Validations

GMP compliant validations to cleanrooms, equipment and systems

We perform individual validations and measurements and control the entire validation process. When needed we can participate in compliance assessment even during the idea or design phase of a new plant, facility or process.

All validations are based on materials and instructions approved by the client.

Life-cycle management of cleanrooms, equipment and systems

Project phase

• creating of user requirement
• risk assessments
• creation of validation plan and testing protocol
• performing the validation and reporting
• creation of SOP- instructions and commissioning training

Operation phase

• Change management
• Training and support
• Deviation management and CAPA Process
• Maintenance schedule
• Regular assessments and revalidations

When needed, we will perform all four phases of a validation process:n mukaan kaikki validoinnin neljä vaihetta:

1. Design qualification (DQ): the plans are in accordance with the requirements of the client and the authorities
2. Installation qualification (IQ): installation is in compliance with the accepted design
3. Operational qualification (OQ): testing the functionalities
4. Performance qualification (PQ): testing the performance and the overall process

Clean room validation

• GMP
• Assessments and reports in accordance with ISO 14644

Equipment validation

• Production equipment and processes
• Washing machines
• Autoclaves

System validations

• Computer systems (ERP, FMS, BMS)
• Pneumatic tube systems
• Purified water systems (PW, WFI)
• Ventilation systems (HVAC)
• Clean-in-place systems
• Medical gases
  • Oxygen
  • PSA medical oxygen generators
  • Nitrogen
  • Compressed air