Catalogue Number

KWSCA3TTT1

Trade Name

• Opticap^®

Description

Opticap^® XLT30 Milligard^® 1.2/0.5 µm 1-1/2 in. TC/TC

Format

Double Layer

Device Configuration

Capsule

Connections, Inlet/Outlet

38 mm (1-1/2 in.) Sanitary Flange

Filter Grade

Standard Milligard^® Media

Housing Material

Polypropylene (PP)

Maximum Differential Pressure, bar (psid)

3.5 bar (50 psid) @ 25 °C

Maximum Inlet Pressure, bar (psi)

5.5 bar (80 psi) @ 23 °C; 2.75 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C

Good Manufacturing Practices

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

T-line/Gauge Port

T-line

Quality Level

MQ400

Bacterial Endotoxins

Aqueous extraction contains ?0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test

Media

Milligard^®

Sterilization

3 autoclave cycles of 30 min @ 121 °C; not in-line steam sterilizable

Pore Size

1.2 / 0.5 µm

Inlet Connection

Sanitary Flange

Outlet Connection

Sanitary Flange

Gravimetric Extractables

The extractables level was equal to or less than 165 mg per capsule after 24 hours in water at controlled room temperature.

Indirect Food Additive

All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.

Maximum Inlet Pressure (psig)

80 psig

Maximum Inlet Temperature

25 °C

Non-Fiber Releasing

This product was manufactured with a media combination which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

USP Bacterial Endotoxins

A sample aqueous extraction contains less than 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.

Cartridge Nominal Length

30 in. (75 cm)

Length

87.1 cm (34.3 in.)

Filtration Area

2.07 m²

Inlet to Outlet Width

15.2 cm (6.0 in.)

Device Size

30 in.

Inlet Connection Diameter

1-1/2 in.

Nominal Pore Size

1.2 / 0.5 µm

Outlet Connection Diameter

1-1/2 in.

Chemistry

• Mixed Cellulose Esters (MCE)

Device Material

• Polypropylene

Seal Material

Silicone (SI)

Support Material

Polyester

Vent Cap Material

Polypropylene (PP)

Material Size

1

Material Package

Double Easy-Open bag

Oxidizable Substances

Will meet the USP Oxidizable Substances Test requirements after a water flush of ?15 L