Linde-KCA-Dresden GmbH Company Portrait

Transcription

Competence in Engineering & Contracting
for the Pharmaceutical Industry
Postal address:
Postfach 21 03 53
01265 Dresden, Germany
House address:
Bodenbacher Straße 80
01277 Dresden, Germany
Linde-KCA-Dresden GmbH
Section Pharmaceutical Plants
Phone:
Fax:
E-Mail:
Internet:
+49 3 51 250 3707
+49 3 51 250 4814
[email protected]
www.linde-kca.com
The Company Linde-KCA-Dresden GmbH
Competence in Engineering & Contracting for the Pharmaceutical Industry
The Competence of Linde in
Engineering & Contracting of Pharmaceutical Plants
Linde-KCA-Dresden GmbH is a part of the Linde group with its headquarters in Wiesbaden, Germany, and more than 47’000 people employed
worldwide. We are a part of the Linde Business Segment ‘Gas and Engineering’ and have qualified ourselves as a leading contractor for the design and construction of pharmaceutical, chemical and biotechnological
plants.
As planer and contractor for plants for the production of pharmaceuticals,
our major duty is to assure the keys to success of the investor: product
quality and a short time to market. Furthermore, the engineering must be
moulded by tailoring it to project flows typical of the pharmaceutical industry and current market requirements.
Starting point of our projects is always the elaboration of the process.
Around this core element, our scope of supply covers all disciplines of the
projects, including the architecture and civil construction, technical equipment of the building and cleanrooms, logistics and storage as well as IT.
Through the extensive utilisation of modular planning elements we achieve
short planning periods with the highest planning reliability possible. All engineering tasks and also the procurement can be done from our own Linde
personnel located in Dresden, Germany, and Basel, Switzerland.
Our procedure of project execution is based on the experience of Linde in
the field of engineering and contracting of the last decades. It has been
specifically adapted to pharmaceutical projects. It links accurately all work
processes spread over different parties and describes the interfaces between them. Its foundation is a phase model which has been developed by
Linde specifically as management tool for pharmaceutical facilities to
guarantee a well structured work- and document flow. This manner of
project execution is the base of a successful project with regard to content, target date and costs.
From the beginning of the project on, and, if necessary, all the way
through until the start-up of the installation and its qualification, the flexible
Linde project teams work as a task force at the client’s site.
The execution of the projects is always done according to GMPCompliance and ISPE Baseline Guides. The qualification is an integrated
part of the project flow from the start of the project on and a part of the
Linde Quality Management Systems.
In case you are considering to plan and realise a pharmaceutical project,
please feel free to contact us any time and to profit from our competence,
our commitment and our efficiency. We would like to convince you of our
capability and to acquire you as a satisfied customer.
If you would like to get more detailed information, you are very welcome to
visit us in our offices in Dresden and near Basel.
2
The Linde Group
Linde’s business segments have established
leading positions in their
markets.
Engineering
Gas
Material Handling
Refrigeration
LINDE-KCA-DRESDEN GMBH
Linde Engineering Division
Engineering Operations and Sales Offices
The Linde group with its
offices is worldwide
present.
Chicago
Tulsa
Houston
Dresden
Aldershot
Paris
München
Birsfelden
Grenzach-Wyhlen
Dalian
New Jersey Pfungen
New York
Abu
Beijing
Rom
Pennsylvania
Dhabi
Seoul
Baroda
Atlanta
Bangkok
Riyadh
Kuala
Lumpur
Johannesburg
Engineeringoperations
Sydney
Linde’s
pharmaceutical
engineering
services are
performed by:
- Linde-KCA-Dresden
(head office) with its
offices in
Basle region (CH, D)
- Linde Process Inc. in
Tulsa (USA)
Sales offices
3
Head Office of
Linde-KCA in Dresden,
the capital of Saxony.
Production lines
Chemical and
Gas Plants
Gas cleaning and gas
separation
Pharmaceutical
Plants
for
Environmental
Plants
for
Production of API
Wastewater treatment
Pharmaceutical finished
dosage forms
Waste treatment facilities
Air separation
Olefins
Biotechnological products
Synthesis gases
Fractionation of blood plasma
Polymers
Water treatment
The activities of LindeKCA-Dresden comprise
three different lines.
We offer the full
engineering scope from
the project
development up to the
commissioning of the
plant.
Exhaust gas / exhaust air
purification
Refineries
Plants for
Tank farms
Fine chemicals
Plastics processing
Crop protectives
4
Linde-KCA in Figures
1997
1998
1999
2000
2001
479
488
494
530
530
97
97
Sales (million €)
106
120
117
147
146
Orders received (million €)
157
130
133
151
136
Employees
from this Pharmaceutical Plants
Company Organization
103
96
104
During the last years
the sales of the division
Pharmaceutical Plants
represented about
30 to 40 % of the company sales.
New:
In the year 2002 the
number of employees of
the division Pharmaceutical Plants increased to 146.
This is a consequence
of the integration of the
formerly independent
Linde Syntech GmbH,
located in the Basel region, as a new department within Linde-KCA.
(per 01.09.2002)
The organization of
Linde-KCA-Dresden
allows to execute largescale and small-scale
projects, as well as process oriented engineering tasks like project development and
conceptual
design.
All necessary
engineering services
are in house.
5
Linde‘s Activities for Pharmaceutical Industry
Plant Spectrum
Biotechnological
Plants
Plants for
Pharmaceutical
Production
API-Plants
Plant Spectrum
&
Activities
Pilot Plants
Plants for
Fine Chemicals
All types of
pharmaceutical
plants have been
engineered,
constructed,
commissioned
and qualified
by Linde.
Supply and
Ancillary
Equipment
Reconstruction/
GMP-upgrading
of Plants
Laboratories
Pharmaceutical Plants
Our Offer
Project Development/
Consulting
Engineering
Services
4 Front End Engineering
4 Conceptual Design
4 Licenses
4 Feasibility Studies
4 Basic- and Detail Engineering
4 Second Opinion
4 Procurement
4 Assistance in Scale-up
4 Construction and Installation
Supervision
4 Documentation for
the Approval and
Registration
4 Assistance in Developing
the Planning Bases
4 Technology Transfer
4 Preparation and Assistance
in Commissioning
4 Qualification (DQ, IQ, OQ)
4 Joint Ventures
4 Financing
4 Staff Training
Linde-KCA offers its
engineering services as
General Contractor or
as EPCM-Partner.
With regard to the contract we are rather flexible. Invoicing can be
done at cost or based
on a fixed price defined
and agreed on in the
contract.
4 Validation Assistance
Please ask for
further offers!
6
Linde-Disciplines
HVAC, Sanitary
Layout,
Civil Construction,
Logistics
Linde has all relevant
engineering disciplines
in house.
Process Technology,
Utilities
Project management
Authority
Engineering,
Safety
Pharmaceutical
Plants
Clean Room
Technology
Electrical
Installation, PLT, IT
All works are executed
according to an
established project plan,
division of work, certified interfaces and
standard execution
schedule.
GMP,
Rules, Guidelines,
Qualification
Why Linde?
g
Detailed knowledge in pharmaceutical processing technology
g
References in designing and constructing API-plants, biotech
plants and plants for the production of finished dosage forms
g
All engineering disciplines are in house
g
Technology transfer experience
g
Internationally experienced project management
g
Flexibility in cooperation due to on-site presence and use of
state-of-the art system technology compatible with client's
requirements
g
Willingness to take on fixed price scope of work and to execute
turn-key plants
g
Pharmaceutical engineering offices located in Europe and
the USA
We live on the success
of our clients. Using innovative technology and
comprehensive knowhow, we turn their goals
into ours. Fair, transparent and aware of the
cost. ...*
* excerpt of the mission of
Linde-KCA-Dresden GmbH
7
Our Customers
■
ALTANA PHARMA AG
■
GALENICA AG
■
AVENTIS BEHRING GmbH
■
GEDEON RICHTER Ltd.
■
AVENTIS PHARMA
DEUTSCHLAND GmbH
■
HEXAL AG
■
BAYER AG
■
INFRALEUNA
INFRASTRUKTUR UND SERVICE GmbH
■
BAYER BIOLOGICALS SrI.
■
JENAPHARM GmbH
■
BIOMED (UA)
■
MERCK KGaA
■
BIOTEST PHARMA GmbH
■
MERCKLE GmbH
■
BOEHRINGER INGELHEIM
■
OCTAPHARMA PHARMAZEUTIKA
PRODUKTIONSGESELLSCHAFT m.b.H.
■
CHEMTEC
■
RHEIN BIOTECH
■
DEGUSSA-HÜLS AG
■
RÜTGERS ORGANICS GmbH
■
ENZIM
■
SCHERING AG
■
FDS PHARMA ASS
SKW TROSTBERG AG
■
■
F. HOFFMANN-LA ROCHE AG
■
SOLVAY PHARMACEUTICALS B.V.
After 12 years of engineering & contracting
for the pharmaceutical
industry, we can look
back on the experience
of over 60 projects.
Reference Situation of Linde-KCA-Dresden GmbH
Development Phases of Pharmaceutical Products of Chemical and Biotech API-Plants
Laboratory
Laboratory
Development
Development Laboratory
Laboratory
Pilot
Pilot Plant
Plant (Scale
(Scale up
up ))
Production
Production Plant
Plant
Project Examples
Linde-KCA-Dresden
has expertise and references for all development phases of a
pharmaceutical product.
Aventis
Aventis Behring
Behring Marburg
Marburg
BAYER
BAYER Elberfeld
Elberfeld
Aventis
Aventis Pharma
Pharma Frankfurt
Frankfurt
BAYER
BAYER Kogenate
Kogenate (KG3)
(KG3) Elberfeld
Elberfeld
Degussa
Degussa Trostberg
Trostberg
F.
F. Hoffmann-La
Hoffmann-La Roche
Roche Basel
Basel
Biotest
Biotest Dreieich
Dreieich
Boehringer
Boehringer Ingelheim
Ingelheim
Galenica-Bern
Galenica-Bern St.
St. Gallen
Gallen
Rhein
Rhein Biotech
Biotech Düsseldorf
Düsseldorf
Rütgers
Rütgers Organics
Organics
Schering
Schering // Jenapharm
Jenapharm Jena
Jena
Octapharma
Octapharma Vienna
Vienna
Phase Work Planning
In Operation
Erection phase
Design Phase
The following two projects are current :
- Octapharma in Vienna
> Conceptual design
to detail engin. for
the construction of
an aseptic filling
line with barrier
isolator and
- Biotest near Frankfurt
> e.g. qualification +
project management for a new plant
for the production of
blood coagulation
products
8

Linde-KCA-Dresden GmbH Company Portrait

Transcription

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