Solvex™ Solvent Filters
Aperçu
Optimized filtration means meeting the changing requirements of your processes and the regulations that govern them.
This is why Millipore offers you a choice. Solvex hydrophobic 0.22 μm solvent filtration products provide validated, robust and cost-effective solvent filtration. Millipore Solvex brand cartridge filters combine high-performance polytetrafluoroethylene (PTFE) membranes with a robust cartridge design to deliver validated, reliable sterile filtration and efficient particulate removal. A polymer with a broad chemical and caustic compatibility, PTFE is ideal for use in the manufacture of active pharmaceutical ingredients containing methylene chloride, acetone, isopropyl alcohol, ethyl acetate and other organic solvents.
Benefits
- Ideal for sterile manufacture of highly regulated active pharmaceutical ingredients (API)
- Suitable for filtration of a wide variety of organic solvents
- Robust construction and easy scale-up to meet changing process needs
Caractéristiques
| Cartridge Filters | |
| Per 10-inch Cartridge | |
| Nominal Dimensions | |
| Outside diameter: | 70 mm (2.8 in.) |
| Maximum length: | |
| 10-inch cartridge: | 319 mm (12.6 in.) |
| 20-inch cartridge: | 568 mm (22.0 in.) |
| 30-inch cartridge: | 816 mm (32.1 in.) |
| Filtration Area | 0.65 m2 (7.0 ft2) |
| Materials of Construction | |
| Filter media: | PTFE membrane |
| Supports: | Polypropylene |
| Structural components: | Polypropylene |
| O-rings: | EPDM |
| Maximum Differential Pressure | |
| Forward: | 5.5 bar (80 psid) at ambient temperature 1.8 bar (25 psid) at 80 °C |
| Reverse: | 4.1 bar (60 psid) at ambient temperature |
| Diffusion at 23 °C | Through a 70/30 IPA/water wet membrane at 965 mbar (14 psig) nitrogen: ≤ 24 cc/min per 10-inch cartridge |
| Bubble Point at 23 °C | ≥ 1310 mbar (19 psig) in a 70/30 IPA/water wet membrane using nitrogen |
| Gravimetric Extractables | After autoclaving and a 24-hour soak in 70/30 IPA/water at controlled room temperature: ≤ 35 mg per 10-inch cartridge |
| Bacterial Endotoxin | Aqueous extraction contains < 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test. |
| Bacterial Retention | Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 107 CFU/cm² using ASTM® F838 methodology. |
| Sterilization | May be steam sterilized 50 times (forward) and 50 times (reverse) for 30 minutes at 135 °C. |
| Non-Fiber Releasing | PTFE membrane meets the criteria for a “non-fiber releasing” filter as defined in 21 CFR 210.3 (b) (6). |
| Component Material Toxicity | Component materials meet the criteria of the USP <88> Reactivity Test for Class VI Plastics. This product is non-cytotoxic per ISOR 10993-5 and USP <87> Cytotoxicity MEM Elution Test. |
Guide d'achat
Documentation
Produits & Applications associés
Produits associés classés par : Application Facete
| Dialysis and Filtration |
Catégories
| Biopharmaceutical Manufacturing > Drug Substance > Sterile Filtration |
| Cartridge Filters | |
| Per 10-inch Cartridge | |
| Nominal Dimensions | |
| Outside diameter: | 70 mm (2.8 in.) |
| Maximum length: | |
| 10-inch cartridge: | 319 mm (12.6 in.) |
| 20-inch cartridge: | 568 mm (22.0 in.) |
| 30-inch cartridge: | 816 mm (32.1 in.) |
| Filtration Area | 0.65 m2 (7.0 ft2) |
| Materials of Construction | |
| Filter media: | PTFE membrane |
| Supports: | Polypropylene |
| Structural components: | Polypropylene |
| O-rings: | EPDM |
| Maximum Differential Pressure | |
| Forward: | 5.5 bar (80 psid) at ambient temperature 1.8 bar (25 psid) at 80 °C |
| Reverse: | 4.1 bar (60 psid) at ambient temperature |
| Diffusion at 23 °C | Through a 70/30 IPA/water wet membrane at 965 mbar (14 psig) nitrogen: ≤ 24 cc/min per 10-inch cartridge |
| Bubble Point at 23 °C | ≥ 1310 mbar (19 psig) in a 70/30 IPA/water wet membrane using nitrogen |
| Gravimetric Extractables | After autoclaving and a 24-hour soak in 70/30 IPA/water at controlled room temperature: ≤ 35 mg per 10-inch cartridge |
| Bacterial Endotoxin | Aqueous extraction contains < 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test. |
| Bacterial Retention | Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 107 CFU/cm² using ASTM® F838 methodology. |
| Sterilization | May be steam sterilized 50 times (forward) and 50 times (reverse) for 30 minutes at 135 °C. |
| Non-Fiber Releasing | PTFE membrane meets the criteria for a “non-fiber releasing” filter as defined in 21 CFR 210.3 (b) (6). |
| Component Material Toxicity | Component materials meet the criteria of the USP <88> Reactivity Test for Class VI Plastics. This product is non-cytotoxic per ISOR 10993-5 and USP <87> Cytotoxicity MEM Elution Test. |