Why is a Fully Disposable TFF System Necessary?

TangenX® SiusTM Filter Plate Insert and Holder For Lab to Process Scale Tangential Flow Filtration

Disposable TangenX® SiusTM Filter Plate Insert (FPI) Benefits:

• In combination with SiusTM cassettes, obtain a complete disposable system for TFF! • Pre-sanitized single-use and ready-to-use FPI for easy and simple processing • Shorter process time due to minimum preparation and cleaning • Compatible with traditional holders and hardware • Cost-effective solution • Simplified SiusTM TFF holder implies reduced investment

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TFF systems are typically used in a process and then cleaned between uses with a clean in place (CIP) operation. The standard method of reuse requires a significant investment in raw materials, energy, and time. That is why Novasep has developed the first truly disposable TangenX® SiusTM cassettes, compatible with traditional holders. The time needed to prepare, clean and validate the cassettes was drastically reduced, while the productivity improved. However, it was still necessary to clean the stainless steel holder. To avoid this issue, Novasep has introduced a single-use TangenX® SiusTM Filter Plate Insert. Combining both Sius™ cassettes and the Sius™ FPI enables a complete disposable system for tangential flow filtration, saving time and money due to minimum preparation and cleaning.

As a consequence, the SiusTM holder, composed of only two stainless steel plates without any contact with the process fluid, is much less complex than traditional holders and, thus, less expensive. Using the Sius™ FPI and holder also improves process safety by reducing the risk of cross-contamination. In addition, Novasep experts provide you with a user guide and any data and documentation needed to meet cGMP guidelines and regulatory requirements.

Clamp Top Plate

Disposable Isolation Plate

Disposable EPDM Gaskets

SiusTM Disposable Cassette

SiusTM Disposable FPI

Clamp Bottom Plate

Feed

Retentate Permeate

SiusTM Cassette

SiusTM 4BMC Holder

SiusTM V2BC Holder

SiusTM-LS FPI

SiusTM-75 FPI

SiusTM-99 FPI

SiusTM-LS Cassette

SiusTM Cassette

SiusTM-LS 2BMC Holder

The Sius™ single-use FPI offers the same flow characteristics as traditional stainless steel holders. Each Sius™ FPI is delivered pre-sanitized, packaged in 0.2M sodium hydroxide and ready to be used for processing after rinsing with buffer. The fully disposable TFF solution comprising SiusTM cassettes and the FPI can be used with your existing holder, using our appropriate spacers when necessary. Four different Sius™ FPIs are available so as to be compatible with Sius™ cassettes in a range of surface areas from 0.01m² to 30.0m². Five SiusTM holders are available, compatible with all Sius™ FPIs and cassettes.

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Applications Biopharma, Biotech, Life Sciences:

• Microfiltration, ultrafiltration / diafiltration • Concentrate and desalt proteins, peptides, nucleic acids (DNA, RNA, oligonucleotides) • Separate and purify biopharmaceuticals • Recover and purify antibodies or recombinant proteins from cell culture media • Fractionate diluted protein mixtures • Remove pyrogens from water, buffer, and media solutions • Sample preparation prior to chromatography

Quality & Properties and Compatibility • Manufacturing & Quality

• SiusTM Holder Specifications

SiusTM-LS SiusTM

The Sius™ FPI is manufactured and quality controlled in a cGMP compliant manufacturing facility. Quality control lot release testing includes 100% testing to meet release specifications. The result is scalable process development and reproducible manufacturing. Each Sius™ device is sanitized and individually packaged in a sealed foil-lined bag and outer cardboard carton. Each FPI is packaged in 0.2M sodium hydroxide as a sanitizing agent.

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2BMC 4BMC V1BC V2BC V3BC Holder

Capacity 0.01 to 0.5 m² (0.1 to 5.4 sq ft)

0.5 to 5.0 m² (5.4 to 54 sq ft)

1.0 to 10.0 m² (10.8 to 108 sq ft)

1.0 to 20.0 m² (10.8 to 215 sq ft)

1.0 to 30.0 m² (10.8 to 323 sq ft)

Plates Tie Rods 304L Stainless Steel

Rails N/A 304L Stainless Steel Spacers 304L Stainless Steel N/A Washers 304L Stainless Steel Brass

Brass (Manual) Hex Nuts Brass 304L Stainless Steel (Hydraulic)

Compatibility SiusTM-LS Packet / Cassette SiusTM Cassette / Block

Torque Range

120-180 in-lbs 300-450 in-lbs (35-50 N-m)

600-900 in-lbs (14-20 N-m) (70-100 N-m)

Hydraulic Option No Yes

Hex Socket 11/16’’ 1-1/4’’

• SiusTM FPI Specifications

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SiusTM-LS LHV SiusTM-LS SiusTM-75 SiusTM-99 Holder

Compatibility 2BMC 4BMC VxBC VxBC

Cassette Compatibility

LP1L, LP1J, LP1K LP2L, LP2J, LP2K L01L, L01J, L01K

G05L, G05J, G05K G15L, G15J, G15K G25L, G25J, G25K

FPI Natural or White Polypropylene (Class VI, BSE free) Isolation Plate Natural Polypropylene (Class VI, BSE free)

Connections Female Luer with 1/8 NPT

Integral 0.5’’ Tri-Clamp

Integral 1’’ Tri-Clamp

Integral 1.5’’ Tri-Clamp

Max Flowrate 0.48 LPM 9 LPM 49 LPM 140 LPM

Contacts

EUROPE – Novasep Process 81, Boulevard de la Moselle – BP 50

54340 Pompey – France Phone: + 33 (0)3 83 49 70 00

Fax: + 33 (0)3 83 49 70 02

USA – TangenX 910 Boston Turnpike Road

Shrewsbury, MA 01545 – USA Phone: + 1 508 845 6400

Fax: + 1 508 845 3030 sius@novasep.com

Ordering & Specifications

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When placing an order, please include the Novasep code directly on your PO:

SiusTM-LS 2BMC TSLDI-2BMC SiusTM 4BMC TSPDI-4BMC Holder

(without FPI) SiusTM VxBC where x = 1 up to 10 m² 2 up to 20 m² 3 up to 30 m²

TSPDI-VxBC

SiusTM-LS LHV Filter Plate Insert (0.48 LPM) TFPLS-LVFL SiusTM-LS Filter Plate Insert (9 LPM) TFPLS-SA08 SiusTM-75 Filter Plate Insert (49 LPM) TFP75-SE16

FPI

SiusTM-99 Filter Plate Insert (140 LPM) TFP99-SP20 Torque Wrench for SiusTM-LS (50-250 in-lbs) TX019 Torque Wrench for SiusTM (200-1000 in-lbs) TX026 Hydraulic Auto-Torque Option (includes pump) TX020 SiusTM-LS Polypro Isolation Plate (1 pk) TFPLS-PP

Options

SiusTM Polypro Isolation Plate (1 pk) TFPPS-PP

www.novasep.com