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VPMD102NB1 Millipore

Viresolve Pro Modus 1.2 Device

  •  eCl@ss 32031690

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Properties

Related Categories Biopharmaceutical Manufacturing, Biopharmaceutical Process Development and Manufacturing, Sterile Filtration for Biopharmaceutical Manufacturing More...
Quality Level   400
material   PVDF housing
  polyethersulfone membrane
  silicone gasket
mfr. no.   Viresolve®
parameter   60 psig max. inlet pressure
H   7.85 cm (3.09 in.)
L   18.62 cm (7.33 in.)
W   9.22 cm (3.63 in.)
filtration area   0.07 m2
overall size   1.2 in.
impurities   <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
fitting   1/4 in. integrated vent hose barb (with double O-ring seal)
  3/4 in. sanitary TC inlet/outlet fitting(s)

Description

General description

Device Configuration: Modus 1.2 Device

Other Notes

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

Directions for Use

• Organism Retention: Parvovirus
• Mode of Action: Filtration (size exclusion)
• Application: Protein purification
• Intended Use: Viral clearance
• Instructions for Use: Please see the user guide shipped with this product
• Storage Statement: Store at room temperature
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

Preparation Note

This product was manufactured with materials that meet the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

Analysis Note

TOC/Conductivity
After a controlled water flush of 50 L/m², samples exhibited less than 500 ppb TOC per USP <64>> and less than 1.3 µS/cm per USP <64>>.

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.

Safety & Documentation

Safety Information

Safety Information for this product is unavailable at this time.

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