LWSX5436EEXX101 LWSX5436EEXX301 LWSX5436EERX101LWSX5436IEXX101 LWSX5436IEXX301 LWSX5436IERX101LWSX5436EQXX101 LWSX5436EQXX301 LWSX5436EQRX101LWSX5436IQXX101 LWSX5436IQXX301 LWSX5436IQRX101LWSX5436QQXX101 LWSX5436QQXX301 LWSX5436QQRX101LWSX5436IIXX101 LWSX5436IIXX301 LWSX5436IIRX101LWSX5436EEXT101 LWSX5436EEXT301 LWSX5436EEXT101LWSX5536EEXX101 LWSX5536EEXX301 LWSX5536EERX101LWSX5536IEXX101 LWSX5536IEXX301 LWSX5536IERX101LWSX5536EQXX101 LWSX5536EQXX301 LWSX5536EQRX101LWSX5536IQXX101 LWSX5536IQXX301 LWSX5536IQRX101LWSX5536QQXX101 LWSX5536QQXX301 LWSX5536QQRX101LWSX5536IIXX101 LWSX5536IIXX301 LWSX5536IIRX101LWSX5536EEXT101 LWSX5536EEXT301 LWSX5536EEXT101LWSX5636EEXX101 LWSX5636EEXX301 LWSX5636EERX101LWSX5636IEXX101 LWSX5636IEXX301 LWSX5636IERX101LWSX5636EQXX101 LWSX5636EQXX301 LWSX5636EQRX101LWSX5636IQXX101 LWSX5636IQXX301 LWSX5636IQRX101LWSX5636QQXX101 LWSX5636QQXX301 LWSX5636QQRX101LWSX5636IIXX101 LWSX5636IIXX301 LWSX5636IIRX101LWSX5636EEXT101 LWSX5636EEXT301 LWSX5636EEXT101LWSX5336EEXX101 LWSX5336EEXX301 LWSX5336EERX101LWSX5336IEXX101 LWSX5336IEXX301 LWSX5336IERX101LWSX5336EQXX101 LWSX5336EQXX301 LWSX5336EQRX101LWSX5336IQXX101 LWSX5336IQXX301 LWSX5336IQRX101LWSX5336QQXX101 LWSX5336QQXX301 LWSX5336QQRX101LWSX5336IIXX101 LWSX5336IIXX301 LWSX5336IIRX101 LWS15436EEXX101 LWS15436EEXX301 LWS15436EERX101LWS15436IEXX101 LWS15436IEXX301 LWS15436IERX101LWS15436EQXX101 LWS15436EQXX301 LWS15436EQRX101LWS15436IQXX101 LWS15436IQXX301 LWS15436IQRX101LWS15436QQXX101 LWS15436QQXX301 LWS15436QQRX101LWS15436IIXX101 LWS15436IIXX301 LWS15436IIRX101LWS15436EEXT101 LWS15436EEXT301 LWS15436EEXT101LWS15536EEXX101 LWS15536EEXX301 LWS15536EERX101LWS15536IEXX101 LWS15536IEXX301 LWS15536IERX101LWS15536EQXX101 LWS15536EQXX301 LWS15536EQRX101LWS15536IQXX101 LWS15536IQXX301 LWS15536IQRX101LWS15536QQXX101 LWS15536QQXX301 LWS15536QQRX101LWS15536IIXX101 LWS15536IIXX301 LWS15536IIRX101LWS15536EEXT101 LWS15536EEXT301 LWS15536EEXT101LWS15636EEXX101 LWS15636EEXX301 LWS15636EERX101LWS15636IEXX101 LWS15636IEXX301 LWS15636IERX101LWS15636EQXX101 LWS15636EQXX301 LWS15636EQRX101LWS15636IQXX101 LWS15636IQXX301 LWS15636IQRX101LWS15636QQXX101 LWS15636QQXX301 LWS15636QQRX101LWS15636IIXX101 LWS15636IIXX301 LWS15636IIRX101LWS15636EEXT101 LWS15636EEXT301 LWS15636EEXT101LWS15336EEXX101 LWS15336EEXX301 LWS15336EERX101LWS15336IEXX101 LWS15336IEXX301 LWS15336IERX101LWS15336EQXX101 LWS15336EQXX301 LWS15336EQRX101LWS15336IQXX101 LWS15336IQXX301 LWS15336IQRX101LWS15336QQXX101 LWS15336QQXX301 LWS15336QQRX101LWS15336IIXX101 LWS15336IIXX301 LWS15336IIRX101 Capsule filters, filters, asepticap
- Absolute retention
- 100% integrity tested
- Low hold up volume
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
|
Low Protein Binding:
| Results in increased overall product yield.
|
High Throughputs:
| Translates to lower filtration costs, less number of filter changes and overall economy of operations.
|
Low Extractables:
| Mean less addition to impurity profile of the biological product from the filters.
|
Sterile Filtration of:
- Cell culture media
- Growth regulators
- Small Volume Parenterals
Construction |
Membrane |
Hydrophilic PVDF |
Pore size |
0.1 µm |
Prefilter Pore Size |
0.2µm,0.45µm |
Support Layers |
Polyester |
Plastic parts |
Polypropylene |
Body and Core |
Gamma Stable Polypropylene |
Size |
Size |
|
Effective Filtration Area |
3000 cm² | 6000 cm² | 12000 cm² | 18000 cm² |
|
Dimensions (End to End) - 1½" Sanitary Flange I/O |
205 mm |
330 mm |
600 mm |
855 mm |
|
Dimension (End to End) - 1½" Sanitary Flange Inlet ½" Hose Barb Outlet |
|
Dimension (End to End) - ¾" Sanitary Flange I/O |
|
Dimension (End to End) - ½" Single Step Hose Barb I/O |
218 mm |
336 mm |
630 mm |
890 mm |
|
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 | 332 mm | 634 mm | 885 mm | |
Vent and Drain |
¼" Hose Barb with Silicone "O" ring |
Integrity Testing / Retention |
Microbial Retention |
LRV >7 for Acholeplasma laidlawii (ATCC 23206) per cm² |
Bubble Point (with 50% IPA) |
> 31psi |
Operational |
Max. Operating Temperature |
80°C @ < 2Kg/cm² (30 psi) |
Max. Differential Pressure |
< 4 Kg/cm² (60 psi) @ 30° C |
Sterilization By Irradiation |
Gamma Irradiatable up to 50 kGy |
Shelf Life |
2 years after gamma sterilization |
Assurance |
Toxicity |
Passes Bioreactivity test, In Vivo, as per USP <88> for Class VI plastics |
Cytotoxicity |
Passes Biological Reactivity Tests, In Vitro, USP <87> for cytotoxicity |
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 |
Particle Release |
The filtrate complies with USP <788> test for particulate matter in injections |
Indirect Food Additive |
All Polypropylene components meet the FDA Indirect Food Additive requirements cited in 21 CFR 177.1520 |
Good Manufacturing Practice |
These products are manufactured in a facility which adheres to Good Manufacturing Practices |
Oxidizable Substances |
Within limits as specified in USP |
Quality Management System |
ISO-9001 Certified |
USFDA |
DMF No. 015554 |
Type | LWL (Single Layer) | LWLX | LWS (0.2 μm Upstream | LWS1 | LWS (0.45 μm Upstream | LWSX | | Size | Size | Code | 5" | 53 | 10" | 54 | 20" | 55 | 30" | 56 | | Pore Size | Pore Size
| Code | 0.1µm | 36 | | Inlet/Outlet | 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 | | Radiation Sterilizable | | Code | Yes | R | No* | X | | Inline/T-Line | | Code | Inline | X | T-line** | T | | Sterility | | Code | Non Sterile | 1 | Gamma Sterile | 3 | | Pack Size | Pack Size | Code | 1 | 01 | |
*1” Hose Barb is not available in 5” capsule filters
** Gamma sterilized filters cannot be gamma irradiated again
*** T-line Capsule Filters are available with 1½” Sanitary Flange I/O Connections Only
****3/4" Sanitary Flange end connection is available only in 5" and 10" capsule filters
Example: Example for Non Sterile: LWS15436QQRX101 Example for Gamma Sterile: LWS15436QQXX301