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Polysep II Filters
Polysep II Filters
Polysep™ II Filters
Superior filters provide multiple filtration stages in a single
compact configuration for critical prefiltration applications.
Serum • Perfect choice when high flow rate and high throughput are required
Polysep™ II prefilters remove lipids, colloids and particles from • Ideal for designing scalable solutions from bench top to full-scale
serum before final sterilizing filtration without obstructing the manufacturing
passage of serum proteins.
The OptiScale® single-use capsule is ideally suited for process development and screening.
OptiScale® capsules are faster and easier to set up than conventional 47 mm discs.
OptiScale® Filters
Opticap® XL and XLT Single-Use Capsule Filters
Opticap® XL 2, 4, 5 and 10 Capsule Filters
Opticap® XL single-use capsule filters with Polysep™ II media are available in multiple
filtration areas, providing an optimal choice for every application. The unique capsule design
with pleated Polysep™ II media minimizes hold-up volume and reduces production losses.
Robust Construction
Opticap® XL and XLT’s capsule design allows unparalleled thermal and hydraulic stress
resistance in a single-use filter, resulting in reliability, high confidence in the sterility process
and improved cleanliness.
Cartridge Filters
Polysep™ II cartridge filters provide high throughput and flow rates with minimal
differential pressure. Cartridges are robust, designed to withstand multiple steam-in-place
cycles. A full range of filtration areas is available to suit your application requirements.
A variety of connection options are offered for easy adaptation to existing housings.
Cartridge Filters
Specifications
OptiScale® Single-Use Capsules
OptiScale®
Nominal Dimensions
Maximum length: 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
Diameter: 69 mm (2.75 in.)
Weight: 2.4 oz (69 g)
Filtration Area (see legend below)
W1, W3, W6, W2, W9: 17.7 cm2
Materials of Construction
Filter media: Borosilicate glass microfiber and mixed esters of cellulose
Structural components: Polycarbonate
Vent cap: PVDF
Internal seal rings: Fluoroelastomers
Housing Vent Adjustable vent with male luer and female Luer-Lok™ connections on inlet side of device.
Maximum Inlet Pressure 5.5 bar (80 psi) at 25 °C
Oxidizable Substances Capsules meet the requirements of the USP Oxidizable Substance for Sterile Water for Filtration Test after a water flush of
100 mL.
Sterilization May be autoclaved for 3 cycles of 60 minutes at 121 °C
Good Manufacturing Practices These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Non-Fiber Releasing Polysep™ II media 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.
Polysep™ II Filters meet the requirements of the current USP <88> Safety Test.
Indirect Food Additive All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177–182.
4
Specifications
OptiCap® Single-Use Capsules
Opticap® XL 2 Opticap® XL 4 Opticap® XL 5 Opticap® XL 10 Opticap® XLT 10 Opticap® XLT 20 Opticap® XLT 30
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.) 37.6 cm (14.8 in.) 62.5 cm (24.6 in.) 87.1 cm (34.3 in.)
Body Diameter 8.4 cm (3.3 in.) 8.4 cm (3.3 in.) 10.7 cm (4.2 in.) 10.7 cm (4.2 in.) — — —
Fitting to Fitting
Sanitary flange to — — — — 15.2 cm (6.0 in.) 15.2 cm (6.0 in.) 15.2 cm (6.0 in.)
sanitary flange:
Sanitary flange to — — — — 17.5 cm (6.9 in.) 17.5 cm (6.9 in.) 17.5 cm (6.9 in.)
hose barb:
Hose barb to hose barb: — — — — 19.8 cm (7.8 in.) 19.8 cm (7.8 in.) 19.8 cm (7.8 in.)
Filtration Area
(see legend below)
W2, W3, W6, W9: 0.06 m2 (0.6 ft2) 0.11 m2 (1.2 ft2) 0.19 m2 (2.0 ft2) 0.46 m2 (5.0 ft2) 0.46 m2 (5.0 ft2) 0.93 m² (10.0 ft²) 1.39 m² (15.0 ft²)
W1: N/A N/A 0.17 m2 (1.8 ft2) 0.42 m2 (4.5 ft2) 0.42 m2 (4.5 ft2) 0.85 m² (9.1 ft²) 1.26 m2 (13.6 ft2)
Materials of Construction
Filter media: Borosilicate glass microfiber and mixed esters of cellulose
Structural components*: Polypropylene
Supports: Polypropylene
Vent cap: Polypropylene
Vent O-ring: 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: 3.4 bar (50 psid) at 25 °C.
NVR Gravimetric After autoclaving and a 24 hour soak in ASTM® Type 1 reagent grade water at controlled room temperature:
Extractables
≤ 45 mg after ≤ 85 mg after ≤ 61 mg after ≤ 145 mg after ≤ 145 mg after ≤ 290 mg after ≤ 435 mg after
a 600 mL flush a 1.2 L flush a 5 L flush a 5 L flush a 5 L flush a 10 L flush a 15 L flush
USP Bacterial Endotoxin Aqueous extraction contains < 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test.
Oxidizable Substances Capsules meet the requirements of the USP Oxidizable Substances Test after a water flush of:
≤ 1000 mL ≤ 2000 mL ≤ 2000 mL ≤ 5000 mL ≤ 5000 mL ≤ 10,000 mL ≤ 15,000 mL
Sterilization May be autoclaved for 3 cycles of 30 minutes at 121 °C. (Cannot be steam sterilized in-line.)
Good Manufacturing These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Practices
Non-Fiber Releasing Polysep™ II media meets the criteria for a “non-fiber releasing” filter as defined in 21 CFR 210.3 (b) (6).
Component Material Component materials meet the requirements of the USP <88> Reactivity Tests for Class VI Plastics.
Toxicity This product meets the requirements of the USP <88> Safety Test utilizing a 0.9% sodium chloride extraction.
Indirect Food Additive All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177–182.
5
Specifications (continued)
4-inch Cartridge Per 10-inch Cartridge
Nominal Dimensions
Outside diameter: 6.9 cm (2.7 in.) 6.9 cm (2.7 in.)
Filtration Area (see legend below)
W2, W3, W6, W9: 0.19 m2 (2.0 ft2) 0.46 m2 (5.0 ft2)
W1: 0.17 m2 (1.8 ft2) 0.42 m2 (4.5 ft2)
Materials of Construction
Filter media: Borosilicate glass microfiber and mixed esters of cellulose
Structural components*: Rigid polypropylene
Supports: Spun bonded polypropylene
O-rings: Silicone
Maximum Differential Pressure
Forward: 3.4 bar (50 psid) at 25 °C.
NVR Gravimetric Extractables After autoclaving and a 24 hour soak in ASTM® Type 1reagent grade water at controlled room temperature,
extractables level was ≤ 140 mg per 10-inch element after a 5000 mL flush.
Bacterial Endotoxin Aqueous extraction contains < 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test.
Oxidizable Substances Cartridges meet the requirements of the USP Oxidizable Substances Test after a water flush of ≤ 5000 mL per 10-inch
element.
Sterilization May be autoclaved for 10 cycles of 30 minutes at 121 °C, or steam sterilized for 10 cycles of 30 minutes at 121 °C, or
hot water sanitized for 40 cycles of 30 minutes at 80 °C.
Good Manufacturing Practices These products are manufactured in a facility which adheres to FDA Good Manfacturing Practices.
Non-Fiber Releasing Polysep™ II media 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 the USP <88> Reactivity Tests for Class VI Plastics.
This product meets the requirements of the USP <88> Safety Test utilizing a 0.9% sodium chloride extraction.
Indirect Food Additive All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177–182.
6
Typical Clean Water Flow Rates
Opticap® XL 2 Capsule with Polysep™ II Opticap® XL 2 Capsule with Polysep™ II Opticap® XL Capsule Legends Refers
Media — 1.0/0.2 µm Nominal (W3) Media — 1.0/0.5 µm Nominal (W6) to Connection Type
gpm gpm
0 1 2 3 4 5 0 1 2 3 4 5
TT = 3 8 mm (11⁄2 in.) Sanitary
2.5
35
1.6 Flange Inlet and Outlet
TT
30
1.4
TT
FF 20 FF = 1 9 mm (3⁄4 in.) Sanitary Flange
2.0 FF
HH 1.2 HH Inlet and Outlet
FH 25 FH
Pressure Drop (bar)
psid
0.0 0 0.0 0
0 2 4 6 8 10 12 14 16 18 20 0 2 4 6 8 10 12 14 16 18 20
HH 10 HH
FH 0.5 FH 7
Pressure Drop (bar)
0.6
6
0.5 0.4
5
0.4 0.3
5 4
0.3
0.2 3
0.2
2
0.1 0.1
1
psid
psid
0.0 0 0.0 0
0 2 4 6 8 10 12 14 16 18 20 0 2 4 6 8 10 12 14 16 18 20
TT 0.9 TT
1.2 12
FF 0.8 FF
HH 15 HH
1.0 FH 0.7 FH 10
Pressure Drop (bar)
Pressure Drop (bar)
0.6
0.8 8
10 0.5
0.6 0.4 6
0.4 0.3 4
5
0.2
0.2 2
0.1
psid
psid
0.0 0 0.0 0
0 2 4 6 8 10 12 14 16 18 20 0 2 4 6 8 10 12 14 16 18 20
0.4
6 5
0.4
5 0.3
4
0.3 4
0.2 3
0.2 3
2 2
0.1
0.1 1
1
psid
psid
0.0 0 0.0 0
0 2 4 6 8 10 12 14 16 18 20 0 2 4 6 8 10 12 14 16 18 20
7
Typical Clean Water Flow Rates
Opticap® XL 5 Capsule with Polysep™ II Opticap® XL 5 Capsule with Polysep™ II Opticap® XL Capsule Legends Refers
Media — 1.0/0.2/0.1 µm Nominal (W1) Media — 1.0/0.2 µm Nominal (W3) to Connection Type
gpm gpm TT = 3 8 mm (11⁄2 in.) Sanitary
0 2 4 6 8
3.5 3.0
0 5 10 15 20
Flange Inlet and Outlet
50
3.0 TT 45 TT
40 FF = 1 9 mm (3⁄4 in.) Sanitary Flange
2.5
FF 40
FF
HH
Inlet and Outlet
2.5 HH
30 HH = 1 4 mm (9⁄16 in.) Hose Barb Inlet
Pressure Drop (bar)
psid
0.0 0 0.0 0
0 5 10 15 20 25 30 35 0 10 2 0 30 40 50 60 70 80
Opticap® XL 5 Capsule with Polysep™ II Opticap® XL 5 Capsule with Polysep™ II Opticap® XL 5 Capsule with Polysep™ II
Media — 1.0/0.5 µm Nominal (W6) Media — 1.0/1.2 µm Nominal (W2) Media — 2.0/1.2 µm Nominal (W9)
gpm gpm gpm
0 5 10 15 20 0 5 10 15 20 0 1 2 3 4 5 6 7
2.5 2.5 2.5
35 35
TT TT TT
FF 30 30 FF 25
2.0 2.0 FF 2.0
HH HH HH
25 25
Pressure Drop (bar)
20
1.5 1.5 1.5
20 20
15
psid
psid
bar
Opticap® XL 10 Capsule with Polysep™ II Opticap® XL 10 Capsule with Polysep™ II Opticap® XL 10 Capsule with Polysep™ II
Media — 1.0/0.2/0.1 µm Nominal (W1) Media — 1.0/0.2 µm Nominal (W3) Media — 1.0/0.5 µm Nominal (W6)
gpm gpm gpm
0 5 10 15 20 0 5 10 15 20 0 5 10 15 20
2.5 2.5 2.5
35 35 35
TT TT TT
2.0 FF 30 2.0 FF 30 2.0 FF 30
HH HH HH
Pressure Drop (bar)
25
Pressure Drop (bar)
Pressure Drop (bar)
25 25
1.5 1.5 1.5
20 20 20
10 10 10
0.5 0.5 0.5
5 5 5
psid
psid
psid
1.5 1.5
20 20
1.0 15 1.0 15
10 10
0.5 0.5
5 5
psid
psid
0.0 0 0.0 0
0 10 2 0 30 40 50 60 70 80 0 10 2 0 30 40 50 60 70 80
8
Typical Clean Water Flow Rates
Opticap® XLT 10 Capsule with Polysep™ II Opticap® XLT 10 Capsule with Polysep™ II Opticap XLT Capsule Legends Refer
Media — 1.0/0.2/0.1 µm Nominal (W1) Media — 1.0/0.2 µm Nominal (W3) to Connection Type
gpm gpm TT = 3 8 mm (11⁄2 in.) Sanitary Flange
0 5 10 15 20 0 5 10 15 20 Inlet and Outlet
4.0 3.0
TT
55 40 TH = 3 8 mm (11⁄2 in.) Sanitary Flange
3.5 50 TT
TH
45
2.5 TH Inlet and 16 mm (5⁄8 in.) Hose Barb Outlet
3.0 HH HH
BB 40 30 HH = 1 6 mm (5⁄8 in.) Hose Barb Inlet and Outlet
Pressure Drop (bar)
psid
0.0 0 0.0 0
Opticap® XLT 10 Capsule with Polysep™ II Opticap® XLT 10 Capsule with Polysep™ II Opticap® XLT 10 Capsule with Polysep™ II
Media — 1.0/0.5 µm Nominal (W6) Media — 1.0/1.2 µm Nominal (W2) Media — 2.0/1.2 µm Nominal (W9)
gpm gpm gpm
0 5 10 15 20 0 5 10 15 20 0 5 10 15 20
3.0 3.0 3.0
40 40 40
TT TT TT
2.5 2.5 TH 2.5
TH TH
HH HH HH
30 BB 30 30
Pressure Drop (bar)
psid
psid
0.0 0 0.0 0 0.0 0
0 10 20 30 4 0 50 60 70 80
Opticap® XLT 20 Capsule with Polysep™ II Opticap® XLT 20 Capsule with Polysep™ II Opticap® XLT 20 Capsule with Polysep™ II
Media — 1.0/0.2/0.1 µm Nominal (W1) Media — 1.0/0.2 µm Nominal (W3) Media — 1.0/0.5 µm Nominal (W6)
gpm gpm gpm
0 5 10 15 20 0 5 10 15 20 0 5 10 15 20
3.5 50 3.0 3.0
40 40
3.0 TT 45 TT TT
TH 2.5 TH 2.5 TH
40
HH HH HH
2.5 30 30
BB 35 BB BB
Pressure Drop (bar)
2.0 2.0
2.0 30
25 1.5 1.5
20 20
1.5
20
1.0 1.0
1.0 15
10 10
10
0.5 0.5 0.5
5
psid
psid
psid
Opticap® XLT 20 Capsule with Polysep™ II Opticap® XLT 20 Capsule with Polysep™ II
Media — 1.0/1.2 µm Nominal (W2) Media — 2.0/1.2 µm Nominal (W9)
gpm gpm
0 5 10 15 20 0 5 10 15 20
3.0 3.0
40 40
TT TT
2.5 TH 2.5
TH
HH HH
BB 30 30
Pressure Drop (bar)
2.0 2.0 BB
1.5 1.5
20 20
1.0 1.0
10 10
0.5 0.5
psid
psid
0.0 0 0.0 0
9
Typical Clean Water Flow Rates
Opticap® XLT 30 Capsule with Polysep™ II Opticap XLT 30 Capsule with Polysep™ II Opticap® XLT Capsule Legends Refer
Media — 1.0/0.2/0.1 µm Nominal (W1) Media — 1.0/0.2 µm Nominal (W3) to Connection Type
gpm gpm TT = 38 mm (11⁄2 in.) Sanitary Flange Inlet
0 5 10 15 20 0 5 10 15 20 and Outlet
3.0 3.0
TT
40 40 TH = 38 mm (11⁄2 in.) Sanitary Flange Inlet
TT
2.5 TH 2.5 TH and 16 mm (5⁄8 in.) Hose Barb Outlet
HH HH
BB 30 BB 30 HH = 16 mm (5⁄8 in.) Hose Barb Inlet
Pressure Drop (bar)
psid
0.0 0 0.0 0
Opticap XLT 30 Capsule with Polysep™ II Opticap XLT 30 Capsule with Polysep™ II Opticap XLT 30 Capsule with Polysep™ II
Media — 1.0/0.5 µm Nominal (W6) Media — 1.0/1.2 µm Nominal (W2) Media — 2.0/1.2 µm Nominal (W9)
gpm gpm gpm
0 5 10 15 20 0 5 10 15 20 0 5 10 15 20
3.0 3.0 3.0
40 40 40
TT TT TT
2.5 TH 2.5 2.5
TH TH
HH HH HH
BB 30 30 30
Pressure Drop (bar)
psid
psid
0.0 0 0.0 0 0.0 0
Cartridges with Polysep™ II Media — Cartridges with Polysep™ II Media — 1.0/0.2 Cartridges with Polysep™ II Media —
1.0/0.2/0.1 µm Nominal (W1) µm Nominal (W3) 1.0/0.5 µm Nominal (W6)
gpm gpm gpm
0 5 10 1 5 20 0 5 10 1 5 20 0 5 10 1 5 20
2.5 0.7 10 0.35 5
35
4-inch 4-inch 4-inch
10-inch 0.6 10-inch 0.30 10-inch
2.0 20-inch 30 20-inch 8 20-inch 4
30-inch 0.5 30-inch 0.25 30-inch
Pressure Drop (bar)
15 0.3 0.15
1.0 4 2
10 0.2 0.10
0.5 2 1
5 0.1 0.05
psid
psid
psid
40-inch 40-inch
0.10 1.5
0.4 6
0.08
0.3 1.0
4 0.06
0.2
0.04
2 0.5
0.1 0.02
psid
psid
10
Ordering Information
OptiScale® Capsule Filters
S G A 4 7 3
K G A
K G A 1
Accessory
Description Qty/Pk Catalogue No.
Standard Opticap® XLT Capsule Filter Stand 1/pk XLTS TAN D1
*Not all configurations available as standard product.
11
Ordering Information
Cartridge Filters
C G T 0 3
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Merck Millipore, the M logo, Opticap, and OptiScale are registered trademarks and
Polygard is a trademark of Merck KGaA, Darmstadt, Germany.
ISO is a registered trademark of the International Organization for Standardization.
ASTM is a trademark of American Society for Testing and Materials.
Luer-Lok is a trademark of Becton Dickinson and Company.
Lit. No. DS180EN00 Ver. 1.0 12/2015 PS-13-09383
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