|Solvex Solvent Filtration Cartridge Filters|
- Ideal for sterile manufacture of active pharmaceutical ingredients (API)
- Suitable for filtration of a wide variety of organic solvents
- Easy scale-up to meet changing process needs
For the aseptic processing of solvent-based active pharmaceutical ingredients, Millipore’s Fortis SL cartridge filters offer superior bacterial retention, efficient particle removal and consistent performance across the life of the filter. With the quality you expect from a Millipore filter and broad chemical and caustic compatibility of polytetrafluoroethylene (PTFE), these filters are ideal for use in the manufacture of active pharmaceutical ingredients containing methylene chloride, acetone, isopropyl alcohol, ethyl acetate and other organic solvents. Fortis SL cartridge filters are available in 10-, 20- , and 30-inch sizes.
Fortis SL cartridge filters promote a consistent, repeatable manufacturing process characterized by high-capacity, low extractables, and resistance to thermal and hydraulic stress. The proven performance of Millipore’s filtration devices ensures uniform results every time. Fortis SL cartridges can be steamed in place up to 135 °C.
The robust design of the Fortis SL cartridge delivers superior bacterial retention and particle removal with a value to match your bulk processing needs.
Merck Millipore cartridges are designed and thoroughly validated for product and process quality. Each lot of Fortis SL filters is verified during manufacture and prior to release for integrity, flow rate, hydraulic stress, bacterial endotoxins and oxidizable substances.
|Per 10-inch Cartridge|
|Materials of Construction|
|Supports and Structural Components||Polypropylene|
|Filtration Area||0.52 m²|
|Maximum Differential Pressure, bar (psid)||Forward: 5.5 bar (80 psid) @ 25 °C; 1.8 bar (25 psid) @ 80 °C. Reverse: 4.1 bar (60 psid) @ 25 °C|
|Nitrogen Diffusion||≤24 mL/min @ 965 mbar (14 psig) with 70/30 % IPA/water|
|Gravimetric Extractables||≤35 mg per 10-inch cartridge after autoclaving and a 24-h soak in 70/30 IPA water|
|Bacterial Retention||Quantitative retention of 107 CFU/cm2 Brevundimonas diminuta (ATCC® 19146) per HIMA® methodology|
|Bacterial Endotoxins||Aqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test|
|Sterilization||May be steam sterilized 15 times (forward) and 15 times (reverse) for 30 minutes at 135 °C|
|Toxicity||Non-toxic per MEM elution ISO® 10993-5|
|Non-Fiber Releasing||Component materials meet the "non-fiber releasing" criteria as defined in 21 CFR 210.3 (b) (6).|