Durapore 0.45 µm Hydrophilic Cartridge Filter

Description

Durapore 0.45 µm hydrophilic filters are manufactured from polyvinylidene fluoride (PVDF) membrane with a cellulose ester (RW06) prefilter layer for greater throughput and polypropylene components for broad chemical compatibility. They also exist without prefilter layer.

Durapore filters are 100% integrity tested during manufacturing to guarantee integrity.

Regulatory Compliance

Filters with hydrophilic Durapore membrane are designed, developed, and manufactured in accordance with a Quality Management System approved by an accredited registering body to an ISO® 9000 Quality Systems Standard and are shipped with a Certificate of Quality. Each cartridge filter is integrity tested during manufacturing and is supported by a Validation Guide for compliance with regulatory requirements.

For traceability and easy identification, each device is marked with the product name and identifying characteristics.

Typical Applications

Durapore 0.45 µm hydrophilic filters remove particles and microorganisms from aqueous liquid streams. These filters are ideally suited for large volume parenteral or ophthalmics manufacturing, where prefiltration is either unnecessary or already present at an earlier point in the process, or where protein binding must be minimized.

OptiScale and Millipak Capsules
	OptiScale 25 Capsules	OptiScale 47 Capsules	Millipak 100	Millipak 200
Nominal Dimensions
Maximum length:	39 mm (1.52 in.) with female Luer-Lok inlet/male Luer-Lok outlet	82 mm (3.24 in.) with flange inlet/hose barb outlet 74 mm (2.91 in.) with flange inlet/flange outlet 94 mm (3.70 in.) with hose barb inlet/hose barb outlet	13 cm (5.1 in.)	15.5 cm (6.1 in.)
Diameter:	31 mm (1.21 in)	69 mm (2.75 in.)	7.6 cm (3.0 in.)
Weight:	0.19 oz (5.5 g)	2.3 oz (67 g)	—	—
Filtration Area	3.5 cm²	17.7 cm²	500 cm² (0.54 ft²)	1000 cm² (1.08 ft²)
Materials of Construction
Filter membrane:	Hydrophilic polyvinylidene fluoride (PVDF)
Structural components:	Polypropylene	Polycarbonate
Supports:	Polypropylene		Polycarbonate
Vent caps:	Polypropylene	Polyvinylidene fluoride (PVDF)
Internal seal rings:	Fluoroelastomers		—
Housing Vent	Capped Vent with female Luer connections on inlet side of device.	Adjustable vent with male luer and female Luer-Lok connections on inlet side of device.
Maximum Inlet Pressure	4.1 bar (60 psig) at 25 °C	5.5 bar (80 psig) at 25 °C	5.2 bar (75 psig) at 25 °C
Maximum Differential Pressure
Forward:	4.1 bar (60 psig) at 25 °C	5.5 bar (80 psig) at 25 °C	4.1 bar (60 psid) at 25 °C 1.7 bar (25 psid) at 80 °C 345 mbar (5 psid) at 123 °C
Reverse:	0 bar (0 psig)	0.7 bar (10 psig) at 25 °C	690 mbar (10 psid) at 25 °C
Bubble Point at 23 °C	—	—	≥ 1790 mbar (26 psig) air with water
Gravimetric Extractables	—	—	After autoclaving and a 24-hour soak in ASTM Type 1 reagent grade water at controlled room temperature:
			≤ 2.5 mg	≤ 5.0 mg
Bacterial Endotoxin	Aqueous extraction contains	—	Aqueous extraction contains
Oxidizable Substances	—	Meets the requirements of the USP Oxidizable Substance Test after a water flush of:
		≤ 100 mL	200 mL	200 mL
TOC/Conductivity	This product exhibited less than 500 ppb TOC per USP <643> and less than 1.3 µS per USP <645> after autoclave and a WFI water flush of 15 mL.	—
Sterilization	May be autoclaved for 1 cycle of 60 minutes at 123 ° C	May be autoclaved for 3 cycles of 60 minutes at 126 °C	May be autoclaved for 3 cycles of 90 minutes at 123 °C. Capable of 45 kilogray (4.5 Megarad) gamma exposure (cannot be steam sterilized in-line).
Good Manufacturing Practices	These products are manufactured in a Millipore facility which adheres to FDA Device Good Manufacturing Practices.
Non-Fiber Releasing	Durapore membrane meets the criteria for a “non-fiber releasing” filter as defined in 21 CFR 210.3 (b) (6).
Component Material Toxicity	Component materials meet the requirements of USP <88> Reactivity Test for Class VI Plastics. This product is non-toxic per the current USP <88> Safety Test.
Indirect Food Additive	The Durapore membrane used in these products meets the FDA Indirect Food Additive requirements cited in 21 CFR 177.2910. All other components meet the FDA Indirect Food Additive requirements cited in 21 CFR 177 – 182.

Opticap XL Capsules and Cartridge Filters
	Opticap XL 2	Opticap XL 4	Opticap XL 5	Opticap XL 10	Cartridge (per 10-inch element)
Nominal Dimensions
Maximum length:	14.2 cm (5.6 in.)	19.6 cm (7.7 in.)	21.6 cm (8.5 in.)	33.5 cm (13.2 in.)	—
Diameter:	8.4 cm (3.3 in.)		10.7 cm (4.2 in.)		6.9 cm (2.7 in.)
Filtration Area	0.09 m² (0.93 ft²)	0.19 m² (2.09 ft²)	0.35 m² (3.7 ft²)	0.69 m² (7.4 ft²)
Materials of Construction
Filter membrane:	Hydrophilic PVDF
Prefilter media:	Mixed esters of cellulose
Film edge:	—				Polypropylene
Structural components:	Polypropylene
Supports:	Polypropylene
Vent O-rings:	Silicone				—
O-rings:	—				Silicone
Vent/Drain	¼ in. hose barb with double O-ring seal				—
Maximum Inlet Pressure	5.5 bar (80 psi) at 23 °C 2.8 bar (40 psi) at 60 °C 1.0 bar (15 psi) at 80 °C
Maximum Differential Pressure
Forward:	5.5 bar (80 psid) at 25 °C (with prefilter) 1.0 bar (15 psid) at 80 °C (with prefilter) 3.4 bar (50 psid) at 25 °C (without prefilter)				5.5 bar (80 psid) at 25 °C 1.8 bar (25 psid) at 80 °C 345 mbar (5 psid) at 135 °C
Reverse:	3.4 bar (50 psid) at 25 °C, intermittent				3.5 bar (50 psid) at 25 °C, intermittent
Bubble Point at 23 °C	≥ 1930 mbar (28 psig) air with water
Air Diffusion	Through a water wet membrane at ambient temperature at 1.5 bar (22 psi):				Through a water wet membrane at 23 °C at 1.5 bar (22 psi):
	—	≤ 4.5 cc/min	≤ 7.5 cc/min	≤ 15 cc/min
Gravimetric Extractables	After autoclaving and a 24-hour soak in ASTM Type 1 reagent grade water at controlled room temperature:
With prefilter:	—	—	—	≤ 50 mg	≤ 45 mg
Without prefilter:	≤ 10 mg		≤ 15 mg	≤ 25 mg	≤ 20 mg
Bacterial Endotoxin	Aqueous extraction contains < 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test.
Oxidizable Substances	Meets the requirements of the USP Oxidizable Substance Test after a water flush of:
	500 mL			1000 mL
Sterilization (with Prefilter)
Autoclaved:	3 cycles of 60 minutes at 121 °C.				10 cycles of 60 minutes at 121 °C
Steam Sterilization:	Cannot be steam sterilized in-line.				10 cycles of 30 minutes at 121 °C
Hot Water Sanitization:	—				30 cycles of 30 minutes at 80 °C
Sterilization (without Prefilter)
Autoclaved:	3 cycles of 60 minutes at 126 °C				30 cycles of 60 minutes at 126 °C
Steam Sterilization:	Cannot be steam sterilized in-line.				30 cycles of 30 minutes at 135 °C
Hot Water Sanitization:	—				30 cycles of 30 minutes at 80 °C
Good Manufacturing Practices	These products are manufactured in a Millipore facility which adheres to FDA Good Manufacturing Practices.
Non-Fiber Releasing	Durapore membrane meets the criteria for a “non-fiber releasing” filter as defined in 21 CFR 210.3 (b) (6).
Component Material Toxicity	Component materials were tested and meet the criteria of the USP <88> Reactivity Test for Class VI Plastics. Sterilizing-grade Durapore Filters are non-toxic per the current USP <88> Safety Test.
Indirect Food Additive	Durapore membrane meets the FDA Indirect Food Additive requirements cited in 21 CFR 177.2910. All other component materials also meet the FDA Indirect Food Additive requirements cited in 21 CFR 177 – 182.
European Pressure Equipment Directive	Millipore Corporation certifies that this product complies with the European Pressure Equipment Directive, 97/23/EC of 29 May 1997. This product has been classified under Article 3 § 3 of the Pressure Vessel Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 3 § 3 of this Pressure Equipment Directive, this product does not bear the CE mark.				—

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