Bosch - Pharmatec GmbH

Transcription

1 Bosch - Pharmatec GmbH GMP Compliant Pure Media Systems and Process Equipment for Pharmaceutical and Biotechnology Industry Dipl. Ing. Volker Szczeczinski, Sales Manager Germany, East Europe 1

2 Pharmatec GmbH Pharmatec GmbH a member of Bosch 2

3 Pharmatec GmbH Our Company History: Employees: Address: 1993 founded in Dresden, Germany 2007 bought by Bosch Packaging General Manager: Ralf Kretzschmar 97 employees; there of: 47 in Engineering 15 in Assembling / Orbital weld 12 in Service 7 in Sales / Project development 16 in Administration Pharmatec GmbH Elisabeth-Boer-Straße Dresden, Germany Tel.: 0351/ Fax: 0351/ pharmatec@bosch.com web: 3

4 Pharmatec GmbH - Pharmaceutical production process of sterile liquids CIP/SIP Equipment Pure water WFI/PS preparation filling sterilization pac kaging Systems All systems we design and execute are fully cgmp compliant with our total process guarantee. 4

5 Pharmatec GmbH - Pharmaceutical production process of sterile liquids Production of Water for Injection Production of AP/HPW Storage and Distribution of AP/HPW Storage of Water for Injection Distribution of WFI Distribution of Pure Steam Production of Pure Steam Thermal Inactivation CIP/SIP/WIP Plants for production of sterile liquids Fermentation Filling of liquids Product Sterilization 5

6 Pharmatec GmbH Processes and products Production process of sterile pharmaceutical liquids as classical chemic-physical process PW generation Stills / PSG Product Preparation / Substrate Preparation up stream Pure Media Systems CIP / SIP Units down stream Filling Sterilisation SBM (Schoeller Bleckmann Medizintechnik) Final packing 6

7 Pharmatec GmbH Processes and products Production process of sterile pharmaceutical liquids as biotechnological process Stills / PSG Product Preparation / Substrate Preparation Product Sterilisation up stream Pure Media Systems Fermentation CIP / SIP Units Product Harvesting Product Cleaning Disposal (Inactivation) down stream Filling Sterilisation SBM (Schoeller Bleckmann Medizintechnik) Final Packing 7

8 Pharmatec GmbH - Engineering Project handling - quality management ISO documented project execution procedure 8

9 Pharmatec GmbH - Engineering 3D-planning of single equipment 9

10 Pharmatec GmbH - Engineering 3D-planning of equipment systems 10

11 Pharmatec GmbH - Engineering 3D-planning of equipment systems 11

12 Pharmatec GmbH - Automation Automation components Siemens hardware as standard 12

13 Pharmatec GmbH - Automation Hardware configuration of formulation equipment 13

14 Pharmatec GmbH - Automation Operation screen layout 14

15 Pharmatec GmbH - Automation Parameter trends 15

16 Pharmatec GmbH - Automation Batch reporting 16

17 Pharmatec GmbH - Automation User administration 17

18 Pharmatec GmbH - our workshop Assembly of standard equipment, prefabricated modules for water systems an and process systems at m² 18

19 Pharmatec GmbH - our workshop Complete pre-assembling and testing of complex systems 19

20 Pharmatec GmbH - our workshop Technical room to supply utilities for factory acceptance tests (FAT) 20

21 Pharmatec GmbH - GMP compliant piping GMP compliant pipe work installation and pipe work documentation Orbital welding technology Test certificates Approved welder on EN T BW W11 TÜV North Boroscopical inspection & video print Permissions Authorised company on AD data sheet HP 0 TÜV-proofed company on 19 ( Water supply law ) Certification on DIN ISO 9001 Surface quality inspection Ferrite content inspection 21

22 Pharmatec GmbH - Service 24 hours service hotline, 7 days per week Training of operator and maintenance staff Maintenance, service and repair works Maintenance contracts Hard- and software upgrade of own and by third parties produced equipment Spare and wear part delivery Support in IQ/OQ Recalibration and requalification of own and by third parties produced equipment 22

23 Pharmatec GmbH Thank you for your attention! 23

24 Pharmaceutical water and pure steam Pharmatec PW and HPW generation units 400 l/h l/h Customized design of pre-treatment according to the feed water quality RO/EDI/UF technology Specials: CO² removal by fibre membrane technology hot water sanitation of softener hot water sanitisation of RO/EDI 24

25 Pharmaceutical water and pure steam Pharmatec stills 50 l/h l/h Qualified standard design on attractive price level Pyramide VT Handbuch Customized design with a lot of optional accessories as: pre-heaters providing pure steam from the first column CFR 21/11 requirements GAMP 4 requirements electrical heating up to 400 l/h 25

26 Pharmaceutical water and pure steam Pharmatec still at Fresenius AG, output l/h 26

27 Pharmaceutical water and pure steam Pure steam generators 50 kg/h kg/h at 3 bar(g) Qualified standard design on attractive price level Customized design with a lot of optional accessories as: feed water pre-heater monitoring and recording of conductivity degassing facility for removal of non condensable gases CFR 21/11requirements GAMP 4 requirements electrical heated up to 200 kg/h 27

28 Pharmaceutical water and pure steam Pharmatec provides the design and dimensioning of pure media systems according to the consumption requirements at points of use PW generation Quality monitoring in the loop return Heat exchanger for sanitization PW system 20 C Ozon Heat exchanger for recooling Cold sanitisation with Ozone and UV Pharmatec still for WFI generation Pharmatec Pure steam generator Pharmatec CIP/SIP unit 28

29 Pharmaceutical water and pure steam Pharmatec provides the design and dimensioning of pure media systems according to the consumption requirements at points of use Pharmatec still for WFI generation Heat exchanger for keeping temperature WFI system 85 C Cold user points Hot user points 29

30 Pharmaceutical water and pure steam Pharmatec provides the design and dimensioning of pure media systems according to the consumption requirements at points of use Pure steam distribution system Pharmatec Pure steam generator 30

31 Pharmaceutical water and pure steam Storage vessels and distribution skid for PW and WFI at customer s site, completely prefabricated and pre tested at Pharmatec s workshop 31

32 Pharmaceutical water and pure steam Still and pure steam generator corresponding to distribution the skid for PW and WFI at customer s site 32

33 Pharmaceutical water and pure steam Purified water generation unit with pre treatment, RO modules and EDI corresponding to distribution the skid for PW and WFI at customer s site0 33

34 CIP/SIP units and systems CIP/SIP (Cleaning In Place / Steaming In Place) units CIP returns Detergent dosing CIP supplies Buffer vessel for cleaning liquid preparation Quality monitoring Heat exchanger 34

35 CIP/SIP units and systems Special Design 3 Vessel CIP/SIP Unit (special design) 1 Vessel CIP Unit (mobile) 2 Vessel CIP Unit (stationary) 3 Vessel CIP Unit (staple unit) 1 Vessel CIP/SIP Unit (filling lines) Integration of CIP/SIP Units in process equipment Cleaning equipment without vessel 4 Vessel CIP Unit 35

36 CIP/SIP units and systems CIP system for a biotechnological application 36

37 Pharmatec GmbH - Process systems LVP solution preparation system 37

38 Pharmatec GmbH - Process systems Blood bag solution preparation system 38

39 Pharmatec GmbH - Process systems SVP solution preparation 39

40 Pharmatec GmbH - Process systems Vaccine production system 40

41 CIP Unit Pharmatec GmbH - Process systems Blood Plasma Fractionation Basis Fractionation Tempering Module NaOH-Unit Thawing 41

42 Pharmatec GmbH - Process systems Blood plasma fractionation albumin, IgG 42

43 Pharmatec GmbH - Process systems Pilot plant with laminar flow clean room area C mobile vessels with data logging (CFR 21 compliant) After VHP sterilization connection and sterile filling clean room area A/B; in technical area with integrated CIP Unit 43

44 Pharmatec GmbH - Process systems Process system with isolator for toxic products 44

45 Pharmatec GmbH - Process systems Process system with isolator for toxic products 45

46 Pharmatec GmbH Bio system upstream and downstream processes Media preparation Harvest Buffer preparation Mobile vessel and media panels 46

47 Pharmatec GmbH Biotechnological process systems Preparation / Substrate sterilisation 47

48 Pharmatec GmbH Biotechnological process systems Formulation system (vaccine) 48

49 Pharmatec GmbH Vaccine production facility 49

50 Pharmatec GmbH Process systems Fermentation 50

51 Pharmatec GmbH Biotechnological process systems Product cleaning Nanofiltration Cross flow filtration 51

52 Pharmatec GmbH Biotechnological process systems Product cleaning Filtration system with UF-filter, depth filter und chromatography system 52

53 Pharmatec GmbH Biotechnological process systems Continuously running thermal inactivation 53

54 Pharmatec / A Bosch Company Contact Persons Pharmatec GmbH, A Bosch Company Elisabeth-Boer-Straße 3, D Dresden, Phone: , Fax: , pharmatec@bosch.com, Sales Manager Helmut Sommer Muttenzerstraße 107 CH-4133 Pratteln Tel: Fax: Mobil: helmut.sommer@bosch.com Sales Germany / Austria Baltic Area, Poland 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 Russia, Asia, MENA Dr. Thomas Völkel Elisabeth-Boer-Straße 3 D Dresden Tel: Fax: Mobil: thomas.voelkel@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 Pharmatec Schweiz GmbH Daniel Hoda Muttenzerstraße 107 CH-4133 Pratteln Tel: Fax: Mobil: daniel.hoda@bosch.com Pharmatec GmbH Office Moscow Mike Müller ul. 8 Tekstilschikov 11 office 307 RUS Moscow Tel: Fax: Mobil: mike.mueller1@bosch.com 54 PADD 20/09/2011 Robert Bosch GmbH All rights reserved, also regarding any disposal, exploitation, reproduction, editing, distribution, as well as in the event of applications for industrial property rights.

55 Pharmatec GmbH Thank you very much for your attention! Contact details: Phone: Mobile: