Opticap® XL150 Millipore Express® SHC KHGES015HB3

Device Configuration: Capsule
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.

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).
Sterilization Method
3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
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 1.0 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 (Gamma stable), polysulfone , silicone seal
reg. compliance	meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
sterility	sterile
product line	EMPROVE® Filter
feature	hydrophilic
Торговая марка	Millipore Express®
parameter	1.0 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	140 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® SHC
pore size	0.2 µm pore size, 0.5 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 hose barb, outlet hose barb (with Bell), 14 mm (9/16 in.) outlet hose barb (with Filling Bell)