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SCHOTT VialsPerfection in Every Detail

2SCHOTT is a leading international technology group in the areas ofspecialty glass and glass-ceramics. With more than 130 years of outstanding development, materials and technology expertise we offer abroad portfolio of high-quality products and intelligent solutions thatcontribute to our customers’ success.SCHOTT Pharmaceutical Systems is one of the world’s leading suppliersof primary packaging and specialized analytical lab services for thepharmaceutical industry. We provide our customers quality solutionswhile meeting their highest demands with our expertise and broadproduct portfolio; including ampoules, cartridges, vials and syringesmade of glass and COC polymer. Our state-of-the-art productionfacilities and our products comply with the highest international qualitystandards for pharmaceutical needs.

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4SCHOTT Vials – Perfection in Every DetailOur mission at SCHOTT is to convert decades of pharmaceuticalresearch and investment into sustainable success. Working closelytogether with you, our team of forward-thinking professionals –spanning from R&D to sales – is dedicated to developing, producingand delivering vials that are detailed to perfection. By achieving

5extremely tight dimensions and excellent surface quality, we enableyour product to enjoy a notably reliable shelf life.So, tell us – What’s your next milestone?

6Contents8 – 9 FIOLAX – Improved Process Stability through Superior Dimensional Quality10 – 11 SCHOTT Vials – Perfection in Every Detail12 – 13 SCHOTT Vials – From Standardized to Customized Quality Options14 – 15 SCHOTT TopLine Options for Superior Shelf Life16 – 17 SCHOTT TopLine Options for Enhanced Processing

718 – 19 adaptiQ : The Future Fast Forward20 – 21 Our Manufacturing Process – A Clear Commitment to Quality22 – 23 Compliance with International Norms: Quality that Exceeds Standard Expectations24 – 25 SCHOTT – Your Partner throughout the Drug Life Cycle26 – 27 SCHOTT – Global Player. Local Partner.

8FIOLAX – Improved Process Stability throughSuperior Dimensional QualityFIOLAX – The first choice for pharmaceutical packagingGlass has numerous advantages over other primary packagingmaterials available on the market. Otto Schott, founder ofthe present-day SCHOTT AG, was far ahead of his time whenhe introduced FIOLAX tubing in 1911 for pharmaceuticalpackaging. Since then, FIOLAX has been synonymous withpremium quality glass of the first hydrolytic class.This unique product is renowned for its outstandingchemical resistance, neutrality and impermeability, not tomention its exceptional strength. Containers fromFIOLAX are geared to storing and delivering a wide rangeof injectable, as well as sensitive biotech drugs. Today,FIOLAX is still a key base component for top-of-the-rangepharmaceutical packaging containers such as SCHOTTVials DC, SCHOTT Type I plus , etc.

9FIOLAX and SCHOTT Vials – The perfect match forimproved fill finish processing Tight geometric tolerances Reduced glass particles, airlines, inclusions and scratchesfor improved camera inspection

10SCHOTT Vials – Perfection in Every DetailWith the ever-evolving significance of biotech drugs and cost sensitivity in the healthcaresector, drug delivery systems find themselves contending with increased requirements from amarket shift towards tighter regulations. Our most accurate production and gentle vialhandling to date facilitates tight dimensions and premium surface quality that reliably ensuresyour product’s shelf life.Outstanding processability Tight geometric tolerances due to 100 % camera inspectionfor tubing and containers Low cosmetic defect level owing to cosmetic defectdetection during tube drawing and avoidance of glassto-glass contact during container forming Lyo bottom forming and blowback geometry uponrequestReliable product shelf life High hydrolytic resistance of tubing and container Smooth converting process thanks to in-house processdevelopment

11d2ad3d4h3r1No Blowbackh1h2European Blowbacks1tAmerican Blowbackr2s2d1Sizedesignation 1h2h3r1r2s1s2tMassmmmmmmmmmmmmmmmmg min.max. 2.51.5mmmmmmTol 0.2–0.3max. 0.2 32.530R37.550R62 42.540 0.473100R123 73.547 0.5100116 0.51.2 1 0.2241.5302245324516.520 1.535402212.6 0.25 0.526314530604555356517.5min. 0.77588.5 0.53.5Tol4.40.61 0.045.70.7297.98.79.5412.00.716.24555 0.75Tol5.5102.51.2 0.051 0.7518.921.9496756.541.51.7 0.070.91.534.560

12SCHOTT Vials – From Standardized to CustomizedQuality OptionsA broad range of container geometries, quality levels and controlled surface chemistry enableus to tailor the primary packaging solution to your specific needs. All SCHOTT Vials are manufactured and packed in environmentally controlled areas certified by ISO 9001 and ISO 15378and comply with PH.Eur., USP and JP international standards.StandardLine – Standardized quality level according to ISOThe StandardLine includes: Production in cGMP environment Statistical in-process control Available blowback geometries: NBB, EBB and ABB Dimensional and cosmetic AQL levels according to ISO 100% camera inspection of dimensional parameters and critical cosmetic defectsBulkStandardLineLiquidCrimp neckSizes 1 – 30 mlDrug TypeInjectables1 Crimp neck1Screw neckSolidFlip cap2Sizes 2 – 100 mlDiagnosticSizes 1 – 30 ml2 Double chamberSizes 1, 2, 4, 8, 10 mlLyophilizedSizes 10 – 50 mlNon-InjectablesSCHOTT crimp and screw neck vials are made of SCHOTT FIOLAX or BORO-8330 . SCHOTT flip cap vials are made of ILLAX .

13TopLine – Customized product specifications and quality levelsThe TopLine options include: Production in cGMP environment Statistical in-process control Available blowback geometries: NBB, EBB and ABB Customized dimensional and cosmetic AQL levels Specific lyo-geometries 100 % camera inspection of dimensional and cosmeticparameters Advanced glass surface treatment e. g. functional coatingsand delamination controlled-surfaces Available as sterile and nested packaging configurationsSterileTopLineTopLine1 Crimp neckCrimp neckadaptiQ Sizes 2 – 30 ml34Sizes 2 – 10 ml3Sizes 2 – 100 ml2Sizes 1, 2, 4, 8, 10 ml,custom(lyo bottom)2 Double chamber3 SCHOTT Type I plus (lyo bottom)4 SCHOTT TopLyo 1(lyo bottom)Sizes 2 – 100 ml1 Crimp neckCrimp neck(lyo bottom)adaptiQ Sizes 2 – 30 ml2Sizes 2 – 100 ml1Sizes 2 – 10 ml3 SCHOTT Type I plus Sizes 2 – 100 ml2 SCHOTT Vials DC

14SCHOTT TopLine Options for Superior Shelf LifeSCHOTT Vials DC (Delamination Controlled)Glass delamination resulting in barely visible glass flakes has led to recalls of numerous injectabledrug products over the past few years. In order to prioritize patient safety, the FDA has reactedto this phenomenon by emphazising the importance of container/drug compatibility testingin line with USP 1660.SCHOTT Vials DC – An optimized manufacturingprocess combined with quantitative laboratorytest procedures on delamination resistance hasproven to significantly reduce the risk of glassdelamination.Properties: Chemically homogeneous inner surface thanks tocutting-edge hot forming technology SCHOTT patented Quicktest to verify the reduceddelamination risk of each production batch usinga predefined quantitative limit value Reproducibly improved chemical stability ofcontainer’s inner surfaceBenefits: Significantly reduced delamination risk Applicable to all products already registered – henceno re-registration required SCHOTT Delamination Quickest-related batch certificate All manufacturing-related risk factors for delaminationare covered by one single limit value No delamination observed within accelerated screeningstudy according USP 1660 with model buffer systemsSizes:2R, 4R, 6R, 8R, 10R and 20R ISO formats using FIOLAX Type I glass. Customization available on request.SodiumOxygenBoronAluminiumSilicium

15SCHOTT Type I plus – Reduced Drug Container InteractionProtein adsorption and leaching from primary packaging are known to be root causes ofreduced shelf life in sensitive formulations. Metal ion leaching from type I glass leads to apH shift in water for injectable or unbuffered solutions and can decrease stability or activityof biopharmaceuticals.SCHOTT Type I plus vials have an inside SiO2 coating withoutstanding barrier properties. This reduces the interactionbetween drug product and container surface to a bareminimum, thereby providing a superior packaging solutionfor sensitive ingredients.Properties: Chemically uniform: pure silica (SiO2 coating) Layer thickness: 100 – 200 nm Non-porous, covalent bond between glass matrix andcoating layer Fill finish processability equivalent to uncoatedtype I glass containers Verified barrier owing to a predefined quantitative limitvalue of 0,17 µg/ml Na for all vial sizesBenefits: Increased shelf life stability for sensitive drug formulations Minimized adsorption of proteins in liquid formulations –also prior to lyophilization Minimized adsorption of radioactive moleculesSizes:2R, 4R, 6R, 8R, 10R, 15R, 20R, 25R, 30R, 50R and 100R ISOformats. Customization available on request.Protection of formulation and API against glasscomponents (ions, metals etc.)SiO2 coatingProtection of glass matrix against attacks causedby formulation and the buffer SiO2

16SCHOTT TopLine Options for Enhanced ProcessingSCHOTT TopLyo – Efficient LyophilizationDue to a need to accelerate time-to-market cycles and increase shelf life stability of biopharmaceuticals, a keen interest in robust and cost-efficient lyophilization has leapt into the limelight.A streamlined lyo cake is crucial for better-automated inspectability – and indeed fundamentallyvital to the chief priority of ensuring patient safety.Thanks to their hydrophobic coating SCHOTT TopLyo vialsdemonstrate less fogging during and less disruption of thelyocake after the lyophilization process, in addition toreduced residual volumes and higher dosing accuracy afterreconstitution.Properties: Chemically uniform (Si-O-C-H hydrophobic coating) Layer thickness: 40 nm Non-porous, covalent bond between glass matrix andcoating layer Processability equal to non-coated type I glass vialsBenefits: Cost reduction due to decreased overfilling – given lowerresidual volume Prevention of lyo cake disruption and sidewall fogging forimproved automated inspection Lyo cake stability during transportation Reduced protein aggregation compared to siliconized vialsSizes:2R, 6R, 8R, 10R, 15R, 20R and 50R ISO formats.Customization including lyo bottom available on request.

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18adaptiQ : The Future Fast ForwardWith adaptiQ ready-to-use vials you will be accessing a new era of cutting edge manufacturing.You will gain more freedom with a leaner process, improved quality and more flexibility.Developed in cooperation with innovative and highly regarded machine suppliers, adaptiQ vials can be processed on a wide range of existing and new fill finish equipment, allowingthe vials to remain nested throughout the fill finish process including lyophilization.