Cleanroom Best Practices for New Startups

Setting up a cleanroom is crucial for startups in biotechnology, pharmaceuticals, medical devices, and electronics. Here's what you need to know to establish and maintain an effective cleanroom operation.

Understanding Classifications

• Choose the appropriate ISO classification (ISO 5-8) based on your industry requirements

• Ensure compliance with regulatory standards (e.g., FDA cGMP for pharmaceuticals)

Core Operational Elements

Standard Operating Procedures (SOPs)

• Establish protocols for gowning, cleaning, and material handling

• Document all procedures and update regularly

• Train staff thoroughly on implementation

Environmental Controls

• Monitor air quality, temperature, humidity, and particle levels

• Maintain appropriate pressure differentials

• Conduct regular surface sampling for contamination

Efficient Design

• Create separate zones for gowning, material handling, and operations

• Establish controlled pathways for personnel and materials

• Design ergonomic workstations to minimize unnecessary movement

Personnel Management

• Provide comprehensive training on gowning and cleanroom behavior

• Enforce strict hygiene protocols

• Conduct regular refresher training

Cleaning Protocol

• Implement daily cleaning for high-traffic areas

• Schedule regular deep cleaning for walls and ceilings

• Rotate disinfectants to prevent microbial resistance

Growth Considerations

• Choose modular systems for easy expansion

• Ensure infrastructure can support future capacity

• Plan for flexible space allocation

Documentation

• Maintain detailed records of:

  • Cleaning activities

  • Equipment calibration

  • Environmental monitoring

  • Staff training

  • Compliance checks

Following these guidelines helps ensure product quality, regulatory compliance, and operational efficiency while supporting future growth potential.