0.45µm AseptiCap^® KL/KS-γ 25mm, 50mm

mdi produces a wide range of Sterilizing grade PES membrane devices to meet filtration requirements of biopharmaceutical processing. These filter devices are validated to meet compendia and regulatory requirements and are well characterized. They meet key process requirements such as high retention efficiency, very high protein recoveries, extremely low extractables, high throughputs, wide chemical compatibility and other important characteristics.

With the advantages of pre-filtration layer built into the device for higher throughputs, linear scalability of filter area for smooth transitions from lab scale to pilot to process scale and widest range of end connections for quick and reliable connections to the existing fittings,mdi AseptiCap KL/KS filters are a universal solution for process filtration.

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• Catalog Numbers
• Special Features
• Applications
• Specifications
• Ordering Information
• Flow Rates
• Documentation

IKL Single Layer IKLX, IKS 0.8 μm Upstream IKS5, IKS 0.65 μm Upstream IKS3, IKL without Vent Single Layer IKLX, IKS without Vent IKS5 0.8 μm Upstream IKS5, IKS without Vent 0.65 μm Upstream IKS3, VKL with Vent Single Layer VKLX, VKS with Vent 0.8 μm Upstream VKS5, VKS with Vent 0.65 μm Upstream VKS3, VKS51002BBRX102

• Absolute retention
• 100% integrity tested
• Low protein binding
• Very low hold up volume in filters
• High flow rates
• Serial construction with prefilter for higher throughput with fouling streams
• Bioburden maintained below 1000 cfu/device
• Endotoxin level certified to be <0.25 EU/ml
• Widest range of end connections
• Products available for total scalability from a few ml to thousands of liters
• Total traceability through unique serial number for each filter
• Individual certificate of quality for each device
• Sterilizable by Gamma irradiation 

Bioburden Reduction/ Particulate Removal

• Buffers
• Centrifuge supernatants
• Clarified cell lysates
  

Construction
Membrane	0.45μm Hydrophilic PES
Support Layers	Polyester
Body and Core	Polypropylene
Size
Size	25 mm 50 mm
Effective Filtration Area (Nominal)	5cm² 20cm²
Dimension (End to End) - Female Luer Lock Inlet/ Male Luer Slip	23 mm --
Dimension (End to End) - ¼" SHB	-- 79 mm
Dimension (End to End) - ¾" Sanitary Flange Inlet I/O	-- 51 mm
Operational Radius (with Vent/ Drain)	15 mm 28 mm
Integrity Testing / Retention
Bubble Point	> 30psi (2.11Kg/cm²) with Water
Microbial Retention	LRV> 7 for Serratia marcescens (ATCC 14756) per cm² of filter area
Operational
Max. Operating Temperature	55 °C 60 °C
Max. Differential Pressure	75 psi (5 Kg/cm²) @ 25 °C 42 psi (3 Kg/cm²) @ 30 °C
Burst Pressure	>14 Kg/cm² >8 Kg/cm²
Hold-up Volume(with air purge)	<50µL <300µL
pH Compatibility	Compatible with pH range of 1-10
Sterilization By Irradiation	Gamma Irradiatiable up to 50 kGy. These filters should not be autoclaved or in-line steam sterilized.
Shelf Life	2 years after gamma sterilization
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 Limulus Amebocyte Lysate (LAL) Test
Bioburden	Bioburden level is < 1000 cfu/filter device as per ISO 11737-1 : 2018
Non Fiber Releasing	Passes test as per USP and comply with USFDA 21 CFR Part 210.3(b)(6) for fiber release
Indirect Food Additive	All Polypropylene components meet the FDA Indirect Food Additive requirements cited in 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
Particle Shedding	Passes USP test for particulates in injectables.
TOC/Conductivity at 25 °C	Meets the WFI requirements of USP for TOC <643> and Conductivity <645> after a 500ml flush
Quality Management System	ISO-9001 Certified
USFDA	DMF No. 015554

0.45µm AseptiCap® KL/KS -γ (25mm)

Type IKL (Single Layer) IKLX IKS ( 0.8 μm Upstream ) IKS5 IKS (0.65 μm Upstream) IKS3

Size Dia Code 25mm 06

Pore Size Pore Size Code 0.45µm 02

I/O Connection Connection Code Female Luer lock M Male Luer Slip N ⅛" Hose Barb H ¼" Hose Barb B

Radiation Sterilizable Code Yes R No* X

X

Sterility Code Non Sterile 1 Gamma Sterile 3

Pack Size Pack Size Code 100 04

* Gamma irradiated filters can not be gamma sterlized again

Example:

IKS5

06

02

MN

R

X

1

04

---

0.45µm AseptiCap® KL/KS- γ (50 mm)

Type VKL (with vent) (Single Layer) VKLX VKS (with vent) (0.65 μm Upstream) VKS3 VKS (with vent) (0.8 μm Upstream) VKS5 IKL (without vent) (Single Layer) IKLX IKS (without vent) (0.65 μm Upstream) IKS3 IKS (without vent) (0.8 μm Upstream) IKS5

Size Dia Code 50mm 10

Pore Size Pore Size Code 0.45µm 02

I/O Connection Connection Code ¼" Stepped Hose Barb B** ¾"Sanitary Flange S** Female Luer Lock M***

Radiation Sterilizable Code Yes R No* X

X

Sterility Code Non Sterile 1 Gamma Sterile** 3

Pack Size Pack Size Code 10 02

*Gamma sterilized filters cannot be gamma irradiated again

**¼" Stepped Hose Barb and ¾" Sanitary Flange are available in filters with vent only

***Female luer lock is available in filters without vent only

Example:

VKS5

10

02

BB

R

X

1

02

Datasheet	Download
Certificate of Quality	Download