DGPFMP/GPFMP Sterilizing-grade Gas Filter

Cat. No.	Specification	Unit	Price	Quantity
FCM1504299-01	Membrane: Double-layer or Single-layer hydrophobic polytetrafluoroethylene (PTFE)	each	Inquiry

Product Description

Product Description

DGPFMP Series Filter Cartridges are composed of double-layer hydrophobic PTFE membrane and a thick thermal resistant polypropylene core. They are highly recommended for air and gas sterile fltration of pharmaceutical, biopharmaceutical and fermentation industries. Both inherently hydrophobic and 100% integrity testing ensure absolute sterilization. GPFMP Series Filter Cartridges are composed of single-layer hydrophobic PTFE membrane and a thick thermal-resistant polypropylene core. They are highly recommended for air and gas sterile fltration of pharmaceutical,biopharmaceutical and fermentation industries. Both inherently hydrophobic and 100% integrity testing ensure absolute sterilization.

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

· Absolute sterilization in dry or wet conditions
· High flow rates, low pressure drop, higher retention efficiency
· Better temperature and pressure resistance with a thick thermal-resistance polypropylene core
· High temperature resistance, optional SIP or repeated autoclave
· 100% integrity tested before delivery ensure filter's integrity and sterilization performance when using

Specifications

Materials of Construction

Membrane	Double-layer or Single-layer hydrophobic polytetrafluoroethylene (PTFE)
Support	Polypropylene (PP)
Core/Cage/End Caps	Polypropylene (PP)
End Cap Inserts	316L Stainless Steel, 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'
DGPFMP	68 mm	0.003 μm (gas)	0.75 m²
DGPFMP	68 mm	0.22 μm (liguid)	0.75 m²
GPFMP	68 mm	0.01 μm (gas)	0.68 m²
GPFMP	68 mm	0.22 μm (liquid)	0.68 m²

Integrity Test Standards @10inch, 20°C (DGPFMP)

Membrane Pore Size	Bubble Point	Diffusion Flow (Air)	Water Flow Test
0.003 μm/0.22 μm	≥ 0.11 MPa, 60% IPA, 40% Water, Air test	≤ 20 ml/min @ 0.08 MPa, 60% IPA, 40% Water	≤ 0.50 ml/min @ 0.25 Mpa

Integrity Test Standards @10inch, 20°C (GPFMP)

Membrane Pore Size	Bubble Point	Diffusion Flow (Air)	Water Flow Test
0.01 μm/0.22 μm	≥ 0.10 MPa, 60% IPA, 40% Water, Air test	≤ 24 ml/min @ 0.095 MPa, 60% IPA, 40% Water	≤ 0.75 ml/min @ 0.25 Mpa

Bacterial Retention

Model	Content
DGPFMP 0.22 μm	Bacterial quantitative retention of 10⁷ cfu/cm² Brevundimonas diminuta (ATCC 19146) accordingto ASTM F838 methodology.
DGPFMP 0.003 μm	Retention efficiency for > 1×10⁸ pfu Bacteriophage Phi-X174 (ATCC 13706-B1) phage aerosol LRV > 7
GPFMP 0.22 μm	Bacterial quantitative retention of 10⁷ cfu/cm² Brevundimonas diminuta (ATCC 19146) accordingto ASTM F838 methodology.
GPFMP 0.01 μm	Retention efficiency for > 1×10⁸ pfu Bacteriophage Phi-X174 (ATCC 13706-B1) phage aerosol LRV > 7

Sterilization

In-line steam sterilization	Up to 100 forward cycles and 50 reverse cycles (145°C for 30 min, differential pressure < 30 kPa per forward cycle and differential pressure < 10 kPa per reverse 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:

DGPFMP (Double-layer)

Outer Diameter	Type	Membrane Pore Size	End Cap	Nominal Length	Seal Material	Industry
Blank 68mm	DGPFMP	S003 0.003 µm	DOE Double Open End	05 5 inch	S Silicone	P
		0022 0.22 µm	HTF 222/Fin	10 10 inch	E EPDM
			SSF 226/Fin (SS insert)	20 20 inch	V Vition
			HSF 226/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)

GPFMP (Single-layer)

Outer Diameter	Type	Membrane Pore Size	End Cap	Nominal Length	Seal Material	Industry
Blank 68mm	GPFMP	0001 0.01 µm	DOE Double Open End	05 5 inch	S Silicone	P
		0022 0.22 µm	HTF 222/Fin	10 10 inch	E EPDM
			SSF 226/Fin (SS insert)	20 20 inch	V Vition
			HSF 226/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: DGPFMPS003DOE05SP (DGPFMP, 0.003µm, Double open end, 5 inch, Silicone, Pharmaceutical)