Quality Segment
material
PTFE membrane, polypropylene , polypropylene housing
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)
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.
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
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
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 trademark of Merck KGaA, Darmstadt, Germany
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