Opticap XL Disposable Capsule Filters with Hydrophobic Aervent Membrane

Superior Filters for the Sterile Filtration of Gases

The 0.2 µm hydrophobic Aervent® polytetrafluoroethylene (PTFE) membrane provides sterility assurance, high flow rates and throughput. The Aervent membrane contributes to clean processes due its non-fiber releasing properties.

Opticap XL capsule filters eliminate the time and expense associated with assembling, cleaning, and validating stainless steel housings. The capsule patented design allows unparalleled thermal and hydraulic stress resistance, resulting in reliability, high confidence in the sterility process and improved cleanliness.

Regulatory Compliance

Filters with hydrophobic Aervent 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 Opticap capsule filter is integrity tested during manufacturing and is supported by a comprehensive Validation Guide for compliance with regulatory requirements.

For traceability and easy identification, each filter is labeled with the product name, lot number and serial number.

Multiple Formats Available

Opticap XL capsule filters with hydrophobic Aervent membrane are available in multiple filtration areas, providing an optimal choice for every application.

Specifications

	Opticap XL 2	Opticap XL 4	Opticap XL 5	Opticap XL 10
Filtration Area, m²	0.1	0.21	0.32	0.65
Materials of Construction
Filter media	Hydrophobic PTFE
Supports	Polypropylene
Structural components	Polypropylene
Vent O-ring	Silicone
Vent/Drain	1/4 in. hose barb with double O-ring seal
Integrity Test
Bubble Point	≥1100 mbar (16 psig) nitrogen with 70/30 % IPA/water
Diffusion	—	≤9 mL/min @ 965 mbar (14 psig) in 70/30 % IPA/water	≤12 mL/min @ 965 mbar (14 psig) in 70/30 % IPA/water	≤24 mL/min @ 965 mbar (14 psig) in 70/30 % IPA/water
HydroCorr Test	≤0.12 mL/min @ 2.6 bar (38 psig)	≤0.25 mL/min @ 2.6 bar (38 psig)	≤0.38 mL/min @ 2.6 bar (38 psig)	≤0.75 mL/min @ 2.6 bar (38 psig)
Maximum Inlet Pressure, bar (psid)	5.5 (80) @ 23 °C; 2.8 (40) @ 60 °C; 1.0 (15) @ 80 °C
Maximum Differential Pressure, bar (psid)	Forward: 5.5 (80) @ 25 °C; 1.0 (15) @ 80 °C. Reverse: 4.1 (60) @ 25 °C, intermittent
NVR Gravimetric Extractables	The extractables level was equal to or less than 15 mg after 24 hours in a 70/30% IPA/water mixture at controlled room temperature.	The extractables level was equal to or less than 15 mg after 24 hours in a 70/30% IPA/water mixture at controlled room temperature.	The extractables level was equal to or less than 28 mg after 24 hours in a 70/30% IPA/water mixture at controlled room temperature.	The extractables level was equal to or less than 45 mg after 24 hours in a 70/30% IPA/water mixture at controlled room temperature.
Bacterial Endotoxins	Aqueous extraction contains Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
Bacterial Retention	Quantitative retention of 10⁷ CFU/cm² Brevundimonas diminuta (ATCC® 19146) per ASTM F838-83 methodology
Sterilization	30 autoclave cycles of 30 min @ 135 °C; not in-line steam sterilizable
Toxicity	Non-toxic per MEM elution ISO® 10993-5
Good Manufacturing Practices	These products are manufactured in a facility which adheres to FDA Device Good Manufacturing Practices.
Non-Fiber Releasing	Component materials meet the "non-fiber releasing" criteria as defined in 21 CFR 210.3 (b) (6).
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.
Viral Retention	Rated for aerosol retention of a total challenge of 10⁸–10¹⁰ plaque forming units of ΦX-174 virus particles at 85 Nm³/h (50 SCFM) per cartridge.
Bacterial Aerosol Growth	Retains Brevundimonas diminuta liquid aerosol for 21 days at a minimum challenge of 10⁷ CFU/cm².

Typical Air Flow Rate

Opticap XL 2 Capsule with 0.2 µm Aervent Membrane—FF Fitting

Opticap XL 2 Capsule with 0.2 µm Aervent Membrane—HH Fitting

Opticap XL 2 Capsule with 0.2 µm Aervent Membrane—TT Fitting

Opticap XL 4 Capsule with 0.2 µm Aervent Membrane—FF Fitting

Opticap XL 4 Capsule with 0.2 µm Aervent Membrane—HH Fitting

Opticap XL 4 Capsule with 0.2 µm Aervent Membrane—TT Fitting

Opticap XL 5 Capsule with 0.2 µm Aervent Membrane — FF Fitting

Opticap XL 5 Capsule with 0.2 µm Aervent Membrane—HH Fitting

Opticap XL 5 Capsule with 0.2 µm Aervent Membrane—TT Fitting

Opticap XL 10 Capsule with 0.2 µm Aervent Membrane — FF Fitting

Opticap XL 10 Capsule, HH Fitting

Opticap XL 10 Capsule with 0.2 µm Aervent Membrane—TT Fitting

Compare	Catalogue No.	Connections, Inlet/Outlet
	KTGRA02FF3	19 mm (3/4 in.) Sanitary Flange
	KTGRA02HH3	14 mm (9/16 in.) Hose Barb
	KTGRA02TT3	38 mm (1-1/2 in.) Sanitary Flange

Compare	Catalogue No.	Connections, Inlet/Outlet
	KTGRA04FF3	19 mm (3/4 in.) Sanitary Flange
	KTGRA04HH3	14 mm (9/16 in.) Hose Barb
	KTGRA04TT3	38 mm (1-1/2 in.) Sanitary Flange

Compare	Catalogue No.	Connections, Inlet/Outlet
	KTGRA05FF1	19 mm (3/4 in.) Sanitary Flange
	KTGRA05HH1	14 mm (9/16 in.) Hose Barb
	KTGRA05TT1	38 mm (1-1/2 in.) Sanitary Flange

Compare	Catalogue No.	Connections, Inlet/Outlet
	KTGRA10FF1	19 mm (3/4 in.) Sanitary Flange
	KTGRA10HH1	14 mm (9/16 in.) Hose Barb
	KTGRA10TT1	38 mm (1-1/2 in.) Sanitary Flange

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