The design, construction and operation of cleanrooms represent a technical challenge that requires compliance with a broad spectrum of regulations, from those specific to environmental control and biosafety to those related to materials, occupational safety and data integrity. The convergence of these regulations is essential to ensure that cleanrooms not only fulfill their primary function, but also meet quality, safety and sustainability standards.
This article presents a partial and indicative list of the most relevant regulations for cleanrooms, organized by areas and sectors. Although not intended to be exhaustive, it provides essential technical guidance for professionals specialized in the design and execution of projects in highly regulated environments.
Table of Contents
International Standards
ISO 14644
The ISO 14644 series regulates the classification and operation of cleanrooms and controlled environments and is applicable to various industrial sectors. Its most relevant parts include:
- ISO 14644-1: Classification of air in clean rooms according to the maximum allowable particulate concentration per cubic meter.
- ISO 14644-2: Monitoring and verification requirements for maintaining classified conditions.
- ISO 14644-3: Test methods for validating air cleanliness, such as filter leakage and recovery tests.
- ISO 14644-4: Guidelines for the design and construction of cleanrooms, covering materials and configurations.
- ISO 14644-5: Protocols for cleanroom operation, including clothing, access and procedures.
- ISO 14644-7: Specific requirements for devices such as isolators, RABS and laminar flow cabinets.
- ISO 14644-16: Introduces design principles to optimize energy efficiency without compromising environmental quality.
Good Manufacturing Practices (GMP)
GMPs are key regulations in the pharmaceutical industry, with the Annex 1 providing specific guidelines for cleanrooms used in the manufacture of sterile products:
- Classification of areas in Grades A, B, C and D: According to the concentration of particles and microorganisms.
- Operating states: Evaluates rooms in “at rest” and “in operation” conditions.
- Microbiological control: Includes specific limits for air and surfaces.
Sector and Specific Regulations
Pharmaceutical Industry
- EudraLex Volume 4 (EU): Includes the GMP applicable to the manufacture of medicines.
- 21 CFR Part 211 (FDA): Regulations of the Food and Drug Administration (FDA) in the United States for Good Manufacturing Practices (GMP) applied to the production of drugs. This standard establishes:
- Environmental control: Strict requirements to ensure air quality, such as continuous particle monitoring and differential pressure control.
- Process validation: Methods to ensure that operating conditions consistently meet established standards.
- Documentation: Mandatory recording of environmental data, test results and deviations to ensure traceability and regulatory compliance.
- ICH Q7: Good manufacturing practice for active pharmaceutical ingredients.
Food Industry
- EC Regulation 852/2004: Hygiene rules for the manufacture of food in controlled environments.
- ISO 22000: Food safety management throughout the supply chain.
Hospital Industry
- Standard UNE 100713: Specific for hospital air conditioning, with emphasis on operating rooms and critical areas.
- WHO Guidelines: Guidelines for the prevention of infections in hospital settings.
Health and Safety
- Reglamento de Seguridad e Higiene en el Trabajo (RSP): Ensures safe conditions for operators in Spain.
- ATEX regulations: Applicable to areas with explosive atmospheres, especially in pharmaceutical and chemical processes.
- OSHA 1910 (USA): Occupational Safety Regulations.
Energy Efficiency
- ISO 50001: Energy management systems to optimize consumption in facilities.
- European Directive 2012/27/EU: Promotion of energy efficiency in the design of industrial systems.
Materials and Safety Standards in Clean Room Construction
Cleanroom design and construction requires materials and finishes that meet strict quality and safety standards. Some key regulations include:
- EN 13501-1: Classification of fire resistance of materials used in construction.
- EN 1822: Specifications for HEPA and ULPA filters, ensuring the removal of particles in HVAC systems.
- UNE 60601: Electrical requirements to ensure operational safety in controlled environments.
- EC Regulation 305/2011: European standard for construction products, applicable to clean rooms.
Data and Computer Systems Integrity
The control and recording of data in clean rooms are regulated by standards that guarantee their integrity and traceability:
- 21 CFR Part 11 (FDA): Requirements for computerized systems used in regulated environments.
- GMP (EU) Annex 11: Guidelines for the validation and operation of computerized systems.
- ISO/IEC 27001: Information security management in digital systems.
Final considerations
Regulatory compliance in cleanrooms is a multidisciplinary challenge ranging from air quality standards to safety regulations, materials and computerized data.
Specialized engineering must master this regulatory framework to design and execute successful projects that meet the stringent requirements of the most demanding industries.
This article provides a partial and indicative list; it is recommended to consult the complete regulations applicable to each project.
