Where it fits
This sterilising-grade PES cartridge is the last barrier in an aseptic process: sterile filtration of vaccines, antibody drugs and water for injection before filling or entry into the sterile core. Unlike fine filtration, the pass criterion here is not that the filtrate looks clean but whether traceable retention and integrity evidence can be produced.
Key characteristics
The 0.2 µm grade is validated for complete retention under a Brevundimonas diminuta challenge of at least 1x10^7 CFU/cm2 to ASTM F838. That test is what defines a sterilising-grade filter — a 0.2 µm cartridge without it is fine filtration and cannot be claimed as sterilising.
The asymmetric polyethersulfone membrane is naturally hydrophilic with low protein binding, and for expensive biologics adsorptive loss is real yield loss. The cartridge withstands repeated 121 °C autoclave and steam-in-place cycles, is flushed with purified water and endotoxin tested before shipment, and sterile packaging is available on request.
Choosing between options
Against the general-purpose PES cartridge in the same family, it comes down to ratings and validation:
| Item | Sterilising-grade PES (this) | General PES pleated |
|---|---|---|
| Rating | 0.1 / 0.2 / 0.45 µm | 0.05 – 5 µm |
| Bacterial challenge | 0.2 µm validated to ASTM F838 | — |
| Sterilisation | Repeated 121 °C autoclave and steam-in-place | — |
| Choose it when | A sterile barrier needing traceable documentation | Fine filtration and clarification across scattered ratings |
Operation & change-out
Naturally hydrophilic, so no alcohol pre-wetting. The user can verify integrity by bubble point or diffusive flow before and after use. Change out when ΔP reaches 3–5 times the clean initial value or 0.24 MPa (35 psi).