Linde-KCA-Dresden GmbH is a company of the Linde Group with approximately 530 employees. Linde qualifies as a leading contractor for the design and construction of pharmaceutical, chemical and biotechnological plants.
The scope of the Division for Pharmaceutical Plants at Linde-KCA-Dresden GmbH includes design and erection of plants in the field of chemistry and biotechnology for active pharmaceutical ingredients as well as of plants for production of finished pharmaceuticals, plants for fine chemicals and crop protectives.
We are able to provide support on the transfer know-how for transatlantic projects in Europe, CIS, Asia and the Americas. We are represented world-wide by the offices of Linde Gas and Engineering.
As planner 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 molded by tailoring it to the project flow typical of the pharmaceutical industry and current market requirements.
| Project Development & Consulting | Engineering | Services |
| Front End Engineering | Conceptual Design | Licenses |
| Feasibility Studies | Basic and Detail Engineering | Documentation for the Approval and Registration |
| Second Opinion | Procurement | Joint Ventures |
| Assistance in Scale-up | Construction and Installation Supervision | Financing |
| Assistance in Developing Planning Bases | Preparation and Assistance in Commissioning | Staff Training |
| Technology Transfer | Qualification and Validation Assistance |
Pharmaceutical Design & Construction - Scope and Approach
The starting point of our projects is always the elaboration of the process. Our scope of supply covers all disciplines of the project, including the architecture and civil construction, technical equipment of the building and cleanrooms, logistics and storage as well as IT.
Linde also offers all services of a general contractor: technology transfer, conceptual design, works planning, basic and extended basic engineering, detail engineering, layout, procurement, supply and construction, commissioning including all stages of the application (DQ, IQ, OQ) and validation assistance. Through the extensive utilization of modular planning elements, we are able to achieve short planning periods with the highest planning reliability possible. All engineering tasks and procurement can be done by Linde personnel.
Our procedures of project execution are 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 a management tool to guarantee a well structured flow of work and documentation for Pharmaceutical facilities . This manner of project execution is the basis for a successful project with regard to content, target date and costs.
From the beginning of the project, 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 project is always done in accordance to GMP-Compliance and ISPE Baseline Guides. Validation is an integrated part of the project flow and a part of the Linde Quality Management Systems.
Due to our knowledge and expertise in the field of pharmaceutical processes, our successful engineering and sales departments and the financial backing of the Linde Group, we have taken the position as general contractor in several prestigious projects. On the other hand, the structure of our organization also enables Linde to be at our clients' disposal for sections of work, in particular during the step-wise project development.
Pharmaceutical Design & Construction - Plants for active pharmaceutical ingredients (API) and fine chemistry
Linde has years of experience in assisting our customers to design and construct active pharmaceutical ingredient facilities. These facilities vary from the API to intermediates used in the manufacturing of API's. Linde's past experience on these projects provides our customers with our prior experience and the comfort of a quality reference list. Today, Linde has completed the design and construction of several multiproduct API Plants, comprising a larger number of complex chemical and biotechnical process stages.
Pharmaceutical Design & Construction - BioPharmaceutical Plants
Biopharmaceutical projects are of highly increasing significance for Linde today. Linde accessed the new field of Genetechnology years ago, when working with Rhein Biotech in the development of the process for recombinant Hepatitis B vaccine.
Our contribution to the project consisted of engineering services in the upscale and in the operation of a pilot plant. Rhein Biotech has become the third largest manufacturer of Hepatitis B vaccine worldwide and was acquired by Berna Biotech AG, Switzerland, in 2002.
Today, our customers are leading biopharmaceutical companies: For Aventis Pharma Deutschland GmbH we have designed and built a plant for production and were also awarded a contract by them to design and construct a plant for production and packaging of a new type of recombinant insulin.
The total contract comprised the entire engineering of technology, architecture, civil work, infrastructure and information technology including procurement, construction and preparation for commissioning. To date, this is our largest contract for a pharmaceutical plant.
Scope of Work
Basic and Detail Engineering
Procurement (on behalf and on account)
Civil engineering
Mounting
Commissioning
Qualification
Linde elaborated an extensive conceptual design of a manufacturing plant for the recombinant blood coagulation factor VII for Bayer AG. The production is realized by means of mammalian cell culture. In the scope of suppliers and services, Linde included a transatlantic transfer of technology as well as the elaboration of the process description and Process Flow Diagrams.
Scope of Work
Know how and technology transfer from production and R&D into design basis
Conceptual design for all disciplines
See below for a short list of the successful projects in the biopharmaceutical area.
Pharmaceutical Design & Construction - Plants for Pharmaceutical Finished Dosage Forms
Every API generated either by chemical or biotech production has to be brought in dosage form for application as medicine. Linde has a wealth of experience and many references in this area that cover the entire spectrum from initial engineering and conceptual design to turnkey erection.
The manufacturing complex for finished dosage forms for Gedeon Richter Budapest is an example of Linde successfully completing a project according to schedule. Linde was responsible for the engineering and turnkey erection. The project was for hormone production in compliance with cGMP/FDA regulations. At present, this is our largest turnkey project in this area.
Scope of Work
Turnkey plants for production in compliance with FDA
General contractor
Authority engineering
Basic engineering
Detail engineering
Supply of equipment
Mounting
Qualification
Commissioning
Validation
Pharmaceutical Design & Construction - Methods and Tools
The pharmaceutical industry requires the simultaneous executing of plant design and process development, to evaluate the need of process infrastructure and to assess effort, costs and project scheduling during conceptual planning with high efficiency. In order to realize these requirements, Linde uses the following specific methods and tools:
Special planning manuals to ensure a time saving and safe design in all project phases
Linde's phase model is the central guideline for every design engineer starting from the conceptual design. It provides well structured operating sequences with clearly defined interfaces. It guarantees the highest possible efficiency in the realm of design work.
A far-reaching modular planning of process units enables efficient job sequences during design and later operation of the plant.
Our specialists verify together with the customer the scope of the design. Linde designs the process in the conceptual and basic design, supervises the consistency of planning and realization during detail engineering and erects the plant. Linde then qualifies the plant.
The modern state of software and hardware being utilized were adapted for the design tools of Pharmaceutical plants.