Gerresheimer - a leading global partner to the pharma and healthcare industry. Pharmtech Moscow November 2015 Bernd Zeiss, Manager Technical Support

Transcription

1 Gerresheimer - a leading global partner to the pharma and healthcare industry Pharmtech Moscow November 2015 Bernd Zeiss, Manager Technical Support

2 International Trends and Usage of Glass Prefilled Syringes - Gerresheimer RTF AGENDA 1. Gerresheimer as a Company 2. Prefilled Syringe market 3. Market Trends 4. Why to decide for Gerresheimer 5. Syringe and Cartridge Production in Bünde, Germany 6. Products and Quality 7. Development lab 8. Your questions 2

3 Gerresheimer 2014 A leading partner for the pharma & healthcare industry Revenues 2014: EUR 1,290.0 m International presence: Europe, Americas, Asia High quality customer base: Global blue chip customers Employees: about 11,000 Head office: Düsseldorf, Germany Listing: Frankfurt Stock Exchange Percentage of revenues by market segment 3

4 Global Player with strong regional footprint Europe USA Revenues 2014: EUR 1,290m Latin America Asia Regional footprint: More than 40 sites worldwide as of November 30, 2014 Established markets Pharmerging markets (IMS definition) Others 4

5 Our organization with 3 divisions Plastics & Devices Andreas Schütte Primary Packaging Glass Uwe Röhrhoff Life Science Research Rainer Beaujean 5

6 Management Board Uwe Röhrhoff (CEO) Rainer Beaujean (CFO) Andreas Schütte Primary Packaging Glass Division Life Science Research Division Plastics & Devices Division Strategy & Planning Communication & Marketing Human Resources Legal & Compliance Business Excellence & Continuous Improvement Finance Controlling Investor Relations & Creditor Relations Information Technology Internal Audit Mergers & Acquisitions Key Account Management 6

7 Gerresheimer Plastics & Devices Division: Medical Systems Medical Plastic Devices Pharmaceutical: inhalation, injection, pens, auto injectors Medical Technology: lancing devices, lancets, infusion sets, laboratory and molecular diagnostics, point-of-care testing, urology, surgery, dialysis and blood therapy Medical Systems Syringes/Cartridges Gx bulk syringes (glass) Gx RTF syringes (glass) Syringe components and accessories Gx pen cartridges ClearJect COP syringes Plastic Packaging Ophthalmic and rhinologic application systems Tablet containers, PET bottles Special closures 7

8 The Prefillable Syringe Market Some key figures Total PFS market 2015 ~ 3,0 Bil. pcs Markets by size: 1.Eu; 2. USA, 3. China CAGR 5,5 % Staked in needle syringes are 2/3 of the market

9 Market Trends in Prefillable Syringes Needle protection systems (injury prevention) Low particles Low tungsten Reduction of silicone oil COP syringes Biotech applications Anticoagulants Vaccines Cartridges Pen systems Autoinjectors 9

10 Addressing current and future needs in biotec, auto-injectors and home use High quality syringe - low cosmetic defects Tight barrel dimensions - low dosage adaption (bore, shoulder) - low residual volume - exact graduation Needle - shear forces/viscous drugs - high inner needle diameter - Needle protection systems (safety) Rubber parts - low L&E - low cosmetic defects - stoppering method - gliding force profiles Silicone oil - low amounts - baked-on Tungsten residuals - low - specified - tungsten free Glue residuals - Low - specified - distribution 11/30/

11 Production site Development and production of primary packaging made of glass and plastics

12 Gerresheimer Bünde GmbH: Facts and figures Foundation 1947 (Bünder Glas) Highly automated production running 7 days/24 hours Production area: 25,700 sqm (277,000 sqft), of that Clean room class C (acc. GMP): 700 sqm (7,550 sqft) Clean room class D (acc. GMP): 3,100 sqm (33,400 sqft) Machinery: > 55 production lines, of that 40 glass forming lines for syringe barrels, insulin cartridges and customized solutions 13 needle mounting lines 4 RTF lines Employees: about 800 Quality Management according to ISO 9001: 2008 EN ISO 13485: 2012 EN ISO 15378: 2011 DMF Type III 12

13 History Foundation of Bünder Glas Production of tablet tubes, ampoules and dental cartridges Bünder Glas becomes part of Gerresheimer 3 RTF lines operation Bulk prefillable syringe production RTF syringe production Additional RTF line 13

14 Production of glass syringes 1Glass barrel production, 2 needle assembly, 3 RTF processing, 4 sterilization

15 Production Our manufacturing process a clear commitment to high quality Glass barrel production and Needle assembly Glass cutting Barrel forming Printing Cannula Assembly 100 % in-process control (camera station for dimensions and cosmetic camera system) Quality control Needle assembly, clean room class D (acc. GMP) 15

16 G3 Vision Technology for 360 product inspection and strict process control 100 % vision inspection by in-house developed unique camera systems for dimensional and cosmetics aspects Vision inspection of the complete syringe barrel surface Cosmetic controls include differentiation between cracks and scratches, particles and air lines tight dimensions Finger flange Body Shoulder Cone Transition to the finger flange low reject rates at filling line high precision - fit into auto-injectors 16

17 Production Our manufacturing process a clear commitment to high quality RTF processing Clean room ISO class 7 acc. to class B under laminar flow 100 % in-process control Quality control Washing (WFI) Siliconization Closure setting Nesting/coding Packaging 17

18 Products Parenteral packaging for the pharmaceutical industry

19 Our products: Syringes and pen cartridges Glass syringes: ready-to-fill Pen cartridges Gx RTF Gx pen cartridges Fields of application: Glass syringes: bulk Gx bulk Washed, siliconized, preassembled and sterilized (ethylene oxide) Cartridges for insulin (glass type I) Vaccines Heparins Biotec drugs Other applications Pen cartridges: Insulin No RTF-treatment Customized solutions 20

20 Gx RTF syringes (ready-to-fill): Syringe formats Luer cone Luer lock Staked-in needle 0.5 ml 1.0 ml long 1.0 ml standard 1.5 ml 2.25 ml 3.0 ml Customized syringe formats on request 1.0 ml long 1.0 ml standard 1.5 ml 2.25 ml 3.0 ml 0.5 ml 1.0 ml long 1.0 ml standard 1.5 ml 2.25 ml 21

21 Baked-on siliconization of syringe barrels Counting of particles > 10 µm in prefilled syringes filled with WFI* Directly after filling (T0), only 7 % of particles are generated compared to standard spray siliconization After 3 months of storage (T1) particle generation remains low in baked-on RTF syringes (24 % of reference) Benefits over standard siliconization Minimize the risk of interaction between silicone oil particles and drug formulation Drastically reduced amount of subvisible silicone oil particles (less than 10%) Masking and inactivating the glass surface Long-lasting, chemical inert, evenly distributed lubricity coating Very even break loose and gliding force profile Provides optimal functionality and enhanced performance regarding silicone oil particle emittance over drug product shelf life Patented in Europe and USA 22

22 Components and accessories - Overview Closures Luer cone closure: Six Rip Tip Cap Luer lock closure: Tip Cap Gx TELC (Tamper Evident Luer lock Closure) Cannulas Cannulas in steel-quality according to AISI 304 in different Length (½, ⅝ ) Diameters (23G, 25G, 26G, 27G, 29G) Grindings (3 bevel, 3 bevel XL V bevel) Needle shields Flexible Needle Shields (FNS) Rigid Needle Shields (RNS) Proprietary Thermoplastic Elastomer Rigid Needle Shield (Gx TERNS ) Elastomer insert Contact surface to drug product Customized solutions 23

23 Components and accessories - Overview Gx plunger rods Plunger rods in different Sizes (0.5 ml, 1.0 ml long, 1.0 ml short, ml, 3.0 ml) Colors Materials (polypropylene, polystyrene, polycarbonate) Gx backstops Backstops in different Sizes (0.5 ml, 1.0 ml long, 1.0 ml short - 3,0 ml) Colors Plunger stoppers Plunger stoppers in different Sizes (0.5 ml, 1.0 ml long, 1.0 ml short 3.0 ml) Materials (pharmaceutical elastomers, fluorpolymer coatings as an option) Qualities: bulk, ready-to-sterilize, ready-to-use From different suppliers Customized solutions 24

24 Our quality standards 4 Our products comply with: Pharm. Eur., USP, JP ISO requirements for glass primary packaging materials Produced on own-engineered stateof-the-art glass forming and cannula assembly lines in accordance to cgmp Clean room production class B, C, D (acc. GMP) Continuous process improvement G3 camera system in barrel production 25

25 Our services Development Syringes

26 Development Laboratory: Syringe functionality Syringe handling Preparation equipment Syringe siliconization Syringe filling Vent tube setting Vacuum setting Testing machine for tensile and compression testing (Zwick Roell) Mounting/removal forces: tip cap, needle shield, backstop Breakage: finger flange, cone UV glue testing Climate Chamber (temperature, humidity) Siliconization analysis 27

27 Gerresheimer Syringe Functionality Study Syringe type Syringe type: 1 ml long / 1 ml short, all with staked-in needle Siliconization Siliconization: Spray (pure oil) / baked-on RTF (emulsion) Effect on break-loose and gliding force? Filling Stioppering Plunger Filling: Empty and filled [WFI] Stoppering: Vacuum and vent tube setting Plunger article from 2 manufacturers: diff. rubber formulations, designs, coated (and siliconized)/non-coated Time Time: T0, after 3, 6, 12, 24, 36 months, acc. aging at 3 months, 6 months 28

28 High quality cartridges

29 Our products Pen Cartridges Gx Cartridges Sizes from 1.5 to 3.0 ml, larger sizes up to 10.0 ml on request Visual inspection systems for 100 % dimensional control Designs according to DIN ISO ; customized formats on request Customized ceramic printing with heavy-metal-free inks Packaging options: PP-box, other options on request Suited to standard filling and packaging equipment Drug Master File Type III 31

30 Glas and plastics expert Products: Standard and customized Materials: Glass and plastics Full Service in Glass and Plastics Services: From the first idea to the finished product 32

31 Why Gerresheimer RTF syringes? Broad syringe portfolio High quality Big variety and many accessories / components High capacities Long term experience Syringe customization strong development dept. RTF 4 latest production equipment GX3 camera systems high end controls Standard and Baked-on siliconization - baked on RTF TELC -Tamper Evident Luerlock Closure TERNS -Thermoplastic Elastomer Rigid Needle Shield Integration into devices like auto-injectors 11/30/2015 To change footer select "INSERT" > "HEADER AND FOOTER" 33

32 Спасибо Any questions?

33 контакт Name Михаил Синицын Address Россия, Москва, Ленинградское шоссе, д.25 корп.1 Phone + 7 (495) Website office@emb-pharma.ru Name Bernd Zeiss, Manager Technical Support Gerresheimer Phone b.zeiss@gerresheimer.com Name Bernd Janas Sales Director Gerresheimer Phone b.janas@gerresheimer.com 35