UA-44035381-1
  • AseptiVent<sup>®</sup> VF-γ 5", 10", 20", 30"

AseptiVent® VF-γ 5", 10", 20", 30"

mdi AseptiVent® VF-γ Hydrophobic PVDF membrane vent filters are validated for microbial retention with liquid bacterial challenge test as per ASTM F838-05 to provide a high degree of sterility assurance for critical applications.

Consistent and Reliable Quality
AseptiVent® 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
Air Flow Rates
AseptiVent® is produced using a high hydrophobicity PVDF membrane. This ensures good flow rates even with high moisture content in the inlet air.
AseptiVent® capsule filters are designed to offer high air/gas flow rates at low differential pressures
  • Sterile air sparging
  • Sterile venting
  • Fermentor exhaust
Construction
Membrane Hydrophobic PVDF
Pore size 0.2 µm
Support Layers Polyester
Body and Core Gamma Stable Polypropylene
Size
Size
5" 10" 20" 30"
Effective Filtration Area
3000 cm²6000 cm²12000 cm²18000 cm²
Dimensions (End to End) - 1½" Sanitary Flange I/O
205 mm 330 mm 600 mm 855 mm
Dimension (End to End) - 1½" Sanitary Flange Inlet ½" Hose Barb Outlet
212 mm
334 mm
620 mm
870 mm
Dimension (End to End) - ¾" Sanitary Flange I/O
214 mm 335 mm -- --
Dimension (End to End) - ½" Single Step Hose Barb I/O
218 mm 336 mm 630 mm 890 mm
Dimension (End to End) - 1" Hose Barb I/O
-- 405 mm 635 mm 895 mm
Operational Radius (with Vent/ Drain)
78 mm 78 mm 78 mm 78 mm
Dimension (End to End) - 3/8" Hose Barb I/O
211 mm 332 mm 634 mm 885 mm
Vent and Drain ¼" Hose Barb with Silicone "O" ring
Integrity Testing / Retention
Bubble Point (with 50% IPA) > 1.26 Kg/cm² (18 psi)
Bacterial Retention LRV> 7 for B. diminuta per cm² of filter area as per ASTM F 838-05 (liquid bacterial Challenge)
Operational
Max. Operating Temperature 80°C @ < 2Kg/cm² (30 psi)
Max. Differential Pressure < 4 Kg/cm² (60 psi) @ 30° C
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 for Class VI plastics
Bacterial Endotoxin Aqueous extracts exhibit < 0.5 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 Comply with USFDA 21 CFR Part 177.1520
Good Manufacturing Practice These products are manufactured in a facility which adheres to Good Manufacturing Practices
Oxidizable Substances Within limits as specified in USP <1231>
Particle Shedding Passes USP test for particulates in injections
Quality Management System ISO-9001 Certified
USFDA DMF No. 015554

Type
AseptiVent® VF-γ
 LVLX
Size
Code
5" 53
10" 54
20" 55
30" 56
Pore Size
Code
0.2µm 01
Inlet/Outlet
Code
½" Single Step Hose Barb Q
1½" Sanitary Flange E
3/4” Sanitary Flange*** S
3/8” Hose Barb I
1” Hose Barb Z
Radiation Sterilizable
Code
Yes R
No* X
Inline/T-Line
Code
Inline X
T-line** T
Sterility
Code
Non Sterile 1
Gamma Sterile 3
Pack Size
Pack Size Code
1 01

* Gamma sterilized filters cannot be gamma irradiated again

** T-line is not available in 5” Capsule filter

** T-line Capsule Filter are available with 1½” Sanitary Flange I/O Connections Only

*** 3/4" Sanitary Flange end connection is available only in 5" and 10" capsule filters


     Example:

LVLX 54 01 EE R X 1 01
Example for Non Sterile: LVLX5401QQRX101                                                            Example for Gamma Sterile: LVLX5401QQXX301

AseptiCap VF gamma large flow rates

Datasheet Download
Certificate of Quality Download