AseptiCap® NNZ 1", 2", 5", 8"
mdi AseptiCap NNZ positively charged Nylon 66 membrane capsule filters are absolute retention filtration devices for sterilization of liquids.
The positive charge of the membrane offers enhanced capability to retain negatively charged contaminants such as endotoxins and debris 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
- Absolute reliability
- 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 | ||||
| Support Layers | Polyester | ||||
| Body and Core | Polypropylene | ||||
| Size | |||||
| Size |
|
||||
| Effective Filtration Area (Nominal) - AseptiCap NNZ |
|
||||
| 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 cycle | ||||
| Shelf Life | 3 years after EO sterilization | ||||
| 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 | ||||
| Fiber Release | 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 :
| DNNZ | 52 | 01 | BB | X | X | 1 | 01 |
