UA-44035381-1
  • AseptiCap<sup>®</sup> Nano 5", 10", 20", 30"

AseptiCap® Nano 5", 10", 20", 30"

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
5"10" 20"30"
Effective Filtration Area
1750cm²3500cm²7000cm²10000cm²
Operational Radius (with Vent/ Drain)
80 mm80 mm80 mm80 mm
Vent and Drain ¼” Hose Barb with Silicone “O” rings
Integrity Testing / Retention
Air Diffusion Flows @20 psi
< 4.2 ml/min< 8.4 ml/min< 16.8 ml/min< 25 ml/min
Operational
Max. Operating Temperature 80 °C @ < 30 psi (2 Kg/cm²)
Max. Differential Pressure 60 psi (4 Kg/cm²) @ 30 °C
Sterilization By Autoclave Autoclavable at 125 °C for 30minutes. Can not be in-line steam sterilized
Assurance
100% Integrity Tested
Each AseptiCap® Nano is tested for integrity to comply with validated Acceptable Integrity Test Specifications.
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>
Bioburden Device bioburden is tested as per ISO 117 37-1 and assured to be <1000 cfu/device.
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 10 liter flush for 5” capsule filters and 20 liter flush for 10” capsule filters
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
Package Integrity AseptiCap® Nano capsule filters are fitted with vent caps and are packed in bags to ensure package integrity during transit as well as to prevent particulate contamination while transferring to clean room assembly or process areas.
Type
AseptiCap® Nano
 LKNX
Size
Size Code
5" 53
10" 54
20" 55
30" 56
Retention Rating
S7
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
Pack Size
Pack Size Code
1 01

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

*T-line Capsule filter are available with 1½" Sanitary Flange I/O connection only

***3/4" Sanitary Flange end connection is available only in 5" and 10" capsule filters


Example :

LKNX 57 S7 EE X X 1 01
Datasheet Download
Certificate of Quality Download

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