LPF Sterilizing-Grade Solvent Filter

Cat. No.	Specification	Unit	Price	Quantity
FCM1504338-01	Membrane: Hydrophilic polytetrafluoroethylene (PTFE)	each	Inquiry

Product Description

Product Description

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

· Inherently hydrophobic
· Excellent resistance for corrosion, oxidation and organic solvent, compatible with a variety of corrosive liquids
· Broad chemical compatibility - pH 1-14, compatible with strong acid and alkali
· High flow rates
· Low extractables
· 100% integrity testing to ensure sterilization performance

Specifications

Materials of Construction

Membrane	Hydrophilic polytetrafluoroethylene (PTFE)
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'
68 mm	LPF 0.22 μm	0.68 m²
68 mm	LPF 0.45 μm	0.78 m²

Integrity Test Standards @10inch, 20°C

Membrane Pore Size	Bubble Point	Diffusion Flow (Air)	Water Flow Test
LPF 0.22 μm	≥ 0.11 MPa, 60% IPA, 40% Water, Air test	≤ 16 ml/min @ 0.08 MPa, 60% IPA, 40% Water	≤ 0.38 ml/min @ 0.25 Mpa
LPF 0.45 μm	≥ 0.05 MPa, 60% IPA, 40% Water, Air test	/	/

Bacterial Retention

Model	Content
LPF 0.22μm	Bacterial quantitative retention of 10⁷ cfu/cm² Brevundimonas diminuta (ATCC 19146) accordingto 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 400 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
68mm	LPF	0022 0.22 µm	DOE Double Open End	05 5 inch	S Silicone	P
		0045 0.45 µm	HTF 222/Fin	10 10 inch	E EPDM
			SSF 226/Fin (SS insert)	20 20 inch	V Viton
			HSF 222/Fin (PBT insert)	30 30 inch	P FEP/PFA encapsulated O-rings
			SSCM 226/Flat (SS insert)	40 40 inch
			HSCG 226/Flat (PBT insert)

* Example: LPF0022DOE05SP (LPF, 0.22µm, Double open end, 5 inch, Silicone, Pharmaceutical)

Applications

Application Description

Solvent sterile filtration
Corrosive liquid sterile filtration
and particle removal
Strong oxidizing liquid