Designing a cleanroom facility requires careful consideration of various factors to ensure a controlled environment with minimal contaminants. Here are key points to consider:

Cleanroom Classification:

ISO (International Organization for Standardization), FDA (U.S. Food and Drug Administration), and Health Canada have their guidelines for cleanroom classification:

ISO Standards:

ISO 14644-1 is the primary international standard for cleanroom classification. It defines the maximum allowable particle counts for different particle sizes in the air. The ISO classes range from ISO 1 (the cleanest) to ISO 9 (the least clean). ISO 1 has the strictest requirements for particle counts, while ISO 9 has the most lenient.

The ISO cleanroom classification is based on the maximum allowable particle count per cubic meter (ISO 1 to ISO 5) or per cubic foot (ISO 6 to ISO 9) at specified particle sizes.

FDA Guidelines:

The FDA doesn’t have its specific cleanroom classification standards but often refers to ISO 14644-1 for guidance. The FDA emphasizes the importance of controlling particulate and microbial contamination in pharmaceutical manufacturing to ensure product quality and safety.

Health Canada Guidelines:

Like the FDA, Health Canada does not have its cleanroom classification standards but generally aligns with international standards such as ISO 14644-1. Compliance with these standards is crucial in industries where Health Canada regulations apply, such as pharmaceuticals and healthcare.

Facility Location:

• Choose a location away from sources of contamination such as industrial areas, high-traffic zones, and environmental pollutants.
• Consider proximity to utilities, shipping/receiving areas, and personnel access points.

Building Design:

• Optimize the layout to minimize cross-contamination and maintain a smooth workflow.
• Implement proper zoning for different cleanliness requirements within the cleanroom.

Environmental Controls:

• Install effective HVAC systems to control temperature, humidity, and air cleanliness.
• Ensure a unidirectional airflow to minimize particle dispersion and contamination.
• Use high-efficiency particulate air (HEPA) or ultra-low penetration air (ULPA) filters.

Materials and Finishes:

• Choose materials that are easy to clean and resistant to chemical reactions.
• Minimize particle-generating materials in construction and finishes.
• Seal joints, seams, and penetrations to prevent air leaks.

Cleanroom Garments and Personal Protective Equipment (PPE):

• Establish proper gowning procedures to ensure the cleanliness of personnel entering the cleanroom.
• Provide designated changing and storage areas for cleanroom garments.
• Implement a thorough training program on gowning practices for personnel.

Equipment and Furnishings:

• Select cleanroom-compatible equipment with smooth surfaces and minimal particle generation.
• Minimize the number of furnishings and equipment to reduce potential contamination sources.

Monitoring and Control Systems:

• Install a robust monitoring system for temperature, humidity, particle counts, and pressure differentials.
• Implement an automated control system to maintain environmental parameters within specified limits.

Cleaning and Maintenance Protocols:

• Develop a comprehensive cleaning schedule and protocol using approved cleaning agents.
• Establish regular maintenance routines for HVAC systems, filters, and equipment.

Training and Documentation:

• Provide ongoing training for personnel on cleanroom protocols and procedures.
• Maintain detailed documentation of cleanroom design, construction, and ongoing operation for compliance and troubleshooting.

Validation and Certification:

• Conduct thorough validation processes to ensure the cleanroom meets specified standards.
• Regularly perform certification tests to verify and document the cleanroom’s performance.

Contact Us:

To streamline your cleanroom designing processes and optimize your compliance efforts in the life sciences manufacturing industry, please do not hesitate to contact our team of experts at info@gxpcellators.com. We can always assist you if you have inquiries or wish to schedule a consultation. At GxP Cellators, we are committed to equipping our clients with the tools and knowledge they need to succeed in compliance. Thank you for considering us as your trusted partner for compliance excellence.