Turn key solution - GMP
Cleanrooms construction projects
Integrated construction - Turn key solution
The study, design and construction of clean - sterile areas (Cleanrooms) is implemented according to the international standards EN ISO 14644 and according to the rules of GMP (Good manufacturing practice).
Cleanroom technology
ventilation technology
Qualification/ validation
Monitoring systems consulting
Calibration
staff training
Maintenance
Applications
Hospitals
Pharmaceutical industry
Food industry
Microelectronics
Workshops
Research centres
Industry
High-tech applications
Evaluation System & Evaluation System Certification
The system for evaluating the construction processes and categorization of cleanrooms is defined by the following quality protocols:
QYALIFICATION PROTOCOLS
Risk Analysis (R.A.)
Design Qualification (D.Q.)
Installation Qualification (I.Q.)
Operational Qualification (O.Q.)
Performance Qualification (P.Q.)
Checks and tests according to ISO 14644
Air purity testing according to ISO 14644-1 (Classification measurements)
Leakage test of absolute filters according to ISO 14644-3 (Integrity & leakage test)
Velocity and airflow control of absolute filters according to ISO 14644-3 (Velocity test)
Air flow control according to ISO 14644-3 (Smoke test)
Differential pressure test according to ISO 14644-3 (Differential pressure test)
Temperature control according to ISO 14644-3 (Temperature test)
Humidity test according to ISO 14644-3 (Humidity test)
Noise level control according to ISO 14644-3 (Noise level control)
List of main cleanrooms construction projects
| Fuzion Grade B - C - D galenic drugs laboratory in Drosia |
| Cleanroom for the production of special food products Maria Mitrofanis IKE in Trikala |
| Negative pressure and cytostatic drugs manufacturing unit at Corfu General Hospital |
| Cytostatic drugs manufacturing unit at the Theagenio hospice in Thessaloniki |
| Cleanroom Grade B - C - D at the oncology department "Elpida" of Agia Sophia Children's Hospital |
| Unit for the production of Grade C - D cytostatic drugs at G.N.N.Th.A. The Salvation |
| Medically assisted reproduction unit at P.G.N. Larissa | Cleanroom in the laboratories of the quality assurance & control company Q.A.C.S. in Metamorfosi | Cleanroom for Grade B - C - D cell cultures in the bone marrow transplantation unit at the General Hospital of Athens. Evangelismos. | Cleanrooms at the Camark surgical suture production company in Axioupolis. | Grade C - D gene therapy unit at the General Hospital of Papanikolaou. | Cytostatic drug manufacturing unit at 401 G.S.N.A. | Translational Stem Cell Centre of the Aristotle University of Thessaloniki. |
