Regulatory compliance
What we do
Pressure vessels:
- Consulting for the application of Directive 2014/68/UE (PED)
- Periodical inspections of pressure vessels according to article 71 – D. Lgs 81/2008
- Consulting and assistance for pressure vessel notification to the Italian Authorization
- Pressure vessel safety reports/analysis for Italian Authorities
- PED technical file for pressure vessels and assemblies
- On-site N.B. interface and follow-up for pressure vessels and assemblies conformity assessment
- Risk Based Inspection (RBI) analysis according to API 580/581
- Ultrasonic tests for thickness check of pressure vessels
Explosion hazardous area:
Pharmaceutical plants:
- Zoning of explosion hazardous areas (EN 60079-10/CEI 31-30 and ATEX directive)
- Explosion risk assessment (D. Lgs. 81/2008-Testo Unico Sicurezza)
Validation of process, equipments and critical systems
for medical production - Directive 2003/94/EC:
- DQ design qualification
- IQ installation qualification
- OQ operational qualification
- PQ performance qualification
- PV process validation
- CL cleaning validation
