| Gamma Stable Opticap® XL 50 Capsule Filters with Millipore Express® SPG Hydrophobic membrane |
| Filtration Area, m2 |
0.00196 (19.6 cm2) |
| Materials of Construction |
| Filter Structural Components |
Hydrophobic Polyethersulfone Gamma Stable Polybutylene terephthalate based blend |
| Inlet/Outlet |
Stepped Hosebarb Inlet and Outlet for silicone flexible tubing with 6.5 to 9.5 mm internal diameter; female Luer slip interior |
| Maximum Pressure, bar (psid) |
Forward: 4.2 bar (60 psid) @ 25 °C; Reverse: 2.1 bar (30 psid) @ 25 °C, intermittent |
| Hydrocorr Test |
≤ 0.03 mL/min @ 38 psi |
| Bacterial Retention |
Quantitative retention of 107 CFU/cm2 Brevundimonas diminuta (ATCC® 19146) per ASTM® F838-05 (2005) methodology |
| Bacterial Endotoxin |
Aqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test |
| Gamma/Autoclave Stability |
Gamma compatible to 45 kGy; OR up to 3 autoclave cycles of 60 min @ 126 °C; not in-line steam sterilizable |
| Component Material Toxicity |
Component materials meet the criteria of the USP <88> Reactivity Test for Class VI Plastics. These products meet the requirements of the USP <88> Safety Test, utilizing a 0.9% sodium chloride extraction. |
| USP Toxicity |
Non-toxic per MEM elution ISO 10993-5 |
| Good Manufacturing Practices |
These products are manufactured in a facility, which adheres to FDA Good Manufacturing Practices. |
| Non-Fiber Releasing |
Component materials meet the "non-fiber releasing" criteria as defined in 21 CFR 210.3 (b) (6). |
| Indirect Food Additive |
All component materials meet the FDA Indirect Food Additive requirementscited in 21 CFR 177–182 and the European food contact regulation EC Directive 2002/72/EC. |
