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APSEA Sterilizing-Grade Liquid Filter

Cobetter APSEA cartridge is a double-layer membrane filter: polypropylene pre-filtration layer and asymmetric PES membranes for bacterial reduction, LRV/cm2 > 6

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Description Specifications Ordering Information

Description

Features

Excellent long life and cost-effective
Asymmetric, high loading capacity, bacterial reduction pre-filtration

Applications

Bacterial reduction before final sterilization and filtration
Reduces bioburden

Quality

100% Integrity testing in manufacturing
Each filter is fully traceable with unique serial number
Manufactured in a facility which adheres to ISO 9001:2015 Practices

Flow Rate Characteristics

Specifications

Materials of Construction

Membrane	Hydrophilic polyethersulfone (PES)
Support	Polypropylene (PP)
Core/Cage/End Caps	Polypropylene (PP)
End Cap Inserts	Polybutylene terephthalate (PBT)
Seal Material	Silicone / EPDM / Viton FEP/ PFA encapsulated O-rings

Operating Conditions

Max. Operating Temperature	80°C
Max.Operating Pressure	0.69 MPa@25°C 0.40 MPa@60°C 0.24 MPa@80°C
Max. Differential Pressure (Forward)	0.69 MPa@25°C 0.40 MPa@60°C 0.24 MPa@80°C
Max. Differential Pressure (Reverse)	0.30 MPa@25°C 0.10 MPa@80°C

Filtration Area

Outer Diameter	Membrane Pore Size	Area/10"
69 mm	0.22 μm	0.66 m2
69 mm	0.45 μm	0.66 m2
69 mm	0.65 μm	0.66 m2
69 mm	0.8 μm	0.66 m2
69 mm	1.0 μm	0.66 m2
69 mm	1.2 μm	0.66 m2
69 mm	3.0 μm	0.66 m2
69 mm	5.0 μm	0.66 m2
69 mm	8.0 μm	0.66 m2
69 mm	10.0 μm	0.66 m2

Integrity Test Standards @10inch，20°C

Membrane Pore Size	Bubble Point
0.22 μm	≥ 0.11 MPa，60% IPA, 40% Water, Air test
0.45 μm	≥ 0.07 MPa，60% IPA, 40% Water, Air test
0.65 μm	≥ 0.04 MPa，60% IPA, 40% Water, Air test

Bacterial Retention

Model	Content
APSEA 0.22 μm	LRV/cm2 ＞6 for 10? cfu/cm2 Brevundimonas diminuta（ATCC 19146）
APSEA 0.45 μm	LRV/cm2 ＞6 for 10? cfu/cm2 Serratia marcescens (ATCC 14756)

Sterilization

In-line steam sterilization	Up to 100 cycles (135 °C for 30 min and differential pressure < 30 kPa per cycle)
Autoclave	Up to 200 cycles (130 °C for 30 min per cycle)

Regulatory Compliance

Autoclaved filter effluent meets the USP<788> requirement of particulate matter in large volume injection.
Component materials meet the criteria for a "Non-fiber-releasing filter" as defined in 21 CFR 210.3(b)(6).
Aqueous extraction from a cartridge contains less than 0.25EU/ml as determined by Limulus Amebocyte Lysate (LAL), meeting requirements of USP<85>.
Meet the requirement of USP <87> In Vitro Cytotoxicity Test.
Component materials meet the requirements of the current USP<88> for plastic class VI-121°C.
All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.
Based on the current information from our suppliers, all component materials used in the manufacture of this product are animal-free.

End Cap

Ordering Information

Outer Diameter	Type	Membrane Pore Size	End Cap	Nominal Length	Seal Material	Industry
69mm	APSEA	0022 0.22 μm	DOE 平壓	05 5英寸	S Silicone	P
		0045 0.45 μm	HTF 222/尖頭式	10 10英寸	E EPDM
		0065 0.65 μm	HSF 226/尖頭式	20 20英寸	V Viton
		0080 0.8 μm	HTCG 222/平頭式	30 30英寸	P FEP/PFA encapsulated O-rings
		0100 1.0 μm	HSCG 226/平頭式	40 40英寸
		0120 1.2 μm
		0300 3.0 μm
		0500 5.0 μm
		0800 8.0μm
		1000 10.0μm

* Example：APSEA0022DOE05SP (APSEA，0.22μm，Double open end，5 inch，Silicone，Pharmaceutical)

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