Sartocon X-Cap 15

Laboratory scale single use filter for Biopharmaceutical applications

Specifications Materials of Construction Membrane Polyethersulfone| Hydrosart Silicone Polypropylene Polyurethane with no product contact Polycarbonate

Crossflow Filtration

Gaskets Spacer Encapsulation Connector

Pore Size|Retention Rate PESU ultrafiltration cassettes are available in the following nominal molecular weight cut-offs: 10kD, 30kD. Hydrosart ultrafiltration cassettes are available in the following nominal molecular weight cut-offs: 10 kD and 30 kD. Description Sartocon X-Cap 15 The Sartocon X-Cap 15 is a ready to use 15 cm2 fully disposable crossflow module that is ideally suited for membrane screening. Available in a variety of MWCOs and Polymers. The X-Cap 15 can easily be interfaced with the SARTOFLOW Slice 200 Benchtop system as well as other laboratory scale crossflow systems. The Polyethersulfone Membrane The polyethersulfone membrane (PESU) is a membrane polymer that is well established in the biotechnological and pharmaceutical industries. The PESU membrane is a stable polymer that features a broad pH and temperature range. Polyethersulfone membranes are designed for use in the biotechnological and pharmacheutical industries. The Hydrosart Membrane Hydrosart is a stabilized cellulose based membrane that has been optimized for the biotechnological and pharmaceutical industry. The Hydrosart membrane is a stable polymer that features a broad pH range. Hydrosart is also extremely hydrophilic, making it non-protein binding, virtually non-fouling, and has extremely high flux. Membrane depyrogenation can be accomplished by using NaOH even at elevated temperatures. These features make Hydrosart an ideal membrane for biological applications. Product Profile Sartocon X-Cap 15 is available with Hydrosart or Polyethersulfone membrane. It can easily be interfaced with the SARTOFLOW Slice 200 Bench Top system. Feature Low adsorption Low protein-binding Self contained unit Luerlock Female ports Benefits Minimal loss of proteins High product yield Ready to use quick connection to existing equipment ready to use on SARTOFLOW Slice 200 Benchtop System low product volume evaluation possible Available Filterholder No need for a dedicated filterholder. Optional holding device for vertical orientation available. Filtration Area Filter area Sartocon X-Cap 15 15 cm2 Operating Parameters Feed pressure, Pin 58 psi |4 bar maximum 114 < 0.5 ml/min

Operating temperature 50C maximum pH stabilty Air diffusion rates at Pin = 43 psi |3 bar

available with low surface area

Sterilization No thermal sterilization possible. Regulatory Compliance All materials have passed the current USP Biological Test and Cytotoxicity Test. All materials are BSE and TSE free. Quality Control Each X-Cap 15 is individually assigned a serial number, integrity tested and certified. This Data Sheet is filed under the Drug Master File Number DMF 5967 by the Food and Drug Administration, Washington, DC. Validation information is available upon request. For further assistance, please contact your local Sartorius Stedim Biotech Application Specialist. Technical References: Validation Guide Publication No.: SPC5707 Directions for Use Publication No.: SPC6038

Average Dynamic Water Flux Cut-off Hydrosart 15 cm2 filter area Permeate Pfeed = 2 bar |29 psi, Pret = 0.5 bar | 7 psi, Pperm = open 10 kD 0.12 l/h 30 kD 0.3 l/h

Polyethersulfone 15 cm2 filter area Permeate Pfeed = 2 bar |29 psi, Pret = 0.5 bar | 7 psi, Pperm = open 0.4 l/h 0.7 l/h

Protein Markers (PESU Ultrafilter) [NMWCO]; = not measured Substance Approx. 1 kD 5 kD 8 kD 10 kD PESUmax 30 kD Mol. Wt. [%] [%] [%] [%] kD [%] [%] Vitamin B12 1,200 >70 50 80 Cytocrome C 12,400 99 >95 60 90 Albumin 67,000 >99.9 -Globulin 169,000 Dextran 2,000,000 Hydrosart (Ultrafilter) [NMWCO]; = not measured Substance Approx. Mol. Wt. 2 kD 5 kD Vitamin B12 1,200 > 88% Inulin 5,000 > 96% Cytochrome C 12,400 Albumin 67,000 -Globulin 169,000

50 kD 100 kD 300 kD [%] [%] [%] >95 >99 <80 > 98 <70 >95

10 kD > 97.5%

30 kD > 97.5%

100 kD <60% > 96%

Order Information Available Sartocon X-Cap 15 Types with female luerloc connector Cut-off Hydrosart Polyethersulfone 15 cm2 filter area 15 cm2 filter area 10 kD 3D91443915ELLPU 3D91463915ELLPU 30 kD 3D91445915ELLPU 3D91465915ELLPU

Sartorius Stedim Biotech GmbH August-Spindler-Strasse 11 37079 Goettingen, Germany Phone +49.551.308.0 Fax +49.551.308.3289 www.sartorius-stedim.com USA Toll-Free +1.800.368.7178 UK +44.1372.737159 France +33.442.845600 Italy +39.055.63.40.41 Spain +34.91.3586102 Japan +81.3.3740.5407
Specifications subject to change without notice. Printed and copyrighted by Sartorius Stedim Biotech GmbH WG Publication No.: SPC2065-e09041 Order No.: 85034-537-81 Ver. 05 | 2009