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SPSHR Sterilizing-Grade Liquid Filter

Cobetter SPSHR series filters have ultra-low diffusion flow levels, establishing integrity values associated with bacterial challenges to ensure sterile effectiveness. Each filter element is strictly tested for bubble point and diffusion flow during manufacturing, providing a complete set of verification guidelines for customer verification. The SPSHR series of filters has a full line of scalable products, suitable for all stages from research and development to production, to accelerate the product to market.

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Description Specifications Ordering Information

Description

Features

Good hydrophilicity for easy wetting test
Each filter cartridge has an independent serial number, which can fully trace the production history of the product
Excellent temperature resistance
100% integrity test before delivery to ensure the integrity of the filter and sterilizing effect

Applications

Sterile filtration of LVP, SVP
Sterile filtration of large quantities of liquid medicine
Buffer sterile filtration
Sterile filtration of water-based antibiotic materials

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	0.1 μm	0.58 m²
69 mm	0.22 μm	0.58 m²
69 mm	0.45 μm	0.58 m²

Integrity Standard @10inch，20°C

Membrane Pore Size	Bubble Point	Diffusion Flow (Air)
0.1 μm	≥ 0.38 MPa (water), Air test	≤ 25 ml/min @ 0.345 MPa (water)
0.22 μm	≥ 0.32 MPa (water), Air test	≤ 25 ml/min @ 0.275 MPa (water)
0.45 μm	≥ 0.20 MPa (water), Air test	≤ 25 ml/min @ 0.15 MPa (water)

Bacterial Retention

Model	Content
SPSHR 0.1μm	Bacterial quantitative retention of 10⁷ cfu/cm² Brevundimonas diminuta (ATCC 19146) accordingto ASTM F838 methodology.
SPSHR 0.22μm
SPSHR 0.45μm	Bacterial quantitative retention of 10⁷ cfu/cm² Serratia marcescens (ATCC14756) according to ASTM F838 methodology

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	SPSHR	0010 0.1µm	DOE Double Open End	05 5 inch	S Silicone	P
		0022 0.22µm	HTF 222/Fin	10 10 inch	E EPDM
		0045 0.45µm	HSF 226/Fin	20 20 inch	V Viton
			HTCG 222/Flat	30 30 inch	P FEP/PFA encapsulated O-rings
			HSCG 226/Flat	40 40 inch

* Example：SPSHR0010DOE05SP (SPSHR，0.1µm，Double open end，5 inch，Silicone，Pharmaceutical)