UA-44035381-1
  • AseptiCap NL/NS 1", 2", 5", 8"

AseptiCap NL/NS 1", 2", 5", 8"

mdi AseptiCap NL/NS Nylon 66 membranes 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
0.2µm0.45µm
Support Layers Polyester
Body and Core Polypropylene
Prefilter Pore Size (In case of AseptiCap NS)
0.8µm, 0.45µm0.8µm
Integrity Testing / Retention
Microbial Retention
LRV >7 for Brevundimonas diminuta (ATCC 19146) per cm²LRV >7 for Serratia marcescens (ATCC 14756) per cm²
Bubble Point (with 50% IPA)
> 17psi (1.19Kg/cm²) > 11psi (0.77Kg/cm²)
Size
Size
1"2"5"8"
Effective Filtration Area (Nominal) - AseptiCap NL
250cm²900cm²1800cm²2700cm²
Dimension (End to End) - 1½" Sanitary Flange Inlet ½" Single Step Hose Barb Outlet
-- 111 mm 162 mm 212 mm
Effective Filtration Area (Nominal) - AseptiCap NS
200cm²700cm²1400cm²2100cm²
Dimension (End to End) - ¾" Sanitary Flange Inlet I/O
91 mm103 mm155 mm205 mm
Dimension (End to End) - 1½" Sanitary Flange I/O
91 mm 110 mm 161 mm 211 mm
Dimension (End to End) - ½" Hose Barb I/O
90 mm112 mm164 mm215 mm
Dimension (End to End) - ½" Single Step Hose Barb I/O
-- 115 mm 165 mm 217 mm
Operational Radius (with Vent/ Drain)
30 mm65 mm65 mm65 mm
Vent and Drain
--¼" Hose Barb with Silicone "O" rings for 2", 5" and 8" only
Operational
Max. Operating Temperature 80 °C @ < 30 psi (2 Kg/cm²)
Max. Differential Pressure < 60 psi (4 Kg/cm²) @ 30 °C
Sterilization By Gas Sterilizable by Ethylene Oxide
Sterilization By Autoclave Autoclavable at 125 °C for 30 minutes 25cycles 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)(3) 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 NL DNLX
AseptiCap NS* (0.45 μm Upstream) DNSX
AseptiCap NS (0.8μm Upstream) DNS5
Size
Size Code
1" 51
2" 52
5" 53
8" 57
Pore Size
Pore Size Code
0.2µm 01
0.45µm 02
I/O Connection
Connection Code
¼" SHB A
¼" MNPT B
½" MNPT** C
½" Hose Barb D
1½" Sanitary Flange E
¾" Sanitary Flange S
Quick Connector J
Single Step ½" Hose Barb** Q
Female Luer Lock*** U
Male Luer Slip**** W
3/8" Hose Barb** I
3/16" Hose Barb N
X
Bell
Code
Yes***** B
No Bell X
Bell with cover C
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

**1” Capsule Filters are not available with ½” Single step Hose Barb, ½" MNPT and 3/8" Hose Barb

***Female luer lock is available in 1” and 2” capsule filters only

****Male luer slip is available only in 1” capsule filter as outlet

*****Bell is available with:

  • ½" Hose Barb outlet connections in 1", 2", 5" and 8" capsule filters
  • ¼" SHB outlet connection in 1" capsule filters only

        Example :

DNS5 52 01 DD X X 1 01
Example for Non Sterile: DNS55201DDXX101                                                            Example for EO Sterile: DNS55201DDXX201


Datasheet Download
Certificate of Quality Download

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