ISO 8573 Air Testing
The ISO 8573 standard consists of purity classes for contaminants in compressed air: particles, water, and oil. In addition, ISO 8573-1:2010 also identifies microbiological contaminants. The ISO 8573 purity classes can be used to describe the quality of a compressed air system or to specify the required quality for a precise application. Compressed air specifications should meet product performance requirements.
In the absence of specified standards governing compressed air quality testing in the pharmaceutical manufacturing process, it is often best to use site-specific air testing programs for Points of Use (POU). This may be the most assured way to produce valid, repeatable testing results that will reinforce your site’s quality. TRI recommends a Baseline Test, Direct Product Contact, Indirect Product Contact, United States Pharmacopeia (USP), the European Pharmacopeia, or the ISO 8573 air standard for Points of Use (POU). We can also test nitrogen, oxygen, argon, carbon dioxide, custom compressed air specifications and more.
The air used in the manufacturing processes should be evaluated by a competent technical individual to determine the appropriate requirements to protect the safety of the employees and the integrity of the products. We suggest a baseline test before validation. TRI has experienced validation and qualification Dealers that can work with your requirements and staff to produce the validatable systems, descriptions and documents you need to move your project forward.
The quality of the independent laboratory you use is critical to ensuring that your facility’s efforts to achieve compressed air best practices are optimized. Understanding your true compressed air quality needs and utilizing high-quality laboratory support are keys to air quality compliance in manufacturing.
TRI is ANSI/ISO/ASQ 9001-2008 and ISO 17025-2005 compliant, an AIHA-LAP, LLC accredited laboratory and participates in a compressed air quality proficiency program. These accreditation and proficiencies ensure that our lab meets the highest standards of quality and can deliver reliable, consistent results for every test. Our compressed air quality testing equipment is scientifically designed to meet valid testing methods. TRI highly recommends a routine testing schedule for your compressed air quality program for verification and compliance with FDA enforced cGMP.