Supracap Depth Filter Capsules

Transcription

1 USD 2463b Supracap Depth Filter Capsules Providing the Benefits of Seitz High Performance Depth Filter Media in Scalable Capsule Formats

2 Scalable Single-use Depth Filtration The range of Supracap capsules provides a scalable and reliable depth filter platform for rapid process development for volumes from < 1 liter to over 100 liters, utilizing the same design, flow path, and filter media as larger scale Pall Supradisc depth filter modules and Stax capsules. Scalable both linearly in performance and seamlessly through product format transitions, Supracap capsules will save time and costs during critical screening, development and process operations. The fully disposable design eliminates any cleaning or handling concerns typically associated with housings, especially when dealing with biological and hazardous products. Inside Supracap 100 Capsules Benefitting from the proven Pall Supradisc II mechanically robust module design, Supracap 100 capsules enable consistent, reliable filtration results from batch to batch. Through the use of dual drainage plates, the Supradisc II module design imparts the structural integrity necessary for: Unobstructed process flow Consistent filtration results Minimized risk to filter media rupture in the event of reverse pressure 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 cm 2 ) 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

3 S calability Following on from Supracap 60 capsules, Pall Supracap 100 capsules are available in 4 sizes ranging from 0.025m 2 to 0.3m 2 (0.27 ft 2 to 3.23 ft 2 ) 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 p (bar) Volumetric Throughput (L/m²) Supracap 60 capsule (1) Supracap 60 capsule (2) Supracap 60 capsule (3) Supracap in. capsule Supracap in. capsule Stax capsule Culture Harvest Conditions - Total Cells x 10 6 /ml, Viable Cells x 10 6 /ml, Viability , 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. 3

4 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 10 in. in-line Supracap 100 capsule. 4

5 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 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 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. 5

6 Proven High Performance Depth Filter Media Incorporating Seitz Depth Filter Media Supracap capsules are available in a wide range of advanced pharmaceutical grade Seitz depth filter media. Supported with comprehensive validation guides, Seitz depth filter media meet the highest pharmaceutical standards for: Quality Lot-to-lot consistency Manufacturing control Low extractable content Low endotoxin content Scalability - Depth Filter Sheet Media Formats P-series HP-series Bio-series Biopharm Product Filtration Advanced Pharmaceutical Grade Depth Filter Media High Performance Cell Culture Clarification (10 grades) (Double layer w/20+ grades) 100 % Organic Filter Matrix Low Product Binding (2 grades) Applications With Pall s wide ranging Pharmaceutical grade depth filter sheets for use in the entire Supracap line of disposable capsules, flexibility to meet your unique process demands is attainable. P-series: Seitz P-series depth filter sheets were specifically developed for the strict requirements in biotechnological and pharmaceutical industries. Manufactured with stringent in-process control methods assures consistent filtration quality, a very high purity of filter medium, and alignment with the requirements of the pharmaceutical industry. For further information, please reference Pall data sheet USD 2205 or validation guide USTR 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 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 Bio-series: Supracap 60 capsules < 1-3 liters Supracap 100 capsules liters Supracap 200 capsules liters Supradisc I modules 50-20,000+ liters Supradisc II modules 50-20,000+ liters Stax capsules 50-20,000+ liters Seitz Bio-series depth filter sheets are specially developed 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

7 Permeability - P-series Typical Permeability (L/m²/min at 1 bar) EKS-P EKM-P SUPRA EK 1-P KS 50 P K 100 P SUPRA 80 P K 200 P K 250 P K 700 P K 900 P Depth filter sheets. Permeability - HP-series Permeability - Bio-series Typical Permeability (L/m²/min at 1 bar) PDD1 PDE2 PDH4 PDK5 Typical Permeability (L/m²/min at 1 bar) Bio 10 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 Micron 7

8 From Bench-top to Process A well integrated suite of single-use devices is critical when 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. 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 performance from bench to process. Scalability - Effective Filter Area Supracap 60 capsules (<1 to 3 liters) Capsule Supracap 100 capsules (3 to liters) 26 cm² (0.028 ft²) of EFA* 5 in. capsules 0.05 m² (0.54 ft²) SL (1) EFA 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 Stax capsules (50 to 20,000 + liters) Small capsules Medium capsules Large capsules 0.5 m² (5.38 ft²) SL EFA 0.25 m² (2.70 ft²) DL EFA 1.0 m² (10.8 ft²) SL EFA 0.5 m² (5.38 ft²) DL EFA 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

9 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 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). Pall UpScale SM Program From drug discovery and basic research, through process development and production, Pall Corporation is the 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 Supracap capsules have been designed to meet industry requirements including autoclaving and low extractables. They offer high flow rates and throughputs and are designed to have minimal hold-up volumes. The translucent shell makes venting and draining easier as liquid levels are now visible. Materials of Construction Supracap 60 Capsules Capsule Vent Supracap 100 Capsules Housing Bowl Housing Head (1) O-rings Polycarbonate Polypropylene Polypropylene Polypropylene Silicone elastomers (1) Formulated with TiO ² whitener which does not contribute to organic extractables Maximum Operating Pressure (2) Supracap 60 & 100 Capsules 3 bar (44 40 ºC (2) 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 Sterilization - Autoclaving Supracap 60 Capsules Supracap 100 Capsules 1.5 bar (22 psi) 2.4 bar (35 psi) 1 cycle: 125 ºC at 30 minutes 1 cycle: 125 ºC at 60 minutes Supracap 60 and Supracap 100 Capsule Filter Area SC6 NP5 N*6 N*7 N*8 Single layer 26 cm² 0.05 m m m m 2 (0.028 ft²) (0.54 ft 2 ) (1.08 ft 2 ) (2.15 ft 2 ) (3.23 ft 2 ) HP-version 26 cm² m m m m 2 (0.028 ft²) (0.27 ft 2 ) (0.54 ft 2 ) (1.08 ft 2 ) (1.61 ft 2 ) * Insert either P (for in-line version) or T (for T-style version) Supracap 100 Capsules Void Volumes (3) Capsule Length NP (ml) NT (ml) 127 mm (5 in.) 652 NA 254 mm (10 in.) mm (20 in.) mm (30 in.) (3) Void volume is defined as amount of liquid required to fill entire capsule with cartridge installed inside 9

10 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 B A A B B 10

11 Ordering Information Supracap 60 Capsules Pall Part Number: SC060 Code PEKS PEKM PEK1 P050 P080 P100 P200 P250 P700 P900 B010 B020 PDD1 PDE2 PDH4 PDK5 Media Grade EKSP EKMP SEK1P KS50P SUPRA 80P K100P K200P K250P K700P K900P BIO10 BIO20 PDD1 PDE2 PDH4 PDK5 Supracap 100 Capsules Pall Part Number: N Code P T Capsule Format In-line T-style Code 5L (1) Nominal Length 5 in. (127 mm) 10 in. (254mm) 20 in. (508 mm) 30 in. (762 mm) Note: Staübli vent and stepped hose barb drain fitted as standard (1) Currently available only with In-line capsule format and connection codes 1, 6, or 7. (2) Currently available only with In-line capsule formats. (3) Currently available only with 5 in. capsule formats. (4) Currently available only with T-style capsule formats. Code PEKS PEKM PEK1 P050 P080 P100 P200 P250 P700 P900 B010 B020 PDD1 PDE2 PDH4 PDK5 Media Grade EKSP EKMP SEK1P KS50P SUPRA 80P K100P K200P K250P K700P K900P BIO10 BIO20 PDD1 PDE2 PDH4 PDK5 Code Connection Options in. sanitary flange inlet and outlet 9 25 mm (1 in.) single barb hose barb inlet and outlet 19 (2) in. sanitary flange inlet and 25 mm (1 in.) single barb hose barb outlet 6 (2) 13 mm ( 1 2 in.) single barb hose barb ` inlet and outlet 7 (3) 1 4 in. hose barb inlet and outlet 16 (2) in. sanitary flange inlet and 13 mm ( 1 2 in.) single barb hose barb outlet 1H1 (4) 1H9 (4) in. sanitary flange inlet and out let with additional 1 2 in. sanitary port on inlet in. sanitary flange inlet and in. single barb hose barb outlet, with additional 1 2 in. sanitary port on inlet 11

12 AllegroSystems The Single-Use Solution Visit us on the Web at us at United States toll free (USA) phone fax Europe +44 (0) phone +44 (0) fax 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, GN USD 2463b