bosch - pharmatec gmbh · 3 pharmatec gmbh | 20/09/2011 | © robert bosch gmbh 2011. all rights...

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

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

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: pharmatec@bosch.comweb: 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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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)

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

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

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 !

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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 24volker.szczeczinski@bosch.com

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, pharmatec@bosch.com, 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 85ralf.roepenack@bosch.com

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 12thomas.voelkel@bosch.com

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 90daniel.hoda@bosch.com

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 70mike.mueller1@bosch.com

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 47albrecht.voigt@bosch.com

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 45helmut.sommer@bosch.com

Contact Persons

54

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:

Volker.Szczeczinski@bosch.com

Phone: 0049 351 28 278 812

Mobile: 0049 172 34 153 24