressure

Qu al i t y


environment



S peci f icat ion

Support & Housing

Sealing Technology


µ

Filter Media


PP

PES/Nylon/PTFE/PP/MCE/PVDF/GF

≥ 0.2 2 2m (2.2ft )


Liquid: 3.5 bar @ 23℃ and 3.0 bar @ 60℃

Hose Barb Capsule Filter for Small Volume & High Value-added Pharmacy

Air&Gas: 3.0 bar @ 23℃ and 2.5 bar @ 60℃

. 0 1 µ m , 0 .1 µ m ,

0 .2 2 µ m P E S / P T F E

Passed the bacterial challenge testing using Brevundimonas diminuta(ATCC19146) at a minimum challenge concentration

7 2 of 1 x 10 CFU/cm .

S

3 autoclave cycles of 30 min at 123 ℃; steam-in-place sterilization not recommended.



m

S PES DS

DE

5inch

CHP 022 DS 5S

Biop

harm

ac

eutic

al

010

022

0.1μm

0.22μm

001 0.01( for air)

μm

NN Nylon

TL HydrophilicPTFE

TA HydrophobicPTFE for Air

T HydrophobicPTFE

P PPGF Glass Fiber

V HydrophobicPVDF

100 1.0μm

045 0.45μm

5

FLOW

Hose barb 13.6mm

7.5

189

166

70

mm

mm

Inlet/Outlet: 13.6mmVent/Drain: 7.5mmWith Silicone

Inlet/Outlet: 13.6mmVent/Drain: 7.5mmWith EPDM

300 3.0μm

500 5.0μm

M MCE

T F 2

300

250

200

150

100

50

0 0.4 0.8 1.2 1.6 2.0

Diff

eren

tial P

ress

ure(

mba

r)

( / )

300

250

200

150

100

50

0 0.5 1.0 1.5 2.0 2.5

Diff

eren

tial P

ress

ure(

mba

r)

( / )

P P P T FE

. μ

.μ

.μ

.μ

. μ. μ



Qu al i t y


environment



S peci f icat ion

Support & Housing

Sealing Technology

D im en s ion s


µ


PP

Length

Inlet/Outlet Please refer to Ordering Information

2.5”, 5”, 10”

● Compact and sturdy construction

● Disposable design, easy change-out

● High pressure resistance

1/4" NPT Capsule Filter for Small Volume & High Value-added Pharmacy

Vent/Drainage Please refer to Ordering Information

2. 5- inch

5-inch

10-inch

≥ ( )2 20.1m 1. 1ft


Liquid: 3.5 bar 23℃, 3.0 bar @ 60℃ @

≥ ( )2 20.2m 2. 2ft

≥ ( )2 20.3m 3. 4ft

Air&Gas: 3.0 bar 23℃, 2.5 bar @ 60℃ @

PES/Nylon/PTFE/PP/GF/PVDF

CNP 1/4"NPT capsule filters are designed to provide smart, disposable and safe filtration for small volume liquid and high value-added pharmacy. Disposable filters can help eliminate cleaning problems and extra validation costs. 100% integrity testable prior to release ensures high quality products.


Filter Media


【】【】

2

5

9 10inch

5inch

【】

2.5inch

CNP 022 B 2

【】【】【】

S

【】

F i l ter 【【

Biop

harm

ac

eutic

al

@

300

250

200

150

100

50

0 0.2 0.4 0.6 0.8 1.0

.μ

Diff

eren

tial P

ress

ure(

mba

r)

( / / . )

300

250

200

150

100

50

0 0.5 1.0 1.5 2.0 2.5

Diff

eren

tial P

ress

ure(

mba

r)

( / / . )

P P P T FE

Inlet/Outlet:1/4"MNPTBVent/Drain: 1/8"MNPT

B type connectionH type for pipe threadconnection adapterSilicone O-ring

BHS

B type connectionH type for pipe threadconnection adapter

O-ringEPDM

BHE

010022

0.1μm 0.22μm

100

045

1.0μm

0.45μm

300

500

3.0μm

5.0μm

0010.01(for air)

μmS PES

NN Nylon

Absolute PP

TL Hydrophilic PTFE

T Hydrophobic PTFE

V Hydrophobic PVDF

P PP

TA Hydrophobic PTFE for air

Multi-layer PPPF

AP

GF Glass Fiber

MCEM

NPT1/4"

Ø67

112

-

4529

Ø6

Ø9.3

FLOW

FLOW

Ø67 Ø67

NPT1/4" NPT1/4"

201

296

FLOW

Unit: mm

.μ

.μ . μ

. μ . μ


F5P filters have good pressure resistance up to 350kpa,2with filtration area of nearly 20 cm .They have high

throughputs under low pressure drops, and can be

reusable after autoclaved. F5P are designed to connect

easily to hose barbs, as well as 6:100 luer slip.


Qu al i t y

S peci f icat ion

Support & Housing

Sealing Technology

D im en s ion s


m , µ m

Filter Media


PP

m

Compact and sturdy construction

Good pressure resistance

Disposable design, easy change-out

Filters produced in a controlled environment



F P φ50 Filter Unit

Small-volume venting

Vent device for sensor

Small or medium batch filtration

Outer DiameterΦ or PTFE

nlet utlet

Φ 0 or PES lon PP F PVDF E

13 mm stepped hose barb connection wit 10 uer slip

For more information on specification, please refer to cartridges

with the same membrane.

Please refer t rderin nformation.

≥ 1 . m 0.0 1 ft

i uid . a 3 ,3.0 ar 0℃ ℃

ir as .0 ba 3 ,℃ ℃. ar 0

PES lon PTFE PP F EPVDF


m

【】【】

F P 0 P 0

【】【】【】

T

【】

Membrane【【

iop

harm

ac

eutic

al

@

3000

2500

2000

1500

1000

500

0 100 200 300 400 500

. μ

3000

2500

2000

1500

1000

500

0 10 20 30 40 50

Diff

eren

tial P

ress

ure(

mba

r)

Diff

eren

tial P

ress

ure(

mba

r)

( / ) ( / )

. μ

. μ

P ES P T FE

69.8

~70.

2mm

Ø58.6

6:100

6:100

for PES/Nylon/MCE/PP/GF69

.8~7

0.2m

m

Ø64.4

6:100

6:100

for PTFE

【】【】

P

one

PPP

lass Fiber

0 on Sterile

0 S

S

on Sterileterile

terile

【】

P PP

DPE

0100

0

0.1μm0. μm

0. μm100 1.0μm

S PESlon

T drophobic PTFE

V PVDFE

F lass FiberP PP

T drophobic PTFE fo ir

T drophilicPTFE fo i uid

. μ


®Easiprep syringe filters are charaterised by various membranes,

diameters, pore sizes and connectors. These filters are disposable,

ideal for clarification, sterile filtration, venting and other demands

in laboratory applications.

®E as ipr ep φ5/ Syringe Filterφ1 /φ /φ /φ

Qu al i t y

Appl icat ion

Filters produced in a controlled environment



Clarification and particle removal

Sterile filtration

Venting and gas filtration

Chromatography sample preparation


Low hold-up volume and low extractables

Various inlet/outlet connectors available

Gamma irradiated or EO sterilized

Various membrane diameter available

Broad chemical compatibility

Available in non-sterile and sterile version

13 mm 0 mm m 33 mm

PP DPE S PP DPE PP DPE

1.3 cm 3.1 cm . m . m

1 .0m 3.0mm 3.0mm 3. mm .0mm .3mm 0.0mm 30.3mm

＜ 100 l μ ＜ 1 0μl ＜ 0μl ＜ 3 0μl

131 ℃( . ℉)

utocla e at 1 3℃ at 1 bar fo 0 minutes( 3. ℉@1 . psi)

＜ 0. ml as determined b h est

. ar 3. ar . bar . ar

Femal ue oc

al uer Slip

Femal ue oc

al ue oc

Femal ue oc

al uer Slip

Female ue oc

ale ue oc

ale uer Slip

ale uer Slip

Female ue oc

ale uer Slip

Please contact us for more details.

m

PP

0.1 m

1 .0m . mm

＜ 1 l μ

.0 bar

Femal uer Slip

al uer Slip


Biop

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Or der in g I n f or m at ion

【】【】

022 P 08N

【】【】【】

T

【】【【【】【】

P

None_

PPP

Glass FiberG

1HN 100 Non-Sterile

2HN50S

1HS

200 Non-Sterile50 Sterile, EO

100 Sterile, EO

【】

P

H

PP

HDPE

010022

045

0.1μm0. μm

0. μm100 1.0μm

S PESlon

T drophobic PTFE

V drophobic PVDF

EF lass Fiber

P PP

T drophobic PTFE fo ir

T drophilic PTFE

S

【】【】

nlet emale luer loc

utlet ale luer unloc

nlet ale luer unloc

utlet ale luer unloc

nlet emale luer loc

utlet ale luer loc

300 3.0μm00 .0μm

【】

S

【】

13

mm

13mm

0 0mm

mm

33 33mm0S

1 S

0 Sterile amma

100 Sterile amma


Appl icat ion

Nylon

� Good mechanical strength � Resistant to alkaline solutions and most

organic solvent

� Alkali

� Organic solvents

� Transfer membrane

� Broad chemical compatibility

� Low protein binding and low extractables

� Terminal filtration

� Environment analysis

� Low protein binding

� Very suitable for biologics filtration

� Clarification

� Biologics

� Microbiological analysis

� Liquids contain protein

� SDI membrane

� Broad chemical compatibility

� Naturally hydrophobic

� Good heat resistance

� Gases

� Organic solvents � Corrosive liquid

� Naturally hydrophobic

� Low protein binding

� Good heat and chemical

resistance

� Gases

� Biologics

� Corrosive liquid

� Transfer membrane


【】【】

MP 045 293 25

【】【】【】

NN

【】

Membrane【【

54

Biop

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ac

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al

This information is a guide to the Part No. structure and possible options. For availability of specific options and housing details, please contact

【】【】

G

【】

Water flow2 rate(ml/cm min

△p=0.1Mpa)20 10 16 4 35 15 30 6 7 3

Sterilization By autoclave at 123 (253.4 ) or EO℃ ℉)

Material

Pore size(μm) 0.45 0.22 0.45 0.22 0.45 0.22 0.45 0.22 0.45 0.22

Bubble point(mbar)

Water@23 (73.4 )℃ ℉ 60%IPA@23 (73.4 )℃ ℉

150 310 150 310 250 350 60 100 40 70

Thickness(μm) 85-110 90-140 110-140 150-250 90-100

pH 3.5-8.0 6-13 1-14 1-14 2-10

010

022

045

0.1μm

0 22. μm

0.45μm

065 0.65μm

080

120

0 8. μm

1.2μm

300 3.0μm

047

090

142

47mm90mm

142mm150 150mm200

250

200mm250mm

293 293mm300 300mm

WithGWithoutN

NN Nylon

T Hydrophobic PTFE

TLHydrophilic

PTFE

M MCE

S PES

V PVDF

25 2550 50

Lauter.


HY series sanitary housings are developed specifically for liquid filtration in the pharmaceutical, food&beverage, microelectronic and chemicalindustry.� Corrosion resistance and durability with 316L/304 stainless steel wetted parts and mirror-polished inner and outer surface� Enhanced cleanability and microbiological safety due to crevice-free, polished and hygienic design� Multiple choices for connections� Single-round and multi-round filter housings are available with cartridges of 10/ 20/ 30/ 40 inch� Cost-effective without sacrificing quality and performance

F eat u r es a n d B en ef i t s S peci f icat ion

Max im u m O per at in g P r es s u r e

Series Stainless Steel Filter Housing for Sanitary Liquid FiltrationH Y

�

�

�

�

�

Operator-friendly and long service life

Low adsorption, easy clean-up and back

washing

No shedding and no leakage

Good heat and corrosion resistance

Suitable for CIP and SIP

-marked�

6bar(87psi)

Max im u m Oper at in g T em per at u r e

Car t r idge Capaci t y

1-round, 3-round, 5-round, 7-round, 9-round, 11-round...

Con n ect ion

Inlet/Outlet

Gauge Port

Cartridge 222/Fin, 226/Fin, DOE

Flange/ Tri-Clamp

Flange/ Tri-Clamp

Housing

Clamp

Seal Silicone/EPDM/Viton/TEV

316L/304 stainless steel

304 stainless steel

140�( 284�)


Order in g In f or m at ion

【】【】

HY 001 10

【】【】【】

D

【【

56

Biop

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ac

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Single-round standard housings

05

10

20

30

225（8.9）

350（13.8）

600（23.6）

850（33.5）

84（3.3）

84（3.3）

84（3.3）

84（3.3）

110（4.3）

110（4.3）

110（4.3）

110（4.3）

127（5）

254（10）

508（20）

762（30）

111.6（4.0）

111.6（4.0）

111.6（4.0）

111.6（4.0）

200（7.9）

200（7.9）

200（7.9）

200（7.9）

C SUS304

D SUS316L

001003

005

009

13

57

0119

007

11

10

2030

40

10inch

20inch30inch

40inch

【】【】

T

【】【】

C

A 222/Fin

E DOEC 226/Fin S

E EPDM

V Viton

T TEVSilicone

【】【】

F

K Tri-Clamp

F Flange

【】【】

25

20 DN20

2538

DN25DN38

40 DN40

Lauter

Lauter.


Car t r idge Capaci t y

Con n ect ion

Inlet/Outlet

Gauge Port

Cartridge 222/Fin, 226/Fin, DOE

Flange/ Tri-Clamp

Flange/ Tri-Clamp

Housing

Clamp



304 stainless steel



6bar(87psi)

140℃(284℉)

Series Stainless Steel Filter Housing for Gas&Air Filtration

HK series sanitary housings are developed specifically for gas&air filtration in

� Corrosion resistance and durability with 316L/304 stainless steel wetted parts and mirror-polished inner and outer surface� Enhanced cleanability and microbiological safety due to crevice-free, polished and hygienic design� Multiple choices for connections� Single-round and multi-round filter housings are available with cartridges of 10/ 20/ 30/ 40 inch� Cost-effective without sacrificing quality and performance

pharmaceutical, food&beverage, microelectronic andchemical industry.

�

�

�

�

Operator-friendly and long service life

Low adsorption

Mirror-polished inner and outer surface


-marked�

1-round, 3-round, 5-round, ...


【】【】

HK 001 10

【】【】【】

D

【【

Biop

harm

ac

eutic

al


C SUS304

D SUS316L

001

003

005

009

1

3

57

0119

007

11

10

203040

10inch

20inch30inch40inch

【】【】

T

【】【】

C

A 222/Fin

E DOE

C 226/Fin SE EPDM

V Viton

T TEV

Silicone

【】【】

F

K Tri-Clamp

F Flange

【】【】

25

20 DN20

25 DN25

05

10

20

30

40

185（7.3）

310（2.2）

560（22.0）

810（31.9）

1060(41.7)

75（3.0）

75（3.0）

75（3.0）

75（3.0）

75（3.0）

158（6.2）

158（6.2）

158（6.2）

158（6.2）

158（6.2）

127（5）

254（10）

508（20）

762（30）

1016(40)

101.6（4.0）

101.6（4.0）

101.6（4.0）

101.6（4.0）

101.6（4.0）

250（9.8）

250（9.8）

250（9.8）

250（9.8）

250（9.8）

20（0.8）

20（0.8）

20（0.8）

20（0.8）

20（0.8）

20（0.8）

20（0.8）

20（0.8）

20（0.8）

20（0.8）

5 5inch

Lauter

Lauter

Lauter.


Con n ect ion

Inlet/Outlet Flange/ Tri-Clamp



6bar(87psi)

140�( 284�)

Series Filter Sanitary Disc Holder

HM series sanitary housings are developed specifically for

liquid and gas filtration in the

Corrosion resistance and durability with 316L/304

stainless steel wetted parts and mirror-polished inner

and outer surface

PTFE lining is available to provide advanced protection

from corrosion

pharmaceutical, food&beverage,

microelectronic and chemical industry.

●

●

●

●

●

Long service life

Low adsorption

Easy installation, clean up, and adjustment


Good heat and corrosion resistance

-marked�

Housing

Membrane Diameter



47mm, 90mm, 100mm, 142mm, 150mm, 293mm


HM 293

【】【】【】

D

【【

Biop

harm

ac

eutic

al


C SUS304

D SUS316L

【】【】

S

【】【】

A

SE EPDM

V VitonT TEV

Silicone

【】【】

K

K Tri-Clamp

F Flange

【】【】

25

A

B

1

2

293mm Disc Filter Holder

293 294（11.5） 15（0.6） 15（0.6） 150（5.9） 293（11.5） 360（14.2）

047

090100

150

47

90100

142

293150

142

293

15 DN15

20 DN20

25 DN25

Lauter

Lauter.


Con n ect ion



6bar(87psi)

140℃(284℉)

Series Titanium Filter Housing

HT series sanitary housings are developed for liquid filtration in the pharmaceutical, food and beverage, microelectronic industry, especially suitable for carbon removal, high temperature and corrosive liquid filtration in infusion and injection manufacturing.� Corrosion resistance and durability with 316L/304 stainless steel wetted parts and mirror-polished inner and outer surface� Use titanium powder sintered filter� Side-in and down-out structure, with multiple choices for inlet and outlet connections� Easy clean up and backwash� Single-round and multi-round filter housings are available with cartridges of 10/ 20/ 30/ 40 inch

�

�

�

�

�

Long service life

Low adsorption


Good corrosion and acid and alkali resistance

Titanium filter is reusable

-marked�

Housing

Clamp

1-round, 3-round, 5-round, 7-round, 9-round, 11-round

Inlet/Outlet

Cartridge



Flange/ Tri-Clamp


Gauge Port Flange/ Tri-Clamp

M20/M30 Thread


HT 011

【】【】【】

D

【【

Biop

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This information is a guide to the Part No. structure and possible options. For availability of specific options and housing details, please contact Lauter.

C SUS304

D SUS316L

【】【】

S

【】【】

M2

S

E EPDM

V Viton

T TEV

Silicone

【】【】

K

K Tri-Clamp

F Flange

【】【】

25

25 DN25

38 DN3840 DN40

M2

M3

M20

M30

10

20

30

40

10inch

20inch

30inch

40inch

5-Round standard housing of 20”

20 508（20） 440（17.3） 420（16.5） 200（7.9） 200（7.9） 290（11.4） 14（0.6） 14（0.6） 121（4.8）

001

003

005

009

1

3

5

7

0119

007

11013 13

【】【】

10

50 DN50

Lauter

F eat u r es a n d B en ef i t sS peci f icat ion

Con n ect ion



6bar(87psi)

140℃(284℉)

●

●

●

Fast filtration, long service life

Mirror-polished inner and outer surface

Low adsorption, no shedding and no leakage

-marked�

Series Sanitary In-line Liquid and Gas Filter Housing

HG series sanitary housings are developed specifically for liquid filtration

in the

such as pure water, ultra pure water, drinking water, distilled water,

acid and alkali, and other chemicals.

Corrosion resistance and durability with 316L/304 stainless steel wetted

parts and mirror-polished inner and outer surface

Enhanced cleanability and microbiological safety due to

crevice-free, polished and hygienic design

Multiple choices for inlet and outlet connections

Single-round and multi-round filter housings are available

pharmaceutical, food&beverage, microelectronic and chemical

industry

Housing

Clamp

1-round, 3-round, 5-round

Inlet/Outlet

Cartridge



304 stainless steel

Flange/ Tri-Clamp

222/Fin, 226/Fin, DOE


Biop

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Single-round standard housings

05102030

127（5）

254（10）

508（20）

762（30）

225（8.9）

350（13.8）

600（23.6）

850（33.5）

44（1.7）

44（1.7）

44（1.7）

44（1.7）

101.6（4.0）

101.6（4.0）

101.6（4.0）

101.6（4.0）

HG 001

【】【】【】

D

【【

C SUS304

D SUS316L

【】【】

S

【】【】

C

S

E EPDM

V VitonT TEV

Silicone

【】【】

K

K Tri-Clamp

F Flange

【】【】

25

10

2030

10inch

20inch30inch

001003005

009

1357

011

9007

11

【】【】

10

A

C

222/Fin

226/Fin5 5inch DN15

20 DN

25

38

40

15

20

DN 25

DN 38

DN 40

Lauter.

Lauter.

Ch em ical Com pat ibi l i t y Gu ide

Classification Name Nylon PVDF PTFE PES PP MCE Silicone EPDM Viton TEV

Acids

Acetic Acid NR R R NR R LR LR R NR RHydrochloric Acid (conc.) NR R R R R NR NR NR NR RHydrochloric Acid (6N) NR R R R R NR NR NR R RNitric Acid (conc.) NR R R - R NR NR NR R RNitric Acid (6N) NR R R - R NR LR NR R RPhosphoric Acid (conc.) NR R R - R NR NR R R R

Sulfuric Acid (conc.) NR R R NR R NR NR NR R RHydrofluoric Acid (6N) NR R R - NR NR NR NR - R

Bases

Ammonium Hydroxide (1N) R LR R R R R R R R R Ammonium Hydroxide (3N) R NR R R R NR R LR LR R Potassium Hydroxide (3N) R LR R R R NR LR R R R Sodium Hydroxide (3N) R LR R R R NR R R R R Sodium Hydroxide (6N) R NR R R R NR R R R R

Alcohols

Amyl Alcohol R R R R R NR NR R R R Benzyl Alcohol (100%) R R R R R NR LR R R R Butanol R R R R R R R R LR R Isopropanol R R R R R - R R R R Methanol LR R R R R LR R R NR R

Ketones

Acetone R LR R NR R NR NR R NR R Cyclohexanone - LR R NR R NR NR NR NR R Methyl Ethyl Ketone LR LR R - R - NR R NR R Methyl Isobutyl Ketone LR LR R NR R - NR R NR R

Oils

Cottonseed R R R - R - R R R Lubricant R R R NR R - R R R R Peanut R R R - R - R R R R

Sesame R R R R R - R R R R

Aromatic

Hydrocarbons

Benzene LR LR R LR NR R NR NR R R Toluene NR LR R NR NR R NR NR R R

Xylene LR LR R NR NR R NR NR R R

Halogenated Hydrocarbons

Carbon Tetrachloride LR LR R LR LR NR NR NR R R Chloroform LR LR R NR LR NR NR NR R R

Ethylene Dichloride LR LR R NR LR R NR NR LR R Freon TF R R R R LR R NR NR R R

Freon TMC LR LR R NR LR R NR NR LR R Methylene Dichloride NR LR R NR LR NR NR NR LR R Perchloroethylene - LR R LR LR R NR NR R R

Trichloroethylene LR NR R LR LR R NR NR R R


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66

Glycols Ethylene Glycol R R R LR R - R R R R

Glycerol R R R LR R R R R R R Propylene Glycol R R R LR R R R R

Ethers

Ethyl Ether NR R R R LR NR LR NR NR R Isopropyl Ether - R R - R NR NR NR NR R

Dioxane R R R - R NR NR NR NR R Tetrahydrofuran NR LR R NR LR NR NR NR NR R

Esters

Amyl Acetate LR R R - R NR NR R NR R Butyl Acetate LR R R - LR NR NR R R R

Cellosolve Acetate - R R R R NR NR R NR R Ethyl Acetate LR R R LR LR NR R R R R Methyl Acetate LR R R NR R NR - R R R

Isopropyl Acetate - R R R R NR LR R NR R

Classification Name Nylon PVDF PTFE PES PP MCE Silicone EPDM Viton TEV

Connections

Aniline LR R R NR LR - NR R R R Dimethyl Formamide R NR R NR R - R R NR R

Formaldehyde (37%) R R R R R - R R NR R Gasoline LR LR LR R LR R NR R R R Hexane (dry) - LR LR LR LR R NR NR R R

Kerosene - R R R R - NR NR R R Phenol R R R NR R R NR NR R R

Pyridine LR R R NR LR NR NR R NR R Turpentine - R R R LR - NR NR R R

Water R R R R R R LR R R R Acetonitrile LR R R R LR NR - R NR R Nickel Sulfate Solution R R R - R - R R - R

Notes: This table is intended to serve as a guide only. Accuracy cannot be guaranteed. Users are responsible

for verifying chemical compatibility under their own conditions of use. Chemical compatibility is affected by

many variables including temperature, pressure, concentration, and chemical purity.

R: Resistance;

LR: Limited resistance;

NR: No resistance;

“-”: No data available.

R

Miscellaneous

222/Fin 222/Flat 226/Fin 226/Flat DOE

Lauter Filter a brand manufactured by:Hangzhou Anow Mincrofiltration Co., Lta.

Website: www.lauterfilter.comE-mail: [email protected]


Office: Room 901-903, Central Building, No. 271, HushuS outhRoad, Hangzhou, ChinaPlant: Qingming Bridge,X in deng industrial Zone, Fuyang, Hangzhou,China

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