STERISYS Industrial Sterilisation Solutions and Services
STERISYS is a dynamic European company in the field of industrial sterilisation that offers an outstanding solution portfolio to medical device manufacturer and service provider for sterilisation.
The ultimate ambition of the healthcare industry is to guarantee and steadily improve the humanity’s wellbeing by enhancing medical treatments and developing precise technologies. As a result, medical devices and pharmaceutical products have become more and more sophisticated. The sterilisation industry is continuously challenged with the adaptation of existing sterilisation processes to meet these new requirements.
Turnkey sterilisation equipment solutions
At STERISYS we are eager to take on those challenges and provide turnkey solutions for our customers. It is our in-depth market knowledge and our high level of expertise of industrial ethylene oxide (EtO) sterilisation systems that ensures personalised services and state-of-the-art solutions.
We seek to complement our wide-ranging solution portfolio by working with competent and reliable partners. In other words, a close cooperation with our carefully selected business partners is fundamental since it yields to the successful mastering of technology challenges and the satisfaction of the specific requirements of the sterilisation industry.
In addition, we focus on a long-term collaboration with our customers. By thoroughly understanding their needs we strive to develop individually conceptualised solutions and services.
It is nonetheless the efficient combination of both our expertise and experience that guarantees an optimal process development.
STERISYS is certified according to EN 13485 standards.
STERISYS supports its customers in every phase of the project. Our extensive solution portfolio ranges from process organisation, layout design, manufacturing and delivery up to installation, commissioning and maintenance services.
Process organisation and layout
Our employees’ many years of experience and field-specific know-how provide our clients with a high quality support throughout the entire project. This early cooperation with the customer is fundamental as it constitutes one of the key success factors for the entire project.
By applying dynamic 3D CAD tools, we progressively refine the overall design of the customer’s sterilisation equipment.
The design process and the integration of new sterilisation equipment into existing processes are thus optimised and investment costs reduced.
Design and manufacturing of sterilisers
Since the steriliser is at the heart of the overall sterilisation process, STERISYS decided to design and manufacture its own sterilisers.
All our sterilisers are fully equipped, including with the STERISYS process control software which guarantees productivity, reliability and process flexibility. A straightforward parametrical cycle configuration is enabled by means of a touch panel or a PC based HMI.
The main characteristics of our STERISYS sterilisers:
- Modular configuration of the sterilisation chambers from 0.5m³ to 32 euro-pallets
- Single or two-door layout (i.e. horizontal sliding, vertical opening or hinge door systems)
- Turnkey sterilisers equipped with all peripheral units (i.e. vacuum unit, chamber heating skid, EtO-vaporizer, air and N2 pre-heating unit , steam supply unit, scale systems)
- State-of-the-art decentralised process control architecture
- Adherence to ATEX, EN 1422, EN 11135, FDA and GAMP standards
- Parametrical validation solutions
Complete portfolio for sterilisation facilities
STERISYS provides its customers with complete turnkey solutions by supplying all the sterilisation process equipment:
- Sterilisation chambers
- External pre-conditioning and degassing (aeration) chambers
- Automatic pallet conveyor solutions
- EtO gas treatment
- EtO monitoring systems
Installation and commissioning of sterilisation equipment
To ensure a smooth workflow, installation and commissioning of the sterilisation equipment are part of our service portfolio.
STERISYS provides the following services:
- Extensive factory acceptance tests (FAT), installation qualification (IQ) and operational qualification (OQ) test phases according to EN1422 and EN11135 standards
- Project and equipment documentation in accordance with CE standards and machinery directives
- Essential training for operators and the maintenance staff
Maintenance of ethylene oxide installations
Our extensive market knowledge guarantees personalised maintenance services for EtO installations.