Opticap® XL2 Durapore® KVGLA02HH3

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 Wetting Instructions for Filter Units with Durapore® Membrane user guide
• Storage Statement: Store in dry location
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

Replaces: KVGL04HB3
Sterilization Method
3 autoclave cycles of 60 min @ 126 °C; not in-line steam sterilizable
This product was manufactured with a Durapore® 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.
Gravimetric Extractables: after 24 hours in water at controlled room temperature
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥500 mL
ASTM is a registered trademark of American Society for Testing and Materials
Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany
Emprove 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	PVDF , polypropylene , polypropylene housing, polypropylene support, polypropylene vent cap, 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	Opticap®
parameter	1.0 bar max. differential pressure (15 psid) at 80 °C (Forward), 1.0 bar max. inlet pressure (15 psi) at 80 °C, 2.8 bar max. inlet pressure (40 psi) at 60 °C, 25 °C max. inlet temp., 3.4 bar max. differential pressure (50 psid) at 25 °C (Reverse; intermittent), 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward), 5.5 bar max. inlet pressure (80 psi) at 23 °C, 80 psig max. inlet pressure
L	14.0 cm (5.5 in.)
cartridge nominal length	2 in. (5 cm)
diam.	12.5 cm (4.9 in.)
filtration area	0.09 m2
inlet connection diam.	9/16 in.
inlet to outlet W	14.0 cm (5.5 in.)
outlet connection diam.	9/16 in.
overall size	2 in.
impurities	0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction), <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
gravimetric extractables	10 mg/capsule
matrix	Durapore®
pore size	0.22 µm nominal pore size, 0.22 µm pore size
input	sample type liquid
bubble point	3450 mbar (50 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