Mini filter cartridges and capsules for the ...

1 mini filter cartridges and capsulesfor the biopharmaceuticalindustrySartorius filter products designed for the pharmaceutical industryAt Sartorius, we don t just sell you a work with experienced Sartorius filtrationengineers, scientists and sales representativeswho first gain a thorough understanding ofyour filtration needs. Only then do we offer aspecific filtration system recommendation,based on an understanding of your productionprocess. More than 60 years of expertise in filtration technology and support of applica-tions, from laboratory bench scale to full manufacturing scale, stand behind our recom-mendations. For ongoing support, our salesrepresentatives and customer service organi-zation are available worldwide. With multiplemanufacturing sites and fully stocked facilitiesworldwide, we are ready to respond to yourproduct requirements at all times.

2 We helpyou maintain productive and efficient use ofyour filtration products with a full range ofsupport services, such as our ConfidenceSMValidation Service Program and filtrationspecialists who provide global offer a complete range of filtration prod-ucts from prefiltration with depth filters tofinal sterilizing membrane filters, in productsranging from flat filter discs to capsules to standard filter designed for all process scales,whether laboratory, pilot plant or full production, are available to match therequirements of your prefilters:Sartorius polypropylene depth filters protectdownstream membrane filters economically,are highly effective at cell removal and arethe most inert depth filters available. Sartoriusglass fiber depth filters add the power of adsorptive retention to the polypropylene filters physical retention.

3 Molecular forceinteraction between colloidal particles and theglass fibers results in retention of particlessmaller than the rating, making Sartorius glassfiber filters very effective for clean-up of biological solutions. Sartorius filter elementscontaining glass fiber layers always include adownstream polypropylene layer or membraneto prevent fibers from shedding into theprocess solutions can contain heavy loadsof submicron particles which can quickly m and smaller membrane prefilter element which combines layers ofdepth and membrane filters can more thandouble the throughput of downstream sterilizing-grade filters, making the entireprocess more proper selection of prefilters, whetherdepth prefilters or membrane prefilters, willresult in lower filtration costs with improvedoverall performance of the final filters.

4 Thiscan result in the uninterrupted filtration ofcomplete batches without the need for over-sized filter systems or costly change-outs during sterilizing grade highly uniform, porous structure of thesesterilizing grade membrane filters providehighly effective filtration by retaining particles and bacteria absolutely, with 100 %retention. The Sartorius product range of sterilizing grade filter elements for liquidsconsists of 3 different types of hydrophilicmembrane filters (Sartobran P, sartopore 2,Sartolon) ideally suited for specific applica-tions in the pharmaceutical industry. Scale-up with entire range of Sartobran P filter cartridges , for example, is made with thesame membranes and materials of constructionfrom the smallest element, our Sartobran 150,to capsules with a m2( ft2) to m2(5 ft2) filter area, all the way to ourstandard filter cartridge systems and MaxiCaps with up to m2(18 ft2) filter area.

5 This product selection gives you the oppor-tunity to easily scale-up from R&D laboratorystages to pilot plant and production processes. Sartorius philosophy of scaling up allows you to adapt the filter element size to meet yourchanging production needs and optimize yourprocess by maximizing flow rates 9001 certified is certified to meet the strictest ofthe IS Ostandards IS O 9001. This covers ourentire organization and ensures the highest ofstandards to provide for a quality managementsystem ranging from R&D to production, ware-housing, materials management and customerservice. Our manufacturing facilities all operate in conformance with cGMP require-ments, in addition to the ISO 9001 philosophy on quality ensures thatour customers receive products and serviceswhich meet the strictest quality controls and regulatory requirements.

6 All Sartorius filtercartridges conform to testing protocols out-lined in our Validation Guides as well as other in-house quality assurance tests. Total qualityof the filter is assured from raw materialsthrough final products, with complete in-process control testing along the way. Oursterilizing grade filter elements are 100 %factory pre-tested prior to release to assurethe highest level of security and quality. Additionally, Sartorius filter capsules are certified as medical devices according to93/42/21 EEC and labeled with a CE our manufacturing Sartorius, our filters are manufactured atfacilities that meet the stringent needs of thepharmaceutical industry. All Sartorius facilitiesworldwide are audited on a regular basisandare available for you to audit.

7 Sartorius Validation filter cartridges are supplied with aquality assurance certificate to assist you inthe validation of your manufacturing product specific validationpackages are available for all Sartorius Validation Guides for prefilter cartridges or sterilizing membrane filter cartridges contain the following information: Technical specifications for the filters Biological Safety Testing, including the current USP Class VI Plastics Test Extractable testing Filtrates analysis according to the current USP Chemical compatibility informationThese results are included in the SartoriusDrug Master File DMF 5967 at the Foodand Drug Administration (FDA).Process validate the filtration products for yourprocess, Sartorius offers a wide range of vali-dation support services.

8 Sartorius has assistedpharmaceutical manufacturers in validatingtheir products and fulfilling the requirementsfor process validation relating to the use offiltration products. Utilization of these support services is growing as regulatoryrequirements and technical you have a technical questionregarding the specifications of our filter products or require assistance in filter selec-tion, our Applications Department is availableto offer you assistance. We can perform filter -ability testing to properly select and optimizeyour filtration process, both in our laboratoriesor at your facilities. Filtration process auditscan also be performed to assure the maximumperformance of your filtration offers a comprehensive trainingprogram for filter users.

9 This seminar seriescovers topics including: General Filtration Theory Integrity Testing Crossflow Filtration and Technology Process Design Validation of Filtration SystemsThese are available at your site for the training and continued education of personnelin your more information or immediate assistance,contact your local Sartorius PSartopore 2 Sartolon ApplicationsReliable and validated retention of microorganisms and particles by fractionated membrane filtration using low adsorption ConstructionProtective polypropylene layerReinforced cellulose acetate membrane Reinforced cellulose acetatemembrane Polypropylene drainage layerMaterialCapsule housing, outer support,core and end caps: polypropyleneMini cartridge O-ringsStandard:SiliconeOptional: EPDM, VitonAvailable Pore Size + + + mCapsule Connectors(Inlet|Outlet)SS = 11" Tri-Clamp (Sanitary)OO =hose barbConstruction Codes mini cartridges : 15; 18 capsules : 13 Filtration ; ; ; ; ; m2| ; ; ; 1; 2.

10 5 ft2 Basic Order and validated retention of microorganisms and particles by fractionated membrane filtra-tion over the entire pH ConstructionProtective polypropylene layerPolyethersulfone membrane Polyethersulfone membrane Polypropylene drainage layerMaterialCapsule housing, outer support,core and end caps: polypropyleneMini cartridge O-ringsStandard:SiliconeOptional: EPDM, VitonAvailable Pore Size + + + mCapsule Connectors(Inlet|Outlet)SS = 11" Tri-Clamp (Sanitary)OO =hose barbConstruction Codes mini cartridges : 15; 18 capsules : 13 Filtration ; ; ; ; ; m2| ; ; ; 1; 2; 5 ft2 Basic Order and validated retention of microorganisms and particles by fractionated membrane filtration with broad ConstructionProtective polypropylene layerReinforced nylon membraneNylon membrane Polypropylene drainage layerMaterialCapsule housing, outer support,core and end caps: polypropyleneMini cartridge O-ringsStandard:SiliconeOptional: EPDM, VitonAvailable Pore Size + mCapsule Connectors(Inlet|Outlet)SS = 11" Tri-Clamp (Sanitary)OO =hose barbConstruction Codes mini cartridges : 15 capsules : 13 Filtration m2|2 ft2 Basic Order Sartoclean CASartoclean GFApplicationsRetention of particles and microorganisms by membrane filtration.