Process and Plant Engineering for the Pharmaceutical...

Process and Plant Engineering for the Pharmaceutical Industry

From the idea to the turnkey production

ConsultingDesignEngineeringImplementation

1

International Glatt Group

Glatt main projects since 1994

Companies of Glatt Group

Our focus is customer‘s satisfaction:1954: company foundation, first pharmaceutical fluid bed unit today: global leader for integrated process technologyinternational group of companies: about 1500 employees in an international network of about 20 companiesover 50 permanent agencies as local points of contact for customers around the world

2Process and Plant Engineering for the Pharmaceutical Industry by Glatt - presented at Workshops Green Tech and Medical Technologies on Thursday, February 18, 2010

International Glatt Group – Range of Products & Services

Process Technology and Equipment

process development & -optimization, scale-upequipment: laboratory units, production units, product handling systems …

Development in own Technology Centers

product & formulation development for solid dosage formsprocess development for granules and pellets for food/feed and fine chemical applications

Contract Manufacturing

all kind of granules and pellets for pharmaceu-tical, food/feed and fine chemical industries

Process and Plant Engineering

new building, renovation, GMP-upgrading, extension, displacement of production


PlantEngineeringValidation

Qualification

Process-Technology(Equipment)

ProductDevelopment


Process-Technology(Equipment)

BU IIIBU I BU II


BU IV

BU III – Management:

Glatt Ingenieurtechnik GmbH Weimar / Germany

headed by Reinhard Böber

International Glatt Group – Structure in Business Units

Pharmaceutical industry and Biotechnologies

Food industry

Feed industry

Chemical / Fine chemical industry


Glatt Ingenieurtechnik Weimar - Milestones

Glatt Business Unit III 1981 development of continuous fluid bed technology

1983 first continuous fluid bed unit type “AGT”

1991 establishment of Glatt Ingenieurtechnik GmbH in Weimar

1994 transfer to new company building (Nordstrasse)

1996 development of Glatt fluid bed unit type “GF”

1996 representative office Shanghai, China

1997 first turnkey-project: insulin production (Ukraine)

2000 representative office Moscow, Russia

2001 branch office Wiesbaden, Germany

2004 development of spouted bed unit type “ProCell”

2006 branch office Kirov, Russia

2006 branch office Moscow, Russia

2007 PGS engineering (joint venture) in Milan, Italy

2008 branch office New Delhi, India

2009 extension of technology center + offices in Weimar (Nordstrasse)


Glatt Engineering Locations

Weimar, Germany (Headquarters)

Glatt Ingenieurtechnik GmbH

Wiesbaden, Germany


Moscow, Russia


Kirov, Russia


Kopenhagen, Denmark


Dijon, France


Pratteln, Switzerland

Pharmatronic AG,

Milan, Italy

pgs engineering

New Delhi, India

Glatt (India) Pharma Engineering Pvt. Ltd.,

Ramsey, USA

Ramsey Design Group (Division of Glatt Air Techniques Inc.),


Glatt Engineering: Your Project Partner for Plant Engineering

7

consulting, design, engineering and implementation

also as general planner or as general contractor

for new buildings, modifications, modernizations and extensions

for processes, production lines, complete facilities

in pharmaceutical industry, biotechnologies, food and feed industries, chemical and fine chemical industries

From the Idea to the turnkey production

Process and Plant Engineering for the Pharmaceutical Industry by Glatt - presented at Workshops Green Tech and Medical Technologies on Thursday, February 18, 2010

Glatt Engineering: Processes and Production Facilities in Focus

8

Solid and semi/solid dosage forms

from sterile and non/sterile processestablets/film-coated tablets sugar-coated pillscapsulespowders and granulateointments/cremessuppositories

Liquid dosage forms

from sterile and non/sterile processesblood plasma productvaccinesinsulininfusion solutionsinjection solutionstinctures, extracts, juices, drops


Production of an API of a X-Ray Contrast Agent – turn key plant

customer: GE Healthcare AS Norwaylocation: Lindesnes, Norway

schedule: 2008product: API of a X-Ray contrast agent

capacity: 270 kg/hscope of process engineering:

supply: - transport and distribution of liquid raw material

- redesign of bulk transfer system

delivery of the total process equipment:- continuous Glatt fluid bed granulator

GFG 350- auxiliary equipment

work at site during running production:- installation- commissioning- qualification (DQ, IQ, OQ)- validation support

9

Changing the production from batch to a costefficient continuous processing

other projects based on continuous technologies:

Bayer, Italy

Henkel,Germany

Kemira, Sweden

Ajinomoto, Italy

Rohm&Haas, France

OCI, USA

Element Six, South Africa

Sweetener, Singapore


Blood Plasma Fractionation Plant – Turn Key Project

Construction of a new production facility for the manufacturing of human blood plasma products

customer: Rosplasma, Russian Federationlocation: Kirov, Russian Federation

schedule: 2006 – 2010

products/capacity: blood plasma fractionation 600,000 l/year to: - Albumin in 50 ml, 250 ml bottles

1,600,000 bottles/year- IgG Immunglobulin in 50, 100, 200 ml

bottles - 440,000 bottles/year- factor VIII in 20 ml bottles

134,000 bottles/year- factor IX in 20 ml bottles

94,000 bottles/year

scope of supply: turnkey project- conceptual, basic + detail engineering - site development and buildings- delivery, assembly and installation

of the complete facility- supply of production licenses - commissioning- qualification of process equipment- validation assistance- staff-training

10

other projects applied to pharmaceutical liquid dosage forms:

B.Braun, Germany

B.Braun/ Gematek, Russia

TEVA, Israel

AB Pharm, Kazakhstan

Olainfarm, Latvia

Biomed, Ukraine


customer: TEVA Pharmaceutical Industries Ltd.

location: Jerusalem, Israel

schedule: 2005

product: tablets and capsules

capacity: 8.000 Mio units/year

scope of supply: process design for the erection of a pharmaceutical production facility:from weighing - via bulk production - to packaging- conceptual design for storage and production

- basic engineering - integrated engineering:

Glatt-technologies forweighing, fluid bed processes, blending, handling and container washing

Pharma - New Production Facility according to GMP-EU- & FDA-Standard

Construction of a new production facilityfor tablets and capsules

11

other projects applied to pharmaceutical solid dosage forms:

Altana, Ireland

Altana, Germany

Boehringer Ingelheim, Germany

Novartis, Germany

Helvetica Pharmaceuticals, Nigheria

Intervet, Austria

Leo Pharma-ceutical, Denmark


Business opportunities

Delivery of Glatt equipment for Batch and Continuous production of granules and pellets and product development

Engineering services in different levels

Engineering services in different scopes of supply up to turnkey engineering for new production facilities

Engineering support for your investment in emerging markets, e.g. Russia, India and China


Germany - Thuringia - Weimar - Site Opportunities

WeimarLocated in the heart of GermanyExcellent & state-of-the-art infrastructureAttractive incentivesCultural City of Europe 1999Residence of the famous German poets Goethe and SchillerNietzsche ArchiveHome of the Bauhaus - founded by Walter Gropius 1919



Nietzsche Archive

Nietzsche Archive



Residence of the famous Germanpoets Goethe and Schiller



Nietzsche Archive

Home of the Bauhaus - founded by Walter Gropius 1919


Process and Plant Engineering for the Pharmaceutical...

Documents

Transcript of Process and Plant Engineering for the Pharmaceutical...