UA-44035381-1
  • 0.2µm AseptiCap<sup>®</sup> KL/KS-γ 25mm, 50mm

0.2µm AseptiCap® KL/KS-γ 25mm, 50mm

mdi AseptiCap® KL/KS- γ are gamma sterilizable disposable PES membrane capsule filters offering a convenient lab scale solutions for process development with identical materials of construction for easy scale up to pilot scale and finally production scale filters.

Consistent and Reliable Quality:
AseptiCap® capsule filters are produced with ISO 9001 certified quality management systems.
Regulatory Compliance:
Meet all pharmacopeial and compendia requirements and are registered with USFDA DMF #015554
Low Protein Binding:
Results in increased overall product yield
High Throughputs:
Translates to lower filtration costs, less number of filter changes and overall economy of operations.
Low Extractables:
Mean less addition to impurity profile of the biological product from the filters.

  • Bioburden reduction from cell harvest supernatants
  • Filtration of equilibrating, washing and elution buffers for chromatography columns
  • Sterilization of biopharmaceuticals such as vaccines and therapeutic proteins
  • Sterilization of buffers
  • Sterilization of adjuvants

Construction
Membrane Hydrophilic PES
Final Filter Pore Size 0.2µm
Prefilter Pore Size 0.8 µm, 0.65µm, 0.45µm
Support Layers Polyester
Body and Core Polypropylene
Size
Size
25 mm50 mm
Effective Filtration Area (Nominal)
5cm²20cm²
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 mm28 mm
Integrity Testing / Retention
Bubble Point > 50psi (3.52Kg/cm²) with Water
Microbial Retention LRV >7 for Brevundimonas diminuta(ATCC 19146) per cm²
Operational
Max. Operating Temperature
55 °C60 °C
Max. Differential Pressure
5 Kg/cm² (75 Psi) @ 25°C3 Kg/cm² (42 Psi) @ 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

0.2µm AseptiCap® KL/KS -γ (25mm)

Type
AseptiCap® KL-γ (Single Layer)
 IKLX
AseptiCap® KS-γ
 (0.45 μm **Upstream)		 IKSX
AseptiCap® KS-γ
(0.65 μm Upstream)		 IKS3
AseptiCap® KS-γ
( 0.8 μm Upstream )		 IKS5
Size
Dia Code
25mm 06
Pore Size
Pore Size Code
0.2µm 01
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

** 0.45µm upstream is available with 0.2µm pore size only

* Gamma irradiated filters can not be gamma sterlized again

Example:

IKSX 06 01 MN R X 1 04

Example for Non Sterile: IKLX0601MNRX104      Example for Gamma Sterile: IKLX0601MNXX304

0.2µm AseptiCap® KL/KS- γ (50 mm)

Type
AseptiCap® KL-γ (with vent) (Single Layer)
 VKLX
AseptiCap® KS-γ (with vent)
(0.45 μm* Upstream)		 VKSX
AseptiCap® KS-γ (with vent)
(0.65 μm Upstream)		 VKS3
AseptiCap® KS-γ (with vent)
( 0.8 μm Upstream )		 VKS5
AseptiCap® KL-γ (without vent) (Single Layer)
 IKLX
AseptiCap® KS-γ (without vent)
(0.45 μm* Upstream)		 IKSX
AseptiCap® KS-γ (without vent)
(0.65 μm Upstream)		 IKS3
AseptiCap® KS-γ (without vent)
( 0.8 μm Upstream )		 IKS5
Size
Dia Code
50mm 10
Pore Size
Pore Size Code
0.2µm 01
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

*0.45µm upstream is available with 0.2µm pore size only

**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:

VKSX 10 01 SS R X 1 02

Example for Non Sterile: VKSX1001BBRX102      Example for Gamma Sterile: VKSX1001BBXX302

asepticap kl ks gamma inline flowrates

Datasheet Download
Certificate of Quality Download