Applications

Application

• Blood and Plasma
• Vaccine Production

Industry

Pharma / Biotech

Biological Information

Bacterial Retention

Quantitative Retention of 1 × E7 CFU/cm² Brevundimonas Diminuta ATCC® 19146 per ASTM methodology

Compliance Information

Bacterial Endotoxins

< 0.25 EU/mL as determined by the LAL test

Biological Reactivity

All materials of this filter element meet the requirements of the current USP Biological Reactivity tests <88> for plastics Class VI (Systemic Injection, Intracutaneous and Implantation tests).

Extractables

The total amount of extractables is well below the limits established by the current USP unter "Sterile Water for Injection".

Connections (Physical)

Connector Inlet

2-Flange Bayonet Adapter with 226 Double O-ring (25)

Connector Outlet

2-Flange Bayonet Adapter with 226 Double O-ring (25)

Dimensions

Filter Size

10"(0.6 m² / 6.5 ft²)

Filtration Area

0.6 m² / 6.5 ft²

Outer Diameter

70 mm

General Specifications

Capsule/Cartridge Format

Cartridges

Maximum Allowable Back Pressure

2 bar (29 psi) at 20°C; 1 bar (14.5 psi) at 80°C

Maximum Diffusion

15 mL/min at 2.5 bar | 36 psi

Minimum Required Bubble Point

2.0 bar | 29 psi

Vent Valve

N/A

Materials of Construction

Housing Material

Polypropylene (PP)

Material o-ring | seal

EPDM

Support Fleece

Polypropylene (PP)

Operating Conditions

Maximum Differential Pressure

20 °C: 5 bar; 80 °C: 2 bar

Physicochemical Information

Non-Fiber Releasing

This filter product complies with the title 21 of the Code of Federal Regulations (CFR), section 210.3(b)(6) and 211.72.

Pore Size Final-filter

0.2 µm.

Pore Size Pre-filter

0.45 µm

Sterility

Sterilization Method

Autoclavable & In-Line Steam Sterilizable

Usage Protocols

Sterilization Procedures

In-Line Steam Sterilization: at 134 °C, 20 min., 0.5 bar, min. 25 Cycles

Autoclaving: at 134°C, 30 min, 2 bar, min. 25 Cycles