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KMP8G1STH1 MilliporeMilligard® PES 1.2/0.8 µm, Opticap® T-line 10, TC/HB with gauge port

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Replacement Information

Description
Catalogue Number	KMP8G1STH1
Trade Name	Milligard^®PES
Description	Milligard® PES 1.2/0.8 µm, Opticap® T-line 10, TC/HB with gauge port

References

Product Information
HS Code	8421 29 90
Device Configuration	Capsule
Connections, Inlet/Outlet	38 mm (1.5 in.) Sanitary Flange Inlet and 19 mm (6/8 in.) Hose Barb Outlet.
Maximum Differential Pressure, bar (psid)	Forward: 4.5 bar (65 psid) at 4-25°C; 1.7 bar (25 psid) at 80°C, Reverse: 1.4 bar (20 psid) at 25°C
Maximum Inlet Pressure, bar (psi)	4.5 bar (65 psi) at 25 °C
Quality Level	MQ400

Applications

Biological Information
Bacterial Endotoxins	Aqueous extraction contains <0.25 EU/mL per device as determined using the Limulus Amebocyte Lysate (LAL) test, meeting requirements of USP <85>, EP 2.6.14 and JP 4.01.
Media	Milligard^® PES
Sterility	Autoclavable/Gamma Compatible
Sterilization	3 autoclave cycles of 60 min @ 123 °C; gamma exposure up to 40 kGy
Wettability	Hydrophilic

Physicochemical Information
Pore Size	1.2/0.8 µm
Inlet Connection	Sanitary Flange
Outlet Connection	Hose Barb
Bubble Point at 23 °C	990 mbar (14.3 psi) air with water
Non-Fiber Releasing	Devices tested and meet requirements of USP <788> for large volume parenterals.

Dimensions
Filtration Area	0.57 m2 (6.1 ft2)
Inlet Connection Diameter	1.5 in.
Outlet Connection Diameter	19 mm (6/8 in)

Materials Information
Chemistry	Polyethersulfone (PES)
Device Material	Hydrophilic polyethersulfone
Support Material	Polyester
Vent Cap Material	Silicone

Toxicological Information

Safety Information according to GHS

Safety Information

Product Usage Statements

Storage and Shipping Information

Packaging Information
Material Size	1
Material Package	PE Bag

Transport Information

Supplemental Information

Specifications

Global Trade Item Number
Katalogové číslo	GTIN
KMP8G1STH1	04065267513713

Documentation

Material Qualification Dossier

Title	Version
EMPROVE® Material Qualification Dossier - KMP8G1STH1	3.0

Quality Management Dossier (Open Access)

Title
Milligard® PES 1.2/0.8 µm, Opticap® T-line 10, TC/HB with gauge port

Operational Excellence Dossier

Title
Milligard® PES 1.2/0.8 µm, Opticap® T-line 10, TC/HB with gauge port

Operational Excellence Dossier (Second Sterilization)

Title
Milligard® PES 1.2/0.8 µm, Opticap® T-line 10, TC/HB with gauge port

Technical Info

Title
How Membrane Prefilters Enhance Bioprocessing Efficiency
Processing mAb streams - How a bioburden reduction filter can improve process efficiency

User Guides

Title
User Guide -Opticap® Small Scale 300, Opticap® XL and XLT , and T-line Capsules

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