Stawiając czoła przyszłości farmacji - pakowanie,znakowanie,logistyka. Innowacje w projektowaniu bezpośrednich materiałow opakowaniowych

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1 Stawiając czoła przyszłości farmacji - pakowanie,znakowanie,logistyka Innowacje w projektowaniu bezpośrednich materiałow opakowaniowych V Kongres Swiata Przemysłu Framaceutycznego Marek Miszczak Dyrektor ds. Rozwoju Gerresheimer Plastic Packaging

2 Gerresheimer opakowania z tworzyw sztucznych formy płynne 1

3 Gerresheimer opakowania z tworzyw sztucznych formy suche 2

4 Gerresheimer opakowania z tworzyw sztucznych Opakowania PET 3

5 Gerresheimer Plastic Packaging Udział w runku Rest of Europe 9,1% Solid 25,3% Spain 10,6% Germany 10% France 5% Poland 4,5% PET packaging 42,7% South America 49,5% Asia 4,4% Other 6,9% Personal care 6,3% Other 10,6% Ophthalmic 15,1% % by region % by product segment 4

6 Opakowania do leków ocznych i donosowych Opakowania kompletne: butelki, nakrętki zakraplacze, aplikatory Certyfikaty ISO 9001 / / FDA DMF- Type III Pełna dokumentacja wyrobów gotowych Zgodność z wymaganiami EuPh i USP Usługi dodatkowe Badania mikrobiologiczne i chemiczne Charakterystyka produktów: Nakrętki z pierścieniem gwarancyjnym, child resistant, senior-friendly Grawerowanie Szeroki zakres pojemności (3 ml 250 ml) Zakraplacze dostosowane do wymagań klienta Znakowanie kolorami 5

7 Plastic Packaging product ranges: ophthalmic and nasal applications Dropper bottle systems, nebulizers and spray bottles DROPPER BOTTLE SYSTEM B >>> OTHER APPLICATIONS Nebulizer bottle systems <<< DROPPER BOTTLE SYSTEM CL DROPPER BOTTLE SYSTEM Q >>> spray bottle systems 6

8 Centers of excellence in Europe Denmark, Poland and Spain Gerresheimer Haarby Gerresheimer Vaerloese Tablet containers Tablet containers Gerresheimer Boleslawiec Droptainers Gerresheimer Zaragoza PET bottles Gerresheimer Valencia Droptainers 7 7

9 Polityka jakości Słuchamy naszych klientów... Własne narzędziownie Centra rozwojowe CAD, CAM: Proengineer-3D Autocad, SolidWorks Rapid prototyping Laboratoria pomiarowe CMM (coordinate measuring machine) Smartscops Laboratorium mikrobiologiczne i chemiczne Bio burden test Particle counting 8 8

10 Gerresheimer Plastic Packaging Know-how w przetwórstwie tworzyw sztucznych 10 zakładów na 3 kontynentach Lider w Europie i Ameryce Południowej Najwyższa jakość Ponad 400 maszyn, IBM, IM, ISBM, ML,EBM, CBM Systemy wizyjne Automatyczne procesy pakowania 9 9

11 Gerresheimer Plastic Packaging Rozwój nowych produktów i zarzadzanie projektami Preparation of Input Data Review of Input Data 1. Jasno zdefiniowana ścieżka projektowania, zgodnie z PMBOK Preparation and Approval of Project Project Plan Distribution Implementation of Project Activities Project Verification Project Validation Preparation and Distribution of FPS- Project Completion 10 10

12 Strengths of Gerresheimer Plastic Packaging Rozwój nowych produktów i zarzadzanie projektami 2. Statystyczna kontrola dla wszystkich procesów produkcyjnych 11 11

13 Strengths of Gerresheimer Plastic Packaging Nowe podejście do projektowania 3. Implementation of Quality by Design - Systematic approach to product, process design and development, where all critical sources of variability are identified and understood. - Quality is achieved already at the beginning of product shelf life. - Approach does replace the Quality by Inspection. 4. Implementation of Design of Experiments - Design of any information-gathering exercises where variation is present, whether under the full control of the experimenter or not. - Important part of QbD, where correlation between critical product and process parameters must be understood and confirmed

14 Pharma understanding R&D Quality by Design in practice/ DoE-design space Experiment: 3 factors 13 13

15 Pharma understanding R&D Quality by Design in practice/ Critical process parameters-doe 4.Design of experiment 14 14

16 Quality by Design in practice/ analyze data Find corelation between process and products parameters -1 D 1 D T 1 21,15-21,20 21,20 21,10 21,15-21,10 21,15 21,05 21,05-21,10 21,00 21,00 T -1-21,05-1 D 1 D C 1 21,20 21,15-21,20 21,15 21,10-21,10 21,15 21,05-21,0521,10 21,00-21,0021,05 C

17 Strengths of Gerresheimer Plastic Packaging Zarządzanie ryzykiem i kwalifikacja 4. Risks analysis focused on product and processes - People (Communication, training) - Methods (Incorrect standard work charts) - Machines (Fixtures) - Materials (Incorrect parts delivered to line) - Measurements 5. A strong Qualification Plan including: - Design Qualification (DQ) - Installation Qualification (IQ) - Operational qualification (OQ) - Performance qualification (PQ). with SAT = site acceptance test FAT = Factory acceptance test UAT = User acceptance test USR = User system requirement 16 16

18 Gerresheimer Plastic Packaging Innovative packaging solutions 17

19 MultiShell : High-performance multilayer vials for parenteral and diagnostic applications Our Innovation: a MULTILAYER vial with strong combined performances Inner layer COP (Cyclic Olefin Polymer) Middle layer PA (Polyamide) Outer layer COP (Cyclic Olefin Polymer) secures lowest level of drugcontainer interaction is responsible for the improved barrier and break resistance protects inner layers and have glass-like transparency Winner of German Packaging Award 2011 Finalist of the CphI Innovation awards Improved compatibility - Reduced adsorption - Minimized degradation of the solution - better drug stability over shelf-life - safety for operators, caregivers and patients - smooth surface - ease the inspection and improve quality impression 18

20 MULTISHELL vials: Standard, Ready to Sterilize (RTS) and Ready to Use (RTU) Main characteristics: Unique oxygen barrier Superior break resistance Reduced protein adsorption to container surface Inert over a wide ph range Excellent drainability No heavy metal ion release Available in 2, 5, 10, 15, 50 and 100 ml For challenging formulations: Larger molecules (protein-derived compositions) Unbuffered solutions, low-volume fill Aggressive complexing agents (citric acid, EDTA) Solutions that are sensitive towards metal ions (i.e. Na, Al, B, Fe, Ti) Contrast media which contain radio isotopes tending to ion exchange Drug formulation with high ph-value High potency and toxic drug solutions i.e. cytotoxics, growth hormones / (Safety for caregivers) 19

21 MULTISHELL vials Available in 2, 5, 10, 15, 50 and 100 ml 20

22 MULTISHELL vials 21

23 MultiShell RTU values How can we support customers fill/finish operations? MULTISHELL DELIVERED ON TRAYS Glass vial unpacking RTU, Ready-to-Use reduce the intermediate processing steps at a minimum. Vial washing Class C, ISO 7 Stoppers Vial sterilization Bulk solution Stopper washing ASEPTIC FILLING LINE Sterile filtration Stopper sterilization Stopper setting Class A, ISO 5 Crimping caps Crimping LF-area Inspection 22

24 cm³/vial*24h*1bar MultiShell : Reduced degradation by oxidation Oxygen transmission rate *) HIGH OXYGEN BARRIER 0,05 Low barrier 0,04 0,03 0,02 0,01 High barrier 30 to 40 times less than monolayer vials Significantly reduced gas permeation 0 Monolayer vial Multilayer vial *) Test method according to ASTM D3985:95 with complete vial at 23 C, 85% RH and 100% O2-partial pressure 23

25 MultiShell : Improved safety and reduction of production loss BREAK RESISTANCE and INTEGRITY Improved resistance against impact or dropping Superior impact resistance of middle layer keeps integrity although outer layer is cracked Weight of ball (g) Drop height (cm) Energy (Joule) Result 43,5 38,5 0,164 not cracked Ball m 80 cm 63,8 80,0 0,500 not cracked 60 cm 129,9 80,0 1,020 not cracked In-house developed test method: Tube 40 cm Vial is placed in a rectangular cavity below a tube. Metal balls with defined mass are dropped through the tube on the vial. Drop height is varied and measured to achieve different impact energies. Vial 20 cm 0 cm Test method : Vial is filled, stoppered and crimped. The integrity test has been performed according to the Defect Evaluation List for blow-moulded plastic containers. Vial on the right side has been intentionally damaged for the purpose of the integrity test. 24

26 MultiShell : Reduced adsorption and very low level of extractables Multilayer Plastic Vial shows less absorption than glass vials Test procedure: First rinsing with Acetone followed by a second rinsing with WFI Treatment with 20% Bovine Serum Albumin (BSA) solution for 24 h Treatment with 0,1% Coomassie Violet R200 dye solution for 24 h No metal ion release above the detection limits of 7-30 pbb Element test solution (ppm) blank solution (ppm) Aluminium < 0,021* < 0,021* Barium < 0,007* < 0,007* Boron 0,089** 0,055** Cadmium < 0,006* < 0,006* Calcium 0,12** 0,56** Chromium < 0,007* < 0,007* Cobalt < 0,014* < 0,014* Copper < 0,014* < 0,014* Iron < 0,014* < 0,014* Lead < 0,021* < 0,021* Magnesium < 0,021* < 0,021* Manganese < 0,003* < 0,003* Molybdenum < 0,011* < 0,011* Nickel < 0,014* < 0,014* Potassium 0,18** 0,17** Silver < 0,007* < 0,007* Sodium 0,66** 3,32** Zinc 0,016** 0,016** * Concentrations are below detection limits of 7-30 ppb. ** Boron, Calcium, Zinc and Sodium concentrations are from glassware of analytical equipment, see results from the blank solution. Test method: Vials are extracted with WFI under reflux. Resulting solution is analyzed by Inductive Coupled Plasma/Optical emission spectroscopy 25

27 Sterilization process and Post-sterilization performance Multilayer plastic vials can be sterilised by traditional methods: Steam (121 C, 20 min) ETO (45 C, 6 h, c = 600mg/l ETO) E-beam (25 kgr) Gamma radiation (25 kgy) selected for MULTISHELL RTU ONGOING ACTIONS FOR THE VALIDATION OF MULTISHELL RTU 1.Sterilization validation incl. Dose setting+mapping 2. Packaging validation 2.1) Package transport simulation (simulation of transport by shake-shock & drop test) 2.2) Package integrity validation (testing of package before and after transportation challenge) 2.3) Package microbiological challenge 3. Product post-sterilisation performance (Performance tests at various time pulls) REGULATORY COMPLIANCE ISO ISTA 3E ISO EMA guideline 3AQ4a MULTISHELL RTU Sterility testing Supportive documentation / Certified per batch Parametric release 26

28 Thank you for your attention! Krzysztof Dabrowski Sales Director, Primary Plastic Packaging Mobile: Marek Miszczak R&D Director European R&D Coordinator Mobile: