UA-44035381-1
  • AseptiCap<sup>®</sup> Nano 25mm, 50mm

AseptiCap® Nano 25mm, 50mm

Sterilizing filtration of nano particle drug delivery systems, is a challenge. The nano particle size range is from 140nm to 160nm which tend to get retained by the 0.2μm (200nm) sterilizing membrane filter, Thereby drastically effecting the downstream yield.

mdi AseptiCap® Nano Capsule filters are ready to use, disposable, highly retentive filtration devices specially designed for difficult to filter nano particles based drug formulations. These filters house specifically designed asymmetric PES membrane which allows high yield (> 90%) while assuring a sterile downstream.

These filter devices are validated to meet compendia and regulatory requirements and are well characterized. They meet key process requirements such as high retention efficiency, extremely lowextractables, high throughputs, wide chemical compatibility and other important characteristics.

  • Absolute retention
  • 100% integrity tested
  • Low hold up volume for minimal filtration losses
  • Very low extractables
  • High flow rates
  • Bioburden maintained below 1000 cfu/device
  • Endotoxin level certified to be <0.25 EU/ml
  • Widest range of end connections
  • Products available for total scalability
  • Total traceability through unique serial number for each filter
  • Individual certificate of quality for each device

Sterilizing filtration of nano particles based drug products

Construction
Membrane Hydrophilic PES
Plastic parts Polypropylene
Size
Size
25 mm50 mm
Effective Filtration Area (Nominal)
5cm²20cm²
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
Sterilization By Autoclave Autoclavable at 125 °C for 30minutes. Can not be in-line steam sterilized
Assurance
Toxicity Passes Biological Reactivity Tests, 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 as per USP <85>
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 500ml flush
Indirect Food Additive Comply with USFDA 21 CFR Part 177.1520
Extractables with WFI Passes NVR test as per USP <661>
Oxidizable Substances Within limits as specified in USP <1231>
Quality Management System ISO-9001 Certified
USFDA DMF No. 015554

AseptiCap® Nano (25 mm)

Type
AseptiCap® Nano
 IKNX
Size
Dia Code
25mm 06
Retention Rating
S7
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
Pack Size
Pack Size Code
100 04

Example :

IKNX 06 S7 MN X X 1 04

AseptiCap® Nano (50 mm)

Type
AseptiCap® Nano (with vent)
 VKNX
AseptiCap® Nano (without vent)
 IKNX
Size
Dia Code
50mm 10
Retention Rating
S7
I/O Connection
Connection Code
¼" Stepped Hose Barb B*
¾" Sanitary Flange S*
Female Luer Lock M**
X
X
Sterility
Code
Non Sterile 1
Pack Size
Pack Size Code
12 08

    

    *¼" Stepped Hose Barb and ¾" Sanitary Flange are available in filters with vent only

    **Female luer lock is available in filters without vent only

Example :

VKNX 10 S7 BB X X 1 08

Datasheet Download
Certificate of Quality Download

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