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



Pharmatec GmbH


Pharmatec GmbH a member of Bosch




Pharmatec GmbH


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




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




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



Pharmatec GmbH – Processes and products


Product Preparation /Substrate Preparation

Filling

up stream

Sterilisation

Final packing


SBM (Schoeller Bleckmann Medizintechnik)


down stream

CIP / SIP Units

PW generationStills / PSG

Pure Media Systems

Production process of sterile pharmaceutical liquids

as classical chemic-physical process



Pharmatec GmbH – Processes and products


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


SBM (Schoeller Bleckmann Medizintechnik)


down stream

Production process of sterile pharmaceutical liquids

as biotechnological process



Pharmatec GmbH - Engineering


Project handling

- quality management ISO 9001-2008

- documented project execution procedure





3D-planning of single equipment





3D-planning of equipment systems





3D-planning of equipment systems



Pharmatec GmbH - Automation


Automation components – Siemens hardware as standard





Hardware configuration of formulation equipment





Operation screen layout





Parameter trends





Batch reporting





User administration



Pharmatec GmbH - our workshop


Assembly of standard equipment, prefabricated modules for water systems an and process systems at 2.500 m²





Complete pre-assembling and testing of complex systems





Technical room to supply utilities for factory acceptance tests (FAT)



Pharmatec GmbH - GMP compliant piping


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



Pharmatec GmbH - Service


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



Pharmatec GmbH


Thank you for your attention !



Pharmaceutical water and pure steam


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





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





Pharmatec still at Fresenius AG, output 15.000 l/h





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





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






WFI system

85°C

Pharmatec still for WFI generation

Cold user points

Heat exchanger for keeping temperature

Hot user points





Pharmatec Pure steam generator

Pure steam

distribution

system






Storage vessels and distribution skid for PW and WFI at customer’s site, completely prefabricated and pre tested at Pharmatec’s workshop





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





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



CIP/SIP units and systems


CIP/SIP (Cleaning In Place / Steaming In Place) units

CIP returns

CIP suppliesDetergent dosing

Buffer vessel for cleaning liquid preparation

Heat exchanger

Quality monitoring





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





CIP system for a biotechnological application



Pharmatec GmbH - Process systems


LVP solution preparation system





Blood bag solution preparation system





SVP solution preparation





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,




NaOH-Unit

CIP Unit

Thawing

Tempering Module





Blood plasma fractionation … albumin, IgG





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





Process system with isolator for toxic products





Process system with isolator for toxic products



Pharmatec GmbH


Harvest

Buffer preparation

Media preparation

Mobile vessel and media panels

Bio system … upstream and downstream processes




Preparation / Substrate sterilisation

Pharmatec GmbH – Biotechnological process systems




Formulation system (vaccine)




Pharmatec GmbH


Vaccine production facility



Pharmatec GmbH – Process systems


Fermentation





� Nanofiltration � Cross flow filtration

Product cleaning




� Filtration system with UF-filter, depth filter und chromatography system

Product cleaning





Continuously running thermal inactivation


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


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


Sales Export Russia, Asia, MENA Dr. Thomas Völkel


D-01099 Dresden

Tel: +49 351 282 78-613

Fax: +49 351 282 78-820


Pharmatec Schweiz GmbH Daniel Hoda

Muttenzerstraße 107

CH-4133 Pratteln

Tel: +41 61 465 10-92

Fax: +41 61 465 10-91


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


Sales Export WestN/S America, W Europe Albrecht Voigt


D-01099 Dresden

Tel: +49 351 282 78-614

Fax: +49 351 282 78-820


Sales ManagerHelmut Sommer

Muttenzerstraße 107

CH-4133 Pratteln

Tel: +41 61 465 10-94

Fax: +41 61 465 10-91


Contact Persons

54



Pharmatec GmbH


Thank you very much for your attention!Contact details:

[email protected]

Phone: 0049 351 28 278 812

Mobile: 0049 172 34 153 24

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Bosch - Pharmatec GmbH · 3 Pharmatec GmbH | 20/09/2011 | © Robert Bosch GmbH 2011. All rights...

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