A clean room is a rigorously controlled environment that has a low level of environmental pollutants such as dust, airborne microbes, aerosol particles and chemical vapours. The air entering a clean room is filtered and then continuously circulated through high efficiency particulate air (HEPA) and/or ultra-low particulate air (ULPA) filters to remove internally generated contaminants. Staff wearing protective clothing must enter and exit through airlocks, while equipment and furniture inside the clean room is specially designed to produce minimal particles.
- Clean, safe and contaminant-free environment is imperative for manufacturing efficacious, safe and good quality drug products or packaging material or allied accessories
- Also critical to protect employees from contact with hazardous materials or pathogens and prevent health problems from prolonged exposure to chemicals or allergens
- Clean rooms are part of GMP requirement and GMP is statutory in nature.
- Design, Certifications and Documentation