Suphatec has extensive experience in designing installations and starting up ethylene oxide sterilization plants.
Suphatec accompanies the customer from the DQ where the client's requirements are specified, to the installation of all the necessary elements for the sterilization process, qualification and support for the PQ.
Also the subsequent startup, including remote support by Internet for the operational production processes.
The main objective for Suphatec, is help to the companies to reduce the energy cost during the sterilization process, reduce the costs of civil engineering infrastructure, reduce the time of the sterilization process and gain time in logistics and reduce at maximum the O2
emissions to the atmosphere.
Suphatec is an eco-friendly company. Our principal priority is to guarantee the Quality in our production lines and services.
See the Quality Policy document
UNE EN 1422
All the steralizers manufactured by Suphatec comply with the requirements of the UNE-EN 1422:2014 regulations.
All sterilization cycles by Ethylene Oxide carried out inside our sterilizers comply with the validations specifications according to ISO 11135:2015.
The automated control system, supplies a report with all the necessary information and documents to be submitted to the Control Organisms.
Suphatec is recently being certified to comply with the ISO 9001:2015 regulation, approved by the prestigious TÜV Rheinland Group company.
CFR 21 Part 11
The automatic control software is designed by Suphatec and is specifically designed for Ethylene Oxide sterilizers. This control system is prepared to be validated by FDA CFR 21 Part 11.
All of our sterilizers, without exception, are designed under the AD-Merkblatter guideline, which allows us to offer a 10-year warranty against design defect.
Being conscious of the particular characteristics of Ethylene Oxide, we comply Strictly with the ATEX Directive.
All sterilizers have a CE mark, so it is mandatory to comply with the Safety of Machinery Directive 2006/42 /CE.
Compliance with the Low Voltage Directive 2014/35/EC
Compliance with the Electromagnetic Compatibility Directive 2014/30/EC