RAMS Ltd, with the ENGINEERING & VALIDATION Department, supports its customers to manage and directly perform all the validation phases.
RAMSA has extensive experience in the preparation of Validation Master Plans a at all levels, whether for an establishment or for a single project, on behalf of the main international companies for all types of pharmaceutical products (APIs, solid and liquid forms, sterile products and more).
RAMS Team is composed of Engineers, Chemists and Pharmaceutical experts who, through the skills of qualified Technicians, manage and perform Qualification activities for all kinds of equipment and systems in the Pharmaceutical and related Industries. Moreover, RAMS has consolidated expertise in helping clients to solve the problems that frequently arise for documentation deficiencies and other technical aspects.
RAMS SYSTEM services:
- GAP Analysis
- Risk Analysis / Impact Assessment
- Design Qualification
- Validation Master Plan Preparation
- IQ / OQ / PQ of Manufacturing Equipment & Critical System
- Maintenance & Calibration
- Calibration Plans
- Preventive Maintenance Plan
- Specialized services (vacuum, thermography…)
- Troubleshooting
- SOPs
CLEAN ROOMS QUALIFICATION IN ACCORDANCE TO ISO 14644
- Hepa / Ulpa Filter integrity Test
- Airborne particulate cleanliness counts
- Air Volume flow rate and air changes rate measurements
- Air and room Pressure Differential Measurements
- Airflow Visualization studies
- Recovery Performance Tests
- Temperature and Humidity Monitoring
- Lighting Level Measurements