UA-44035381-1
  • AseptiVent<sup>®</sup> VF-γ 1", 2", 5", 8"

AseptiVent® VF-γ 1", 2", 5", 8"

mdi AseptiVent® VF-γ gamma sterilizable 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
1"2" 5"8"
Effective Filtration Area (Nominal)
250 cm²500 cm²1000 cm²2000 cm²
Dimension (End to End) - Quick Connector
100 mm111 mm163 mm212 mm
Dimension (End to End) - ¾" Sanitary Flange Inlet I/O
85 mm 104 mm 155 mm 206 mm
Dimension (End to End) - 1½" Sanitary Flange I/O
92 mm112 mm164 mm216 mm
Dimensions (End to End) - ½" Single Step Hose Barb I/O
--
115 mm162 mm218 mm
Dimension (End to End) - ½" Hose Barb I/O
90 mm112 mm162 mm214 mm
Dimension (End to End) - ¼" SHB
94 mm 122 mm 172 mm 223 mm
Dimensions (End to End) Inline Capsule Filters - 1½" Sanitary Flange Inlet ½" Single Step Hose Barb Outlet
--
112 mm165 mm216 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" only
Integrity Testing / Retention
Bubble Point > 18 psi (1.26 Kg/cm²) with 50% IPA/Water
Microbial Retention LRV >7 for Brevundimonas diminuta (ATCC 19146) per cm²
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.
Assurance
Toxicity Passes Bioreactivity test, In Vivo, as per USP <88> for Class VI plastics
Bacterial Endotoxin AAqueous 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 All Polypropylene components meet the FDA Indirect Food Additive requirements cited in 21 CFR 177.1520
Bacterial Retention LRV >7 for B. diminuta per cm² of filter area as per ASTM F 838-05 (liquid bacterial Challenge)
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
DVLX
Size
1"* 51
2" 52
5" 53
8" 57
Pore Size
Pore Size Code
0.2µm 01
I/O Connection
Connection Code
¼” SHB A
¼" MNPT 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
Radiation Sterilizable
Code
Yes R
No**** X
X
Sterility
Code
Non Sterile 1
Gamma Sterile 3
Pack Size
Pack Size Code
1 01

*1” Capsule Filters are not available with ½” Single step Hose Barb, ½" MNPT and 3/8" Hose Barb

**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

****Gamma sterilized filters cannot be gamma irradiated again

Example :

DVLX 57 01 EE R X 1 01
Example for Non Sterile: DVLX5301QQRX101                                                            Example for Gamma Sterile: DVLX5301QQXX301

AseptiCap VF gamma Small flow rates

Datasheet Download
Certificate of Quality Download

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