Sterilizing-Grade & Depth Filtration — Food/Beverage/Biological Process Fluids

Strainrite's compliance stack is the content: ISO 9001:2015, cGMP manufacturing in validated ISO Class 7 clean rooms, USP Class VI biological reactivity, LAL endotoxin testing, bacterial challenge validation to ASTM F838, FDA-listed materials, steam and gamma sterilization validation, every cartridge individually integrity-tested via air diffusion test. Endo-MAXX CN's zeta-potential mechanism is genuinely differentiated — it removes charged particles SMALLER than its own absolute rating, which nothing else in the corpus does. Commercial angle: the vendor cites domestic US manufacturing specifically to avoid the 6-12 month delivery delays it says competitors face. This is strong evidence.

Materials documented for this service: PES membrane (0.2µm sterilizing grade), Hydrophobic PTFE, double-layer (Vent-MAXX), Charged nylon (Endo-MAXX CN), Ultrapure polypropylene (capsules), FDA-listed materials of construction. Chemical compatibility depends on exact concentration, temperature, and duty cycle — confirm with a spec review before final specification.

Named chemicals in this documentation: beer, wines, beverage process water, endotoxin-bearing process fluids, biopharmaceutical media, tank vent gas.

Documented examples include Strainrite Pur-MAXX SG and Mem-Pleat SG (sterilizing-grade 0.2µm PES membrane; 0.45/0.2, 0.2/0.2 and 0.2/0.1 µm; USP Class VI certified, USP 665 certified, bacterial retention validated to Brevundimonas diminuta, steam-durable, 100% integrity tested), Strainrite Vent-MAXX (double-layer hydrophobic PTFE for tank vent and gas filtration, validated to air and liquid standards), Strainrite Endo-MAXX CN (charged nylon 0.2µm, positive zeta potential removes charged particles smaller than the absolute retention rating), Strainrite MAXX-Cap and Brevi-Cap ultrapure polypropylene capsules, 2" up to 40", 0.2/0.1 µm, Strainrite filter bags, membrane/depth cartridges, large diameter cartridges, housings & vessels.