Page 1
1 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
Packaging Technology
Bosch - Pharmatec GmbHGMP Compliant Pure Media Systems and Process Equipment for Pharmaceutical and Biotechnology Industry
Dipl. Ing. Volker Szczeczinski, Sales Manager Germany, East Europe
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2 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
Pharmatec GmbH
Packaging Technology
Pharmatec GmbH a member of Bosch
Packaging Technology
Page 3
3 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
Pharmatec GmbH
Packaging Technology
Our Company
1993 founded in Dresden, Germany2007 bought by Bosch Packaging
Pharmatec GmbHElisabeth-Boer-Straße 301099 Dresden, GermanyTel.: 0351/28278-0Fax: 0351/28278-662E-Mail: [email protected] : www.pharmatec.de
History:
Employees:
Address:
General Manager: Ralf Kretzschmar97 employees; there of:47 in Engineering 15 in Assembling / Orbital weld 12 in Service 7 in Sales / Project development
16 in Administration
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4 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
Packaging Technology
Equipment
Systems
Pure water WFI/PS filling sterilization pac kaging
CIP/SIP
preparation
All systems we design and execute are fully cGMP compliant with our total process guarantee.
Pharmatec GmbH - Pharmaceutical production process of sterile liquids
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5 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
Packaging Technology
Storage and Distributionof AP/HPW
Production ofPure Steam
Production of Water for Injection
Storage of Water for Injection
Distributionof WFI
Product SterilizationFilling
of liquids
Production ofAP/HPW
Distribution ofPure Steam
CIP/SIP/WIP
Fermentation
Plants for production of sterile liquids
Thermal Inactivation
Pharmatec GmbH - Pharmaceutical production process of sterile liquids
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6 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
Pharmatec GmbH – Processes and products
Packaging Technology
Product Preparation /Substrate Preparation
Filling
up stream
Sterilisation
Final packing
Packaging Technology
SBM (Schoeller Bleckmann Medizintechnik)
Packaging Technology
down stream
CIP / SIP Units
PW generationStills / PSG
Pure Media Systems
Production process of sterile pharmaceutical liquids
as classical chemic-physical process
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7 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
Pharmatec GmbH – Processes and products
Packaging Technology
Product Preparation /Substrate Preparation
Fermentation
Product Harvesting
Filling
CIP / SIP Units
Stills /PSG
Pure Media Systems
up stream
Disposal(Inactivation)
Product Cleaning
Product Sterilisation
Sterilisation
Final Packing
Packaging Technology
SBM (Schoeller Bleckmann Medizintechnik)
Packaging Technology
down stream
Production process of sterile pharmaceutical liquids
as biotechnological process
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8 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
Pharmatec GmbH - Engineering
Packaging Technology
Project handling
- quality management ISO 9001-2008
- documented project execution procedure
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9 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
Pharmatec GmbH - Engineering
Packaging Technology
3D-planning of single equipment
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10 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
Pharmatec GmbH - Engineering
Packaging Technology
3D-planning of equipment systems
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11 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
Pharmatec GmbH - Engineering
Packaging Technology
3D-planning of equipment systems
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12 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
Pharmatec GmbH - Automation
Packaging Technology
Automation components – Siemens hardware as standard
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13 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
Pharmatec GmbH - Automation
Packaging Technology
Hardware configuration of formulation equipment
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14 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
Pharmatec GmbH - Automation
Packaging Technology
Operation screen layout
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15 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
Pharmatec GmbH - Automation
Packaging Technology
Parameter trends
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16 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
Pharmatec GmbH - Automation
Packaging Technology
Batch reporting
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17 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
Pharmatec GmbH - Automation
Packaging Technology
User administration
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18 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
Pharmatec GmbH - our workshop
Packaging Technology
Assembly of standard equipment, prefabricated modules for water systems an and process systems at 2.500 m²
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19 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
Pharmatec GmbH - our workshop
Packaging Technology
Complete pre-assembling and testing of complex systems
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20 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
Pharmatec GmbH - our workshop
Packaging Technology
Technical room to supply utilities for factory acceptance tests (FAT)
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21 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
Pharmatec GmbH - GMP compliant piping
Packaging Technology
PermissionsAuthorised company on AD data sheet HP 0TÜV-proofed company on § 19 („Water supply law“)Certification on DIN ISO 9001
Test certificatesApproved welder on EN 287-1 141 T BW W11 TÜV North Boroscopical
inspection & video print
Orbital welding technology
Ferrite content inspection
Surface quality inspection
GMP compliant pipe work installation
and pipe work documentation
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22 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
Pharmatec GmbH - Service
Packaging Technology
24 hours service hotline, 7 days per week
Maintenance, service and repair works
Support in IQ/OQ
Spare and wear part delivery
Maintenance contracts
Training of operator and maintenance staff
Hard- and software upgrade of own and by third parties produced equipment
Recalibration and requalification of own and by third parties produced equipment
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23 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
Pharmatec GmbH
Packaging Technology
Thank you for your attention !
Page 24
24 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
Pharmaceutical water and pure steam
Packaging Technology
Pharmatec PW and HPW generation units 400 l/h … 25.000 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
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25 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
Pharmaceutical water and pure steam
Packaging Technology
Pyramide VT Handbuch
Pharmatec stills 50 l/h … 15.000 l/h
Qualified standard design on attractive price level
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
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26 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
Pharmaceutical water and pure steam
Packaging Technology
Pharmatec still at Fresenius AG, output 15.000 l/h
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27 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
Pharmaceutical water and pure steam
Packaging Technology
Pure steam generators 50 kg/h ….5.000 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 recor-ding of conductivity
• degassing facility for removal of non condensable gases
• CFR 21/11requirements• GAMP 4 requirements• electrical heated up to 200 kg/h
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28 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
Pharmaceutical water and pure steam
Packaging Technology
Pharmatec provides the design and dimensioning of pure media systems according to the consumption requirements at points of use
PW system
20°C
PW generation
Pharmatec Pure steam generator
Pharmatec CIP/SIP unit
Pharmatec still for WFI generation
Heat exchanger for recooling
Heat exchanger for sanitization
Quality monitoring in the loop return
Cold sanitisation with Ozone and UV
Ozon
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29 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
Pharmaceutical water and pure steam
Packaging Technology
Pharmatec provides the design and dimensioning of pure media systems according to the consumption requirements at points of use
WFI system
85°C
Pharmatec still for WFI generation
Cold user points
Heat exchanger for keeping temperature
Hot user points
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30 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
Pharmaceutical water and pure steam
Packaging Technology
Pharmatec Pure steam generator
Pure steam
distribution
system
Pharmatec provides the design and dimensioning of pure media systems according to the consumption requirements at points of use
Page 31
31 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
Pharmaceutical water and pure steam
Packaging Technology
Storage vessels and distribution skid for PW and WFI at customer’s site, completely prefabricated and pre tested at Pharmatec’s workshop
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32 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
Pharmaceutical water and pure steam
Packaging Technology
Still and pure steam generator corresponding to distribution the skid for PW and WFI at customer’s site
Page 33
33 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
Pharmaceutical water and pure steam
Packaging Technology
Purified water generation unit with pre treatment, RO modules and EDI corresponding to distribution the skid for PW and WFI at customer’s site0
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34 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
CIP/SIP units and systems
Packaging Technology
CIP/SIP (Cleaning In Place / Steaming In Place) units
CIP returns
CIP suppliesDetergent dosing
Buffer vessel for cleaning liquid preparation
Heat exchanger
Quality monitoring
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35 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
CIP/SIP units and systems
Packaging Technology
Special Design
1 Vessel CIP Unit (mobile) 2 Vessel CIP Unit (stationary)
3 Vessel CIP/SIP Unit (special design)
Cleaning equipment without vessel
1 Vessel CIP/SIP Unit (filling lines)
Integration of CIP/SIP Units in process equipment
3 Vessel CIP Unit (staple unit)
4 Vessel CIP Unit
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36 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
CIP/SIP units and systems
Packaging Technology
CIP system for a biotechnological application
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37 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
Pharmatec GmbH - Process systems
Packaging Technology
LVP solution preparation system
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38 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
Pharmatec GmbH - Process systems
Packaging Technology
Blood bag solution preparation system
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39 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
Pharmatec GmbH - Process systems
Packaging Technology
SVP solution preparation
Page 40
40 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
Pharmatec GmbH - Process systems
Packaging Technology
Vaccine production system
Page 41
41
Blood Plasma Fractionation … Basis Fractionation
Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
Pharmatec GmbH - Process systems
Packaging Technology
NaOH-Unit
CIP Unit
Thawing
Tempering Module
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42 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
Pharmatec GmbH - Process systems
Packaging Technology
Blood plasma fractionation … albumin, IgG
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43 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
Pharmatec GmbH - Process systems
Packaging Technology
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
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44 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
Pharmatec GmbH - Process systems
Packaging Technology
Process system with isolator for toxic products
Page 45
45 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
Pharmatec GmbH - Process systems
Packaging Technology
Process system with isolator for toxic products
Page 46
46 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
Pharmatec GmbH
Packaging Technology
Harvest
Buffer preparation
Media preparation
Mobile vessel and media panels
Bio system … upstream and downstream processes
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47 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
Packaging Technology
Preparation / Substrate sterilisation
Pharmatec GmbH – Biotechnological process systems
Page 48
48 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
Packaging Technology
Formulation system (vaccine)
Pharmatec GmbH – Biotechnological process systems
Page 49
49 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
Pharmatec GmbH
Packaging Technology
Vaccine production facility
Page 50
50 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
Pharmatec GmbH – Process systems
Packaging Technology
Fermentation
Page 51
51 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
Packaging Technology
Pharmatec GmbH – Biotechnological process systems
� Nanofiltration � Cross flow filtration
Product cleaning
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52 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
Packaging Technology
� Filtration system with UF-filter, depth filter und chromatography system
Product cleaning
Pharmatec GmbH – Biotechnological process systems
Page 53
53 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
Packaging Technology
Continuously running thermal inactivation
Pharmatec GmbH – Biotechnological process systems
Page 54
PADD | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction, editing,
distribution, as well as in the event of applications for industrial property rights.
Pharmatec / A Bosch Packaging Technology Company
Packaging Technology
Sales Germany / AustriaBaltic Area, PolandVolker Szczeczinski
Elisabeth-Boer-Straße 3
D-01099 Dresden
Tel: +49 351 282 78-812
Fax: +49 351 282 78-820
Mobil: +49 172 341 53 [email protected]
Pharmatec GmbH, A Bosch Packaging Technology CompanyElisabeth-Boer-Straße 3, D-01099 Dresden, Phone: +49 351 282 78-0, Fax: +49 351 282 78-662, [email protected] , www.pharmatec.de
Sales Germany / AsiaRalf Roepenack
Eschborner Landstraße 130-132
D-60489 Frankfurt
Tel: +49 69 790 93-40
Fax: +49 69 790 93-45
Mobil: +49 174 188 82 [email protected]
Sales Export Russia, Asia, MENA Dr. Thomas Völkel
Elisabeth-Boer-Straße 3
D-01099 Dresden
Tel: +49 351 282 78-613
Fax: +49 351 282 78-820
Mobil: +49 174 316 10 [email protected]
Pharmatec Schweiz GmbH Daniel Hoda
Muttenzerstraße 107
CH-4133 Pratteln
Tel: +41 61 465 10-92
Fax: +41 61 465 10-91
Mobil: +41 79 427 71 [email protected]
Pharmatec GmbHOffice Moscow Mike Müller
ul. 8 Tekstilschikov 11
office 307
RUS-109129 Moscow
Tel: +7 499 176 92-58
Fax: +7 499 176 92-58
Mobil: +7 916 991 58 [email protected]
Sales Export WestN/S America, W Europe Albrecht Voigt
Elisabeth-Boer-Straße 3
D-01099 Dresden
Tel: +49 351 282 78-614
Fax: +49 351 282 78-820
Mobil: +49 172 369 22 [email protected]
Sales ManagerHelmut Sommer
Muttenzerstraße 107
CH-4133 Pratteln
Tel: +41 61 465 10-94
Fax: +41 61 465 10-91
Mobil: +41 79 697 84 [email protected]
Contact Persons
54
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55 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights reserved, also regarding any disposal, exploitation, reproduction,
editing, distribution, as well as in the event of applications for industrial property rights.
Pharmatec GmbH
Packaging Technology
Thank you very much for your attention!Contact details:
[email protected]
Phone: 0049 351 28 278 812
Mobile: 0049 172 34 153 24