| 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 |
|
| 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
