In pharmaceutical cleanrooms, precise temperature and humidity control is essential for product quality, safety, and compliance. Here's why:
Product Quality and Stability:
- Many products, such as tablets, powders, and injectables, are sensitive to temperature and humidity.
- High humidity can cause powders to clump or degrade, while low humidity can make materials brittle.
- Temperature fluctuations can affect chemical stability, potency, and shelf life.
Microbial Control:
- High humidity promotes microbial growth, which is unacceptable in aseptic manufacturing.
- Maintaining controlled humidity reduces contamination risks significantly.
Electrostatic Discharge (ESD) Control:
- Low humidity can cause static electricity buildup, interfering with sensitive equipment and attracting contaminants.
- Optimal humidity levels minimize static discharge and particle attraction.
Personnel Comfort and Safety:
- Controlled temperature ensures a comfortable environment for operators wearing protective gowns and PPE.
- Prevents excessive sweating, reducing contamination risks.
Regulatory Compliance:
Standards like ISO 14644, GMP, and FDA guidelines specify acceptable temperature and humidity ranges depending on the cleanroom classification.
Typical Ranges:
- Temperature: 18°C to 22°C (64°F to 72°F).
- Humidity: 30% to 60% RH, depending on process and product sensitivity.
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