DLHPFB Sterilizing-Grade Liquid Filter

Cat. No.	Specification	Unit	Price	Quantity
FCM1504337-01	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

· Hydrophilic PTFE membrane which requires no pre-wetting
· Excellent chemical compatibility (pH 1-14), especially suitable for solvent-containing liquid filtration
· Low preservative-adsorption with ophthalmic solutions
· Very low extractables/leachables

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'
69 mm	0.22 μm	0.56 m²
69 mm	0.45 μm	0.65 m²

Integrity Test Standards @10inch, 20°C

Membrane Pore Size	Bubble Point
0.22μm	≥ 0.30 MPa (water), Air test
0.45μm	≥ 0.20 MPa (water), Air test

Bacteria Retention

Model	Content
DLHPFB 0.22μm	Bacterial quantitative retention of 10⁷ cfu/cm² Brevundimonas diminuta (ATCC 19146) accordingto ASTM F838 methodology.

Sterilization

In-line steam sterilization	Up to 35 cycles (135°C for 30 min and differential pressure < 30 kPa per cycle)
Autoclave	Up to 120 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	DLHPFB	0022 0.22 µm	DOE Double Open End	05 5 inch	S Silicone	P
		0045 0.45 µm	HTF 222/Fin (PBT insert)	10 10 inch	E EPDM
			HSF 226/Fin (PBT insert)	20 20 inch	V Viton
			HTCG 222/Flat (PBT insert)	30 30 inch	P FEP/PFA encapsulated O-rings
			HSCG 226/Flat (PBT insert)	40 40 inch

* Example: DLHPFB0022DOE05SP (DLHPFB, 0.22µm, Double open end, 5 inch, Silicone, Pharmaceutical)

Applications

Application Description

Antibiotic sterile filtration
Disinfectant and sanitizing agent sterile filtration
Water-based or organic solvent-based liquid sterile filtration
Ophthalmic solution sterile filtration
Liquid sterile filtration