AseptiSure® TH Standard
MDI AseptiSure® TH PTFE mini cartridge filters are specially designed high temperature resistant PTFE filters which are steam sterilizable at upto 135°C. These filters are validated with liquid microbial challenge test as per ASTM F 838-05 to offer absolute retention even under high moisture conditions.
These are also validated for other key performance parameters such as chemical compatibility, extractable, heat stability, flow rates, blow through and ability to withstand accidental reverse pressure. These are available in a variety of pore sizes to suit specific microfiltration needs in critical and specialized process applications for air as well as liquid.
- 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
- High temperature WFI tank venting
| Construction | |||||
| Membrane | High Temperature Resistant Hydrophobic PTFE | ||||
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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 | 95 °C @ < 30 psi (2 Kg/cm²) | ||||
| Max. Differential Pressure | 50 psi (3.5 Kg/cm²) @ 25 °C | ||||
| Reverse Pressure | < 10 psi (0.7 Kg/cm²) @ 25 °C | ||||
| Sterilization | Autoclavable/In-line steam sterilizable at 135 °C for 30minutes, 80 cycles @ 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 as per USP <85> | ||||
| Bioburden | Bioburden level is < 1000 cfu/filter device as per ISO 11737-1: 2018 | ||||
| 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 Code A0 (7P) and A1 (7P without fin) only
Example :
| CPTH | 53 | 01 | A0 | SS | 1 | 01 |
Example for Non Sterile: CPTH5301A0SS101
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