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Opticap XL Disposable Capsule Filters with Clarigard Media

Opticap XL capsule filters eliminate the time and expense associated with assembling, cleaning, and validating stainless steel housings. More

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Overview

Description

Clarigard® filters' 99.99% retention rating characteristic makes them ideal for the protection of critical downstream process steps such as membrane filters or chromatography columns. The graded-density depth structure of Clarigard filter media provides maximum filtration capacity, and the all-polypropylene construction offers low extractables levels and broad chemical compatibility.

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. The unique capsule design with Clarigard media minimizes hold-up volume and reduces production losses.

Regulatory Compliance

Clarigard filters 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™ XL capsule and cartridge filter is supported by a Validation Guide for compliance with regulatory requirements.

For traceability and easy identification, each filter is marked with identifying characteristics.

Multiple Formats Available

Opticap XL disposable capsule filters with Clarigard media are available in multiple filtration sizes, providing an optimal choice for every application.

Typical Applications

Precipitate Removal
Protein processing
Plasma fractions
Undissolved Constituent Removal
Cell culture media
Buffer salts
Ophthalmics
LVP/SVP
Carbon Fine Removal
Carbon beds in water processing
Powdered carbon in chemical synthesis
Gases
Dust, rust and other solids

Specifications

	Opticap XL 1	Opticap XL 5	Opticap XL 10
Materials of Construction
Filter medium	Polypropylene (PP)	Polypropylene (PP)	Polypropylene (PP)
Structural components	Polypropylene	Polypropylene	Polypropylene
O-rings	Silicone (SI)	Silicone (SI)	Silicone (SI)
Maximum Inlet Pressure, bar (psi)	5.5 bar (80 psi) @ 23 °C; 2.75 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C
Maximum Differential Pressure, bar (psid)	4.8 bar (70 psid) @ 20 °C	4.8 bar (70 psid) @ 20 °C	4.8 bar (70 psid) @ 20 °C
Gravimetric Extractables	The extractables level was equal to or less than 10 mg per capsule after 24 hours in water at controlled room temperature.	The extractables level was equal to or less than 10 mg per capsule after 24 hours in water at controlled room temperature.	The extractables level was equal to or less than 15 mg per capsule after 24 hours in water at controlled room temperature.
Oxidizable Substances	Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L	Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L	Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥3 L
Bacterial Endotoxins	Aqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
Sterilization	3 autoclave cycles of 30 min @ 126 °C; not in-line steam sterilizable
Component Material Toxicity	Component materials meet the criteria of the USP <88> Reactivity Test for Class VI Plastics. These products meet the requirements of the USP <88> Safety Test, utilizing a 0.9% sodium chloride extraction.
Non-Fiber Releasing	Component materials meet the "non-fiber releasing" criteria as defined in 21 CFR 210.3 (b) (6).
Indirect Food Additive	All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.
European Pressure Equipment Directive	EMD 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 Vessel Directive, this product does not bear the CE mark.

Typical Clean Water Flow Rate vs Pressure Drop

Opticap XL Capsule Legends Refer to Connection Type:
T T = 38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet
FF = 19 mm (3/4 in.) Sanitary Flange Inlet and Outlet
HH = 14 mm (9/16 in.) Hose Barb Inlet and Outlet

Opticap^® XL 1 Capsule with Clarigard^® Media 0.2 µm Nominal (K002)

Opticap^® XL 5 Capsule with Clarigard^® Media 0.2 µm Nominal (K002)

Opticap^® XL 10 Capsule with Clarigard^® Media 0.2 µm Nominal (K002)

Opticap^® XL 1 Capsule with Clarigard^® Media 0.3 and 0.5 µm Nominal (K003, K005)

Opticap^® XL 5 Capsule with Clarigard^® Media 0.3 and 0.5 µm Nominal (K003, K005)

Opticap^® XL 10 Capsule with Clarigard^® Media 0.3 and 0.5 µm Nominal (K003, K005)

Opticap^® XL 1 Capsule with Clarigard^® Media 1.0 µm Nominal (K010)

Opticap^® XL 5 Capsule with Clarigard^® Media 1.0 µm Nominal (K010)

Opticap^® XL 10 Capsule with Clarigard^® Media 1.0 µm Nominal (K010)

Opticap^® XL 1 Capsule with Clarigard^® Media 3.0 µm Nominal (K030)

Opticap^® XL 5 Capsule with Clarigard^® Media 3.0 µm Nominal (K030)

Opticap^® XL 10 Capsule with Clarigard^® Media 3.0 µm Nominal (K030)

Question	Answer
Are prefilters available in the Opticap format?	Yes they are. We have a Selection Guide for Opticap Prefiltration & Clarification Filters, literature # PF1511EN00

C9123Opticap XL capsule filters eliminate the time and expense associated with assembling, cleaning, and validating stainless steel housings.

	Opticap XL 1	Opticap XL 5	Opticap XL 10
Materials of Construction
Filter medium	Polypropylene (PP)	Polypropylene (PP)	Polypropylene (PP)
Structural components	Polypropylene	Polypropylene	Polypropylene
O-rings	Silicone (SI)	Silicone (SI)	Silicone (SI)
Maximum Inlet Pressure, bar (psi)	5.5 bar (80 psi) @ 23 °C; 2.75 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C
Maximum Differential Pressure, bar (psid)	4.8 bar (70 psid) @ 20 °C	4.8 bar (70 psid) @ 20 °C	4.8 bar (70 psid) @ 20 °C
Gravimetric Extractables	The extractables level was equal to or less than 10 mg per capsule after 24 hours in water at controlled room temperature.	The extractables level was equal to or less than 10 mg per capsule after 24 hours in water at controlled room temperature.	The extractables level was equal to or less than 15 mg per capsule after 24 hours in water at controlled room temperature.
Oxidizable Substances	Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L	Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L	Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥3 L
Bacterial Endotoxins	Aqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
Sterilization	3 autoclave cycles of 30 min @ 126 °C; not in-line steam sterilizable
Component Material Toxicity	Component materials meet the criteria of the USP <88> Reactivity Test for Class VI Plastics. These products meet the requirements of the USP <88> Safety Test, utilizing a 0.9% sodium chloride extraction.
Non-Fiber Releasing	Component materials meet the "non-fiber releasing" criteria as defined in 21 CFR 210.3 (b) (6).
Indirect Food Additive	All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.
European Pressure Equipment Directive	EMD 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 Vessel Directive, this product does not bear the CE mark.