To guarantee the high-quality production of active ingredients and prescription drugs, well-trained staff and reliable production plants are essential for the manufacture of pharmaceutical products. A partner who is familiar with all stages of the qualification process – DQ – IQ – OQ – and boasts its own quality standards of the highest order can contribute significantly to this reliability.
ESAU & HUEBER can draw on decades of manufacturing and installation experience with manufacturers of pharmaceutical and biotechnological products.
Preparation systems for nutrient media and buffer solutions are an excellent example of our performance capabilities.
A robust production process with valid and reproducible product qualities is only possible with 100% reliable and sustainable cleaning of all the equipment and systems involved.
Both MOBILE and STATIONARY CIP/SIP systems are applied.
Every production process needs its own individual process system that meets all the necessary hardware and software requirements.
The customer-specific process requirements must be taken into account along with the requirements of all the measurement and control technology in use.
The preparation of chemically or biotechnologically produced active ingredients takes place in a strictly controlled environment.
Liquid and gaseous output media are usually fed to the production plants via permanently installed systems.
The specified quality at the point-of-use can only be guaranteed continuously through a high level supply system.
We plan and construct supply systems for all liquid and gaseous media in your production process.
Our expertise extends to the correct selection and design of all materials and components as well as the high-quality installation of all modules and plants in your production area.
Residual quantities of active substances and contaminated cleaning water are among the greatest challenges for a subsequent waste water treatment system. The treatment of this waste water with a wide variety of processes, in conjunction with a reliable media installation, represents an excellent alternative to traditional but cost-intensive disposal.
Storage & distribution systems
The STORAGE and DISTRIBUTION of products and active ingredients are at the heart of the production process.
In close cooperation with our sister company, HINKE Tankbau GmbH, we are able to meet all the requirements for a modern storage and distribution system in the pharmaceutical / biotechnological environment.
The success or failure of a company is not only determined by the quality of the various individual services. An equally decisive role is played by the willingness and ability to respond flexibly, innovatively and quickly to changes and the demands of customers and markets. This is a complex requirement that can only be met with a comprehensive quality management system. Further, a general commitment to QUALITY is an indispensable prerequisite for success.
As good and as stable as all process and procedure descriptions may be, errors and carelessness can also occur where people are involved.
In order to nevertheless guarantee 100% quality, wide ranging test and inspection procedures must be applied and implemented.
In addition to the flawless execution of these tests, complete documentation is essential.
Since the entire VALIDATION PROCESS of our customers must meet stringent internal and external requirements, we see it as our duty to successfully support our customers – as far as possible – in this process.
As a plant manufacturer, our focus is on the complete DOCUMENTATION of our entire value-added processes.
The QUALIFICATION PROCESS in the pharmaceutical and biotechnology industry is extremely formal and stringent. Thanks to our extensive experience in this sector, we are very familiar with
- specifications and requirements
- FAT – Factory Acceptance Test
- DQ – IQ – OQ & PQ
and use them as the tools of our trade on a daily basis.