Class 100
1.Airborne Particulate Cleanliness Classes in Cleanrooms and Clean Zones
2. are maintained in areas where parenteral products are filled into clean, sterile container
3. an area that can be controlled to contain fewer than 100 particles, 0.5 µm and larger per cubic foot of air
1 make the development, manufacturing and supply of
products and services more efficient, safer and cleaner
2 facilitate trade between countries and provide governments with a technical base for health, safety
and environmental legislation, and conformity assessment
3 share technological advances and good management practice
4 disseminate innovation
5 safeguard consumers, and users in general, of products and services
1. The system minimizes or eliminates the risk of marketing
unsafe products
2. It guarantees conformance to regulatory requirements
3. It guarantees product efficacy
4. It reduces operating costs
5. It reduces operating losses
6. It produces higher employee morale
7. It motivates the pharmaceutical/ medical
professions to sell or prescribe the product
