Millipak® Final Fill Filters
 
Stacked disc filters designed to maximize recovery and enhance protection of your high value product
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Stacked disc filters designed to maximize recovery and enhance protection of your high value product Less
 
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Overview
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Millipak® Final Fill capsules are designed for reliable sterile filtration of small volume, high value solutions. In final filling it is critical to maximize product recovery and maintain sterility. The capsule's stacked disc design minimizes hold up volume over standard pleated devices, increasing product recovery. These user-friendly filters contain a multi-purpose port that simplifies venting, integrity testing and sampling and is validated to maintain an aseptic flowpath even after multiple actuations. Millipak® Final Fill capsules contain the proven and trusted Durapore® membrane in multiple pore sizes offering flexibility for your specific process needs.
| Materials of Construction | |
| Housing; support disc | Polysulfone | 
| Membrane | Durapore® PVDF (polyvinylidene fluoride) membrane | 
| AMPP | polyethersulfone | 
| Filtration Area, cm2 | |
| Millipak® Final Fill 20 | 100 cm2 | 
| Millipak® Final Fill 40 | 200 cm2 | 
| Millipak® Final Fill 60 | 300 cm2 | 
| Millipak® Final Fill 100 | 500 cm2 | 
| Millipak® Final Fill 200 | 1000 cm2 | 
| Maximum Differential Pressure, bar (psi) | |
| Millipak® Final Fill 20 | Forward: 60 psi (4.1 bar) at 25°C; 50 psi (3.5 bar) at 25°C (5 µm); 25 psi (1.7 bar) at 80°C; Reverse: 10 psi (0.7 bar) at 25°C | 
| Millipak® Final Fill 40, 60, 100, 200 | Forward: 80 psi (5.5 bar) at 25°C (0.1 µm, 0.22 µm, 0.45 µm, hydrophobic 0.22 µm); Reverse: 10 psi (0.7 bar) at 25°C | 
| Maximum Inlet Pressure, psi (bar) | |
| Millipak® Final Fill 20 | 60 psi (4.1 bar) at 25°C | 
| Millipak® Final Fill 40, 60, 100, 200 | 80 psi (5.5 bar) at 25°C | 
| Bacterial Retention (for 0.1 µm and 0.22 µm only) | Quantitative retention of 107 CFU/cm2 Brevundimonas diminuta ATCC® 19146 per ASTM® F838 methodology. | 
| Bacterial Endotoxins | Aqueous extraction contains < 0.25 EU/mL per device as determined using the Limulus Amebocyte Lysate (LAL) test, meeting requirements of USP <85>, EP 2.6.14 and JP 4.01. | 
| Toxicity | Component materials meet the criteria for Class VI testing based on USP <88> Biological Reactivity, in vivo, USP <87> Biological Reactivity, in vitro, and ISO 10993-5 Tests for in vitro Cytotoxicity. This product also meets physicochemical specifications, as described in USP <661>Containers-Plastics. | 
| Sterilization | Device integrity and retention was maintained after 3 autoclave cycles of 90 minutes at 126 °C. Devices can withstand a dose ≤ 40 kGy gamma exposure. | 
| Bubble Point at 23°C | |
| 0.1 µm | ≥ 70 psi (4830 mbar) air with water | 
| 0.22 µm | ≥ 50 psi (3450 mbar) air with water | 
| 0.45 µm | ≥ 26 psi (1790 mbar) air with water | 
| Hydrophobic 0.22 µm | ≥ 29 psi (2000 mbar) air with water;≥ 18 psi (1240 mbar) in 60/40% IPA/water; ≥ 17 psi (1170 mbar) in 70/30% IPA/water | 

 


 
  

 
 
 








