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.
Ingersoll Rand Class 0 Oil-Free compressed air technologies help pharmaceutical manufacturers adhere to this regulation by ensuring production processes remain 100% free of compressor created contaminants.
Ingersoll Rand also offers long-term rental solutions, CARE packages, as well as compressed air system audits that align with GMP requirements and PAT initiatives. Our innovative Intellisurvey tool allows us to monitor and analyze current air system performance in order to determine solutions that will maximize your system reliability and efficiency.
Over 145 years of experience to help you improve reliability and uptime with higher levels of efficiency, minimized risk, reduced waste and to meet your goals for sustainability.