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BioPro<sup>®</sup> KS Standard

BioPro® KS Standard

The BioPro® KS cartridge filters are designed for protecting your critical and high value downstream systems.

These filters help in significant reduction of bioburden and complete removal of particulate contamination and are ideal for applications which do not require sterilization but where reduction in bio load in the process fluid is the objective.

These filters improve the process efficiency by reducing filter sizing and prolonging life of expensive sterilizing filters.

  • Low protein binding
  • High throughputs
  • Long service life
  • Pre-flushed to minimize particulate release after installation
  • Non-toxic material of construction
  • Multiple autoclavable/SIP
  • Absolute retention
  • 100% integrity tested
  • High flow rates
  • Bioburden maintained below 1000 cfu/device
  • Endotoxin level certified to be <0.25 EU/ml
  • Unique identification number is laser etched on each filter
  • Individual certificate of quality for each device
  • Sterilizable by Autoclaving/Steaming in place (SIP)

  • Clarification of cell harvest
  • Buffer filtration
  • In process protein filtration
  • Prefiltration to sterile filtration
  • Prefiltration to virus filtration

Construction
Filter Membrane Polyethersulfone
Housing Polypropylene
Integrity Testing / Retention
Bubble Point
0.1μm: > 40psi (2.8 Kg/cm²) with Water
0.2μm: > 30psi (2.11Kg/cm²) with Water
Bacterial Retention
0.1µm: LRV> 6 for Brevundimonas diminuta per cm² of filter area
0.2µm: LRV> 5 for Brevundimonas diminuta per cm² of filter area
Materials of Construction
Operating Conditions
Maximum Operating Temperature 80° C @ < 2 Kg/cm2
Maximum Differential Pressure < 3.5 Kg/cm2 @ 30° C
Operational
Sterilization By Autoclave Autoclavable / In-line steam sterilizable at 121°C for 30 minutes, 30 cycles
Assurance
Toxicity Passes Bioreactivity test, In-vivo, as per USP <88> for Class VI plastics
Cytotoxicity Passes Biological Reactivity Tests, In Vitro, USP <87> for Cytotoxicity
Bacterial Endotoxin Aqueous extracts exhibit < 0.25 EU/ml as established by LAL Test as per USP <85>
Fiber Release Complies with USFDA CFR Title 21 Part, 210.3 (b) (6)
Particle Release The filtrate complies with USP <788> test for particulate matter in injections
Oxidizable Substances Passes test as per USP <1231>
Extractables Passes NVR test as per USP <661>

Type
BioPro® KS CBKS
Size
Code
5″* 53
10″ 54
20″ 55
30″ 56
Pore Size
Code
0.1µm 36
0.2µm 01
0.45µm 02
Adaptor
Code
7P A0
7P Without Fin A1
28 with fin C0
‘O’ D0
Elastomer
Code
Silicone SS
Viton SV
EPDM SE
FEP Encapsulated Viton FV*
Sterility
Code
Non Sterile 1
Pack Size
Qty Code
1 01

*FV is available in adaptor code A0 (7P) only

*Size 5″ is available in Adapter Code A0 (7P) and A1 (7P without fin) only

CBKS 56 01 A0 SS 1 01

Example for Non Sterile: CBKS5601A0SS101

File Type Download
Datasheet Download

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