Description
The application of Good Manufacturing Practices (GMP) within Active Pharmaceutical Ingredients (API) processes as described in the ICHQ7A guidance document is becoming increasingly important. Pall Q grade products are high quality, economical filters aimed at applications within API processes. These products are supplied with a ‘Q’ certificate of quality, incorporating essential product and manufacturing quality details. Pall Emflon FM filter cartridges (Q Grade) are designed for cost-effective clarification of solvents used in the manufacture of antibiotics and other Active Pharmaceutical Ingredients (APIs). These filters contain a proprietary PTFE membrane and are compatible with a broad range of chemicals. Applications include removal of carbon or catalyst fines, and these filters are often used downstream of bulk solids removal.
Features and Benefits
- Broad chemical compatibility
- Very high flow rates
- Low extractables
High Quality Standards
- Manufactured for use under GMP
- Supplied with a ‘Q’ Certificate of Quality
- Lot number traceable
- FDA listed materials per 21 CFR
- The filter components have met the specifications for biological tests listed in the current revision of the USP for Class VI - 121 °C plastics.
Compatibility at 20 °C¹
Emflon FM filter cartridges (Q Grade) are specifically designed for improved compatibility and optimized economics in polishing a broad array of challenging solvents, including:- Acetic Acid, Glacial
- Acetone
- Acetonitrile
- Dimethylacetamide (DMAC)
- Dimethylformamide (DMF)
- Dimethylsulfoxide (DMSO)
- Ethanol
- Ethyl Acetate
- Hexane
- Hydrochloric mAcid 38%
- Isopropyl Alcohol (IPA)
- Methanol
- Methylene Chloride
- Methyl Isobutyl Ketone (MIBK)
- Methyl Tertiary Butyl Ether (MTBE)
- n Heptane
- Pyridine
- Sodium Hydroxide, 50%
- Tetrahydrofuran (THF)
- Toluene
- Water
- Xylene
This partial list is provided for general guidance only.
¹ Because so many factors (eg elevated temperatures) can affect the chemical resistance of a given product, you should pre-test under your own operating conditions observing applicable safety practices such as those given in the Material Safety Data Sheet for each chemical. Pall Corporation can provide specific compatibility guidance, testing and data upon request.
Specifications
Materials of Construction
| Membrane | PTFE (hydrophobic) |
| Support and Drainage Layers | Polypropylene |
| Core, Cage and Endcaps | Polypropylene |
Operating Parameters
| Max Differential Pressure (Dp) | 4.1 bar (60 psi) @ 23°C (73°F) 2.1 bar (31 psi) @ 60°C (140°F) |
| Max Operating Temperature | 95°C (203°F) at 1.0 bar (14 psi) (Dp) |
Extractables*
| Water | < 5mg |
| Acetone | 90 mg |
| Ethyl acetate | 240 mg |
| Methylene chloride | 600 mg |
| Toluene | 515 mg |
*These typical extractables are based on tests of sampled 254 mm (10 inch) modules with cages at 20°C
Filter Area (Per 254 mm module)
| Typical Effective Filtration Area | 0.58m² (6.2 ft²) |
Removal Ratings**
| Particle size | Beta Ratio (Efficiency) |
| 0.6 µm | 100 (99.0%) |
| 1 µm | 1000 (99.9%) |
| 2 µm | 5000 (99.98%) |
| 3 µm | >5000 (99.98%) |
| 4 µm | >5000 (99.98%) |
| >5 µm | >5000 (99.98%) |
**As determined by a modified OSU-F2 test
Packaging
| Bulk packaged in quantity of 12 filter cartridges per box. Each filter cartridge is individually wrapped in a labelled bag. 1 ‘Q’ certificate per box. |
Type
Filter Cartridges
Use
Air, Gas, and Vent Filtration
Product Summary
For cost-effective filtration of solvents used in biopharmaceutical processing and other Active Pharmaceutical Ingredient production.
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