UA-44035381-1
  • AseptiVent TF 25mm, 37mm, 50mm

AseptiVent TF 25mm, 37mm, 50mm

mdi AseptiVent TF Disposable inline PTFE gas filters are convenient pre-fabricated devices used for sterilization of gases and as a bacterial air vent in various pharmaceutical and biopharmaceutical processes.

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 PTFE 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 for cell factories
  • Venting of small bioreactors
Construction
Membrane Hydrophobic PTFE
Pore size
0.2µm0.45µm
Support Layers Polypropylene
Body and Core Polypropylene
Integrity Testing / Retention
Bubble Point
> 22psi (1.55Kg/cm²)with 70% IPA/Water Solution> 10psi (0.7Kg/cm²)with 70% IPA/Water Solution
Microbial Retention
LRV >7 for Brevundimonas diminuta(ATCC 19146) per cm²LRV >7 for Serratia marcescens(ATCC 14756) per cm²
Size
Size
25 mm37 mm50 mm
Effective Filtration Area (Nominal)
5cm²10cm²20cm²
Dimension (End to End) - Female Luer Lock Inlet/ Male Luer Slip
23 mm----
Dimension (End to End) - ¾" Sanitary Flange
----51 mm
Dimension (End to End) - ¼" SHB
--64 mm79 mm
Dimension (End to End) ⅛" MNPT
----56 mm
Operational Radius (with Vent/ Drain)
15 mm23 mm28 mm
Operational
Max. Operating Temperature 60°C
Max. Differential Pressure 3Kg/cm² (42 psi) @ 30 °C
Burst Pressure
>14 Kg/cm²>8 Kg/cm²>8 Kg/cm²
Sterilization By Gas Sterilizable by Ethylene Oxide
Sterilization By Autoclave Autoclavable at 125°C for 30minutes, 30 cycles and it cannot be in-line steam sterilized
Shelf Life 3 years after EO 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 < 0.5 EU/ml as established by Limulus Amebocyte Lysate (LAL) Test
Bioburden Bioburden level is < 1000 cfu/filter device as per ANSI/AAMI/ISO 11737-1 : 1995
Microbial Retention Validated as per ASTM F 838-05
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
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- TF (25mm)

Type
AseptiVent TF ITFX
Size
Dia
Code
25mm 06
Pore Size
Pore Size Code
0.2µm 01
0.45µm 02
I/O Connection
Connection Code
Female Luer Lock M
Male Luer Slip N
⅛" Hose Barb H
¼" Hose Barb B
XX
Sterility
Code
Non Sterile 1
EO Sterile 2
Pack Size
Pack Size Code
100 04

     Example :

ITFX 06 01 MN XX 1 04
Example for Non Sterile: ITFX0801BBXX104                                                    Example for EO Sterile: ITFX0601MNXX204

AseptiVent- TF (37mm, 50mm)

Type
AseptiVent TF ITFX
Size
Dia
Code
37mm 08
50mm 10
Pore Size
Pore Size Code
0.2µm 01
0.45µm 02
I/O Connection
Connection Code
¼” SHB* B
" MNPT C
¾" Sanitary Flange*** S
XX
Sterility
Code
Non Sterile 1
EO Sterile 2
Pack Size
Pack Size Code
10 [50mm] 02
20 [37mm]** 09

* Note: AseptiVent TF- 37 mm is available with BB connection only

*** ¾" Sanitary Flange is available as outlet only

** 37mm filter are available in pack of 20 only

     Example :

ITFX 08 01 BB XX 1 09
Example for Non Sterile: ITFX0801BBXX109                                                            Example for EO Sterile: ITFX0801BBXX209

Datasheet Download
Certificate of Quality Download

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