Kleenpak™ Capsules with Fluorodyne® II DBL Membrane

Bioburden reduction and prefiltration of liquid formulations DescriptionThis 0.45 μm rated filter is predominantly used in pre-filtration applications or viscous fluid filtrations. Validated retention of Serratia marcescens (ATCC 14756) with typical TR of >106 (6 LRV) makes it also suitable for bioburden control. The serial layer (0.65/0.45 μm) membrane construction allows for high throughputs and high flow rates compared to other 0.45 μm rated filters.

Pall Kleenpak capsules are rugged and compact filter capsules available in 4 different sized formats designed for a variety of small to large scale pharmaceutical manufacturing applications with volumes of 30 L to 1000 L.

Key Featuresu Encapsulated format for higher flexibility,

minimized cleaning and low installation costs

u Built in prefiltration

u Minimal hold up volume

u Low extractables

u High protein transmission

u Rapid preservative recoveries

u Easy integrity testing

u Compatible with organic solvents, acids and chemicals1

u Resin and surfactant-free

u Melt-sealed, non shedding1Except ketones and amides.

USD3275

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Quality Standardsu Manufactured for use in conformance with cGMP

u 100 % integrity tested

u ISO 9000 Certified Quality System

u Meets USP Biological Reactivity Test, in vivo, for Class VI-121 °C Plastics

u Every filter tested during manufacture. Test correlated to microbial retention

u Certificate of Test provided includes: • Fabrication integrity • Bacterial retention • Materials of constructions • Effluent quality for cleanliness, TOC and water conductivity,

pH and pyrogens

SpecificationsMaterials of ConstructionFilter Membrane Hydrophilic modified PVDF

Support and Drainage Layers Polypropylene

End Cap, Core and Cage Polypropylene

Capsule Shell Polypropylene

Sealing Technology Thermal bonding without adhesives

Extractables1

Typical Extractables in Water at 20 °C All Styles < 5 mg per capsule

1 Tested on capsules without pre-flushing

Nominal Effective Filtration AreaKA1 400 cm2 (0.4 ft2)KA2 800 cm2 (0.9 ft2)KA3 1500 cm2 (1.6 ft2)KA4 3300 cm2 (3.6 ft2)

Operating Parameters2

Maximum Temperature 40 °C

Maximum Operating Pressure 5.2 bar (75 psi) at 20 °C4.0 bar (58 psi) at 40 °C

Maximum Differential Pressure (forward direction) 4.0 bar (58 psi) at 40 °C

2 In compatible fluids which do not soften, swell or adversely affect the filter or its materials of construction

Sterilization3,4

Autoclavable “G” Version 5 x 60 minutes at 140 °C

Autoclavable “blank” Version 30 x 60 minutes at 125 °C10 x 60 minutes at 140 °C

Autoclavable “S” Version 1 x 30 minutes at 125 °C

Gamma Irradiation Maximum of 50 kGy

3 Kleenpak capsules must not be sterilized in-situ by passing steam under pressure

4 Pre-sterilized Kleenpak capsules must not be re-sterilized.

Typical Flow Rates

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Nominal Dimensions KA1 KA2 KA3 KA4

Diameter incl. Valves 94 mm (3.7 in.) 94 mm (3.7 in.) 105 mm (4.1 in.) 105 mm (4.1 in.)Length - Code 1 117 mm (4.6 in.) 157 mm (6.2 in.) 174 mm (6.8 in.) 287 mm (11.3 in.)Length - Code 2 158 mm (6.2 in.) 198 mm (7.8 in.) - -Length - Code 6 157 mm (6.2 in.) 157 mm (6.2 in.) 210 mm (8.3 in.) 327 mm (12.8 in.)Length - Code 12 137 mm (5.4 in.) 177 mm (7.0 in.) - -Length - Code 16 137 mm (5.4 in.) 177 mm (7.0 in.) 192 mm (7.6 in.) 305 mm (12.0 in.)

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www.pall.com 3

Ordering Information

Code Inlet / Outlet Connection

1 1½ in. (25 – 38 mm) sanitary flange2 ¼ - ½ in. (6 – 13 mm) stepped hose barb6 ½ in. (13 mm) single hose barb12 1½ in. (25 – 38 mm) sanitary flange inlet. ¼ - ½ in. (6 – 13 mm) stepped hose barb outlet16 1½ in. (25 – 38 mm) sanitary flange, ½ in.

(13 mm) single hose barb outlet

Code Shipping Format

G Non-sterile gamma irradiatable / autoclavableS Presterilized using gamma irradiationBlank Non-sterile autoclavable

Code Nominal Area

1 400 cm2 2 800 cm2 3 1500 cm2 4 3300 cm2

KA DBL P

Visit us on the Web at www.pall.com/biotechE-mail us at biotech@pall.com

© 2018, Pall Corporation. Pall, , and Kleenpak are trademarks of Pall Corporation. ® indicates a trademark registered in the USA. TM indicates a common law trademark. Filtration.Separation.Solution. is a service mark of Pall Corporation.

4/18, PDF, GN18.07053 USD3275

Corporate HeadquartersPort Washington, NY, USA+1.800.717.7255 toll free (USA)+1.516.484.5400 phonebiotech@pall.com e-mail

European HeadquartersFribourg, Switzerland+41 (0)26 350 53 00 phonebiotech@pall.com e-mail

Asia-Pacific HeadquartersSingapore+65 6389 6500 phonesgcustomerservice@pall.com e-mail

International OfficesPall 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.