UA-44035381-1
  • AseptiVent<sup>®</sup> VF-γ 25mm, 37mm, 50mm

AseptiVent® VF-γ 25mm, 37mm, 50mm

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 such as small bioreactors, sterile tank venting, bottle venting etc.

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 0.2µm
Support Layers Polyester
Body and Core Gamma Stable Polypropylene
Size
Size
25 mm37 mm50 mm
Effective Filtration Area (Nominal)
5cm²10cm²20cm²
Dimension (End to End) - ¼" SHB I/O
--64 mm79 mm
Dimension (End to End) - ¾" Sanitary Flange Inlet I/O
----51 mm
Dimension (End to End) - Female Luer Lock Inlet/ Male Luer Slip Outlet
23 mm----
Operational Radius (with Vent/ Drain)
15 mm23 mm28 mm
Integrity Testing / Retention
Bubble Point > 18psi (1.26Kg/cm²) with 50% IPA/ Water Solution
Microbial Retention LRV >7 for Brevundimonas diminuta (ATCC 19146) per cm²
Operational
Max. Operating Temperature 80° C @ < 0.5 Kg/cm² (7psi)
Max. Differential Pressure 1.5 Kg/cm² (22 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 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
Bacterial Retention LRV >7 for B. diminuta per cm² of filter area as per ASTM 838-05 against 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

AseptiVent®- VF- γ 25mm

Type
AseptiVent VF®- γ
IVFX
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
     * Gamma sterilized filters cannot be gamma irradiated again

     Example :

IVFX 06 01 MN R X 1 04

Example for Non Sterile: IVFX0601MNRX104                                                            Example for Gamma Sterile: IVFX0601MNXX304


AseptiVent®- VF- γ (37mm, 50mm)

Type
AseptiVent® VF- γ
IVFX
Size
Dia
Code
37mm 08
50mm 10
Pore Size
Pore Size Code
0.2µm 01
I/O Connection
Connection Code
¼” SHB B
¾" Sanitary Flange S
Radiation Sterilizable
Code
Yes R
No* X
X
Sterility
Code
Non Sterile 1
Gamma Sterile 3
Pack Size
Pack Size Code
10 (50 mm) 02
20 (37 mm)*** 09

     * Gamma sterilized filters cannot be gamma irradiated again

     ***37mm is available with ¼” SHB I/O connection and in pack size 20 only


     Example :

IVFX 08 01 BB R X 1 08

Example for Non Sterile: IVFX0801BBRX109                                                            Example for Gamma Sterile: IVFX0801BBXX309

AseptiVent VF gamma Inline flow rates

Datasheet Download
Certificate of Quality Download

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