USD 2463b Supracap™ Depth Filter Capsules Providing the Benefits of Seitz® High Performance Depth Filter Media in Scalable Capsule Formats Scalable Single-use Depth Filtration The range of Supracap capsules provides a scalable and Inside Supracap 100 Capsules reliable depth filter platform for rapid process development Benefitting from the proven Pall Supradisc II mechanically for volumes from < 1 liter to over 100 liters, utilizing the robust module design, Supracap 100 capsules enable same design, flow path, and filter media as larger scale consistent, reliable filtration results from batch to batch. Pall Supradisc™ depth filter modules and Stax™ capsules. Through the use of dual drainage plates, the Supradisc II Scalable both linearly in performance and seamlessly through module design imparts the structural integrity necessary for: product format transitions, Supracap capsules will save time Unobstructed process flow and costs during critical screening, development and process Consistent filtration results operations. The fully disposable design eliminates any Minimized risk to filter media rupture in the event of reverse pressure cleaning or handling concerns typically associated with housings, especially when dealing with biological and hazardous products. The Supracap range of capsules has been designed to provide cost effectiveness, flexibility and ease-of-use, while minimizing the exposure risks for operators. Supracap 60 Capsules Ideal for developing and optimizing processes during scale-up and scale-down studies, the Supracap 60 capsules (effective filtration area [EFA] 26 cm2) can be used to quickly and accurately determine the exact Seitz depth filter media necessary for process filtration success. And because the Supracap 60 capsules utilize similar design, filter media, and flow path construction as the larger Supracap 100 capsules, assurance of performance and process design during scale-up and scale-down studies is achieved. 2 S ca la bility Following on from Supracap 60 capsules, Pall Supracap 100 capsules are available in 4 sizes ranging from 0.025m2 to 0.3m2 (0.27 ft2 to 3.23 ft2) EFA. These capsules can also be manifolded together to create even larger systems, to ensure we can meet your process requirements for perfect scale up when transitioning from small scale development through to commercial phase manufacturing. Comparison of Scalability - CHO Clarification (Post Fermenter) Filter Grade - PDK5 at 150 Lmh 1.6 1.4 ∆p (bar) 1.2 1.0 0.8 0.6 0.4 0.2 0 0 50 100 150 200 250 300 Volumetric Throughput (L/m²) Supracap 60 capsule (1) Supracap 60 capsule (2) Supracap 60 capsule (3) Supracap 100 5 in. capsule Supracap 100 10 in. capsule Stax capsule Culture Harvest Conditions - Total Cells - 9.68 x 10 6/mL, Viable Cells - 1.99 x 10 6/mL, Viability - 20.6, Turbidity - >1000 NTU Top: Supracap 100 internal cartridge. Bottom: (from left to right) 5 in. and 10 in. Supracap 100 capsules, Stax capsule and center bottom Supracap 60 capsule. www.pall.com 3 Flexibility of Design Designed to Provide Choice and Flexibility The Supracap range of disposable capsules comes in a variety of options to enable you to select the correct capsule to meet your specific process requirements, offering different configurations for: Filter area Depth filter media grade Capsule configuration Inlet/outlet connections Complete Single-Use Systems With the additional benefit of being able to manifold the Supracap 100 capsules together, or with other Pall Kleenpak™ Nova capsule filters, the Supracap 100 capsules can be easily incorporated into Pall Allegro™ disposable systems. These Allegro systems can combine depth filters, final sterile filters and biocontainers – making a complete filter train – What could be better? A complete single-use system designed to your specifications, ready to use straight out of the box! Simple, Scalable, Disposable. Pall Supracap capsules provide high performance filtration and flexibility, in single-use format. Applications Appropriate for use in primary and secondary filtration steps in applications including: Mammalian cell cultures Yeast E.coli lysates and refolds Vaccines Blood plasma proteins and serum Media 4 10 in. in-line Supracap 100 capsule. Features and Benefits Complete flexibility – Choices in filter media, effective filtration area, capsule configuration, and connection styles enables customized filtration solutions Low hold-up volume – Increased product recovery requiring low post use rinse volumes Seamless linear scalability – Greater flexibility and assurance of process success from <1 to 100+ liters. Scalable to Pall’s entire line of traditional Supradisc modules as well as Stax capsules Minimized risk – Mechanically robust design provides unobstructed process flows, consistent and scalable filtration results, as well as a high filter media integrity Technical Service For the best possible results and maximum reliability, Pall recommends performing filter evaluations utilizing your process and process conditions. Pall specialists can provide valuable assistance, either at your facility or in our SLS (Scientific and Laboratory Services) laboratories. Pall offers hands-on assistance and places its extensive technical resources at your disposal in the form of worldwide technical advice, including cost-reduction programs, process review and problem solving. No housings – Easier to use and manipulate while eliminating capital expenditures Completely disposable – Eliminates the need for cleaning and cleaning validation Encapsulated design – Reduces operator exposure to potential biohazards www.pall.com 5 Proven High Performance Depth Filter Media Incorporating Seitz Depth Filter Media Applications Supracap capsules are available in a wide range of With Pall’s wide ranging Pharmaceutical grade depth advanced pharmaceutical grade Seitz depth filter media. filter sheets for use in the entire Supracap line of disposable Supported with comprehensive validation guides, Seitz depth capsules, flexibility to meet your unique process demands filter media meet the highest pharmaceutical standards for: is attainable. Quality P-series: Lot-to-lot consistency Seitz P-series depth filter sheets were specifically Manufacturing control developed for the strict requirements in biotechnological Low extractable content and pharmaceutical industries. Manufactured with stringent Low endotoxin content in-process control methods assures consistent filtration quality, a very high purity of filter medium, and alignment Scalability - Depth Filter Sheet Media Formats with the requirements of the pharmaceutical industry. For further information, please reference Pall data sheet USD 2205 or validation guide USTR 2366. Advanced Pharmaceutical Grade Depth Filter Media HP-series: Seitz HP-series depth filter sheets are comprised of two distinct layers of Seitz P-series depth filter sheets; a coarser layer upstream followed by a finer layer downstream. These performance-enhanced depth filter sheets have been designed for use in low viability, high solids containing P-series HP-series Bio-series Biopharm Product Filtration High Performance Cell Culture Clarification 100 % Organic Filter Matrix – Low Product Binding (10 grades) (Double layer w/20+ grades) (2 grades) applications. As small shifts in process conditions can cause dramatic differences in filtration requirements, the flexibility of combining any combination of P-series media in an HP format allows for improved process optimization. For further information, please reference Pall data sheet USD 2335 or validation guide USTR 2404. Bio-series: Supracap 60 capsules Supracap 100 capsules Supracap 200 capsules Supradisc I modules Supradisc II modules Stax capsules Seitz Bio-series depth filter sheets are specially developed < 1-3 liters 3-100+ liters 50-2000+ liters 50-20,000+ liters 50-20,000+ liters 50-20,000+ liters from highly purified natural and modified cellulose fibers and contain no inorganic materials such as diatomaceous earth (DE), perlite or glass fibers. The lack of these inorganic substances significantly reduces the levels of ash and heavy metal extractables. For further information please reference Pall data sheet USD 2201. 6 Typical Permeability (L/m²/min at 1 bar) Permeability - P-series 2500 2000 1500 1000 500 K 900 P K 700 P K 250 P K 200 P SUPRA 80 P K 100 P KS 50 P SUPRA EK 1-P EKM-P EKS-P 0 Depth filter sheets. Permeability - Bio-series 200 Typical Permeability (L/m²/min at 1 bar) Typical Permeability (L/m²/min at 1 bar) Permeability - HP-series 180 160 140 120 100 80 60 40 20 0 PDD1 PDE2 PDH4 120 110 100 90 80 70 60 50 40 30 20 10 0 Bio 10 PDK5 Bio 20 The above HP grades are examples of only 4 of the many grades available. Nominal Retention Rating of Seitz P-series, HP-series and Bio-series Depth Filter Sheet Media Bio 20 Bio 10 PDK5 PDH4 PDE2 PDD1 K900P K700P K250P K200P K100P S80P KS50P SEK1P EKMP EKSP 0.1 0.5 1 5 10 25 50 100 Micron www.pall.com 7 From Bench-top to Process A well integrated suite of single-use devices is critical when Scalability - Effective Filter Area scaling up or down a process for further analysis. Apart from the ease of use aspect of these disposable products, designing them with similar flow resistance, flow paths and filter area utilization will produce results that more accurately predict what will be demonstrated at larger scales. Supracap 60 capsules (<1 to 3 liters) Capsule Supracap 100 capsules (3 to 100 + liters) 5 in. capsules 0.05 m² (0.54 ft²) SL(1) EFA 0.025 m² (0.27 ft²) DL(2) EFA 10 in. capsules 0.1 m² (1.08 ft²) SL EFA 0.05 m² (0.54 ft²) DL EFA 20 in. capsules 0.2 m² (2.15 ft²) SL EFA 0.1 m² (1.08 ft²) DL EFA 30 in. capsules 0.3 m² (3.23 ft²) SL EFA 0.15 m² (1.61 ft²) DL EFA Supported by these complimentary technologies, Pall has extended this seamless approach to products to their larger Stax capsule system (50 to 20,000+ liters). Building upon the same criteria for design, flow path, and filter media Pall has established a comprehensive suite of enabling single-use technologies providing seamless linear scalability in filtration 26 cm² (0.028 ft²) of EFA* performance from bench to process. Stax capsules (50 to 20,000 + liters) Small capsules 0.5 m² (5.38 ft²) SL EFA 0.25 m² (2.70 ft²) DL EFA Medium capsules 1.0 m² (10.8 ft²) SL EFA 0.5 m² (5.38 ft²) DL EFA Large capsules 2.0 m² (21.5 ft²) SL EFA 1.0 m² (10.8 ft²) DL EFA * EFA = Effective Filtration Area (1) SL = Single layer Seitz depth filter media such as P-series and BIO-series (2) DL = Double layer Seitz depth filter media such as HP-series Top: Pilot Scale Stax chassis arranged with one large capsule, one small capsule and the vent manifold kit. Right: Supracap 60 capsule 8 Technical Specifications High Quality Standards Batch tested in order to meet all quality requirements Manufactured under a Quality Management System certified to ISO 9000 and ISO 9001 and an Environmental Management System certified to ISO 14001 All plastic components used in construction meet the specifications for Biological Reactivity Tests in vivo for Class VI Plastics (121 °C) as described in the current United States Pharmacopoeia (USP). Materials of Construction Supracap 60 Capsules Capsule Vent Supracap 100 Capsules Housing Bowl Housing Head(1) O-rings (1) Maximum Operating Pressure(2) Supracap 60 & 100 Capsules From drug discovery and basic research, through process (2) single source for all your filtration and separation needs. Our UpScale program provides you with the scalable products and support you need to bring new products to market faster. Supracap Capsules Meet Industry Requirements Polypropylene Polypropylene Silicone elastomers Formulated with TiO² whitener which does not contribute to organic extractables Pall UpScaleSM Program development and production, Pall Corporation is the Polycarbonate Polypropylene 3 bar (44 psi) @ 40 ºC In compatible fluids which do not soften, swell, or adversely affect the filter or its materials of construction Maximum Differential Pressure Supracap 60 Capsules Supracap 100 Capsules 1.5 bar (22 psi) 2.4 bar (35 psi) Sterilization - Autoclaving Supracap 60 Capsules Supracap 100 Capsules 1 cycle: 125 ºC at 30 minutes 1 cycle: 125 ºC at 60 minutes designed to have minimal hold-up volumes. Supracap 60 and Supracap 100 Capsule Filter Area SC6 NP5 N*6 N*7 Single layer 26 cm² 0.05 m2 0.1 m2 0.2 m2 (0.028 ft²) (0.54 ft2) (1.08 ft2) (2.15 ft2) 2 2 HP-version 26 cm² 0.025 m 0.05 m 0.10 m2 2 2 (0.028 ft²) (0.27 ft ) (0.54 ft ) (1.08 ft2) The translucent shell makes venting and draining easier * Insert either P (for in-line version) or T (for T-style version) Supracap capsules have been designed to meet industry requirements including autoclaving and low extractables. They offer high flow rates and throughputs and are as liquid levels are now visible. Supracap 100 Capsules Void Volumes(3) Capsule Length NP (mL) 127 mm (5 in.) 652 254 mm (10 in.) 1125 508 mm (20 in.) 2291 762 mm (30 in.) 3399 (3) N*8 0.3 m2 (3.23 ft2) 0.15 m2 (1.61 ft2) NT (mL) NA 1160 2578 3747 Void volume is defined as amount of liquid required to fill entire capsule with cartridge installed inside www.pall.com 9 Technical Specifications Supracap 60 Capsules Nominal Dimensions Maximum Height (A) Maximum Diameter (B) Single layer media 32.5 mm (1.28 in.) 75 mm (2.95 in.) HP media 36 mm (1.42 in.) 75 mm (2.95 in.) Supracap 100 Capsules Nominal Dimensions In-line NP5 NP6 NP7 NP8 Maximum diameter (B) including valves 154 mm (6.1 in.) 154 mm (6.1 in.) 154 mm (6.1 in.) 154 mm (6.1 in.) Height (A) with hose barb inlet/outlet 263 mm (10.4 in.) 397 mm (15.6 in.) 644 mm (25.4 in.) 895 mm (35.2 in.) Height (A) with sanitary inlet/outlet 213 mm (8.4 in.) 335 mm (13.2 in.) 584 mm (23.0 in.) 834 mm (32.8 in.) T-style NT5 NT6 NT7 NT8 Maximum diameter (B) NA 240 mm (9.5 in.) 240 mm (9.5 in.) 240 mm (9.5 in.) Height (A) including valves NA 349 mm (13.7 in.) 598 mm (23.5 in.) 848 mm (33.4 in.) Supracap 60 Capsules Supracap 100 NP Style Capsules Supracap 100 NT Style Capsules A A A B B B 10 Ordering Information Supracap 60 Capsules Pall Part Number: SC060 Code Media Grade PEKS EKSP PEKM EKMP PEK1 SEK1P P050 KS50P P080 SUPRA 80P P100 K100P P200 K200P P250 K250P P700 K700P P900 K900P B010 BIO10 B020 BIO20 PDD1 PDD1 PDE2 PDE2 PDH4 PDH4 PDK5 PDK5 Supracap 100 Capsules Pall Part Number: N Code Capsule Format Code Nominal Length Code Media Grade Code Connection Options P In-line 5L(1) 5 in. (127 mm) PEKS EKSP 1 1 – 11⁄2 in. sanitary flange inlet and outlet T T-style 6 10 in. (254mm) PEKM EKMP 9 7 20 in. (508 mm) PEK1 SEK1P 25 mm (1 in.) single barb hose barb inlet and outlet 8 30 in. (762 mm) P050 KS50P 19(2) P080 SUPRA 80P 1– 11⁄2 in. sanitary flange inlet and 25 mm (1 in.) single barb hose barb outlet P100 K100P 6(2) ` 13 mm (1⁄2 in.) single barb hose barb inlet and outlet P200 K200P 7(3) 1 P250 K250P 16(2) P700 K700P 1– 11⁄2 in. sanitary flange inlet and 13 mm (1⁄2 in.) single barb hose barb outlet 1H1(4) 1– 11⁄2 in. sanitary flange inlet and out let with additional 1⁄2 in. sanitary port on inlet 1H9(4) 1 – 11⁄2 in. sanitary flange inlet and 11⁄2 in. single barb hose barb outlet, with additional 1⁄2 in. sanitary port on inlet Note: Staübli vent and stepped hose barb drain fitted as standard (1) (2) (3) (4) Currently available only with In-line capsule format and connection codes 1, 6, or 7. Currently available only with In-line capsule formats. Currently available only with 5 in. capsule formats. Currently available only with T-style capsule formats. P900 K900P B010 BIO10 B020 BIO20 PDD1 PDD1 PDE2 PDE2 PDH4 PDH4 PDK5 PDK5 ⁄4 in. hose barb inlet and outlet www.pall.com 11 ™ AllegroSystems The Single- Use Solution Visit us on the Web at www.pall.com/biopharm e-mail us at biotech@pall.com United States 800.717.7255 toll free (USA) 516.484.5400 phone 516.801.9548 fax biotech@pall.com e-mail Europe +44 (0)23 9230 3303 phone +44 (0)23 9230 2506 fax BioPharmUK@europe.pall.com e-mail International Offices Pall Corporation has offices and plants throughout the world in locations such as: Argentina, Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, India, Indonesia, Ireland, Italy, Japan, Korea, Malaysia, Mexico, the Netherlands, New Zealand, Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, the United Kingdom, the United States, and Venezuela. Distributors in all major industrial areas of the world. The information provided in this literature was reviewed for accuracy at the time of publication. Product data may be subject to change without notice. For current information consult your local Pall distributor or contact Pall directly. © 2009, Pall Corporation. Pall, , Allegro, the Allegro design, Kleenpak, Seitz, Stax, Supracap, and Supradisc are trademarks of Pall Corporation. ® indicates a trademark registered in the USA. Filtration. Separation. Solution.SM and UpScale is a service mark of Pall Corporation. Stäubli is a trademark of Stäubli AG. 9/09, PDF, GN09.3517 USD 2463b