LNS55301EEXX101 |
LNSX5301QQXX101 |
LNSX5401EEXX101 |
LNSX5401EEXX201 |
LNSX5501EEXX101 |
capsule filters, filters, nylon
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 |
|
Prefilter Pore Size |
|
Support Layers |
Polyester |
Body and Core |
Polypropylene |
Size |
Size |
|
Effective Filtration Area (Nominal) |
3000cm² | 6000cm² | 12000cm² | 18000cm² |
|
Dimension (End to End) - ¾" Sanitary Flange I/O |
|
Dimension (End to End) - 1½" Sanitary Flange I/O |
|
Dimensions (End to End) Inline Capsule Filters - 1½" Sanitary Flange Inlet ½" Single Step Hose Barb Outlet |
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Dimensions (End to End) Inline Capsule Filters - ½" Single Step Hose Barb I/O |
|
Dimension (End to End) - 1" Hose Barb I/O |
|
Operational Radius (with Vent/ Drain) |
|
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 |
Integrity Testing / Retention |
Microbial Retention |
LRV >7 for Brevundimonas diminuta (ATCC 19146) per cm² | LRV >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) |
|
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 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 ISO 11737-1 : 2018 |
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 3 liter of WFI 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 | | | 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 :
Example for Non Sterile: LNS55401EEXX101 Example for EO Sterile: LNS55401EEXX201