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AseptiCap WS 25mm, 50mm

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AseptiCap WS 25mm, 50mm
  •  AseptiCap WS are low protein binding hydrophilic PVDF gamma sterilizable membrane inline capsule filters, designed for sterile filtration of very small fluid volumes in formulation and process development labs.
  • These capsule filters are validated to meet compendia and regulatory requirements and are well characterized. They meet key process requirements such as absolute retention efficiency, extremely low extractables, high throughputs, wide chemical compatibility and other important characteristics.
Features:
  • Absolute retention
  • 100% integrity tested
  • Low protein binding
  • Low extractables
  • Very low hold up volume
Applications:
Sterile Filtration of:
  • Antibodies
  • Protein Solutions
  • Buffers
  • Heat labile additives
  • Cell culture media
  • Vaccine concentrates
  • Small Volume Parenterals
Specifications:
Catalogue No LSCPF51
CONSTRUCTION
Membrane 0.2 µm Hydrophilic PVDF
Prefilter Membrane 0.45 µm Hydrophilic PVDF
Plastic parts Polypropylene
Integrity Testing / Retention
Bubble Point > 50psi (3.52 Kg/cm²) with Water
Microbial Retention LRV>7 for Brevundimonas diminuta (ATCC 19146) per cm²
Size
Size
25 mm 50 mm
Effective Filtration Area (Nominal)
5 cm² 20 cm²
Dimension (End to End) - Female Luer Lock Inlet/ Male Luer Slip
23 mm --
Dimension (End to End) - ¼" SHB
-- 79 mm
Dimension (End to End) - ¾" Sanitary Flange Inlet I/O
-- 51 mm
Operational Radius (with Vent/ Drain)
15 mm 28 mm
OPERATIONAL
Max. Operating Temperature
55 °C 60 °C
Max. Differential Pressure
75 Psi (5 Kg/cm²)@ 25 °C 42 Psi (3 Kg/cm²) @ 30 °C
pH Compatibility Compatible with pH range of 1-14
Sterilization By Gas Sterilization by Ethylene Oxide
Sterilization - By Autoclave Autoclavable at 125°C for 30 minutes, 25 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 < 0.25 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
TOC and Conductivity Meets the WFI requirements of USP for TOC <643> and Conductivity <645> after a specified minimal flush
Indirect Food Additive All Polypropylene components meet the FDA Indirect Food Additive requirements cited in 21 CFR 177.1520
Extractables with WFI Passes test as per USP
Oxidizable Substances Within limits as specified in USP
Particle Shedding Passes USP test for particulates in injectables.
Quality Management System ISO-9001 Certified
USFDA DMF No. 015554
 
Description

Details

AseptiCap WS 25mm, 50mm
  •  AseptiCap WS are low protein binding hydrophilic PVDF gamma sterilizable membrane inline capsule filters, designed for sterile filtration of very small fluid volumes in formulation and process development labs.
  • These capsule filters are validated to meet compendia and regulatory requirements and are well characterized. They meet key process requirements such as absolute retention efficiency, extremely low extractables, high throughputs, wide chemical compatibility and other important characteristics.
Features:
  • Absolute retention
  • 100% integrity tested
  • Low protein binding
  • Low extractables
  • Very low hold up volume
Applications:
Sterile Filtration of:
  • Antibodies
  • Protein Solutions
  • Buffers
  • Heat labile additives
  • Cell culture media
  • Vaccine concentrates
  • Small Volume Parenterals
Specifications:
Catalogue No LSCPF51
CONSTRUCTION
Membrane 0.2 µm Hydrophilic PVDF
Prefilter Membrane 0.45 µm Hydrophilic PVDF
Plastic parts Polypropylene
Integrity Testing / Retention
Bubble Point > 50psi (3.52 Kg/cm²) with Water
Microbial Retention LRV>7 for Brevundimonas diminuta (ATCC 19146) per cm²
Size
Size
25 mm 50 mm
Effective Filtration Area (Nominal)
5 cm² 20 cm²
Dimension (End to End) - Female Luer Lock Inlet/ Male Luer Slip
23 mm --
Dimension (End to End) - ¼" SHB
-- 79 mm
Dimension (End to End) - ¾" Sanitary Flange Inlet I/O
-- 51 mm
Operational Radius (with Vent/ Drain)
15 mm 28 mm
OPERATIONAL
Max. Operating Temperature
55 °C 60 °C
Max. Differential Pressure
75 Psi (5 Kg/cm²)@ 25 °C 42 Psi (3 Kg/cm²) @ 30 °C
pH Compatibility Compatible with pH range of 1-14
Sterilization By Gas Sterilization by Ethylene Oxide
Sterilization - By Autoclave Autoclavable at 125°C for 30 minutes, 25 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 < 0.25 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
TOC and Conductivity Meets the WFI requirements of USP for TOC <643> and Conductivity <645> after a specified minimal flush
Indirect Food Additive All Polypropylene components meet the FDA Indirect Food Additive requirements cited in 21 CFR 177.1520
Extractables with WFI Passes test as per USP
Oxidizable Substances Within limits as specified in USP
Particle Shedding Passes USP test for particulates in injectables.
Quality Management System ISO-9001 Certified
USFDA DMF No. 015554
 
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