SPSHR Sterilizing-Grade Liquid Filter

Cat. No.	Specification	Unit	Price	Quantity
FCM1504290-01	Membrane: Hydrophilic polyethersulfone (PES)	each	Inquiry

Product Description

Product Description

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.

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

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

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.

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)

Applications

Application Description

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