material
polyester support, polyethersulfone membrane, polypropylene (end cap), polypropylene housing, polysulfone (core)
sterility
non-sterile
sterilization compatibility
autoclavable compatible
gamma compatible
product line
Opticap® XL 5
feature
hydrophobic
parameter
15 psi max. pressure at 80 °C (forward), 30 psi max. pressure at 4—50 °C (reverse), 60 psi max. pressure at 4-50 °C (forward)
technique(s)
gas filtration: suitable
body diam.
10.7 cm (4.2 in.)
capsule L
21.5 cm (8.5 in.)
diam.
14.5 cm (5.7 in.) , vent to vent
filtration area
0.39 m2
inlet connection diam.
1 ½ in.
outlet connection diam.
1 ½ in.
impurities
<0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
gravimetric extractables
≤27 mg
matrix
Millipore Express® SPG
pore size
0.2 μm pore size
fitting
(38.1 mm (1 ½ in.) Sanitary Flange Inlet and Outlet)
shipped in
ambient
Quality Level
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General description
Device Configuration: Capsule
Packaging
Double Easy-Open bag
Preparation Note
Sterilization Method
Gamma compatible to 40 kGy; 1 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
This product was tested and meets requirements of USP <788> for large volume parenterals.
Gamma compatible to 40 kGy; 1 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
This product was tested and meets requirements of USP <788> for large volume parenterals.
Analysis Note
Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 107 CFU/cm² using ASTM® F838 methodology. Gravimetric Extractables:The extractable level was equal to or less than 27 mg/device after 24 hours in a 70/30% IPA/water mixture at controlled room temperature.
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 107 CFU/cm² using ASTM® F838 methodology. Gravimetric Extractables:The extractable level was equal to or less than 27 mg/device after 24 hours in a 70/30% IPA/water mixture at controlled room temperature.
Other Notes
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
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Legal Information
ASTM is a registered trademark of American Society for Testing and Materials
Durapore 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
Disclaimer
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.
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