Section 820.70 (e) of Title 21 of the Code of Federal Regulations set by the FDA states that “each manufacturer shall establish and maintain procedures to prevent contamination of equipment or product by substances that could reasonably be expected to have an adverse effect on product quality.”
In 2011, International Standards Organization (ISO) established a new class of air quality for pharmaceutical manufacturers with the highest standards. Class 0 is the most stringent air quality class, limiting oil contamination in liquid, aerosol and vapor forms.