STERISYS is a leading worldwide provider of state-of-the-art sterilisation solutions.
STERISYS is a provider of ethylene oxide sterilisation equipment for medical devices, developing modern processes for the medical technology and pharmaceutical industries.
The company combines engineering sciences with robust process solutions for efficient systems with a long service life, known for its process strategies and high-quality standards.
STERISYS offers turnkey ethylene oxide sterilisation systems and automated systems for handling pre-filled syringes. Impressive engineering and innovative solutions, paired with personal support and transparent project management, characterise the company’s success story.
The company places the highest quality demands on itself, always working faithfully to its motto, ‘Engineering for Life’, with an awareness that the systems it develops guarantee safety and protect life in the production of medical technology and pharmaceutical products.
Industrial ethylene oxide sterilisation for medical devices and pharmaceutical products
Ethylene oxide exposure sterilises a vast array of medical devices and pharmaceutical products. Sterilisation with ethylene oxide is an established sterilisation modality across healthcare industries, providing definite advantages over other methods.
Due to low process temperature (below 55°C), the use of ethylene oxide is superior to other approaches in terms of material compatibility, suited for the sterilisation of thermolabile products.
However, due to ethylene oxide’s composition, a range of technical and regulatory requirements must be taken into account and fulfilled. STERISYS specialises in this domain, developing and manufacturing equipment following all relevant standards and guidelines.
Solutions for medical device manufacturers and sterilisation service providers
STERYSIS is a chief supplier of ready-to-use ethylene oxide sterilisation systems, developing innovative and compliant solutions, and distributing them to sterilisation service providers and medical device manufacturers worldwide.
Key benefits of STERISYS’ solutions:
- Safe and efficient sterilisation of medical devices and pharmaceutical products
- High degree of flexibility regarding cycle parameterisation
- Reliable reproducibility of sterilisation cycles
- Long-term viability and conservation of value through state-of-the-art components and proven industry standards
- Conformity with all relevant standards and guidelines: ATmosphere EXplosible (ATEX), European Standard (EN)1322:2014, International Organisation of Standardisation (ISO)11135:2014, the US Food and Drug Administration (FDA) 21 Code of Federal Regulations (CFR) and Good Automated Manufacturing Practice (GAMP) 5
- Manufacturing of customised sterilisation units of all sizes, made to order in the company’s Belgium factory
Ethylene oxide overpressure sterilisation systems
STERISYS ethylene oxide overpressure sterilisation process is suitable for small to mid-sized product volumes sterilised in primary packaging. The overpressure process works with a gas blend of 6% ethylene oxide and 94% CO2.
The company develops sterilisation units suited to specific client requirements, based on specifications such as product size, material and packaging type, the purpose of the product, and intended production volume. As well as the sterilisation chamber, STERISYS designs and manufactures trolleys and baskets to store, transport and sterilise medical devices.
Most significantly, STERISYS bases its decisions on the seamless integration of its sterilisation equipment into new and existing infrastructures and productions flow.
STERYSIS sysREG NT control system controls and monitors the company’s overpressure sterilisation systems, offering all functions to ensure operations under EN1422, including the appropriate logging of sterilisation cycles.
Ethylene oxide vacuum sterilisation systems
The ethylene oxide sterilisation process is suitable for high throughput production. In this case, medical devices are sterilised in their tertiary packaging such as on pallets, positioned in one or two rows in the sterilisation chamber, and oriented lengthwise or crosswise, depending on space, as well as client requirements.
Clients define exact chamber size based on production volume, as well as type and height of pallets.
Depending on the size and complexity of the ethylene sterilisation equipment, either the standalone sysREG NT control software or a centralised supervisory control and data acquisition (SCADA) system using sysREG NTX software controls the system. The latter ensures centralised control and monitoring of the entire sterilisation plant.
Within the past months, we were allowed to implement a major project in the field of ethylene oxide (EtO) vacuum sterilisation for the globally operating medtech company pfm medical ag!