Eck Pharmaceutical Consulting
The cooperation of cape7 engineering services GmbH with Eck Pharmaceutical Consulting:
a partnership to your advantage
This cooperation creates most favourable conditions, in order to support the needs of our customers very effectively. cape7 engineering services GmbH developed from - among others - fine chemistry, where projects were successfully realised dealing with topics such as raw material preparation, reactors, mixing- and separation systems, transport and silation, filling and packaging.
Volker Eck, PhD, after many years in leading pharmaceutical companies, has become a well-known address when it comes to consulting, training and coaching of pharmaceutically-based companies by his Eck Pharmaceutical Consulting service. As an important added value for the pharmaceutical industry, cape7 engineering services GmbH offers specific methodology and experience in production and production process development.
Projects within the Pharmaceutical-, Cosmetic- and Food industry are demanding, complex and require an intensive consultation among the involved disciplines.
Our goal is to offer our customers an attractive range of services available to their specific needs, flexible, and in accordance with relevant regulations.
Innovative solutions coupled with personal commitment are important to us. We optimize, for example, at the same time your micro-logistics needs of your plants.
Our service generates added value to you: professionally, economically and personally.
Typical requirements to be considered are:
* hygiene requirements
* microbiological purity
* sterility
* material compatibility
* cleaning requirements
* highest reproducibility
* safe operation
* easy maintenance.
In parallel, "Quality by Design" should allow for continual process improvement in defined limits. We bring the expertise for your project success.
In addition, any project advances or fails depending on the cooperation amongst the people involved. We offer systematic, consistent project management, which is based on the projects needs and acknowledges as well as addresses existing issues.
As a matter of fact, the project manager and his personality are of decisive impact on the success of any project. The team of cape7 engineering services GmbH for many years has been successful in executing project management in the chemical industry, while Dr. Volker Eck with his profound knowledge is covering the operational and regulatory aspects of regulated GMP or GMP-oriented companies. This broad base supports and protects an optimal project flow.
GMP regulations focus inter alia on specific requirements for the engineering, project management and operation of facilities.
In addition to the statutory requirements there are methodological requirements to fulfil, like qualification and validation, documentation and change management, as well as accountability ? in addition there are specific demands for the design operation and quality of premises, air supply and ventilation, clean room technology, process materials such as water, and others. Processes and plants have to meet "current Good Manufacturing Practices" and to provide state of the art technological solutions. Finally, transparent, optimised processes, including material and personnel flow, as well as clear visual structures, which prevent faulty process operations, support quality but at the same time promote successful audits and inspections.
We ensure with personal commitment, skills and an intelligent project management that your projects hit the target!
We offer services that include but are not limited to:
Project Management: We design, implement, install and put into operation production suits and alterations to existing processes in accordance with GMP / VDA standards and in close consultation with you, our customer.
Production Development: We analyse and optimise / develop your production according to evolutionary / or continuous and also random methodologies.
Automation: We advise and support you in all aspects of automation - and implement projects according to your needs, economically and by using advanced approaches.
Consulting: We offer advise on the basis of sound scientific and technological knowledge on processes and procedures. This includes but is not limited to:
* development,
* validation / qualification
* manufacturing
* rules, regulations and industry benchmarking
* Quality Control
* Quality Assurance
* Compliance
* FDA - requirements
What can we do for you? Just send us an e-mail or call us. We look forward to hearing from you.
cape7 engineering services GmbH Eck Pharmaceutical Consulting
Ruchwiesenstrasse 70 Riva Paradiso 32
8404 Winterthur 6900 Lugano
Tel. +41 52 243 14 25 Tel. +41 91 980 47 60
contact@cape7.ch Volker.Eck@eckpharmaconsult.ch
www.cape7.ch www.eckpharmaconsult.ch
