| DKS15136AAXB301 |
| DKS15136AAXX301 |
| DKS15236AAXX301 |
| DKS15236DDXX301 |
| DKS15336DDXX301 |
| DKS15336JJXX301 |
| DKS15336QQXX301 |
| DKS15336SSXX301 |
| DKS15736DDXX301 |
| DKSX5736DDXX301 |
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 |
| Upstream Membrane |
0.2 µm or 0.45 µm Hydrophilic PES |
| Support Layers |
Polyester |
| Plastic parts |
Gamma Stable Polypropylene |
| Size |
| Size |
|
| Effective Filtration Area (Nominal) |
| 250cm² |
500cm² |
1000cm² |
2000cm² |
|
| Dimensions (End to End) - 1½" Sanitary Flange I/O |
| 92 mm |
112 mm |
164 mm |
216 mm |
|
| Dimension (End to End) - ½" Hose Barb I/O |
| 90 mm |
112 mm |
162 mm |
214 mm |
|
| Dimension (End to End) - 1½" Sanitary Flange Inlet ½" Single Step Hose Barb Outlet |
|
| Dimensions (End to End) - ¾" Sanitary Flange I/O |
|
| Dimension (End to End) - ½" Single Step Hose Barb I/O |
|
| Clean water Flow Rate @ 10 psi with ½" Hose Barb Connection |
| 1.3 lpm |
2.5 lpm |
4.8 lpm |
6.5 lpm |
|
| Operational Radius (with Vent/ Drain) |
|
| Vent and Drain |
¼" Hose Barb with Silicone "O" rings for 2", 5" and 8" only
|
|
| Integrity Testing / Retention |
| Bubble Point |
> 26 psi (1.82 Kg/cm²) with 50% IPA > 65 psi (4.56 Kg/cm²) with Water |
| 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 |
| Sterilization By Irradiation |
Gamma Irradiatiable up to 50 kGy. These filters should not be autoclaved or in-line steam sterilized. |
| 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 |
| TOC and Conductivity |
Meets the WFI requirements of USP for TOC <643> and Conductivity <645> after a 3 liter flush |
| Particle Release |
Passes USP test for particulates in injections |
| Indirect Food Additive |
Comply with USFDA 21 CFR Part 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 |
| pH Compatibility |
Compatible with pH range of 1 - 10 |
| Type | AseptiCap® KS-γ (0.2 µm Upstream)
| DKS1 | AseptiCap® KS-γ (0.45µm Upstream)
| DKSX | | | Size | | Size | Code | | 1" | 51 | | 2" | 52 | | 5" | 53 | | 8" | 57 | | | Pore Size | | Pore Size | Code | | 0.1µm | 36 | | | I/O Connection | | Connection | Code | | ¼" SHB | A | | ¼" MNPT | B | | ¼” BSP (19 TPI) | M | | ¼” BSP (19 TPI) with O-ring | P | | ¼” BSP | F | | ½” MNPT* | C | | ½” Hose Barb | D | | 1½" Sanitary Flange | E | | ¾" Sanitary Flange | S | | Quick Connector | J | | Single Step ½” Hose Barb* | Q | | Female Luer Lock | U | | Male Luer Slip** | W | | 3/8" Hose Barb* | I | | 3/16" Hose Barb*** | N | | | Radiation Sterilizable | | Code | | Yes | R | | No**** | X | | | Bell | | Code | | Yes***** | B | | No Bell | X | | Bell with cover***** | C | | | | Sterility | | Code | | Non Sterile | 1 | | Gamma Sterile | 3 | | | Pack Size | | Pack Size | Code | | 1 | 01 | |
*1” Capsule Filters are not available with ½” Single step Hose Barb, ½” MNPT and 3/8" Hose Barb
** Male luer slip is available only in 1” capsule filter as outlet
*** 3/16" Hose Barb end connection is available in:
- 1" and 2" capsule filters as inlet and outlet
- 5" capsule filters as outlet only
**** Gamma sterilized filters cannot be gamma irradiated again
***** Bell and bell with cover is available with:
- ½" HB outlet connections in 1", 2", 5" and 8" capsule filters
- ¼" SHB outlet connection in 1" capsule filters only
Example:
Example for Non Sterile: DKSX5136EERX101 Example for gamma Sterile: DKSX5136EEXX301
