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MTGR85000 Millipore

Aervent-50 Filter Unit 0.2 µm hydrophobic 1/4 in. HB/HB

  •  eCl@ss 32031690

  •  NACRES NB.24

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Properties

Related Categories Biopharmaceutical Manufacturing, Biopharmaceutical Process Development and Manufacturing, Sterile Filtration for Biopharmaceutical Manufacturing More...
Quality Level   400
material   PTFE membrane
  polypropylene
  polypropylene housing
sterility   non-sterile
feature   hydrophobic
mfr. no.   Aervent®
parameter   2.1 bar max. differential pressure at 25 °C
  4.1 bar max. inlet pressure (60 psi) at 25 °C
L   7.2 cm (2.84 in.)
diam.   6.2 cm (2.4 in.)
filtration area   19.6 cm2
impurities   ≤0.5 EU/mL (LAL test, Aqueous extraction)
gravimetric extractables   ≤1.0 mg
matrix   Aervent®
pore size   0.2 μm pore size
bubble point   ≥1100 mbar (16 psig), nitrogen with 60/40% IPA/water at 23 °C
fitting   inlet/outlet hose for 6.5-9.5 mm I.D. silicone tubing
shipped in   ambient

Description

General description

Device Configuration: Capsule

Preparation Note

Sterilization Method
10 autoclave cycles of 30 min @ 130 °C; not in-line steam sterilizable

Analysis Note

Bacterial Retention
Quantitative retention of 107 CFU/cm2Brevundimonas diminuta (ATCC® 19146) per ASTM F838-83 methodology

Gravimetric Extractables: in 70/30 % IPA/water

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 Steam Sterilization & Integrity Testing Procedures guide and first page of Visual Inspection Guide
• Storage Statement: Store in dry location
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

Legal Information

AERVENT is a registered trademark of Merck KGaA, Darmstadt, Germany

ATCC is a registered trademark of American Type Culture Collection

Safety & Documentation

Safety Information

Safety Information for this product is unavailable at this time.
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