UA-44035381-1
  • AseptiCap NL/NS 25mm, 50mm

AseptiCap NL/NS 25mm, 50mm

mdi AseptiCap NL/NS Nylon 66 membrane capsule filters are sterilizing grade filters offering absolute retention, wide chemical compatibility, and very low hold up volumes.

  • Single Layered: AseptiCap NL
  • Multiple Layered:AseptiCap NS

Consistent and Reliable Quality:
AseptiCap 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
Total traceability:
Unique marking on each filter
  • Sterilizing filtration of stability batches in formulation development tabs.
  • Sterilization of Compatible solvents and chemicals.
Construction
Membrane Nylon 66
Final Filter Pore Size
0.2µm 0.45µm
Support Layers Polyester
Body and Core Polypropylene
Prefilter Pore Size (In case of AseptiCap NS)
0.8 µm, 0.45µm0.8 µm
Integrity Testing / Retention
Bubble Point (with 50% IPA)
> 17psi (1.19Kg/cm²)> 11psi (0.77Kg/cm²)
Size
Size
25 mm50 mm
Effective Filtration Area (Nominal)
5cm²20cm²
Dimension (End to End) - ¾" Sanitary Flange Inlet I/O
--51 mm
Dimension (End to End) - ¼" SHB
-- 79 mm
Dimension (End to End) - Female Luer Lock Inlet/ Male Luer Slip Outlet
23 mm--
Operational Radius (with Vent/ Drain)
15 mm28 mm
Operational
Max. Operating Temperature
55 °C60 °C
Max. Differential Pressure
5 Kg/cm² (75 Psi) @ 25° C3 Kg/cm² (42 Psi) @ 30° C
Burst Pressure
>14 Kg/cm²>8 Kg/cm²
Hold-up Volume(with air purge)
<50µL<300µL
Sterilization By Gas Sterilizable by Ethylene Oxide
Sterilization By Autoclave Autoclavable at 125°C for 30minutes 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
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
Microbial Retention
(LRV >7 for) Brevundimonas diminuta (ATCC 19146) per cm²(LRV >7 for) Serratia marcescens (ATCC 14756) per cm²
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
Extractables with WFI Passes test as per USP
Good Manufacturing Practice These products are manufactured in a facility which adheres to Good Manufacturing Practices.
Oxidizable Substances Within limits as specified in USP
Particle Shedding Passes USP test for particulates in injectables.
TOC/Conductivity at 25 °C Meets the WFI requirements of USP <643> for Total Organic Carbon and USP <645> for Water Conductivity after a specified volume of purified water flush
Quality Management System ISO-9001 Certified
USFDA DMF No. 015554

AseptiCap NL/NS- (25 mm)

Type
AseptiCap NL (Single Layer ) INLX
AseptiCap NS (0.45 μm* Upstream) INSX
AseptiCap NS ( 0.8 μm Upstream ) INS5
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
X
X
Sterility
Code
Non Sterile 1
EO Sterile 2
Pack Size
Pack Size Code
100 04

     *0.45μm Upstream is only available in 0.2μm Pore Size

        Example :

INSX 06 01 MN X X 1 04
Example for Non Sterile: INSX0601MNXX104                                                            Example for EO Sterile: INSX0601MNXX204

AseptiCap NL/NS- (50 mm)

Type
AseptiCap NL (Single Layer ) VNLX
AseptiCap NS (0.45 μm* Upstream) VNSX
AseptiCap NS ( 0.8 μm Upstream ) VNS5
Size
Dia
Code
50mm 10
Pore Size
Pore Size Code
0.2µm 01
0.45µm 02
I/O Connection
Connection Code
¼" Stepped Hose Barb B
¾" Sanitary Flange** S
X
X
Sterility
Code
Non Sterile 1
EO Sterile 2
Pack Size
Pack Size Code
10 02

     *0.45μm Upstream is only available in 0.2μm Pore Size

     **¾" Sanitary Flange is available as Outlet only

     Example :

VNSX 10 01 SS X X 1 02
Example for Non Sterile: VNSX1001SSXX102                                                           Example for EO Sterile: VNSX1001SSXX202


Datasheet Download
Certificate of Quality Download

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