UA-44035381-1
  • AseptiVent TF 5", 10", 20", 30"

AseptiVent TF 5", 10", 20", 30"

mdi AseptiVent TF PTFE large capsule filters offer absolute retention and wide chemical compatibility for sterile filtration of air/gases as well as aggressive solvents in large volume.

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 No. 015554
Air Flow rates/ Hydrophobicity:
Translates to lower filtration costs, less number of filter changes and overall economy of operations.
  • Fermentor / Bioreactor sparging
  • Sterilization of environmental air in isolators
  • Venting of sterile collection vessels
  • Cleaning sterile surfaces
Construction
Membrane Hydrophobic PTFE
Pore size
0.2µm0.45µm
Support Layers Polypropylene
Body and Core Polypropylene
Integrity Testing / Retention
Air Diffusion Flow per 10" Capsule Filter (70% IPA/Water Wetted)
< 45 ml/min @ 16 psi(1.12 Kg/cm²)< 45 ml/min @ 8 psi(0.56 Kg/cm²)
Microbial Retention
Brevundimonas diminuta (ATCC 19146) per cm²Serratia marcescens (ATCC 14756) per cm²
Size
Size
5"10" 20"30"
Effective Filtration Area
3000cm²6000cm²12000cm²18000cm²
Dimension (End to End) - 1½" Sanitary Flange Inlet ½" Hose Barb Outlet
203 mm
332 mm
618 mm
878 mm
Dimension (End to End) - ¾" Sanitary Flange I/O
212 mm 345 mm -- --
Dimension (End to End) - 1½" Sanitary Flange I/O
207 mm326 mm605 mm865 mm
Dimension (End to End) - ½" Single Step Hose Barb
217 mm332 mm628 mm888 mm
Dimension (End to End) - 1" Hose Barb I/O
-- 405 mm 635 mm 895 mm
Operational Radius (with Vent/ Drain)
78 mm78 mm78 mm78 mm
Dimension (End to End) - 3/8" Hose Barb I/O
211 mm 330 mm 618 mm 878 mm
Operational
Max. Operating Temperature 80 °C @ <30psi (2Kg/cm²)
Max. Differential Pressure < 60psi (4Kg/cm²) @ 30 °C
Sterilization By Gas Sterilizable by Ethylene Oxide
Sterilization By Autoclave Autoclavable at 125°C for 30minute, 30 cycles and it cannot be in-line steam sterilized
Shelf Life 3 years after Ethylene Oxide 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
Microbial Bacterial Retention Validated as per ASTM F 838-05
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
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 injectables
Quality Management System ISO-9001 Certified
USFDA DMF No. 015554

Type
AseptiVent TF LTLX
Size
Size Code
5" 53
10" 54
20" 55
30" 56
Pore Size
Pore Size Code
0.2µm 01
0.45µm 02
I/O Connection
Connection Code
1½" Sanitary Flange E
3/4” Sanitary Flange** S
3/8” Hose Barb*** I
Single Step ½”Hose Barb Q
1” Hose Barb Z
XX
Inline/T-line
Code
Inline X
T-line* T
Sterility
Code
Non Sterile 1
EO Sterile 2
Pack Size
Pack Size Code
1 01

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

     *T-line Capsule filter are available with 1½" Sanitary Flange I/O connection only

     ***3/8" Hose Barb is available only with inline capsule filters

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

      Example :

LTLX 54 01 EE XX X 1 01
Example for Non Sterile: LTLX5401EEXXX101                                                            Example for EO Sterile: LTLX5401EEXXX201

Datasheet Download
Certificate of Quality Download

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