Turnkey solution - GMP
Cleanroom construction projects
Turnkey solution
The study, design, and construction of cleanrooms are implemented based on international specifications EN ISO 14644 and in accordance with Good Manufacturing Practice (GMP) rules.
Cleanroom technology
Ventilation technology
Qualification/Validation
Monitoring systems consulting
Calibration
Staff training
Maintenance
Applications
Hospitals
Pharmaceutical industry
Food industry
Microelectronics
Workshops
Research centers
Industry
High-tech applications
Evaluation & Certification System
The system for evaluating the manufacturing processes and categorization of cleanrooms is defined by the following quality protocols:
QUALIFICATION PROTOCOLS
Risk Analysis
Design Qualification (D.Q.)
Installation Qualification (I.Q.)
Operational Qualification (O.Q.)
Performance Qualification (PQ)
Checks and tests according to ISO 14644
Air purity testing according to ISO 14644-1 (Classification measurements)
Integrity and leakage test of absolute filters according to ISO 14644-3
Air velocity and flow rate test for HEPA filters according to ISO 14644-3 (Velocity test)
Airflow control according to ISO 14644-3 (Smoke test)
Differential pressure test according to ISO 14644-3
Temperature test according to ISO 14644-3
Humidity test according to ISO 14644-3
Noise level control according to ISO 14644-3
List of major cleanroom construction projects
| Fuzion Galenic Pharmacy Laboratory Grade B - C – D in Drosia |
| Cleanroom for the production of specialized food products Maria Mitrofani IKE in Trikala |
| Negative pressure unit and cytotoxic drug preparation unit at Corfu General Hospital |
| Cytostatic drug preparation unit at the Theageneio Cancer Hospital in Thessaloniki |
| Cleanroom Grade B - C – D at the «Elpida» Oncology Department of Agia Sofia Children's Hospital |
| Cytostatic drug preparation unit Grade C – D at G.N.N.TH.A. "The Sotiria" |
| Assisted reproductive technology unit at the General Hospital of Larissa | Cleanroom at the quality assurance and control company Q.A.C.S. laboratories in Metamorfosi |