AseptiSure® TF Standard
MDI Aseptisure® TF PTFE membrane mini cartridge filters are hydrophobic filters offering absolute retention. These filters are designed for sterilizing filtration of gases. The high quality of membrane and design of cartridge assures long life and ability to withstand adverse process conditions experienced during use.
These filters are validated for key performance parameters such as retention efficiency, chemical compatibility, extractable, heat stability, flow rates and blow through.
- Absolute retention
- Heat sealed
- No leaching
- High heat Stability
- Wide chemical compatibility
- Biologically inert
- Long service life
- Non-toxic material of construction
- Pre-flushed to minimize particulate release after Installation
- 100% integrity tested
- High flow rates
- Bioburden maintained below 1000 cfu/device
- Endotoxin level certified to be <0.25 EU/ml
- Unique identification number is laser etched on each filter
- Individual certificate of quality for each device
- Fermentors venting and aeration
- Sterile filtration of API and injectables
- Sterile compressed air for pharma machineries
- Sterile air for dry powder injectables filling
| Construction | |||||
| Membrane | Hydrophobic PTFE | ||||
| Final Filter Pore Size |
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| Support Layers | Polypropylene | ||||
| Body and Core | Polypropylene | ||||
| Integrity Testing / Retention | |||||
| Microbial Retention |
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| Air Diffusion Flow (with 70% IPA Wetted) |
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| Operational | |||||
| Max. Operating Temperature | 80 °C @ < 2 Kg/cm² (30 psi) | ||||
| Max. Differential Pressure | 3.5 Kg/cm² (50 psi ) @ 25 °C | ||||
| Reverse Pressure | < 0.7 Kg/cm² (10psi) @ 25 °C | ||||
| Sterilization | Autoclavable/In-line steam sterilizable at 121 °C for 30minutes, 100 cycles @ ∆p=5 psi (0.3kg/cm²) | ||||
| Assurance | |||||
| Toxicity | Passes Bioreactivity test, In Vivo, as per USP <88> for Class VI plastics | ||||
| Bacterial Endotoxin | Aqueous extracts exhibit < 0.5 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 | ||||
| Indirect Food Additive | All Polypropylene components meet the FDA Indirect Food Additive requirements cited in 21 CFR 177.1520 | ||||
| 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 | ||||
| Quality Management System | ISO-9001 Certified | ||||
| USFDA | DMF No. 015554 | ||||
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*FV is available in Adapter Code A0 (7P) and A1 (7P without fin) only
**Size 5″ is available in Adapter Code A0 (7P) and A1 (7P without fin) only
Example :
| CPTF | 56 | 01 | A0 | SS | 1 | 01 |
Example for Non Sterile: CPTF5601A0SS101
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