Compliancewithout compromise
Compliance with standards and regulatory requirements requires complete understanding of the detail.
- SOLSTEO is an active member of the ISO technical group TC 198/WG 1 which follows ISO 11135
- SOLSTEO machines are supplied with a comprehensive, clear and ordered set of manufacturer files. All SOLSTEO equipment have EU/EC Declaration of Conformity for CE marking
European ATEX Directives related to Machine Safety have been in place since July 2003. The implementation of these regulations by EO sterilizers’ end-users requires detailed knowledge of the requirements. SOLSTEO always includes expert advice across projects to help MD manufacturers implement ATEX Directives at a factory level.
- SOLSTEO is certified by INERIS to deliver ISM-ATEX trainings from Level 0 up to Level 2E
- We recommend safety audits and ATEX-compliance reviews
Coming largely from a mechanical or engineering background, most EO sterilizer manufacturers consider automation a side activity. At SOLSTEO, software is central to our performance and development strategy. Our SCADA system is a real added value for our customers.
- Pole position in Europe
- CRISTAL CONNECT: control and data acquisition system software
- Adaptability: CRISTAL CONNECT available as a plug-in
- Development following GAMP 5 requirements
- FDA 21 CFR part 11 compliance
SOLSTEO always takes into consideration EO gas treatment post sterilization. We include environmental factors in all of our projects and discuss the options with our customers to allow them to make informed decisions. SOLSTEO designs and manufactures gas treatment system that meet the strictest regulations.
- From simple & efficient solutions to more complex technical processes
- Clear technological responses to TA-LUFT requirements
By your side every step of the way
SOLSTEO's sterilizers comply with current European and international regulations, including:
EN 1422
ISO 11135:2014
EU Directive 2006/42/EC on machinery
EU ATEX Directives (Explosive Atmospheres): 2014/34/EU and 1999/92/EC
Standards for ATEX compliance: EN 60079-0:2010 / EN 60079-14:2008
EU Pressure Equipment Directive (DESP) : 2014/34/UE
FDA Code of Federal Regulations Title 21 Part 11 (21 CFR Part 11) : Use of electronic records and electronic signatures
Software development following GAMP5 requirements (Good Automated Manufacturing Practice)
Our Technical Director Jean-Baptiste Bonnet is an active member in the following standards committees:
ISO/TC 198/WG 1: Sterilization of health care products (producing ISO 11135)
CEN/TC 102/WG 6: Low-Temperature Gas Sterilizers (producing EN 1422)
He's also a INERIS-certified trainer for Ism-ATEX (Installation, Service & Maintenance)
Die Qualitätssicherung von SOLSTEO
Die SOLSTEO-Maschinen werden in unseren Büros im 9. Bezirk von Paris entworfen und entwickelt.
SOLSTEO verfügt über ein solides und zuverlässiges Partnernetzwerk, das dafür sorgt, dass jede einzelne Prozessetappe höchsten Qualitätsanforderungen gerecht wird.
Alle unsere Aktivitäten sind auf Kundenzufriedenheit ausgerichtet und setzen ein einwandfreies technisches Know-how voraus.
Dank diesem Organisationsmodell ist SOLSTEO in der Lage, eine 15-jährige Herstellergarantie auf alle seine Produkte zu gewähren.
