Company Presentation. Pharmatec GmbH / A Bosch Packaging Technology Company. Pharmatec / A Bosch Packaging Technology Company. Packaging Technology

Transcription

1 Company Presentation Pharmatec GmbH / A Bosch Company 1

2 Ownership Structuret Robert Bosch Stiftung GmbH 92% share no voting rights Bosch family Robert Bosch Industrietreuhand KG 7% share 7% of voting rights 93% of voting rights Robert Bosch GmbH 1% share and no voting rights capital stock 1.2 billion EUR 2

3 Worldwide Locations of Bosch Packaging Great Britain Denmark USA France Switzerland Netherlands Germany 7% Slovakia Austria India Russia Japan China Thailand Singapore Brazil 3

4 Worldwide Locations of Bosch Packaging Knowsley/UK Waiblingen/Germany Sandved/Denmark Hangzhou/China FFM/Dtl. Trencin/Slovakei Tokyo/ Funabashi/Japan Minneapolis/USA Tokyo/Honjo/Japan, Cologne/Germany, Shanghai/China, NJ/USA Ternitz/Austria Schopfheim/Germany Crailsheim/Germany Dresden/Germany 4

5 Pharmatec The Company Cent tre of Com peten nce for Biote echno ologic cal Pro cess Tech nolog gy 5

6 The Company in Figures History 1993 founded as a subsidiary of Fresenius AG 2007 acquisition by Bosch Site Manager Ralf Kretzschmar (GM) Employees 98 Employees, thereof: 51 employees in Engineering g 10 employees in Assembly / Orbital Welding 10 employees in Service 12 employees in Sales / Project development 14 employees in Administration 6

7 The Company Organization PADD/GM General Management PADD/GM-Se Assistance PADD/QMM Quality Management PADD/PJM-P & PADD/PJM-M PADD/COR Controlling PADD/SAM Sales/Marketing PADD/STP Service PADD/HRL Human Resources PADD/PJM-G F+C Sales Service PADD/END Purchase Marketing PADD/ECS Stock Receipt PADD/MOE IT 7

8 Pharmaceutical plant engineering g For the manufacturing of sterile and non-sterile medical products and pure media in consideration of relevant, current requirements of national and international pharmaceutical rules and standards Generation Systems for High Purity Media Media Distribution Process Bioprocess Systems Systems Systems 8

9 for a stem Media n Sys urity M ration gh Pu Gene Hig Generation Systems for PW (Purified Water) and HPW (Highly Purified Water) Pre-treatment Systems for potable water Pure Steam Generators Membrane Degassing Units Multiple-Effect Distillation Units 9

10 Generation Systems for High Purity Media Generation Systems for PW (Purified Water) + HPW (Highly Purified Water) Production of Purified Water Reverse Osmosis and EDI for production of purified water (PW) Capacity range from 200 l/h to l/h 10

11 Generation Systems for High Purity Media Generation Systems for PW (Purified Water) + HPW (Highly Purified Water) Pre-treatment Systems for potable water Softening Unit Stainless steel tank for ion exchange resin Chemical or hot water sanitization Capacity range from 200 to l/h 11

12 Generation Systems for High Purity Media Generation Systems for PW (Purified Water) + HPW (Highly Purified Water) Pre-treatment Systems for potable water Ultrafiltration Unit Tight barrier against bacteria and viruses And a wide range of colloidal and suspended material TSS (total suspended solids) Reduzierung Efficient back flash and chemical sanitizable membranes (sanitization with chlorine) 12

13 Generation Systems for High Purity Media Generation Systems for PW (Purified Water) + HPW (Highly Purified Water) Production of Highly Purified Water UF unit as polisher after RO+EDI Capacity range from 200 l/h to l/h 13

14 Generation Systems for High Purity Media Pure Steam Generators (PSG) Pure Steam Generation Production of pure steam in a standard d capacity range from 50 kg/h to kg/h with a pure steam pressure up to 4,0 barg 14

15 Generation Systems for High Purity Media Pure Steam Generators (PSG) Membrane Degassing Units Membrane degassing for continuous separation of non-condensable gases from purified water Capacity range with variable flow rate from l/h to l/h 15

16 Generation Systems for High Purity Media Multiple-Effect Distillation Units Distillation Units Production of WFI in a standard d capacity range from 50 kg/h to kg/h Optional with parallel mode for simultaneous or sequential production of pure steam 16

17 stems stems s ss Sys s Sys Proces ocess Pro Process Systems for the Preparation of Pharmaceuticals Liquids Process Systems (SVP, LVP) CIP/SIP Systems Filtration Units Systems for Thermal Inactivation 17

18 Process Systems Process Systems for the Preparation of Pharmaceutical Liquids Vaccine Manufacturing Plant Preparation and storage systems Collection vessel Filling Sterilization vessel for basic process materials Collection vessel for CIP media Sterile filter for product filtration Process control (PLC) Simatic S7 SCADA-System (PC), 21CFR Part 11 18

19 Process Systems Process Systems for the Preparation of Pharmaceutical Liquids Basic Fractionation Complete fractionation unit with: Blood plasma fractionation Thawing system Storage, mixing and precipitation system Filtration and separation-process p technology Tempering module CIP unit 19

20 Process Systems Process Systems for the Preparation of Pharmaceutical Liquids Preparation of cytotoxic solutions with Isolation Technology protection of both sterile product and human beings Preparation tank with net volume 750 l Preparation tank with net volume 150 l Firmly welded insulators Integrated CIP unit with 4 detergentdosing stations Product piping on plug-in panel on filling station Software/Automation: t ti PCS7 / Profibus PA (ex-protection) 20

21 Process Systems Process Systems for the Preparation of Pharmaceutical Liquids Preparation System for vaccines with 6 tanks which are embedded in the floor Integrated CIP unit, tempering module Process control (PLC) Simatic S7 Visualization and operation via PC with recipe management on data base basis Communication with a superior process control system and Audit-trailfunctionality as well as 2 PCs with operation stations for separate unit operation 21

22 Process Systems Process Systems (SVP/LVP) Multifunctional Process Systems With 2 preparation vessels 2000 l each Floor mixers Heating and cooling equipment for tempering Product transfer via sterile air or N2 heterodyne Batch administration and connection to an superior control For production of infusion solutions (IV plants), buffer and media preparation 22

23 Process Systems CIP/SIP Systems Mobile CIP Unit Process control (PLC) Simatic S7 Heatable with electro-heater or integrated dosage Visualization and operation via multi panel 23

24 Process Systems CIP/SIP Systems Stationary CIP Unit Unit consist of 3 CIP tanks and 1 highly hl purified water tanks (4.000 l net) Equipped with sterilizable sampling device in each tank Process control Simatic S7 with OP37 Integrated recipe management and connection with process control system 24

25 Process Systems Filtration system with UF, deep bed filtration and chromatography unit 25 Filtration Units Downstream process for multi-stage purification of enzymes 6 temperature-controlled stainless steel tanks (1.4539) 2 ultrafiltration units, 1 chromatograpy unit integrated Up to 6 processes (buffer preparation, product cleaning, CIP) possibility of parallel running Process control (PLC) Simatic S7 Visualization of process with Siemens WinCC conform 21CFR Part 11

26 Process Systems Systems for Thermal Inactivation Systems for Thermal Inactivation for continuously working processes Treated waste water meets all legal requirements (safety level BSL1, BSL 2, BSL3) For inactivation temperatures t from 80 to 135 C Waste water above boiling point is hold liquid in the unit (at normal pressure) Adjustable volume stream Minimization of energy intensive start and shut down Soaking temperature zone as pipe coil is also unit socket Above 3 heating transmitter (heater, recuperator, cooler) are arranged 26

27 ms stems ystem ess Sys ss Sy oproce proce Bi Biop Process Systems for Biopharmaceutical Production Purification Systems for Biopharmaceutical Production Fermentation Systems and Fermentation Units for Biopharmaceutical Production Formulation Systems for Biopharmaceutical Production 27

28 Bioprocess Systems Process Systems for Biopharmaceutical Production Buffer preparation system in DSP interval for production solutions for the areas chromatography h and nanofiltration ti Complete buffer storage 4 static tank units ( liter) 4 stations for supply of buffers in cooled bags 2 bags filling stations 28

29 Bioprocess Systems Purification Systems for Biopharmaceutical Production Formulation systems for biopharmaceutical production Designed for complex harvest solutions with multi stage process steps (e. g. preparation, centrifugation, filtration) Production of pharmaceutical liquids in temperature-controlled stainless steel tanks with mixers under addition of chemicals with or without nutrient solutions Also as stand-alone units 29

30 Bioprocess Systems Fermentation Systems and Fermentation Units for Biopharmaceutical Production Fermentation systems for biotechnological products Designed for Batch and Fed Batch processes Laboratory to production scale integrated CIP / SIP functionality Autonomic control Customer oriented design Modular format Qualification IQ / OQ GMP compliant design and documentation 30

31 Bioprocess Systems Formulation Systems for Biopharmaceutical Production Formulation systems for biopharmaceutical production Designed for complex solutions with multi stage process steps (e. g. preparation, filtration, centrifugation, chromatography) 31

32 ms n Syste bution s Distrib stems bution dia D Sys Media Distri Med Storage and Distribution Systems for High Purity Media Pure Steam PW, HPW WFI Sterile air Nitrogen Ethanol 32

33 Media Distribution Systems Storage and Distribution Systems for Highpurity Media Storage and distribution system for purified water, pure steam and gases Tank storage with distribution loop Filling station management Sanitization equipment 33

34 Product Group Service Services Hotline Modem support On site service Consultancy and trainings Repair and maintenance Inspections 34

35 Service Unit Automation ti Services Planning, projection, assembly, installation and commissioning of complete automation solutions incl. hard- and software systems Planning and visualization EPLAN Simatic STEP7, PCS7, RS- Logics Simatic WinCC flexible CFR21 Part 11 and GAMP 4.0/5.0 35

36 Service Unit Design Services 36 Preparation of P&ID and process flowsheets Design and calculation of pressure equipment according to Pressure Equipment Directive (PED) Preparation of construction drawings Layout-planning, complete 3D design of pharmaceutical systems Preparation of design documents, manufacturing support Preparation of as built customer documentation

37 Service Unit Assembly Services Processing of stainless steel and PVDF for pharmaceutical industry and Biotech Manufacturer enterprise in accordance with AD 2000 date sheet HP 0 / HP 100R and TRD 201 Certified specialist in accordance with 19 I WHG Welding method examinations in accordance with AD date sheet HP2/1, DIN EN TÜV certified welding staff in accordance with DIN EN 287-1, orbital welder in accordance with DIN EN 1418 VT 2 inspector for endoscopy 37

38 One Stop Shopping Production of PW/HPW Storage and Distribution Of AP/HPW Production of Water for Injection Storage of Water for Injection Distribution of WFI Distribution of Pure Steam Production of Pure Steam Thermale Inactivation CIP/SIP/WIP Units for production of sterile liquids Fermentation Filling of Liquida Product Sterilization 38

39 Contact t Persons Pharmatec GmbH, A Bosch Company Elisabeth-Boer-Straße 3, D Dresden, Phone: , Fax: , pharmatec@bosch.com, Sales Manager Klaus Rauschenbach Elisabeth-Boer-Straße Dresden Tel: / Fax: / Mobil: / klaus.rauschenbach@bosch.com Sales Export East N/E Europe, Asia, MENA Dr. Thomas Völkel Elisabeth-Boer-Straße 3 D Dresden Tel: Fax: Mobil: thomas.voelkel@bosch.com Pharmatec Schweiz GmbH Heiko Konczalik Muttenzerstraße Pratteln, Schweiz Tel: Fax: Mobil: heiko.konczalik@bosch.com 39 Sales Germany / Austria Volker Szczeczinski Elisabeth-Boer-Straße 3 D Dresden Tel: Fax: Mobil: volker.szczeczinski@bosch.com Sales Germany / Asia Ralf Roepenack Eschborner Landstraße D Frankfurt Tel: Fax: Mobil: ralf.roepenack@bosch.com Sales Export West N/S America, W Europe Albrecht Voigt Elisabeth-Boer-Straße 3 D Dresden Tel: Fax: Mobil: albrecht.voigt@bosch.com Sales Export East Asia Johnson Tjong Elisabeth-Boer-Straße Dresden Tel: / Fax: / Mobil: / johnson.tjong@bosch.com com Pharmatec GmbH Office Moscow Mike Müller ul. 8 Tekstilschikov 11 office 307 RUS Moscow Tel: Fax: Mobil: mike.mueller1@bosch.com