• GMP critical parameters and critical     devices • Terminal sterilization • Aseptic processing area • Protection of the product • Flow of people and materials • Integrated facility design • Barrier isolation technology • Consistent HVAC terminology • HVAC principles • In-operation condition for HVAC • Selection of materials and finishes • Good Engineering Practice (GEP) • Direct impact systems • Enhanced documentation • Indirect impact systems           Airborne Environmental Cleanliness Requirements