Opticap® XL150 Millipore Express® SHF KGEPG015HH3
Device Configuration: Capsule
Sterile capsules meet current USP and AAMI guidelines for sterility utilizing a validated sterilization cycle.
Double Easy-Open bag
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Directions for Use- Organism Retention: Microorganism
- Mode of Action: Filtration (size exclusion)
- Application: BioProcessing
- Intended Use: Reduction or removal of microorganism/bioburden
- Instructions for Use: Please refer installation section of OPTICAP® XL Capsules and OPTICAP® XLT Capsules user guide
- Storage Statement: Store in dry location
- Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.
Sterilization Method
Gamma compatible to 45 kGy; 3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
This product was manufactured with a Millipore Express® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
Bacterial Retention
Samples were quantitatively retentive of a minimum
Brevundimonas diminuta challenge concentration of 1 x 10 CFU/cm using ASTM® F838 methodology.
TOC/Conductivity
After sterilization and a controlled water flush of 2.0 L, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 °C.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L
ASTM is a registered trademark of American Society for Testing and Materials
Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany
MILLIPORE EXPRESS is a registered trademark of Merck KGaA, Darmstadt, Germany
OPTICAP is a registered trademark of Merck KGaA, Darmstadt, Germany
EMD Millipore Corporation certifies that this product complies with the European Pressure Equipment Directive, 97/23/EC of 29 May 1997. This product has been classified under Article 3 § 3 of the Pressure Vessel Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 3 § 3 of this Pressure Vessel Directive, this product does not bear the CE mark.
Quality Level | 400, |
material | polyethersulfone , polyethylene support, polypropylene (gamma-stable), polypropylene housing, polypropylene vent cap, polysulfone , silicone seal |
reg. compliance | meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials) |
product line | EMPROVE® Filter |
feature | gamma compatible, hydrophilic |
Торговая марка | Millipore Express® |
parameter | 1.4 mL/min air diffusion at 2.8 bar (40 psig) and 23 °C (in water), 1.0 bar max. differential pressure (15 psid) at 80 °C (Forward), 1.0 bar max. inlet pressure (15 psi) at 80 °C, 100 psi max. differential pressure (6.9 bar) (intermittent), 2.1 bar max. differential pressure (30 psid) at 25 °C (Reverse; intermittent), 2.75 bar max. inlet pressure (40 psi) at 60 °C, 25 °C max. inlet temp., 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward), 5.5 bar max. inlet pressure (80 psi) at 23 °C, 6.9 bar max. differential pressure (100 psid) at 25 °C (Forward; intermittent), 6.9 bar max. inlet pressure (100 psi) at 23 °C (intermittent), 80 psi max. differential pressure (5.5 bar) (continuous), 80 psig max. inlet pressure |
L | 9.7 cm (3.8 in.) |
cartridge nominal length | 3.8 in. (9.7 cm) |
diam. | 5.6 cm (2.2 in.) |
filtration area | 220 cm2 |
inlet connection diam. | 9/16 in. |
inlet to outlet W | 9.7 cm (3.8 in.) |
outlet connection diam. | 9/16 in. |
impurities | 0.25 EU/mL bacterial endotoxins (LAL test, Aqueous extraction), <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction) |
matrix | Millipore Express® SHF |
pore size | 0.2 µm nominal pore size, 0.2 µm pore size |
bubble point | 4000 mbar (58 psig), air with water at 23 °C |
fitting | 1/4 in. drain/vent hose barb (with double O-ring seal), inlet hose barb, 14 mm (9/16 in.) inlet/outlet hose barb, outlet hose barb |