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P ro j e c t s i n t h e p h a r m a c e u t i c a l i n d u s t r y
From the idea to the turnkey production
Conceptual DesignBasic & Detail engineeringcGMP-compliance studiesValidation/QualificationEPCMV
www.glatt.com
Glatt Engineering - From the idea to the turnkey production 2
The Company
Glatt main projects since 1994
Companies of Glatt Group
Year of Establishment for Glatt GmbH: 1954Year of Establishment for Glatt India Engineering Pvt. Ltd.: 2008today: global leader for integrated process solutionsan international network of about 20 companiesover 50 permanent agencies as local points of contact for customers around the world40+ years of rich experience in Pharma Engineering + Plant & Process Design; globally
Process and Plant Engineering
From the idea to the production
Consulting, process design, basic and detail engineering and validation in pharmaceutical, biotech, nutraceutical, food and chemicalindustries
Green-field facilitiesBrown-field / GMP-upgradingExtensionsSite change
Focused on technology
appropriate implementation of customer’s technologyprocurement of licensors, for a variety of state-of-the-art technologiesimplementation of Glatt technologies
3Glatt Engineering - From the idea to the turnkey production
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Glatt Engineering: Project Elements
guidelines
Glatt Engineering - From the idea to the turnkey production
Glatt Engineering - From the idea to the turnkey production 5
Glatt Engineering: your partner during all phases…
Conceptual Design
DetailEngineering
Tendering/Procurement
Installation,Supervision
Start-up,Qualification
Validation
Feasibility Studies
BasicEngineering
Installation,Qualification
Operation,Qualification
Design,Qualification
RiskAnalysis
Validation Master Plan
general planning / turnkey projects
qualification & calibration
Process and Plant Engineering: Our International Business Network
International Glatt Group
specialistsof Glattnetwork
internationalSwitzerland
RamseyDesignGroup
USAGermany India
Pharma Engineering Private Ltd.
Russia
Glatt Russia
partners
international+ local
Glatt IngenieurtechnikBusiness Unit III
headed by Dr. Reinhard Böber
Glatt Engineering (global offices)
architectureconstruction
logistic
productdevelopment
process know-how
process equipment
contract manufacturing
feasibility studies
Consulting/conceptual design
Process, basic & detail design
GMP-compliance studies
validation & qualification
EPCMV
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Glatt Engineering Locations Worldwide
Weimar (Headquarters)
Glatt Ingenieurtechnik GmbH, Nordstrasse 12, 99427 Weimar / Germanyphone: +49 3643 47-0 fax: +49 3643 47-1231e-mail: [email protected]
New Delhi | India
Glatt (India) Engineering Pvt. Ltd. Plot No. 251 Okhla Industrial Estate – Phase IIINew Delhi – 110020 | Indiaphone: +91 11 40 85 85 85fax: +91 -11 40 85 85 86e-mail: [email protected]
Wiesbaden
Glatt Ingenieurtechnik GmbH, Nordenstadter Str. 36, 65207 Wiesbaden / Germanyphone: +49 611 89069-7 fax: +49 611 89069-88e-mail: [email protected]
Moscow
Glatt Ingenieurtechnik GmbH, ul. Obrucheva, 23, korp., 3117630 Moscow/ Russiaphone: +7 495 787 42 89 fax: +7 495 787 42 91e-mail: [email protected]
Pratteln
Pharmatronic AG, Hohenrainstraße 10, 4133 Pratteln / Switzerlandphone: 41 -61 826-9726 fax: +41 -61 826-9727 e-mail: [email protected]
Ramsey
Ramsey Design Group (Division of Glatt Air Techniques Inc.), 20, Spear Road, Ramsey, NJ 07446 / USAphone: +1 -201 825-1391 fax: +1 -201 825-0389 e-mail: [email protected]
Glatt Engineering - From the idea to the turnkey production
International Glatt Group – Connected by Competence
Glatt Process Technology, Binzen (Germany)
Glatt Maschinen- & Apparatebau, Pratteln (Switzerland)
Glatt Systemtechnik, Dresden (Germany)
Glatt Ingenieurtechnik, Weimar +Wiesbaden (Germany)+ Moskau (Russia) + INDIA (New Delhi)
Glatt Air Techniques, Ramsey (USA)
Glatt Pharmatech, Dijon (France)
Glatt Norden, Kastrup (Denmark)
Glatt Protech, Leicester (UK)
Glatt Pharma, Hradec Kralove (Czech Rep.)
Glatt Ireland, Cork (Ireland)
Glatt Systems Pvt. Ltd., Pune / Mumbai (India)
Glatt (India) Engineering Pvt. Ltd, New Delhi
IPC International ProcessCenter (D)
Pharmatronic (CH)
Ramsey Design Group (USA)
TTC Technology Training Center (D)
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Glatt Engineering - From the idea to the turnkey production 9
Few Software's used
Program Name FunctionFile
FormatMicrosoft Word Documentation *.docx
Microsoft Excel Spread sheets *.xlsx
Microsoft Access Data bases *.mdb
Microsoft PowerPoint Presentations *.pptx
Microsoft Project Project Scheduling *.mpp
Autodesk AutoCad 2014 CAD *.dwg
AutoCad Building Design Suite 2014 MEP *.dwg
AutoDesk Electrical 2014 Electrical Design *.dwg
AutoCAD Revit 2014 3 D design *.rvt
Visio Standard Organisation, process flows *.vsd
Adobe Acrobat 11.0 PDF Reader *.pdf
3-D
Process and Plant Engineering: Focused on Technology
drugs: solids, semi-solid and liquid dosage forms: e. g. tablets, coated tablets, capsules, infusions, injections
blood plasma productsvaccines, insulin
yeast, dairy products,instant products, ingredients: e. g. flavors, enzymes, proteins, vitaminsothers...
fertilizers, detergents components, enzymes, potash, polymers others...
Pharmaceutical industry
Food / Feed industry
Biotechnology
Chemical / Fine chemical industry
References:GMP solids,GermanyInfusions LVPRussiaAPI, NorwayBlood plasma, RussiaBCG vaccine,UkraineInsulin SVPUkraineYeast, SyriaBaby Food, RussiaFlavors, FrancePotash, GermanyDetergents,GermanyNaCN, RussiaSolids, INDIA
10Glatt Engineering - From the idea to the turnkey production
infusions solid dosage forms
Glatt References in Pharma & Biotech
baby food / dairy products
blood plasma products BCG vaccine
infusions solid dosage forms insulin
plasma pheresis
11Glatt Engineering - From the idea to the turnkey production
Why use us?
2/10/2015 Glatt Process and Plant Engineering - From the Idea to the Turnkey Production 12
Why Glatt??
• Ensuring that the project follows clearly laid out guidelines
• Commitment of competent Engineers in all disciplines
• German Project Director during lifecycle of project
• Timely delivery of quality deliverable
• Proven Track record in said field
• Adherence to Project schedule
• Long term association
• Avoiding Surprises
• Trust…
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Glatt Engineering
Glatt your partner in -
Consulting
+ Design
+ Engineering
+ Supply
+ Installation
+ Commissioning
+ Qualification
+ Instruction and Training
+ Support and Service
= Integrated Solutions from ‘one source’…
14Glatt Engineering - From the idea to the turnkey production