MTGR65010

Aervent^® Capsule Filter

pore size 0.2 μm

• Synonym(s): Aervent^®-50 Filter Unit 0.2 µm hydrophobic 1/8 in. NPTM-1/4 in. HB

Properties

• material: PTFE membrane; polypropylene ; polypropylene housing
• Quality Level: 400
• sterility: non-sterile
• sterilization compatibility: gamma compatible
• product line: Aervent^®
• feature: hydrophobic
• manufacturer/tradename: Aervent^®
• parameter: 2.1 bar max. differential pressure at 25 °C; 4.1 bar max. inlet pressure (60 psi) at 25 °C
• technique(s): gas filtration: suitable
• L: 5.3 cm (2.1 in.)
• W: 2.4 in.
• diam.: 6.2 cm (2.4 in.)
• filtration area: 19.6 cm²
• impurities: ≤0.5 EU/mL bacterial endotoxins (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: (3 mm (1/8 in.) NPT Inlet and Outlet)

Description

General description

Prostak^® MF Module are a tangential flow filtration device in a stacked plate configuration with Type V screen open feed channel. A microporous membrane, Durapore^® polyvinylidene fluoride (PVDF), is bonded on both sides of each plate. The plates are then stacked in parallel forming stacks.

This Prostak^® microfiltration open-channel module features a Pore Size of 0.1 μm and a filtration area of 0.17 m². PSVVAG021 is available in a 2 stack, making it applicable for bench-top, pilot, and production scale systems.

The modules can be integrity tested and steam sterilized for 20 cycles.

Prostak^® MF modules must be used with a support holder, which controls deflection and provides sanitary fittings for connection to external piping. Sanitary gaskets supplied with the module provide a leak-free connection between the module(s) and the holder.

Application

Typical Applications

• Sterile venting of vessels and carboys
• Autoclave vacuum break lines
• Low volume sterile filtration of non-aqueous fluids
• Small fermenter inlet and exhaust gas filtration

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

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

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