USD 3322

Small Scale, Gamma Compatible, Sterilizing Grade

Air Filtration

Emflon® ll Membrane in Mini Kleenpak™ Capsules

For single-use installations, from upstream to final formulation and fill, Emflon II membrane is the go-to gas filter for safeguarding cell cultures and drug product from adventitious bacterial and viral contamination.

Mini Kleenpak capsules with Emflon II membrane deliver gamma-compatible sterilizing grade air filtration for use on process gas and vent applications. With a comprehensive validation and quality package, Mini Kleenpak capsules with Emflon II membrane are the perfect air filter technology to implement through clinical development to licensed drug manufacture.

2

Features and Benefits

u Highly-retentive Emflon II membrane for sterility assurance

u High flow-rates associated with low differential pressure enable the use of small filters, leading to reduction of installation and operating costs

u Gamma-irradiatable, autoclavable or available pre-sterilized for maximum convenience

u Integrity testable using the forward flow and bubble point test

u Choice of connection options for enhanced flexibility

High Quality Standards

u Validated in liquids with Brevundimonas diminuta (ATCC 19146) at a challenge level of 107 organisms/cm2 of filter area

u 100 % integrity tested during manufacturing

u Identified by a lot number and unique serial number for complete traceability of manufacturing history and for user traceability systems

u Comprehensive batch/release testing supported with a Pharmaceutical Certificate of Test for each filter

u Validation guide available

u Manufactured under a quality management system certified to ISO 9001:2015

Biological Tests

u Meets USP biological reactivity tests in vivo, in accordance with USP class VI plastics at 121 °C.

Specifications

Materials of Construction l Membrane: Hydrophobic PVDF

l Support and drainage layers: Polypropylene

l End cap and core: Polypropylene

l Outer shell: Polypropylene

Nominal Dimensions l Maximum diameter (including valves):

67 mm (2.6 in.)

l Length with hose barb connections (Code 2):105 mm (4.1 in.)

l Length with sanitary connections (Code 8): 73 mm (2.9 in.)

l Nominal filtration area: 230 cm2 (0.25 ft2)

Sterilization

l Gamma-irradiation maximum dosage (G option only): Up to 50 kGy

l Autoclave sterilization:

– Gamma-irradiated filters: 1 one-hour cycle at 125 ºC for the purpose of post-use decontamination

– Non gamma-irradiated filters: Up to 3 one-hour cycles at 125 ºC

Warning: Mini Kleenpak filters must not be in situ steam-sterilized by passing steam through under pressure. The figures are maximum allowable figures determined by testing under controlled laboratory conditions to the total number of hours indicated. Actual operating conditions may affect the filters long-term response to sterilization. Filters should be qualified for each process application.

Operating Conditions1 l Maximum operating pressure:

4.1 bar (60 psi) at 38 °C 1 In air/nitrogen gas service or other compatible fluids, which do not soften, swell, or adversely affect the filter or its materials of construction.

Visit us on the Web at www.pall.com/biotech Contact us at www.pall.com/contact

International Offices

Pall Corporation has offices and plants throughout the world in: Argentina,

Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, India, Indonesia,

Ireland, Italy, Japan, Korea, Malaysia, New Zealand, Norway, Philippines, Poland,

Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand,

United Kingdom, and Vietnam. Distributors in all major industrial areas of the world.

To locate the Pall office or distributor nearest you, visit www.pall.com/contact.

The information provided in this literature was reviewed for accuracy at the time

of publication. Product data may be subject to change without notice. For current

information consult your local Pall distributor or contact Pall directly.

Corporate Headquarters

Port Washington, NY, USA

+1 800 717 7255 toll free (USA) +1 516 484 5400 phone

European Headquarters

Fribourg, Switzerland

+41 (0)26 350 53 00 phone

Asia-Pacific Headquarters

Singapore

+65 6389 6500 phone© 2020, Pall Corporation. Pall, , Emflon and Kleenpak are trademarks of Pall

Corporation. Filtration.Separation.Solution is a service mark of Pall Corporation.

® indicates a trademark registered in the USA and ™ indicates a common law

trademark.

10/20, PDF, GN19.10236 USD 3322

Part Number Description

KA02V002P2S Mini Kleenpak capsule with Emflon II membrane with ¼ to ½ in. hose barb, gamma-irradiated

KA02V002P2G Mini Kleenpak capsule with Emflon II membrane with ¼ to ½ in. hose barb, non irradiated

KA02V002P8S Mini Kleenpak capsule with Emflon II membrane with ½ in. sanitary flange, gamma-irradiated

KA02V002P8G Mini Kleenpak capsule with Emflon II membrane with ½ in. sanitary flange, non irradiated

Figure 1 Vent conditions for Mini Kleenpak capsules KA02

Figure 2 Operating conditions (2 bar) for Mini Kleenpak capsules

Typical Air Flow Rates2, 3

KA02V002P2 KA02V002P8

0 0.25 0.50 0.75 1.00 1.25 1.50 1.75 2.00 2.25

0 5 10 15 20 25 30 35 40C

lean

Diff

eren

tial P

ress

ure

(psi

)

Cle

an D

iffer

entia

l Pre

ssur

e (m

bar)

0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0

5

10

15

20

25

30

35

40

45

50

Air Flow (L/min)

Air Flow (Nm /h)3

2 For gases other than air or nitrogen, contact your local Pall representative

³ Recommended flow limits have been based on a maximum velocity of 25 m/s through the capsule. Customer tubing sizes should also be considered.

0 2 4 6 8 10 12 14

0 5 10 15 20 25

Cle

an D

iffer

entia

l Pre

ssur

e (p

si)

0

1

2

3

4

5

Cle

an D

iffer

entia

l Pre

ssur

e (m

bar)

350

300

250

200

150

100

50

0

Air Flow (SCFM)

Air Flow (Nm /h)3

KA02V002P2 KA02V002P8

Recommended Limitof P2 connection

Recommended Limitof P8 connection

Ordering Information