Primeco
Consulting and engineering firm providing regulatory compliance, validation, auditing, design and project delivery services for the Life Science industry. Offers facility engineering, construction management, qualification/validation, GMP supplier auditing, technical and management consultancy, training and short-term equipment rental. Active since 2003 and certified for some services by an independent registrar.
Industries
Nr. of Employees
small (1-50)
Services
Conceptual, basic and detailed design of HVAC, electrical, structural works, utilities and functional layouts tailored to regulated production environments.
Project planning, procurement support, site management, safety coordination, cost control, as-built documentation and final maintenance planning for construction and revamping projects.
Qualification of equipment and systems, environmental and process validation, commissioning procedures and plant start-up support.
On-site and remote GMP audits of suppliers and vendors, performed by experienced QA/QC auditors with formal audit reporting.
Senior-level advisory services covering technical, QA/regulatory and management topics including FMEA, Annex 1 support, process optimization, predictive maintenance and financial analysis.
On-site and remote GMP training programs with needs analysis and customized content for technical and managerial staff.
Conceptual, basic and detailed design of HVAC, electrical, structural works, utilities and functional layouts tailored to regulated production environments.
Project planning, procurement support, site management, safety coordination, cost control, as-built documentation and final maintenance planning for construction and revamping projects.
Qualification of equipment and systems, environmental and process validation, commissioning procedures and plant start-up support.
On-site and remote GMP audits of suppliers and vendors, performed by experienced QA/QC auditors with formal audit reporting.
Senior-level advisory services covering technical, QA/regulatory and management topics including FMEA, Annex 1 support, process optimization, predictive maintenance and financial analysis.
On-site and remote GMP training programs with needs analysis and customized content for technical and managerial staff.
Expertise Areas
- Validation and qualification
- GMP auditing and regulatory compliance
- Pharmaceutical facility engineering and design
- Construction and turnkey project delivery
Key Technologies
- Cleanroom and environmental monitoring (ISO 14644)
- HEPA and filter integrity testing (PAO, bubble point)
- Sterilization cycle validation and steam verification (EN285)
- Process water and pure steam validation (PW/WFI)
News & Updates
Company news post referenced on the corporate blog.
Announcement regarding filter integrity testing solutions and related services.
Article discussing wettability testing and related considerations.
News post referencing achievement of ISO 9001 certification.
Company news post referenced on the corporate blog.
Announcement regarding filter integrity testing solutions and related services.
Article discussing wettability testing and related considerations.
News post referencing achievement of ISO 9001 certification.