AcroPak 400 Capsules w/ Fluorodyne II Membrane - 0.2um, Gamma-Irradiated , 1/Pk SKU: 12478

PVDF Capsule Filters - 12478

Hydrophilic PVDF capsule filters combine low extractable profiles with validated retention to meet the demands of regulated pharmaceutical manufacturing environments. Developed with critical workflows in mind, hydrophilic PVDF membrane within the capsule housing combines ultra-low protein binding with validated bacterial retention, preserving active pharmaceutical ingredients while removing microorganisms from production fluid streams. With this in mind, the result is a filtration workflow that scales efficiently from method development through production, delivering consistent retention performance across the full range of capsule effective filtration areas.

Key PVDF Membrane Characteristics

• Rated for continuous operation at temperatures up to 40 degrees Celsius, the capsule maintains structural integrity and retention performance across the normal process temperature range.
• PVDF capsule filters maintain consistent retention and flow performance across the operating pressure and temperature ranges encountered in standard pharmaceutical manufacturing conditions.
• PVDF membrane capsules combine ultra-low protein binding with broad chemical compatibility, balancing sample recovery with resistance to the pharmaceutical solvents encountered in formulation processing.
• PVDF capsule filters generate low extractable levels compatible with parenteral, ophthalmic, and other regulated dosage form applications.
• Hydrophilic PVDF membrane surfaces minimize non-specific adsorption of proteins, preservatives, and active pharmaceutical ingredients, protecting formulation potency through the filtration step.

Key Capsule Construction Features

• Thermally fused polypropylene construction eliminates adhesives, binders, and O-rings from the fluid path, reducing extractable contamination and simplifying material qualification.
• Polypropylene housing materials provide documented biocompatibility and low extractable profiles, supporting integration into pharmaceutical and food-processing filtration applications.
• Polypropylene capsule housing provides broad chemical compatibility from pH 1 to 14, resisting the acids, bases, and process chemicals that degrade alternative housing materials.
• Polypropylene capsule housing supports autoclave sterilization at 121 degrees Celsius and withstands gamma irradiation exposure, accommodating both user-sterilized and factory-sterilized device configurations.

From method development through scale-up to production, your capsule filter choice defines the balance between membrane performance, process integration, and the regulatory documentation trail that supports each filtration event. With these demands in mind, when your filtration step must protect both product purity and product potency, PVDF membrane chemistry delivers the low-binding performance your sensitive formulations require. Take control of your sample preparation variables and ensure that your data reflects the true nature of your work, rather than the quality of your consumables.

Sterilization Guidance

Standard autoclave cycles at 121 degrees Celsius are compatible with the polypropylene housing and membrane assembly, allowing preparation for sterile applications at the point of use.

For more information about chemical compatibility, please review our Chemical Compatibility Chart.

Bubble Point (psi)

46 psi

Burst Pressure (psi)

75 psi

Capsule Format

AcroPak 400

Compliance Standards

USP Class VI <88>; Endotoxin < 0.25 EU/mL (LAL)

Construction

Polypropylene

Diameter

19 cm

Filling Bell (Yes/ No)

No

Filtration Area

400 cm²

Flow Rate

0.5 L/min

Inlet Connection

1/4 to 1/2 in. stepped hose barb

Material

PVDF

Max Batch Volume

Medium-volume batch processing

Maximum Operating Pressure

75 psi

Maximum Operating Temperature (°C)

40 °C

Membrane Brand

Fluorodyne II

Outlet Connection

1/4 to 1/2 in. stepped hose barb

Pack Count

1

Pore Size (µm)

0.2

Prefilter (Yes/No)

No

Sterility

Nonsterile

Sterilization

Autoclave

Vent (Yes/ No)

Yes

Wettability

Hydrophilic

• Biological Products - Membrane processing of sera, biological extracts, and therapeutic proteins with minimal non-specific adsorption losses.
• Diagnostic Reagents - Filtration of sensitive diagnostic solutions where binding-related concentration changes affect assay performance.
• Preservative Sensitive - Filtration of formulations containing benzalkonium chloride and other preservatives susceptible to membrane binding.
• Drug Filtration - Ultra-low binding membrane filtration of pharmaceutical formulations where preservative and API recovery are critical.
• Formulation Processing - Low-binding capsule filtration for pharmaceutical preparations where maintaining labeled potency is essential.
• Protein Solutions - Capsule filtration of protein-containing solutions with ultra-low adsorptive losses across the fluid path.