Opticap® XL5 Millipore Express® SHC KHGEA05TT1

eCl@ss:

32031690

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 @ 126 °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.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L
TOC/Conductivity
After sterilization and a controlled water flush of 9.5 L, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 °C.
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 membrane, polypropylene , polypropylene housing, polypropylene support, 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	hydrophilic
Торговая марка	Millipore Express®
parameter	13.3  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 25 °C (intermittent), 80 psi max. differential pressure (5.5 bar) (continuous), 80 psig max. inlet pressure
L	21.6 cm (8.5 in.)
cartridge nominal length	5 in. (12.5 cm)
diam.	10.7 cm (4.2 in.)
filtration area	0.23 m2
inlet connection diam.	1-1/2 in.
inlet to outlet W	21.6 cm (8.5 in.)
outlet connection diam.	1-1/2 in.
overall size	5 in.
impurities	0.25 EU/mL (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 sanitary flange, 38 mm (1 1/2 in.) inlet/outlet sanitary flange, outlet sanitary flange