Art Solutions for Vaccine Manufacturing

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1 Pharmatec GmbH Pure Media and Process Systems State of the Art Solutions for Vaccine Manufacturing DCVMN Workshop Engineering and GMP compliant systems 30 th October 2014, Delhi 1 Geschäftsbereich PADD/SAM Robert Bosch Lizenzverwaltungsgesellschaft mbh Alle Rechte vorbehalten, auch bzgl. jeder Verfügung,

2 Bosch Packaging Technology - Pharma Portfolio for Complete Production Lines Bosch Pharma Liquid, Crailsheim/Germany Clean Utilities Process Technology Primary Packaging Bosch Pharma Solid, Waiblingen/Germany Pharmatec, Dresden/Germany SBM, Ternitz/Austria t i Moeller & Devicon, Sandved/Denmark Manesty, Knowsley/UK Hüttlin, Schopfheim/Germany Eisai Machinery, Japan Bosch Packaging USA, Minneapolis/USA Bosch Packaging CHINA, Hangzhou/China Bosch Packaging JAPAN, Japan Secondary packaging Bosch Packaging INDIA, Verna/India Bosch Packaging g Systems,, Beringen/CH Bosch Chemical & Cosmetics, Viersen/Germany Valicare, Frankfurt/Germany 2 PADD/SAM Robert Bosch Lizenzverwaltungsgesellschaft mbh Alle Rechte vorbehalten, auch bzgl. jeder Verfügung,

3 Bosch Packaging Technology - Pharma Worldwide Presence Great Britain Denmark USA France Switzerland Netherlands Germany 7% Slovakia Austria India Russia Japan China Thailand Singapore Brazil 3 PADD/SAM Robert Bosch Lizenzverwaltungsgesellschaft mbh Alle Rechte vorbehalten, auch bzgl. jeder Verfügung,

4 NATURAL SOURCE WATER - H2O Total volume approx. 1,36 billion km³ (cube of km length) Fresh water volume approx. 40 million km³ (cube of 340 km length) -> 3% Useable as Potable Water approx. 8 million km³ (cube of 200 km length) -> 0,6% 4

5 NATURAL SOURCE WATER - H2O Many substances dissolve in water and it is commonly referred to as the universal solvent. Water molecule (H 2 O) Therefore all natural waters contain, in various concentrations, dissolved salts which dissociate in water to form charged ions. Positively charged ions are called cations; negatively charged ions are called anions. In general, ionic and polar substances such as acids, alcohols and salts are relatively soluble in water, and nonpolar substances such as fats and oils are not. 5 PADD/SAM Robert Bosch Lizenzverwaltungsgesellschaft mbh Alle Rechte vorbehalten, auch bzgl. jeder Verfügung,

6 POTABLE WATER Definition: Potable water is water intended for human consumption Potable water is not defined in a Pharmacopoeia, it is specified in the local regulations for drinking water Potable water provides a basis for all water qualities defined in the Pharmacopoeias 6 PADD/SAM Robert Bosch Lizenzverwaltungsgesellschaft mbh Alle Rechte vorbehalten, auch bzgl. jeder Verfügung,

7 NATURAL SOURCE WATER - H2O Potable water Potable water varies by country and region. The quality is depending on methods of sourcing and treatment Methods of potable water sourcing: Well water from municipal supplier Well water from a local source (at site) Surface water from: Fresh water lakes Filtrate from river banks Sea water desalination Other sources Further treatmentt t steps have to be individually id designed d according to the analysis of the potable water! 7 Packaging Technology PADD/SAM Robert Bosch Lizenzverwaltungsgesellschaft mbh Alle Rechte vorbehalten, auch bzgl. jeder Verfügung,

8 DEFINITIONS AND REGULATIONS Definition of Water Qualities in the Pharmacopoeias: National Pharmacopoeias European Pharmacopoeia (Ph. Eur.) American Pharmacopoeia (USP) International regulations and guidelines ISPE Pharmaceutical Engineering guides FDA Guide for Inspection of High Purity Water Systems EMEA/CPMP/QWP Note for Guidance on Quality of Water for Pharmaceutical Use 8 PADD/SAM Robert Bosch Lizenzverwaltungsgesellschaft mbh Alle Rechte vorbehalten, auch bzgl. jeder Verfügung,

9 PHARMACEUTICAL WATER CATEGORIES Four water categories are used in the pharmaceutical industry: Potable water Purified water* Highly purified water* ( Ph. Eur. only) Water for injection* * Compendial water qualities (according to the Pharmacopoeias) 9

10 PHARMACEUTICAL WATER CATEGORIES 10

11 PHARMACEUTICAL WATER CATEGORIES 11

12 PHARMACEUTICAL WATER TREATMENT SYSTEMS Potable Water / City Water PW Generation PW Storage + Distribution System Points of Use (PW) WFI Generation = Distillation Unit WFI Storage + Distribution System Points of Use (WFI) Pure Steam Generation = PSG Points of Use (PS) 12 PADD/SAM Robert Bosch Lizenzverwaltungsgesellschaft mbh Alle Rechte vorbehalten, auch bzgl. jeder Verfügung,

13 PHARMACEUTICAL WATER TREATMENT SYSTEMS NaOH Distillation WFI- EP Softener RO 2 HPW- EP Potable Water Antiscalant RO 1 MDG EDI Purified Water WFI- USP Nanofiltration Ultra- filtrationti WFI- JP Pretreatment Section Make up Section Polishing Section 13 PADD/SAM Robert Bosch Lizenzverwaltungsgesellschaft mbh Alle Rechte vorbehalten, auch bzgl. jeder Verfügung,

14 PURIFIED WATER GENERATION Main purpose: p Treatment of potable city water or raw water into water for pharmaceutical use Purified Water according to USP (United States Pharmacopeia) and Ph Eur (European Pharmacopeia) Treatment t steps: Filtration and chemical treatment of incoming water Softening Reverse Osmosis (single or double stage RO) Degassing Continiuos i Electro Deionisation i (CDI / EDI) (Ultra Filtration) 14

15 PURIFIED WATER GENERATION What is needed for the design of a PW system: -> Water analysis or -> Sample of feed water for analysis in laboratory Analysis with information's on: Ions in feed water (at least conductivity) TSS Total Suspended Solids = turbidity SDI Silt-Density-Index (needs to be measured) Hardness (Ca++, Mg++, Ba++, Sr++) Fe, Mn Silica CO2 15 PADD/SAM Robert Bosch Lizenzverwaltungsgesellschaft mbh Alle Rechte vorbehalten, auch bzgl. jeder Verfügung,

16 PURIFIED WATER GENERATION Pretreatment Section Make up Section Polishing Section - NaOH Softener RO 2 Potable Water Ultra- filtration Antiscalant RO 1 MDG 5 6 Purified Water EDI 7 Ultra- filtrationti Highly Purified Water μs/cm 5-20 μs/cm 0,055-0,5 25 C 16

17 PRE-TREATMENT: FILTRATION Pretreatment Section NaOH Make up Section Polishing Section - Softener RO 2 Potable Water Ultra- filtration Antiscalant RO 1 MDG 5 6 Purified Water Filtration process: Removal of suspended solids EDI 7 Ultra- filtrationti Highly Purified Water 17

18 RANGE OF MEMBRANE PROCESSES 18

19 ULTRAFILTRATION (UF) UF module for raw water filtration Cut-off Dalton 19

20 WATER SOFTENING Pretreatment Section NaOH Make up Section Polishing Section- Softener RO 2 Potable Water Ultra- filtration Antiscalant RO 1 MDG 5 6 Purified Water Ion Exchange: Removal of hardness EDI 7 Ultra- filtrationti Highly Purified Water 20

21 WATER SOFTENING 21

22 WATER SOFTENING 22

23 WATER SOFTENING Softening removes water hardness builders such as calcium and magnesium as well as metals like divalent iron (Fe ++ ) and replaces them by sodium ions. Ca ++ HCO 3 - Na Mg ++ softening + HCO 3-3 SO -- 4 NO - 3 Cl - Na + 4 Cl - SO -- 4 NO - 3 Potable Water Softened Water 23

24 REVERSE OSMOSIS (RO) Pretreatment Section NaOH Make up Section Polishing Section Softener RO 2 Potable Water Ultra- filtration Antiscalant RO 1 MDG 5 6 Purified Water Membrane process: Removal of ions and other impurities EDI 7 Ultra- filtrationti Highly Purified Water 24

25 REVERSE OSMOSIS (RO) PW Generation RO = Reverse Osmosis Reverse osmosis is a physical process where ions and other impurities in water are concentrated and where the natural process of osmosis is reversed. 25 PADD/SAM Robert Bosch Lizenzverwaltungsgesellschaft mbh Alle Rechte vorbehalten, auch bzgl. jeder Verfügung,

26 REVERSE OSMOSIS (RO) Spiral wound module 26

27 MEMBRANE DEGASSING ( MDG) Pretreatment Section Make up Section Polishing Section - NaOH Softener RO 2 Potable Water Ultra- filtration Antiscalant RO 1 MDG 5 6 Purified Water Membrane process: Removal carbon dioxide EDI 7 Ultra- filtrationti Highly Purified Water 27

28 MEMBRANE DEGASING Principle of the gas transfer: Gases in the air dissolve in water until saturation is reached. The balance between gas in the gaseous phase and gas in the liquid will be shifted to the side of the gaseous phase by creating a low pressure / Sweep Gas. This results in a driving force that moves gases from the water towards the gaseous phase. Liquid/Gas Contact Surface at the Pore O2 y O2 Vacuum and/or Sweep Gas Wate er 28

29 ELECTRO DE-IONISATION (EDI) Pretreatment Section Make up Section Polishing Section - NaOH Softener RO 2 Potable Water Ultra- filtration Antiscalant RO 1 MDG 5 6 Purified Water EDI 7 Ultra- filtrationti Highly Purified Water Electrochemical process : Removal of ions to final level of conductivity 29

30 ELECTRO DE-IONISATION (EDI) 30

31 ELECTRO DE-IONISATION (EDI) PW Generation Electro Deionisation i (EDI) Electrodeionisation i ti is an electro-chemical l process for the removal of ions. It is a combination of ion-exchange and electrodialysis 31 PADD/SAM Robert Bosch Lizenzverwaltungsgesellschaft mbh Alle Rechte vorbehalten, auch bzgl. jeder Verfügung,

32 PURIFIED WATER GENERATION - ANIMATION PW Generation Electro Deionisation i (EDI) 32 PADD/SAM Robert Bosch Lizenzverwaltungsgesellschaft mbh Alle Rechte vorbehalten, auch bzgl. jeder Verfügung,

33 MULTIEFFECT DISTILLATION UNIT Water for Injection Generation Main purpose: Treatment of Purified Water (PW) into Water for Injection (WFI) according to USP (United States Pharmacopeia) and Ph Eur (European Pharmacopeia) Treatment steps: Evaporation and condensing (= Distillation) 33

34 MULTIEFFECT DISTILLATION UNIT - ANIMATION 34 PADD/SAM Robert Bosch Lizenzverwaltungsgesellschaft mbh Alle Rechte vorbehalten, auch bzgl. jeder Verfügung,

35 PURE STEAM GENERATION Pure Steam Generation Main purpose: Treatment of Purified Water (PW) into Pure Steam (PS) according to quality USP (United States Pharmacopeia) and Ph Eur (European Pharmacopeia) Treatment steps: Degassing (for elimination of non condensable gasses N2, O2, CO2) Evaporation 35

36 PURE STEAM GENERATION - ANIMATION 36 PADD/SAM Robert Bosch Lizenzverwaltungsgesellschaft mbh Alle Rechte vorbehalten, auch bzgl. jeder Verfügung,

37 PURE MEDIA ROOM - LAYOUT 37

38 PHL Sales Force Training Pure Media Generation Pure Media Systems Design criteria i Evaluation of total consumption at all points of use (pou) Simultaneous consumption and interlocking (pou management) ) Generation capacity as small as possible Coverage of peaks by storage vessel Permanent circulation of water (V>1 m/s in the return pipe) Online monitoring of quality critical parameters (Flow, Temperature, Pressure, conductivity, it TOC) Slope <1% No dead legs 3d-rule Drainability Sanitization concept WFI - superheated water, pure steam PW - hot water, ozone 38

39 PURE MEDIA ROOM - ANIMATION 39

40 FAT PURE MEDIA SYSTEM ATBOSCH IN DRESDEN, GERMANY 40 PADD Robert Bosch Lizenzverwaltungsgesellschaft mbh Alle Rechte vorbehalten, auch bzgl. jeder Verfügung,

41 VACCINES PRODUCTION d Solutions: l BOSCH Integrated p An answer to complex requirements! media systems preparation systems secondary packaging i inspection ti primary packaging Packaging Technology 41 PADD / SAM Robert Bosch Lizenzverwaltungsgesellschaft mbh Alle Rechte vorbehalten, auch bzgl. jeder Verfügung,

42 VACCINES PRODUCTION 42 Packaging Technology PADD / SAM Robert Bosch Lizenzverwaltungsgesellschaft mbh Alle Rechte vorbehalten, auch bzgl. jeder Verfügung,

43 VACCINES PRODUCTION 43 Packaging Technology PADD / SAM Robert Bosch Lizenzverwaltungsgesellschaft mbh Alle Rechte vorbehalten, auch bzgl. jeder Verfügung,

44 Pharmatec GmbH - Company Presentation Thank you for your attention! Pharmatec GmbH Tailor-made solutions for the pharmaceutical and biotechnological industries 44 PADD/SAM Robert Bosch Lizenzverwaltungsgesellschaft mbh Alle Rechte vorbehalten, auch bzgl. jeder Verfügung,