Opticap^® XL5 Millipore Express^® SHC

32031690

Device Configuration: 取样皿滤膜

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

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.
Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM^® F838 methodology.

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

400

polyethersulfone membrane
polypropylene
polypropylene housing
polypropylene support
polypropylene vent cap
polysulfone
silicone seal

meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)

EMPROVE^® Filter

hydrophilic

Millipore Express^®

≤13.3  mL/min air diffusion at 2.8  bar (40  psig) and 23 ℃ ( in water)
1.0 bar max. differential pressure (15 psid) at 80 ℃ (Forward)
1.0 bar max. inlet pressure (15 psi) at 80 ℃
100 psi max. differential pressure (6.9 bar) (intermittent)
2.1 bar max. differential pressure (30 psid) at 25 ℃ (Reverse; intermittent)
2.75 bar max. inlet pressure (40 psi) at 60 ℃
25 ℃ max. inlet temp.
5.5 bar max. differential pressure (80 psid) at 25 ℃ (Forward)
5.5 bar max. inlet pressure (80 psi) at 23 ℃
6.9 bar max. differential pressure (100 psid) at 25 ℃ (Forward; intermittent)
6.9 bar max. inlet pressure (100 psi) at 25 ℃ (intermittent)
80 psi max. differential pressure (5.5 bar) (continuous)
80 psig max. inlet pressure

21.6 cm (8.5 in.)

5 in. (12.5 cm)

10.7 cm (4.2 in.)

0.23 m²

1-1/2 in.

21.6 cm (8.5 in.)

1-1/2 in.

5 in.

≤0.25 EU/mL (LAL test, Aqueous extraction)
<0.25  EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)

Millipore Express^® SHC

0.5/0.2 μm pore size

≥4000 mbar (58 psig), air with water at 23 ℃

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

Double Easy-Open bag

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.