Validation
Primeco has the skills and the appropriate team to provide highly professional services on all aspects of Qualification and Validation, using, when needed, dedicated proprietary tools
The constant evolution of regulatory references and technology requires continuous training of our team to ensure our customers receive the best, always up-to-date service.
Contact usValidation
Primeco ensures the full range of validation services in the Life Science sector
- Regulatory Compliance
- Systems and Equipment Qualification
- Monitoring of Sterile Rooms
- Environmental verification and monitoring of particle classes according to ISO 14644/EU-All.GMP 1
- Check Recovery time
- Differential pressure monitoring
- Verification of integrity of HEPA filters (PAO Test)
- Thermal and humidity mapping of autoclaves, climatic chambers, warehouses, cold rooms, thermostats, incubators, etc.
- Periodic checks of laboratory equipment (refrigerators, freezers, incubators, sterilization/decontamination autoclaves, ovens and muffles)
- Pure steam verification for sterilization cycles according to EN285
- Particle and microbiological verification utilities for classified areas processes
- Integrity testing of hydrophobic and hydrophilic sterilizing cartridges using WIT/FFT/Bubble point testing
- Air flows and laminarity on HVAC systems
- Cleanability checks with Riboflavin
- Qualification of powder loading systems
- Qualification of packaging lines and welding machines
- Validation of sanitization cycles with hydrogen peroxide
- Roughness test with certified roughness meter on materials in contact with the product
- Validation of process utilities (PW,WFI,CS)
- Validation of sanitization cycles with dry and moist heat
- Determination of materials in contact with the products with Test Kit
- Smoke testing of air flows and laminarity on HVAC systems
Calibrations
Primeco has the necessary tools to perform calibrations of numerous measurement chains
- Calibration of temperature meters
- Calibration of relative humidity meters
- Calibration of pressure and vacuum meters
- Calibration of speed meters
- Calibration of thermometric equipment meters
- Calibration of digital indicator meters
- Calibration of pH meters and redoximeters
- Calibration of conductivity meters
- Calibration of air speed meters
- Calibration of flow meters
- Calibration of time meters
- Calibration of residual oxygen meters
- Calibration of weighing instruments
- Calibration of viscometers
Commissioning
Drafting of testing procedures and plant start-up
- Primeco offers services to ensure that new systems are installed correctly and operate efficiently according to target parameters, ensuring start-up, documentation and related training of dedicated staff
IT Design
Manufacturing hardware and software design specifications, IT infrastructure
- Primeco is able to propose hardware and software Design specifications, with a detailed description of the requirements and characteristics that a Production IT system must possess
Automation
Automation of industrial processes and systems and Software Development
- Primeco is able to propose automation plans for industrial processes.
Computer System Validation (CSV)
CSV risk analysis and computerized systems validation
- Primeco offers Computer system Validation (CSV) services, i.e. validation of the relevant GXP computer systems.