AseptiCap® NSZ 1", 2", 5", 8"
mdi AseptiCap NSZ positively charged Nylon 66 membrane capsule filters are absolute retention, serial filtration devices for sterilization of liquids. The upstream layer with larger pore size protects the downstream final layer for enhanced throughputs.
The positive charge of the membrane offers enhanced capability to retain negatively charged contaminants such as endotoxins and colloids even smaller than the membrane pore size rating.
These filters are biologically inert, autoclavable, heat resistant, exhibiting wide chemical compatibility, and are suitable for a large number of filtration and sterilization applications including ophthalmic, and injectable solutions.
- Positively charged to retain contaminants smaller than pore size rating
- High flow rates and throughputs
- Minimal extractables
- High heat resistance
- Wide chemical compatibility
- Biologically inert
- Hydrophilic
- Filtration of pharmaceutical solutions
- Sterilizing filtration of wide variety of compatible organic solvents
- Sterilization of laboratory disinfectants
- Filtration of buffers and other non-aqueous solutions
Construction | |||||
Membrane | Positively Charged Nylon 66 | ||||
Final Filter Pore Size | 0.2µm | ||||
Prefilter Pore Size |
|
||||
Support Layers | Polyester | ||||
Body and Core | Polypropylene | ||||
Size | |||||
Size |
|
||||
Effective Filtration Area (Nominal) |
|
||||
Dimension (End to End) - 1½" Sanitary Flange I/O |
|
||||
Dimension (End to End) - ½" Single Step Hose Barb I/O |
|
||||
Integrity Testing / Retention | |||||
Microbial Retention | LRV >7 for Brevundimonas diminuta (ATCC 19146) per cm² | ||||
Bubble Point (with 50% IPA) | > 17psi (1.19Kg/cm²) | ||||
Operational | |||||
Max. Operating Temperature | 80 °C @ < 30 psi (2 Kg/cm²) | ||||
Max. Differential Pressure | < 60 psi (4 Kg/cm²) @ 30 °C | ||||
Sterilization By Gas | Sterilizable by Ethylene Oxide | ||||
Sterilization By Autoclave | Autoclavable at 125 °C for 30 minutes, 1 cycles and it cannot be inline steam sterilized. | ||||
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 | ||||
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 | ||||
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 | ||||
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 |
|
|
|
|
|
|
|
|
*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
****Bell or bell with cover is available with:
- ½" Hose Barb Connections in 1", 2", 5" and 8" capsule filters
- ¼" SHB outlet connection in 1" capsule filters only
Example :
DNZX | 52 | 01 | DD | X | X | 1 | 01 |
Example for Non Sterile: DNZX5201DDXX101 Example for EO Sterile: DNZX5201DDXX201>