UA-44035381-1
  • BioPro<sup>®</sup> KS 1", 2", 5", 8"

BioPro® KS 1", 2", 5", 8"

The BioPro® KS is designed for protecting your critical and high value downstream systems.

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

It improves the process efficiency by reducing filter sizing and prolonging life of expensive sterilizing filters.

These filters provide easy scalability from process development labs to actual manufacturing processes.

  • Validated for high bio-burden reduction
  • High flow rates
  • High throughput
  • Low protein binding
  • No media migration
  • Biologically inert
  • Easy installation
  • Clarification of cell harvest
  • Buffer filtration
  • In process protein filtration
  • Prefiltration to sterile filtration
  • Prefiltration to virus filtration
Construction
Membrane Hydrophilic PES
Final Filter Pore Size (Nominal) 0.1µm, 0.2µm, 0.45µm
Support Layers Polyester
Body and Core Polypropylene
Size
Size
1"2"5"8"
Effective Filtration Area (Nominal)
250cm²500cm²1000cm²2000cm²
Dimension (End to End) - 1½" Sanitary Flange Inlet ½" Single Step Hose Barb Outlet
--
112 mm165 mm216 mm
Dimension (End to End) - ¾" Sanitary Flange I/O
85 mm 104 mm 155 mm 206 mm
Dimension (End to End) - 1½" Sanitary Flange I/O
92 mm 112 mm 164 mm 216 mm
Dimension (End to End) - ½" Hose Barb I/O
90 mm 112 mm 162 mm 214 mm
Dimension (End to End) - ½" Single Step Hose Barb I/O
--
115
162 mm218 mm
Operational Radius (with Vent/ Drain)
30 mm65 mm65 mm65 mm
Vent and Drain ¼" Hose Barb with Silicone "O" rings for 2", 5", and 8" capsule filters
Integrity Testing / Retention
Bacterial Retention
LRV> 6 for B.diminuta ATCC 19146 per cm2 of filter areaLRV> 5 for B.diminuta ATCC 19146 per cm2 of filter area
Bubble Point (with water)
> 40psi (3.52Kg/cm²) with Water> 30psi (2.11Kg/cm²) with Water
Operational
Max. Operating Temperature 80 °C @ < 30 psi (2 Kg/cm²)
Max. Differential Pressure < 60 psi (4 Kg/cm²) @ 30° C
Sterilization By Gas Sterilizable by Ethylene Oxide
Sterilization By Autoclave Autoclavable at 125°C for 30 minutes, 25 cycle and it cannot be In-line steam sterilized
Shelf Life 3 years after EO sterilization
Assurance
Toxicity Passes Bioreactivity test, Invivo, as per USP <88> for Class VI plastics
Bacterial Endotoxin Aqueous extracts exhibit < 0.25 EU/ml as established by LAL Test
Bioburden Bioburden level is < 1000 cfu/filter device as per ISO 11737-1 : 2018
Non Fiber Releasing Complies with USFDA CFR Title 21, 210.3 (b) (6)
Particle Release The filtrate complies with USP <788> test for particulatematter in injections
Indirect Food Additive Passes as per USFDA 21 CFR 177.1520
Extractables with WFI Passes test as per USP
Good Manufacturing Practice These products are manufactured in a facility which adheres to Good Manufacturing Practices.
Oxidizable Substances Within limits as specified in USP
Quality Management System ISO-9001 Certified
USFDA DMF No. 015554

Type
BioPro® KS
DBKS
Size
Size Code
1" 51
2" 52
5" 53
8" 57
Pore Size
Pore Size Code
0.1µm 36
0.2µm 01
0.45µm 02
I/O Connection
Connection Code
¼” SHB A
¼” MNPT (18 TPI) B
¼” BSP (19 TPI) M
¼” BSP (19 TPI) with O-ring P
¼” BSP F
½” MNPT C
½” Hose Barb D
1½" Sanitary Flange E
¾" Sanitary Flange S
Quick Connector J
Single Step ½" Hose Barb* Q
Female Luer Lock U
Male Luer Slip** W
3/8" Hose Barb* I
3/16" Hose Barb*** N
X
X
Sterility
Code
Non Sterile 1
EO Sterile 2
Pack Size
Qty Code
1 01

*1" Capsule filters are not available with ½" Single Step Hose Barb and 3/8" Hose Barb Connections

**Male luer slip is available only in 1” capsule filter as outlet

***3/16" Hose Barb end connection is available in:

  • 1" and 2" capsule filters as inlet and outlet
  • 5" capsule filters as outlet only

     Example :

DBKS 57 01 EE X X 1 01
         Example for Non Sterile: DBKS5701EEXX101                                                            Example for EO Sterile: DBKS5701EEXX201

Biopro ks small flowrates

Datasheet Download
Certificate of Quality Download

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