Opticap^® XL600 Millipore Express^® SHC

NB.24

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.

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).

TOC/Conductivity
After sterilization and a controlled water flush of 3.0 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
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
polyethylene support
polypropylene (gamma-stable)
polypropylene housing
polypropylene vent cap (Gamma stable)
polysulfone
silicone seal

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

EMPROVE^® Filter

gamma compatible
hydrophilic

Millipore Express^®

≤3.7 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 23 ℃ (intermittent)
80 psi max. differential pressure (5.5 bar) (continuous)
80 psig max. inlet pressure

16.5 cm (6.5 in.)

6.5 in. (16.5 cm)

5.6 cm (2.2 in.)

590 cm²

3/4 in.

16.5 cm (6.5 in.)

9/16 in.

≤0.25 EU/mL bacterial endotoxins (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
19 mm (3/4 in.) inlet sanitary flange
outlet hose barb
14 mm (9/16 in.) outlet hose barb

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.