Sartorius Biotechnology FilterCartridges

1 Sartorius BiotechnologyFilter CartridgesSartorius filter products designed for the pharmaceutical industryAt Sartorius , we don t just sell you a work with experienced Sartoriusfiltration engineers, scientists and sales repre-sentatives who first gain a thorough under-standing of your filtration needs. Only thendo we offer a specific filtration system rec-ommendation based on an understanding ofyour production process. More than 60 yearsof expertise in filtration technology andsupport of applications from laboratorybench scale to full manufacturing scale standbehind our ongoing support, our sales representativesand customer service organization are avail-able worldwide. With two manufacturingsites and fully stocked facilities worldwide, weare ready to respond to your product require-ments at all times. We help you maintainproductive and efficient use of your filtrationproducts with a full range of support servicesand filtration specialists offer a complete range of filtration prod-ucts from prefiltration depth filters to finalsterilizing membrane filters in products rang-ing from flat filter discs to capsules, up tostandard filter cartridges and designed for all process scales,whether laboratory, pilot plant or full produc-tion, are available to match the requirementsof your cartridges are available as.

2 Depth prefilters Membrane prefilters Final membrane filtersDepth PrefiltersSartorius polypropylene depth filters protectdownstream membrane filters economically,are highly effective at cell removal and arethe most inert depth filters glass fiber depth filters add thepower of adsorptive retention to thepolypropylene filters physical force interaction between colloidalparticles and the glass fibers results in reten-tion of particles smaller than the rating,making Sartorius glass fiber filters very effec-tive for clean-up of biological filter cartridges containing glassfiber layers always include a downstreampolypropylene layer or membrane to preventthe shedding of fibers into the PrefiltersBiological solutions can contain heavy loadsof submicron particles which can quickly plug m and smaller membrane filters.

3 A prefilter cartridge, that combines layers ofdepth and membrane filters can more thandouble the throughput of downstream steril-izing grade filters, making the entire processmore economical. The proper selection of prefilters, whetherdepth filters or membrane prefilters, willresult in lower filtration costs and improvedoverall performance of the final filters. Thiscan result in the uninterrupted filtration of complete batches without the need foroversized filter systems or costly change-outsduring Membrane FiltersThe highly uniform, porous structure of thesesterilizing grade membrane filters provideshighly effective filtration by retaining parti-cles and bacteria absolutely, with 100%retention. The Sartorius product range of sterilizinggrade filter elements for liquids consists of 3 different types of hydrophilic membranefilters (Sartobran P, sartopore 2, Sartolon)ideally suited for specific applications in thepharmaceutical with SartoriusOur entire range of Sartobran P filters, forexample, is made of the same membranes andmaterials of construction from the smallestelement, our Sartobran 150 with 150cm2 ft2filtration area to capsules withup to m2(5 ft2) filter area, all the way toour standard filter cartridge systems andMaxiCaps with up to m2(18 ft2) filter product selection gives you the opportu-nity to easily scale-up from R&D laboratorystages to pilot plant and production process-es.

4 Sartorius philosophy of scaling up allowsyou to adapt the filter element size to meetyour changing production needs and optimizeyour process by maximizing flow rates a New Industrial StandardWith our new Plant 2001 productionfacilities, we intend to set a new qualitystandard for Biotechnology products. That iswhy we used the top standards of ourcustomers in the pharmaceutical industry as guidance in designing our personnel and materials flowmanagement assures the highest productquality and process 9001 Certifiecl QualitySartorius is certified to meet ISO 9001 stan-dards. This covers our entire organization andensures the highest of standards to providefor a quality management system rangingfrom R&D to production, warehousing, mate-rials management and customer service. Our manufacturing facilities all operate inconformance to cGMP requirements, in addi-tion to the ISO 9001 philosophy on quality ensures thatour customers receive products and servicewhich meet the strictest quality controls andregulatory Sartorius filter cartridges conform totesting protocols outlined in our ValidationGuides, as well as other in-house qualityassurance tests.

5 Total quality of the filter isassured from raw materials through finalproducts, with complete in-process controltesting along the way. Our sterilizing gradefilter cartridges are 100% factory pre-testedprior to release to assure the highest level of security and Our Manufacturing SitesAt Sartorius , our filters are manufactured atfacilities that meet the stringent needs of thepharmaceutical industry. All of the Sartoriusfacilities worldwide are audited on a regularbasis and are accessible for you to GuidesSartorius filter cartridges are supplied with aquality assurance certification to assist in thevalidation of your manufacturing product-specific validationpackages are available for all Sartorius filterelements. All Validation Guides for prefiltercartridges and sterilizing membrane car-tridges contain the following information: Technical specifications for the filters Biological Safety Testing, including theUSP24 Class Vl Plastics Test Extractable testing Filtrate analysis according to USP24 Chemical compatibility informationThese results are included in the SartoriusDrug Master File DMF 5967 at the Foodand Drug Administration (FDA).

6 Process ValidationIn order to validate the filtration products for your process, Sartorius offers a wide rangeof validation support services. Sartorius hasassisted pharmaceutical manufacturers invalidating their products and fulfilling therequirements for process validation relatingto the use of filtration products. The use ofthese support services is growing as regulato-ry requirements and Technical SupportWhether you have a technical questionregarding the specifications of our filterproducts or require assistance in filter selec-tion, our Applications Department is availableto offer you assistance. We can performfilterability testing to properly select andoptimize your filtration process, both in ourlaboratories or at your facility. Filtrationprocess audits can also be performed toassure the maximum performance of yourfiltration SeminarsSartorius offers a comprehensive trainingprogram for filter users.

7 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 train-ing and continued education of personnel in your more information or immediateassistance, contact your local PSartopore 2 Sartolon Sterilizing grade pharma-ceutical filter cartridge for lowunspecific adsorptionApplications Sterile filtration of parenteralsolutions Sterile filtration of vaccines,biologicals and antibiotics Sterile filtration of serum andplasma fractions Sterile filtration of tissueculture media, diagnosticreagents, therapeutic agents,preparations containingproteins, vitamins andpreservatives Substerile filtration ( m)Cartridge Construction Protective polypropylene layer Reinforced cellulose acetatemembrane Reinforced cellulose acetatemembrane Polypropylene drainage layer Polypropylene outer cage, core and end caps Silicone O-rings standard optional EPDM, VitonAvailable Pore + + + mAdapter Types21, 25, 27, 28 Filtration m2(6 ft2) per 10 elementBasic Order grade pharma-ceutical filter cartridge withbroad chemical compatibilityApplications Sterile filtration of parenteralsolutions with high or low pH Sterile filtration of highly vis-cous products, opthlamics Sterile filtration ofdisinfectants Sterile filtration of buffers and media Mycoplasma removal fromserum and cell cuture media( m) Substerile filtration forenhanced sterility assurance( m)

8 Cartridge Construction Protective polypropylene layer Asymmetric polyethersulfonemembrane Asymmetric polyethersulfonemembrane Polypropylene drainage layer Polypropylene outer cage, core and end caps Silicone O-rings standard optional EPDM, VitonAvailable Pore + + + mAdapter Types21, 25, 27, 28 Filtration m2(6 ft2) per 10 elementBasic Order grade pharma-ceutical filter cartridge withreinforced Nylon membrane for broad solvent compatibilityApplications Sterile filtration of solvents Sterile filtration of antibiotics Sterile filtration of parenteralsolutions Sterile filtration of bulkpharmaceuticalsCartridge Construction Protective polypropylene layer Reinforced Nylon membrane Nylon membrane Polypropylene drainage layer Polypropylene outer cage, core and end caps Silicone O-rings standard optional EPDM, VitonAvailable Pore + mAdapter Types21, 25, 27, 28 Filtration m2(6 ft2)

9 Per 10 elementBasic Order GA|LGSartoclean CASartoclean GFPharmaceutical gradehydrophobic PTFE membranefilter cartridgeApplications Sterile venting of tanks Sterile air filtration for fillingequipment Fermentation air filtration Sterile filtration of gases Bioreactor inlet and outletstreams Sterile filtration of aggressivemedia and solvents (LG)Cartridge Construction Protective polypropylene layer PTFE membrane filter Polypropylene drainage layer Polypropylene outer cage, core and end caps Silicone O-rings standard optional EPDM, VitonAvailable Pore m (GA) | m (LG) m (GA) | m (LG) m (LG)Adapter Type25 (GA)25, 28 (LG)Filtration m2( ft2) per 10 element (GA) m2(5 ft2) per 10 element (LG)Basic Order grademembrane prefilter cartridgeApplications Prefiltration of parenteralsolutions Prefiltration of serum andplasma Biological products andvaccines Prefiltration of cell culturemedia Fermentation feed solutions Cell removal from fermentationprocesses Clarification prior to columnchromatography Particle removal in watersystemsCartridge Construction Protective polypropylene layer Reinforced cellulose acetatemembrane(s) Polypropylene drainage layer Polypropylene outer cage, core and end caps Silicone O-rings standard optional EPDM, VitonAvailable Pore Sizes3 + m (double layer) + m (double layer) m (single layer) m (single layer)Adapter Types21, 25, 27, 28 Filtration m2( ft2)

10 Per 10 elementBasic Order cartridge for pharma-ceutical liquids containingcolloids and high bioburdensApplications Prefiltration of serum andplasma fractions Prefiltration of biologicalproducts and vaccines Prefiltration of cell culturemedia Cell removal from fermentationprocesses Clarification prior to columnchromatographyCartridge Construction Protective polypropylene layer Non-woven glass fiber material Reinforced cellulose acetatemembrane Reinforced cellulose acetatemembrane Polypropylene drainage layer Polypropylene outer cage, core and end caps Silicone O-rings, standard optional: EPDM, VitonAvailable Pore SizeCombinations3 + + mAdapter Types21, 25, 27, 28 Filtration m2(6 ft2) per 10 elementBasic Order PP2 Sartopure GF2 Sartofine PPParticle removingpolypropylene depth filter cartridgeApplications Prefiltration of parenteralsolutions Particle removal from DI water systems Particle removal from chemicalsand solvents Particle removal from air andcompressed gases Prefiltration of biologicalsolutionsCartridge Construction Protective polypropylene layer Multiple polypropylene layerswith progressively finerretention ratings Polypropylene drainage layer Polypropylene outer cage, core and end caps Silicone O-rings, standard optional.