SCHOTT vials made of glass
Transcription
SCHOTT vials made of glass
SCHOTT vials made of glass Folder_vials.indd 3 22.09.09 19:18 A full range of vials Expert solutions from SCHOTT forma vitrum: Trust our experience !BROADVARIETYOFVIALSFROMMLTOMLWITHDIFFERENTNECKFINISH DESIGNSWITHORWITHOUTBLOWBACKMEETANYNEEDYOUMAYHAVE For special requirements, we also offer inside-coated vials such as 3#(/444YPE)PLUS®FORIMPROVEDCHEMICALSTABILITYANDINERTNESS as well as SCHOTT TopLyo™ for optimum efficiency of the LYOPHILISATIONPROCESSSEESEPARATEBROCHURE s )NJECTIONVIALS Folder_vials.indd 4 s 3CREWNECKVIALS s 4ABLETVIALS s $UALCHAMBERiMIXERwVIALS s 0ERFUMESAMPLEVIALS 22.09.09 19:19 Three quality options to choose from High quality from standard level up to tailor-made solutions for the highest requirements. Tailor-made solutions for the highest requirements TopLine products are individually designed to meet advanced TopLine product requirements according to customer specifications – ENABLINGYOUTOALWAYSSTAYONESTEPAHEAD Advanced product solutions for superior demands SCHOTT forma vitrum exclusive forming technology and ClearLine 100% dimensional and cosmetic inspection ensure excellent production performance on your filling lines. High quality complying with international standards StandardLine 3#(/44FORMAVITRUM3TANDARD,INEISOURWELLESTABLISHED high-level quality that complies with international standards. Continuous research and development ensures that our product portfolio meets and exceeds the demands of today‘s and tomorrow‘s market place. Consistent high quality through state-of-the-art production equipment Folder_vials.indd 5 22.09.09 19:19 ClearLine – Advanced product solutions for superior demands ClearLineBY3#(/44FORMAVITRUMOFFERSSAFEPACKAGINGOFYOURVALUABLE drugs and an excellent production performance on your filling and packing lines. ClearLine produCTSOFFERTHEFOLLOWINGBENEFITS s i:ERODEFECTwFORCRITICALASPECTS PPMDEFECTRATESFORSPECIFIEDPARAMETERSASPERSIXSIGMACONCEPT s INSPECTIONFORDIMENSIONALPARAMETERSANDCOSMETICDEFECTS OPTOELECTRONICVISIONSYSTEM s /PTIMIZEDQUALITYSTANDARD !1,SMORERIGIDTHANINTERNATIONALINDUSTRYSTANDARDS s 0ROCESSCAPABILITYFORIMPORTANTDIMENSIONSCPK s 0ACKINGUNDERCLEARROOMCONDITIONS 4HESEBENEFITSENABLE s (IGHPRODUCTIVITY s 3UPERIORCOSMETICQUALITYFORTHEMOSTDEMANDINGMARKETS s ,ESSQUALITYISSUESANDREJECTCOST s !CCEPTANCEBYTHEREGULATORYAGENCIES #LEAR,INEBY3#(/44FORMAVITRUMISMEETINGANDEXCEEDINGTHEINCREASED REQUIREMENTSSETBYREGULATORYAGENCIESANDTHEINDUSTRYANDISRECOMMENded for superior quality requirements. Advanced glass forming technology at SCHOTT forma vitrum Folder_vials.indd 6 22.09.09 19:19 TopLine – Tailor-made solutions for the highest requirements TopLine BY3#(/44FORMAVITRUMOFFERSINDIVIDUALLYDESIGNEDPRODUCTSOLUtions for the highest quality requirements. TopLine products are developed in CLOSECOOPERATIONWITHTHEPHARMACEUTICALCOMPANYTOSUBSTANTIALLYREDUCE OVERALLCOSTBYOPTIMIZINGINCOMINGINSPECTIONANDPRODUCTIONPERFORMANCE 4OP,INEPRODUCTSOFFERTHEFOLLOWINGBENEFITS s i:ERODEFECTwFORCRITICALASPECTS PPMDEFECTRATESFORSPECIFIEDPARAMETERSASPERSIXSIGMACONCEPT s !LLCRITERIAINSPECTIONFORDIMENSIONALPARAMETERS ANDCOSMETICDEFECTSOPTOELECTRONICVISIONSYSTEM TopLine guarantees «zero defect» for critical aspects s 3TRONGLYOPTIMIZEDQUALITYSTANDARDSIXSIGMAPROGRAM s #OMPLIANCEWITHCUSTOMERDEFINEDSPECIFICATIONSWITHNARROWEDTOLERANCE for dimensional and cosmetic aspects s 0ACKINGUNDERCLEARROOMCONDITIONS s #ERTIFIEDDELIVERIES 100% reliable quality control is supported by detailed, real-time process feedback from highly advanced, proprietary visual inspection technology 4HESEBENEFITSENABLE s 4AILORMADEPACKAGINGSOLUTIONSFORSPECIFICPRODUCTREQUIREMENTS Partnership for quality improvement programs s %XCELLENTDIMENSIONALANDCOSMETICCHARACTERISTICS s 2EDUCTIONOFINCOMINGINSPECTIONACCEPTANCEONPROTOCOL s 0ROCESSIMPROVEMENTSFORMOREEFFICIENTFILLINGANDPACKINGOPERATIONS )NCLOSECOORDINATIONWITHTHE s -EASURABLEVALUEADDDUETOLESSQUALITYISSUESDURINGANDAFTERTHE customer, TopLine products are PRODUCTIONPROCESSLESSGLASSBREAKAGELESSPRODUCTIONDOWNTIMES STEPBYSTEPTAILOREDTOTHEPRODUCT LESSREJECTS requirements and the production environment of the customer. 4OP,INEPRODUCTSAREESPECIALLYRECOMMENDEDFORTHESTORAGEOFVALUABLE ANDHIGHLYSENSITIVEDRUGSEGDRUGSOFBIOTECHNICALORIGINANDFORTHE optimization of the production performance. Folder_vials.indd 7 22.09.09 19:19 Special expertise Glass -ORETHANYEARSOFEXPERIENCE in glass technology and manufacturing guarantees the superior quality of 3#(/44GLASSTUBING3#(/44&IOLAX® GLASSTUBESAREMADEOFHIGHLYRESISTANT BOROSILICATE4YPE)GLASSOFTHEHIGHEST HYDROLYTICRESISTANCE%XCELLENTBARRIER properties, high chemical resistance, and excellent cosmetic properties as well as tight geometric tolerances in diameter and thickness are the starting point for manufacturing high quality containers with an excellent performance on the FILLINGLINES3#(/44GLASSTUBESMEET '-0REQUIREMENTS Premium quality glass tubing from SCHOTT is the starting point for a perfect pharmaceutical container. !UTOMATED)NSPECTION 3YSTEM!)3 !)3ENABLESTHEHIGHLYSENSITIVEAND RELIABLECLASSIFICATIONOFDEFECTSBYTYPE size and even the position of the defect on the container. The state-of-the-art visual inspection technology was deveLOPEDBY3#(/44FORMAVITRUM )TPROVIDESACCURATECOSMETIC inspection for vials and pen cartridges including containers up to 50 ml and special sizes and shapes. All key surfaces of the container are inspected, including internal neck and collar, seal face, shoulDERBODYHEELANDBOTTOM$EFECTS such as scratches, cracks, micro cracks, CHIPSBLACKSPOTSTOOLINGMARKSDEFORmations, airlines, and particles are automatically classified. !)3ISCOMPLETELYINTEGRATEDINTHEPRODUCTIONPROCESS4HESENSITIVITYOF!)3 CANBEADJUSTEDTOINDIVIDUALCUSTOMER requirements for TopLine products. AIS identifies and differentiates smallest defects by type, size, and position on the container Folder_vials.indd 8 22.09.09 19:19 Production technology meets top standards C'-0RULESARETHEGUIDELINESFORTHEMANUFACTURINGOFHIGHQUALITYPRODUCTS on our modern and technologically advanced production lines. 1 Precise forming technology leads to high Cpk values for dimensional parameters. 2 Inspection for forming defects during production. 3 Dimensional camera inspection with precise accuracy. 4 No more damage and contamination due to extremely smooth transportation. Careful handling of the annealed glass bodies is performed by soft vacuum «fingers». 5 6 The automated visual inspection system, AIS, detects and determines even the slightest defects on the overall surface. The AIS is absolutely reliable and the failure rejection mechanism meets current GMP standards. 7 TopLine and ClearLine products are packed in clear rooms and protected packaging zones respectively. Specially designed packing robots place the product into Akylux® or Biblex® boxes. 2 1 Dimensional inspection 1 4 5 Annealing lehr Production area 6 Visual surface inspection 7 Packaging / Inspection Clear room / Protected packaging zone Tu b e lo ad er Vial machine Background: Ergonomic design of production area to keep permanent high cleanliness level. Folder_vials.indd 9 22.09.09 19:20 Folder_vials.indd 2 10.09/printed in Switzerland Pharmaceutical Systems SCHOTT forma vitrum ag St. Josefen-Strasse 20 CH-9001 St. Gallen Switzerland Phone: +41 71 274 1600 Fax: +41 71 274 1616 [email protected] www.schott.com/pharmaceutical_systems 22.09.09 19:18
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