Our company
Reliability constitutes the basis of our actions: as a family business, we think in the long term and act responsibly. Our guiding principles are led by innovation, quality and the willingness to provide excellent service. An engineering spirit paired with expert knowledge and a motivated team forms the foundation of our success. We work with our customers in the sense of a long-term partnership to jointly develop an appropriate and individual solution.
But success also requires passion. This is our true conviction. Every day, we measure ourselves by our ability to improve the performance, functionality and efficiency of our systems—for the benefit of our customers and the health of the people who use their products or services.
Engineering for life
The central focus of our work is to develop modern processes for the medical technology and pharmaceutical industries, with which we contribute to human health. As a plant constructor with a strong link to life science engineering, we see ourselves first and foremost as solution providers.
Being aware that the systems which we develop are used to ensure safety and protect life in the production of medical technology and pharmaceutical products, we place the highest quality demands on ourselves and always work faithful to our motto: “Engineering for Life”.
STERISYS is certified according to ISO 13485:2016 and the corresponding quality management is firmly anchored in our way of working.
Quality and conformity are measurable
Here at STERISYS, we believe that quality assurance and conformity follow a traceable, certified process.
In the pharmaceutical industry and in medical technology, regulatory requirements are increasing considerably. Our turnkey and ready-to-use solutions are based on extensive knowledge and experience from years of equipment construction.
RELEVANT STANDARDS & GUIDELINES FOR THE MEDICAL TECHNOLOGY & PHARMACEUTICAL INDUSTRY
- FDA 21 CFR part 11
- EU Directives 2006/42/EC
Our systems bear the CE marking.
HANDLING AND PACKAGING OF LIQUID PHARMACEUTICALS
Our equipment construction for the pharmaceutical industry is carried out in accordance with the industry-specific standards and guidelines.
· ISO 10218:2011
· EN ISO 12100:2010
· GMP
EO STERILIZATION SYSTEMS
For the medical technology, our systems also comply with current standards and guidelines such as:
· 2014/30/EU
· 2014/68/EU
· 2014/35/EU
· EN ISO 11135:2020
· EN 1422:2014
· 2014/34/EU
· TA-Luft
· TRGS513
· ATEX
Find here our certificates as download.
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Quality is characterized not merely by the strictest possible adherence to standards and regulations, but also by the traceability and reproducibility of processes.
Aside from quality and conformity in our system solutions, we place top priority on achieving the following goals:
- Our customers’ satisfaction
- Our staff members’ satisfaction
- Quality of our suppliers and partners, and
- Living up to our social responsibilities
