UA-44035381-1
  • AseptiCap<sup>®</sup> VK-γ 5", 10"

AseptiCap® VK-γ 5", 10"

mdi AseptiCap® VK-γ capsule filters incorporate a specially designed combination of validated sterilizing grade hydrophobic PVDF as well as hydrophilic Polyethersulfone (PES) membrane to facilitate and provide unique performance advantages in pre-use integrity testing of aseptic filtration systems.

AseptiCap® VK-γ capsule filters help carry out critical functions such as filter wetting and integrity testing while maintaining sterility of the aseptic filtration system.

  • Absolute retention
  • 100% integrity tested
  • Very low hold up volume in filters
  • High flow rates
  • 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
  • Total traceability through unique serial number for each filter
  • Sterilizable by Gamma irradiation
Construction
Membrane Hydrophobic PVDF and Hydrophilic PES
Support Layers Polyester
Plastic parts Gamma Stable Polypropylene
Size
Size
5"10"
Effective Filtration Area (Nominal)
3000cm2
6000cm2
Operational Radius (with Vent/ Drain)
80mm80mm
Vent and Drain ¼” Hose Barb with Silicone “O” ring
Integrity Testing / Retention
Bubble Point > 18 psi (1.26 Kg/cm²) with 50% IPA/water solution
Microbial Retention LRV >7 for Brevundimonas diminuta (ATCC 19146) per cm²
Operational
Max. Operating Temperature 80 °C @ < 30 psi (2 Kg/cm²)
Max. Differential Pressure 60 psi (4 Kg/cm²) @ 30 °C
Shelf Life 2 years after gamma sterilization
Assurance
100% Integrity Tested Each AseptiCap® VK-γ is tested for integrity to comply with validated Acceptable Integrity Test Specifications.
Toxicity Passes Biological Reactivity tests, 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 as per USP <85>
Non Fiber Releasing Passes test as per USP and comply with USFDA 21 CFR Part 210.3(b)(6) for fiber release
Sterilization by Gamma Irradiation Gamma Irradiatable up to 50 kGy. These filters should not be autoclaved or in-line steam sterilized.
Indirect Food Additive Comply with USFDA 21 CFR Part 177.1520
Bacterial Retention LRV> 7 for B. diminuta (ATCC 19146) per cm² of filter area as per ASTM F 838
Oxidizable Substances Passes test as per USP <1231>
Quality Management System ISO-9001 Certified
USFDA DMF No. 015554
Type
AseptiCap® VK-γ LVKL
Size
Size Code
5" 53
10" 54
Pore Size
Pore Size Code
0.2µm 01
I/O Connection
Connection Code
Single Step ½" Hose Barb* Q
1½" Sanitary Flange E
¾" Sanitary Flange S
3/8" Hose Barb* I
1” Hose Barb Z
Radiation Sterilizable
Code
Yes R
No* X
Inline
Code
Inline X
Sterility
Code
Non Sterile 1
Gamma Sterile 3
Pack Size
Pack Size Code
1 01


    *Gamma irradiated filters can not be gamma sterilized again

     Example:

LVKL 53 01 EE R X 1 01
Example for Non Sterile: LVKL5301QQRX101                                                            Example for Gamma Sterile: LVKL5301QQXX301
Datasheet Download
Certificate of Quality Download
  • Allows unlimited water for injection (WFI) flushing of sterilizing grade product filter for easy wetting
  • Allows fast drying of the filtration system necessary for processes involving oily solutions
  • Acts as a sterile barrier against inadvertent ingress of environmental air