mdi’s AseptiVent TF disposable inline PTFE gas filters are convenient pre-fabricated devices used for sterilization of gases and as a bacterial air vent in various pharmaceutical and biopharmaceutical processes. These PTFE filters are validated to meet all the regulatory requirements for GMP manufacturing and offer a number of key features:
These PTFE filters are fully validated for:
- Bacterial retention as per ASTM F838-05
- Toxicity: As per USP <88> for Class VI plastics
- Bioburden: As per ANSI/AAMI/ISO 11737-1 : 1995
- Non Fiber Releasing: Comply with USFDA 21 CFR Part 211.72 and 210.3 (b)(6) for fiber release
The unique features offered by these filters are:
- High flow rates
- High heat stability
- Heat sealed
- Lightweight and self-supporting
- 100% integrity tested
- Total traceability: unique marking on each filter
Available sizes: 37 mm and 50 mm
Available Pore Sizes: 0.2 µm