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 |
|
||||
Support Layers | Polyester | ||||
Body and Core | Polypropylene | ||||
Prefilter Pore Size (In case of AseptiCap NS) |
|
||||
Integrity Testing / Retention | |||||
Microbial Retention |
|
||||
Bubble Point (with 50% IPA) |
|
||||
Size | |||||
Size |
|
||||
Effective Filtration Area (Nominal) - AseptiCap NL |
|
||||
Dimension (End to End) - 1½" Sanitary Flange Inlet ½" Single Step Hose Barb Outlet |
|
||||
Effective Filtration Area (Nominal) - AseptiCap NS |
|
||||
Dimension (End to End) - ¾" Sanitary Flange Inlet I/O |
|
||||
Dimension (End to End) - 1½" Sanitary Flange I/O |
|
||||
Dimension (End to End) - ½" Hose Barb I/O |
|
||||
Dimension (End to End) - ½" Single Step Hose Barb I/O |
|
||||
Operational Radius (with Vent/ Drain) |
|
||||
Vent and Drain |
|
||||
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 |
|
|
|
|
|
|
|
|
*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
***3/16" Hose Barb end connection is available in:
- 1" and 2" capsule filters as inlet and outlet
- 5" capsule filters as outlet 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 |