1. INTRODUCTION
Cleanrooms are controlled areas designed in accordance with specific standards where environmental contamination is minimized, particularly in sensitive manufacturing areas. In these areas, environmental factors such as airborne particle levels, temperature, humidity and differential pressure are continuously monitored and are subject to legal regulations. They are used especially in critical fields such as pharmaceuticals, biotechnology, microelectronics and the defense industry.
2. LEGAL BASIS
Cleanroom practices in Turkey are based on multiple legal and technical regulations:
2.1. National Legislation
- Good Manufacturing Practices (GMP) Regulation: The fundamental reference in the pharmaceutical industry.
- Medical Device Regulation: Defines the compliance criteria for devices manufactured in cleanrooms.
- Ministry of Health Communiqués and Circulars: Set out the principles for inspection and certification.
2.2. International Standards
- ISO 14644-1 / ISO 14698: Cleanroom classification and biocontamination control.
- EU GMP Annex 1: Cleanroom criteria specialized for sterile manufacturing areas.
- FDA CFR 21 Part 11: The U.S. Food and Drug Administration's regulation on electronic record systems.
3. CLEANROOM CLASSIFICATION
Cleanrooms are classified according to the number of particles in the air:
| ISO Class | 0.5 µm particle/m³ limit |
|---|---|
| ISO 1 | 10 |
| ISO 5 | 3,520 |
| ISO 7 | 352,000 |
| ISO 8 | 3,520,000 |
In addition, the GMP classification uses classes such as "Grade A, B, C, D". These classes impose specific regulations for sterile areas.
4. CLEANROOM DESIGN REQUIREMENTS
4.1. Airflow and Filtration
- HEPA/ULPA filter systems are mandatory.
- Laminar flow design is preferred.
- A minimum of 20 air changes/hour for ISO 7 and 8.
4.2. Pressure Differential
- A positive pressure differential must be maintained between the cleanroom and the surrounding area.
- A differential of at least +15 Pa is recommended.
4.3. Surface Materials
- Antibacterial, dust-free, washable materials must be used.
4.4. Temperature and Humidity Control
- Temperature: 18°C - 24°C range
- Humidity: 45% - 65% RH range
5. VALIDATION, CERTIFICATION AND TESTING
5.1. Validation Steps
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
5.2. Periodic Tests
- Particle measurement
- Airflow smoke test
- Pressure differential tests
- Microorganism count (settle plate, air sampler)
6. CLEANROOM OPERATING PROCEDURES
6.1. Gowning Procedures
- Personnel must put on a tunic, mask, goggles, gloves, cap and sterile overgarment in sequence.
6.2. Cleaning and Disinfection
- Cleaning procedures must be carried out at specific intervals.
- Disinfectant rotation is essential.
6.3. Training and Authorization
- All personnel must undergo annual training.
- Compliance with procedures must be documented.
7. PENALTIES AND INSPECTIONS
7.1. Regulatory Bodies
- Ministry of Health / TİTCK
- Ministry of Environment, Urbanization and Climate Change
- Independent inspection firms (accredited laboratories)
7.2. Sanctions Applied for Non-Conformities
- Suspension of operations
- Certificate revocation
- Monetary fines
8. CONCLUSION
Cleanroom regulations are of vital importance for protecting hygiene, quality and human health in manufacturing and service areas. Compliance with regulations, both at the design and operational stages, both facilitates legal processes and contributes to corporate reputation.
Working with expert firms such as NEVAYS ensures the implementation of fully compliant and efficient cleanroom projects.