Opticap XL5 Clarigard 0.3 μm 9/16 in.HB/HB

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 media combination 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 30 min @ 126 °C; not in-line steam sterilizable

Gravimetric Extractables: after 24 hours in water at controlled room temperature
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L

CLARIGARD is a registered trademark of Merck KGaA, Darmstadt, Germany
OPTICAP is a registered trademark of Merck KGaA, Darmstadt, Germany

400

polypropylene
polypropylene housing
polypropylene support
polypropylene vent cap
silicone seal

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

Opticap ^?

1.0 bar max. inlet pressure (15 psi) at 80 ℃
2.75 bar max. inlet pressure (40 psi) at 60 ℃
25 ℃ max. inlet temp.
4.8 bar max. differential pressure (70 psid) at 20 ℃
5.5 bar max. inlet pressure (80 psi) at 23 ℃
80 psig max. inlet pressure

21.6 cm (8.5 in.)

5 in. (12.5 cm)

10.7 cm (4.2 in.)

9/16 in.

21.6 cm (8.5 in.)

9/16 in.

5 in.

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

≤10 mg/capsule

Clarigard ^?

0.3 μm nominal pore size
0.3 μm pore size

sample type liquid

inlet hose barb
14 mm ( 9/16 in.) inlet/outlet hose barb
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.