Capsule filters, filters, asepticap
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
- Cell culture media containing serum
- Media additives
- Final product concentrates
| Construction |
| Membrane |
0.1 μm Hydrophilic PES |
| Prefilter Membrane |
0.2 μm or 0.45 μm Hydrophilic PES |
| Support Layers |
Polyester |
| Plastic parts |
Polypropylene |
| Size |
| Size |
|
| Effective Filtration Area (Nominal) |
| 3000cm² |
6000cm² |
12000cm² |
18000cm² |
|
| Dimension (End to End) - 1½" Sanitary Flange Inlet ½" Hose Barb Outlet |
| 212 mm |
334 mm |
620 mm
|
870 mm
|
|
| Dimension (End to End) - ¾" Sanitary Flange I/O |
|
| Dimensions (End to End) Inline Capsule Filters - 1½" Sanitary Flange I/O |
| 205 mm |
330 mm |
600 mm |
855 mm |
|
| Dimensions (End to End) Inline Capsule Filters - ½" Single Step Hose Barb I/O |
| 218 mm |
336 mm |
630 mm |
890 mm |
|
| Clean Water Flow Rate @ 10 psi with 1½" Sanitary Flange connection |
| 8 lpm |
17 lpm |
29 lpm |
45 lpm |
|
| Dimension (End to End) - 1" Hose Barb I/O |
|
| Operational Radius (with Vent/ Drain) |
|
| Dimension (End to End) - 3/8" Hose Barb I/O |
|
| Vent and Drain |
¼" Hose Barb with Silicone "O" rings |
| Integrity Testing / Retention |
| Bubble Point |
> 26 psi (1.82 Kg/cm²) with 50% IPA > 65 psi (4.56 Kg/cm²) with Water |
| Max. Air Diffusion Flow (@ 50psi (3.51 Kg/cm²) with water) |
| < 15 ml/min | < 29 ml/min | < 58 ml/min | < 87 ml/min |
|
| Bacterial Retention |
LRV > 7 for Acholeplasma laidlawii ATCC 23206 per cm² of filter area |
| Operational |
| Max. Operating Temperature |
80 °C @ < 30 psi (2 Kg/cm²) |
| Max. Differential Pressure |
60 psi (4 Kg/cm²) @ 30 °C |
| pH Compatibility |
Compatible with pH range of 1-10 |
| Sterilization By Gas |
Sterilizable by Ethylene Oxide |
| Sterilization By Autoclave |
Autoclavable at 125°C for 30 minutes, 25 cycles 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 |
| 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 |
| 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 |
| Particle Release |
Passes USP test for particulates in injectables |
| 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> |
| Oxidizable Substances |
Within limits as specified in USP <1231> |
| Particle Shedding |
Passes USP test for particulates in injectables. |
| Quality Management System |
ISO-9001 Certified |
| USFDA |
DMF No. 015554 |
| Type | AseptiCap® KS (0.2 μm Upstream)
| LKS1 | AseptiCap® KS (0.45 μm Upstream)
| LKSX | | | Size | | Size | Code | | 5" | 53 | | 10" | 54 | | 20" | 55 | | 30" | 56 | | | Pore Size | | Pore Size | Code | | 0.1µm | 36 | | | 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 | |
*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 for Non Sterile: LKSX5436EEXX101 Example for EO Sterile: LKSX5436EEXX201
