CPN55301A0SE101 |
CPN55301A0SR101 |
CPN55301A0SS101 |
CPN55301A0SV101 |
CPN55301E0SE101 |
CPN55301E0SR101 |
CPN55301E0SS101 |
CPN55301E0SV101 |
CPN55301F0SE101 |
CPN55301F0SR101 |
CPN55301F0SS101 |
CPN55301F0SV101 |
CPN55301G0XX101 |
CPN55301H0SE101 |
CPN55301H0SR101 |
CPN55301H0SS101 |
CPN55301H0SV101 |
CPN55301J0SE101 |
CPN55301J0SR101 |
CPN55301J0SS101 |
CPN55301J0SV101 |
CPN55302A0SE101 |
CPN55302A0SR101 |
CPN55302A0SS101 |
CPN55302A0SV101 |
CPN55302E0SE101 |
CPN55302E0SR101 |
CPN55302E0SS101 |
CPN55302E0SV101 |
CPN55302F0SE101 |
CPN55302F0SR101 |
CPN55302F0SS101 |
CPN55302F0SV101 |
CPN55302G0XX101 |
CPN55302H0SE101 |
CPN55302H0SR101 |
CPN55302H0SS101 |
CPN55302H0SV101 |
CPN55302J0SE101 |
CPN55302J0SR101 |
CPN55302J0SS101 |
CPN55302J0SV101 |
CPN55401A0SE101 |
CPN55401A0SR101 |
CPN55401A0SS101 |
CPN55401A0SV101 |
CPN55401B0SE101 |
CPN55401B0SR101 |
CPN55401B0SS101 |
CPN55401B0ST101 |
CPN55401B0SV101 |
CPN55401C0SE101 |
CPN55401C0SR101 |
CPN55401C0SS101 |
CPN55401C0SV101 |
CPN55401D0SE101 |
CPN55401D0SR101 |
CPN55401D0SS101 |
CPN55401D0SV101 |
CPN55402A0SE101 |
CPN55402A0SR101 |
CPN55402A0SS101 |
CPN55402A0SV101 |
CPN55402B0SE101 |
CPN55402B0SR101 |
CPN55402B0SS101 |
CPN55402B0ST101 |
CPN55402B0SV101 |
CPN55402C0SE101 |
CPN55402C0SR101 |
CPN55402C0SS101 |
CPN55402C0SV101 |
CPN55402D0SE101 |
CPN55402D0SR101 |
CPN55402D0SS101 |
CPN55402D0SV101 |
CPN55501A0SE101 |
CPN55501A0SR101 |
CPN55501A0SS101 |
CPN55501A0SV101 |
CPN55501B0SE101 |
CPN55501B0SR101 |
CPN55501B0SS101 |
CPN55501B0ST101 |
CPN55501B0SV101 |
CPN55501C0SE101 |
CPN55501C0SR101 |
CPN55501C0SS101 |
CPN55501C0SV101 |
CPN55501D0SE101 |
CPN55501D0SR101 |
CPN55501D0SS101 |
CPN55501D0SV101 |
CPN55502A0SE101 |
CPN55502A0SR101 |
CPN55502A0SS101 |
CPN55502A0SV101 |
CPN55502B0SE101 |
CPN55502B0SR101 |
CPN55502B0SS101 |
CPN55502B0ST101 |
CPN55502B0SV101 |
CPN55502C0SE101 |
CPN55502C0SR101 |
CPN55502C0SS101 |
CPN55502C0SV101 |
CPN55502D0SE101 |
CPN55502D0SR101 |
CPN55502D0SS101 |
CPN55502D0SV101 |
CPN55601A0SE101 |
CPN55601A0SR101 |
CPN55601A0SS101 |
CPN55601A0SV101 |
CPN55601B0SE101 |
CPN55601B0SR101 |
CPN55601B0SS101 |
CPN55601B0ST101 |
CPN55601B0SV101 |
CPN55601C0SE101 |
CPN55601C0SR101 |
CPN55601C0SS101 |
CPN55601C0SV101 |
CPN55601D0SE101 |
CPN55601D0SR101 |
CPN55601D0SS101 |
CPN55601D0SV101 |
CPN55602A0SE101 |
CPN55602A0SR101 |
CPN55602A0SS101 |
CPN55602A0SV101 |
CPN55602B0SE101 |
CPN55602B0SR101 |
CPN55602B0SS101 |
CPN55602B0ST101 |
CPN55602B0SV101 |
CPN55602C0SE101 |
CPN55602C0SR101 |
CPN55602C0SS101 |
CPN55602C0SV101 |
CPN55602D0SE101 |
CPN55602D0SR101 |
CPN55602D0SS101 |
CPN55602D0SV101 |
CPNX5301A0SE101 |
CPNX5301A0SS101 |
CPNX5301A1SS101 |
CPNX5302A0SE101 |
CPNX5401A0FV101 |
CPNX5401A0SE101 |
CPNX5401A0SS101 |
CPNX5501A0SE101 |
CPNX5501A0SS101 |
cartridge filters, filters
- Absolute Retention
- Wide Chemical Compatibility
- 100% Integrity Tested
Consistent and Reliable Quality: | AseptiSure® cartridge filters are produced with ISO 9001-2008 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 and higher throughputs with biological streams
|
High Throughputs:
| Translates to lower filtration costs, less number of filter changes and overall economy of operations.
|
Total Traceability
| Unique identification number is laser etched on each other.
|
- Sterilization of compatible solvents and chemicals
- Filtration of rinse water for endoscopes
Construction |
Membrane |
Nylon 66 |
Final Filter Pore Size |
|
Prefilter Pore Size |
|
Support Layers |
Polyester |
Body and Core |
Polypropylene |
Size |
Size |
|
Effective Filtration Area |
3000cm² |
6000cm² |
12000cm² |
18000cm² |
|
Integrity Testing / Retention |
Microbial Retention |
Brevundimonas diminuta (ATCC 19146) per cm² |
Serratia marcescens (ATCC 14756) per cm² |
|
Air Diffusion Flow (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 |
< 3.5Kg/cm² (50 psi) @ 25°C |
Reverse Pressure |
< 0.7 Kg/cm² (10 psi) @ 25 °C |
Sterilization |
Autoclavable/In-line Steam Sterilizable at 121°C for 30 minutes @ Δp= 5psi (0.3kg/cm²) |
Assurance |
Toxicity |
Passes Bioreactivity test, In Vivo, as per USP 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 test as per USP |
Good Manufacturing Practice |
These products are manufactured in a facility which adheres to Good Manufacturing Practices. |
Oxidizable Substances |
Within limits as specified in USP |
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 specified volume of purified water flush |
Quality Management System |
ISO-9001 Certified |
USFDA |
DMF No. 015554 |
Type | AseptiSure® NS (0.45µm Upstream) | CPNX | AseptiSure® NS (0.8µm Upstream) | CPN5 | | Size | Size | Code | 5"** | 53 | 10" | 54 | 20" | 55 | 30" | 56 | | Pore Size | Pore Size
| Code | 0.2µm | 01 | 0.45µm***
| 02 | | Adapter | | Code | 7P | A0 | 7P without fin | A1 | 28 with fin | C0 | 'O' | D0 | | Elastomer | | Code | Silicone | SS | Viton | SV | EPDM | SE | FEP Encapsulated Viton | FV* | | Sterility | | Code | Non Sterile | 1 | | Pack Size | Pack Size | Code | 1 | 01 | |
*FV is available in Adapter Code A0 (7P) and A1 (7P without fin) only
**Size 5" is available in Code A0 (7P) and A1 (7P without fin) only
***0.45µm Cartridge filters are available with 0.8µm upstream layer only.
Example for Non Sterile: CPN55501A0SV101