Consulting expertise from the beginning

We offer you the knowledge to ensure the optimal and individual adjustment of process steps to your production requirements.

In addition, we will help you to prepare for the necessary approval procedures (e.g., preparation of the German BImSchG file).

Needs analysis & layout design

We develop an individual concept for your project based on your requirements. This includes:

• capacity calculations;
• layout design;
• ROI simulations;
• preparation of product specifications;
• security and sustainability of your investments.

The use of state-of-the-art components and control systems guarantees you the highest degree of functional reliability and process reproducibility.

Turnkey solution

Our strength lies in the individual implementation of an overall concept that is adapted to your individual specifications and needs.

During project implementation, we focus on meeting the highest quality standards and adhering to the project duration and budget.

Modular design

Based on the experience in previous projects, we developed a modular design system, which now forms the basis for our projects. This allows you to provide both standard solutions and individually customized solutions.

Agile project management

Due to our agile project management skills, we can also flexibly respond to changes during the course of the project. Our employees are constantly undergoing further training in this regard.

System concept

Through the targeted use of our modern 3D CAD visualization tools, we offer you a seamless integration of various system components and the corresponding control software in new and existing customer infrastructures.

Process risk analysis

We use our software tool to create in-house risk analyses in order to ensure risk assessment that conforms to the requirements of applicable standards. Among others, we refer to EN ISO 12100, EN ISO 1497 in regard to medical devices and EN ISO 10218 in regard to industrial robots.

System and project documentation

We prepare the system documentation for you in accordance with EU Machine Directive 2006/42/EC. In addition, we offer all customers professional documentation of the various project phases.

Our specific expertise in all aspects of system design in the medical technology industry and also the pharmaceutical industry makes us a competent partner. As regards our highly qualified employees, we ensure compliance with the applicable standards and guidelines of the respective area of application. Therefore, all our systems are CE-compliant. In addition, STERISYS is an EN ISO 13485:2016 certified company.

You can find our other quality standards here.

Innovative technologies

By using the latest technologies, our systems are developed contemporarily. In this regard, we always strive for innovative solutions.

High-quality suppliers

Our suppliers are specifically selected based on the highest quality standards.

Certified welders

Our welders are certified according to EN ISO 9606-1. Thus, they conform to the highest quality standards. 

Factory acceptance

Before the system is delivered, a factory acceptance test (FAT) is carried out on our shop floor at Eynatten. This provides that all technical and quality-related requirements are met.

Optimal adjustment of the system at your site increases efficiency, reduces your operating costs and also ensures compliance with the specific environmental and occupational health and safety requirements.

Transport

Upon your request, we can organize the transport of the equipment to your site and also its unloading at the final position.

Installation on site

The mechanical and electrical installation of the system is carried out on site by our employees.

Customer acceptance

At your site, you complete the installation qualification (IQ), the operational qualification (OQ) and the performance qualification (PQ). We will gladly assist you in these final validation steps.

Training

After the system has been handed over, we carry out professional training for you on site in accordance with the relevant standards and the EU Machinery Directive. Afterwards we issue a corresponding certificate of proficiency. If there is interest, training courses can also be organized on specific topics (e.g., ethylene oxide, safety) or for individual target groups (e.g., operators, quality management specialists). Such training can be repeated later at any time.

On-site or remote maintenance

Based on your individual requirements and the degree of system use, customer-specific maintenance is scheduled and carried out by us. We offer this service for third-party systems as well. We also take over the calibration of your measuring units.

Repair

We eliminate faults efficiently and in a targeted manner using remote maintenance possibilities or an on-site visit in accordance with the concluded service level agreement. In this regard, fast response times are very important to us.

Support

Our competent team will provide professional and targeted assistance in any general and technical matter.

Spare parts

We will gladly advice you about spare parts and provide them to you. This service is available for our systems and third-party systems.