Non-stop improvement as the fundamental
key applicable in all our processes

VISION

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.

MISSION

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.

ISO 11135

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.

ISO 9001

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.

Ad-merkblatter

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.

d. 2014/34/UE

Being conscious of the particular characteristics of Ethylene Oxide, we comply Strictly with the ATEX Directive.

d. 2006/42/cE

All sterilizers have a CE mark, so it is mandatory to comply with the Safety of Machinery Directive 2006/42 /CE.

d. 2017/35/cE

Compliance with the Low Voltage Directive 2014/35/EC

d. 2014/30/cE

Compliance with the Electromagnetic Compatibility Directive 2014/30/EC

I+D

Under the idea of “Eco-Innovation Continuous progress”, Etolutions is Suphatec’s most ambitious R & D project.
In collaboration with Sterilization S.L, Etolutions won the “SEAL OF EXCELLENCE”, Certificate issued by the European Commission, as an institution that manages Horizon 2020, the EU Program for Research and Innovation 2014-2020.
(See the document)