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.
How Does Compressed Air Quality Affect your Production Lines?
Tablet Production and Coating
Compressed air is frequently used to de-dust tablets and spray on tablet coatings. Class 0 100% oil-free air ensures higher product purity and eliminates the risk of rejections and/or health risks associated with oil contamination.
Mixing and Holding
Compressed air is used to maintain over-pressurization on mixing and holding tanks to ensure product integrity/sterility. Class 0 100% oil-free air prevents the risk of oil contamination damaging this delicate balance.
Product Filling, Packaging and Bottling
Compressed air often has direct contact with the product and/or package during filling/dosing, blister packaging and bottling. Class 0 100% oil-free air prevents oil contamination from being transferred directly to the product.
Whenever your application demands aseptic air, it demands Class 0 100% oil-free air. Oil contamination can
prevent high efficiency particle filters from performing effectively. Class 0 100% oil-free air ensures consistently sterile air.
Learn more by reading our white paper on "Predictability Matters " in the pharmaceutical industry!
Download our white paper now!