Engineering, consulting and general contracting for Turnkey projects of Clean Rooms for Pharmaceuticals and Hospitals. Qualification and validation activity.
The experience and know-how accumulated in the pharmaceutical and food sectors guarantee quality both in terms of timing and conformity.
SOCOTIS sterile offers a complete range of services:
- Feasibility studies
- Basic planning
- Executive planning
- Plant validation
- Commissioning e Start-Up
- GAP analysis e action plan;
- Clean rooms
- Atmosphere and contamination controlled environments
- Data centers
- Drying systems
- Air purging
- Bakery proving systems
- Compressed air and technical gases
- Fluid distribution networks
I SERVIZI DIVISIONE STERILE NEL DETTAGLIO
Facility planning, concept, basic and detail design in compliance with EU cGMP, ISO 14644 and U.S. Fed. Std. Construction and project management on-site. Time-scheduling, quality and risk management. Procurement assistance and suppliers auditing. Facility management and energy management.
AHUs and HVAC systems, hot and chilled water generators, piping and air ducts distribution network, dusters & extractors, industrial gases network (CA, vacuum, nitrogen, oxygen), waste water drainage and local sewer network, normal and power supply low voltage distribution network, UPS, indoor lighting, data network.
Equipment and plant validation. IQ-OQ-PQ-DQ qualification services. FAT and SAT assistance, including start up. Computer system validation, URS outline and documents reviews, risk-analysis based approach, Gap analysis of existing systems and corrective action plan, admin. SOPs definition, personnel training.