Mini Kleenpak™ Filter Capsules with Supor® EX Grade ECV Filter Media product photo Primary L

Mini Kleenpak™ Filter Capsules with Supor® EX Grade ECV Filter Media

High-capacity, high-flow rate sterilizing-grade capsules for process development and small-scale GMP manufacture

Supor EX grade ECV filters incorporate high capacity, high flow rate 0.2 µm sterilizing grade filter media validated for the retention of B.diminuta (ATCC 19146) at a challenge level of 107 cfu per cm2 membrane. A unique polyethersulfone (PES) membrane pairing ensures rapid filtration of cell harvest material, process intermediates, growth media, buffers and final bulk biological process fluids. Supor EX grade ECV filter media also delivers outstanding efficiency with viscous fluids incorporating CMC, or HPC.

The Mini Kleenpak capsule format are the smallest capsule filters in the Supor ECV range to utilize a pleated membrane, suitable for filtration of fluid volumes of 2 L to 50 L in process development and in pilot and manufacturing scale operations.


Feautures and Benefits

 
Feature Benefit
Minimal hold-up volume High yield for low volume GMP manufacture
Small scale pleated filter capsule Ideal for scaling trials
PES membrane Low adsorptions and wide chemical compatibility
Built-in MachV asymmetric prefilter layer Long-life and low filtration costs
 

Quality Standards

 
Manufactured for use in conformance with cGMP
ISO 9000 Certified Quality System
Meets USP Biological Reactivity Test, in vivo, for Class VI-121 °C Plastics
Every filter element integrity tested during manufacture
Certificate of test                Fabrication integrity
                                        Bacterial retention
                                        Compliance with USP standards for effluent cleanliness
                                        Compliance with USP standards for effluent cleanliness
                                        TOC
                                        Water Conductivity
                                        pH and Pyrogens
 


* Required
Need Help?
Download Datasheet
Description

High-capacity, high-flow rate sterilizing-grade capsules for process development and small-scale GMP manufacture

Supor EX grade ECV filters incorporate high capacity, high flow rate 0.2 µm sterilizing grade filter media validated for the retention of B.diminuta (ATCC 19146) at a challenge level of 107 cfu per cm2 membrane. A unique polyethersulfone (PES) membrane pairing ensures rapid filtration of cell harvest material, process intermediates, growth media, buffers and final bulk biological process fluids. Supor EX grade ECV filter media also delivers outstanding efficiency with viscous fluids incorporating CMC, or HPC.

The Mini Kleenpak capsule format are the smallest capsule filters in the Supor ECV range to utilize a pleated membrane, suitable for filtration of fluid volumes of 2 L to 50 L in process development and in pilot and manufacturing scale operations.


Feautures and Benefits

 
Feature Benefit
Minimal hold-up volume High yield for low volume GMP manufacture
Small scale pleated filter capsule Ideal for scaling trials
PES membrane Low adsorptions and wide chemical compatibility
Built-in MachV asymmetric prefilter layer Long-life and low filtration costs
 

Quality Standards

 
Manufactured for use in conformance with cGMP
ISO 9000 Certified Quality System
Meets USP Biological Reactivity Test, in vivo, for Class VI-121 °C Plastics
Every filter element integrity tested during manufacture
Certificate of test                Fabrication integrity
                                        Bacterial retention
                                        Compliance with USP standards for effluent cleanliness
                                        Compliance with USP standards for effluent cleanliness
                                        TOC
                                        Water Conductivity
                                        pH and Pyrogens
 
Applications
Filters - Liquid - Sterile (0.2 micron)
Specifications

Materials of Construction

 
Membrane Polyethersulfone (PES) membrane
Support and Drainage Layers Polypropylene
Capsule Shell Polypropylene
Filling Bell Polycarbonate
Sealing Technology Thermal bonding without adhesives
 

Operating Parameters1

 
Maximum Operating temperature 40°C
Maximum Operating Pressure 4.1 bar (60 psi) at 40°C
Maximum Differential Pressure 4.1 bar (60 psi) at 40°C
 
(1) In compatible fluids which do not soften, swell or adversely affect the filter or its materials of construction

Sterilization2

 
Autoclave 3 x 60-minute cycles at 125°C
Gamma Irradiation Maximum of 50 kGy
 
(2) Pre-sterilized Mini Kleenpak capsules must not be re-sterilized. Mini Kleenpak capsules must not be sterilized in-situ by passing steam under pressure. Water wet filter capsules with Supor ECV filter media prior to autoclave sterilization to retain full water wettability for integrity testing

Typical Extractables3

 
Water at 20 °C <5 mg / capsule
 
(3) After irradiation or autoclave sterilization

Nominal Effective Filter Area (EFA)

 
220 cm2 (0.24 ft2)
 

Typical Water Flow Performance

 
460 mL/min at 100 mbar differential pressure at 20 °C
 

Nominal Dimensions

 
Maximum diameter including valves 53 mm (2.1 in.)
Length - Code 2
6 – 13 mm (1/4 – ½ in.) hosebarb inlet and outlet connections
105 mm (4.1 in.)
Length - Code 8
13 – 19 mm (1/2 in. – ¾ in.) sanitary flange inlet and outlet connections
73 mm (2.9 in.)
 
Ordering Information
 
Description Pkg Part Number
Mini Kleenpak Capsule with Supor EX grade ECV Membrane
6 – 13 mm (1/4 – ½ in.) hosebarb inlet and outlet connections.
Supplied non-sterile
Pack of 3 KA02ECVP2G
Mini Kleenpak Capsule with Supor EX grade ECV Membrane
6 – 13 mm (1/4 – ½ in.) hosebarb inlet and outlet connections.
Supplied sterile
Pack of 3 KA02ECVP2S
Mini Kleenpak Capsule with Supor EX grade ECV Membrane
13 – 19 mm (1/2 in. – ¾ in.) sanitary flange
Supplied non-sterile
Pack of 3 KA02ECVP8G
Mini Kleenpak Capsule with Supor EX grade ECV Membrane.
13 – 19 mm (1/2 in. – ¾ in.) sanitary flange
Supplied non-sterile
Pack of 3 KA02ECVP8S