pall,颇尔,配Supor EKV 膜的Kleenpak 囊式过滤器,

颇尔 Supor® EKV filters are validated sterilizing grade membranes for the most cost effective filtration of a wide range of liquids such as buffers, tissue culture media, and others.The incorporated PES membrane demonstrates very high compatibility over the whole pH range plus very low protein binding to ensure the maximum transmission of the active ingredients.

颇尔 Kleenpak™ capsules are rugged and compact filter capsules available with a broad range of filter media and 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 Features and Benefits

Encapsulated format for higher flexibility, minimized cleaning and low installation costs
Minimal hold up volume
Hydrophilic polyethersulfone membrane for low adsorption and wide chemical compatibility
Good wettability for a reliable integrity test
Patented Ultipleat® technology for high-area and good flow rates
Built-in, MachV asymmetric prefilter layer for long-life and low filtration costs
High-strength construction tolerates up to 1 bard (14.5 psid) differential pressure during steam-in-place sterilization

Quality Standards

Manufactured for use in conformance with cGMP
100% integrity tested
ISO 9000 Certified Quality System
Meets USP Biological Reactivity Test, in vivo, for Class VI-121 °C Plastics
Every filter tested during manufacture.
Test correlated to microbial retention
Certificate of Test provided includes:
- Fabrication Integrity
- Bacterial Retention
- Materials of constructions
- Effluent quality for cleanliness, TOC and Water Conductivity, pH and Pyrogens

材料成分


Filter Membrane	Hydrophilic PES
Support/Drainage	聚丙烯
End Cap, Core and Cage	聚丙烯
囊式过滤器	聚丙烯
Sealing Technology	Thermal bonding without adhesives

Operating Parameters⁽¹⁾


Maximum Temperature	40 °C
最大操作压力	5.2 bar (75 psi) at 20 °C 4.0 bar (58 psi) at 40 °C
Maximum Differential Pressure	4.0 bar (58 psi) at 40 °C

⁽¹⁾ In compatible fluids which do not soften, swell or adversely affect the filter or its materials of construction

Sterilization⁽²⁾


Autoclave	5 x 60 minutes at 125 °C, slow exhaust
Gamma Irradiation	Maximum of 50 kGy

⁽²⁾Pre-sterilized Kleenpak capsules must not be re-sterilized
Kleenpak capsules must not be sterilized in-situ by passing steam under pressure
Water wet Supor EKV capsules prior to steaming to retain full water wettability for integrity testing

Typical Extractables in Water at 20 °C


KA1 / KA2	< 5 mg per capsule
KA3	< 10 mg per capsule

Nominal Dimensions


	KA1	KA2	KA3
Diameter incl.Valves	94 mm (3.7 in.)	94 mm (3.7 in.)	105 mm (4.1 in.)
Length - Code 1	117 mm (4.6 in.)	157 mm (6.2 in.)	174 mm (6.8 in.)
Length - Code 6	157 mm (6.2 in.)	197 mm (7.7 in.)	210 mm (8.3 in.)
Length - Code 16	137 mm (5.4 in.)	177 mm (7.0 in.)	192 mm (7.6 in.)