UA-44035381-1
  • AseptiCap NS 5", 10", 20", 30"

AseptiCap NS 5", 10", 20", 30"

mdi AseptiCap NS Nylon 66 membrane large capsule filters are double layered sterilizing grade filters offering absolute retention, wide chemical compatibility, and serial filtration for enhanced throughputs.

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
  • Sterilization filtration of stability batches in formulation development labs
  • Sterilization of compatible solvents and chemicals
Construction
Membrane Nylon 66
Final Filter Pore Size
0.2µm0.45µm
Prefilter Pore Size
0.8µm, 0.45µm0.8µm
Support Layers Polyester
Body and Core Polypropylene
Integrity Testing / Retention
Microbial Retention
LRV >7 for Brevundimonas diminuta (ATCC 19146) per cm²LRV >7 for Serratia marcescens (ATCC 14756) per cm²
Air Diffusion Flow per 10" Capsule filter (with 50% IPA Wetted)
< 25ml/min @ 16 psi (1.12Kg/cm²)< 25ml/min @ 10 psi (0.7Kg/cm²)
Size
Size
5"10"20"30"
Effective Filtration Area (Nominal)
3000cm²6000cm²12000cm²18000cm²
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
Dimensions (End to End) Inline Capsule Filters - 1½" Sanitary Flange Inlet ½" Single Step Hose Barb Outlet
212 mm332 mm618 mm878 mm
Dimensions (End to End) Inline Capsule Filters - ½" Single Step Hose Barb I/O
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
Vent and Drain ¼" Hose Barb with Silicone "O" rings
Operational
Max. Operating Temperature 80 °C @ < 2 Kg/cm² (30 psi)
Max. Differential Pressure < 4 Kg/cm² (60 psi ) @ 30 °C
Sterilization By Gas Sterilizable 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
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
Indirect Food Additive All Polypropylene components meet the FDA Indirect Food Additive requirements cited in 21 CFR 177.1520
Extractables with WFI Passes NVR test as per USP <661>
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.
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

Type
AseptiCap NS* (0.45μm Upstream) LNSX
AseptiCap NS (0.8μm Upstream) LNS5
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
X
Inline/T-line
Code
Inline X
T-line** T
Sterility
Code
Non Sterile 1
EO Sterile 2
Pack Size
Pack Size Code
1 01

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

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

**T-line Capsule Filters are available with 1½” Sanitary Flange I/O Connections 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 :

LNS5 54 01 EE X X 1 01
Example for Non Sterile: LNS55401EEXX101                                                            Example for EO Sterile: LNS55401EEXX201
Datasheet Download
Certificate of Quality Download

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