Pharmaceutical Compressed Air Testing Service
Compressed Air Validation Standards for the Pharmaceutical Industry
Pharmaceutical compressed air testing includes Direct Product Contact, Indirect Product Contact, United States Pharmacopeia (USP), the European Pharmacopeia, or the ISO 8573 compressed air standard.
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 compressed air baseline test before validation. 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.
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 accreditations and proficiencies ensure that our lab meets the highest standards of quality and can deliver reliable, consistent laboratory test results. To better meet our customer’s expectations, we have expanded our ISO 9001:2008 Quality Program to include applicable elements of cGMP associated with 21 CFR Part 210 and 211.
TRI Air Testing provides independent laboratory support for many pharmaceutical companies. We offer 24-hour turnaround time and online laboratory reports via MyAir™. Validation engineers use air testing equipment and media provided by TRI to collect compressed air samples as part of their facilities’ air quality compliance, safety and validation programs. Solutions for compressed air testing to international standards are provided with excellence in science and quality.
* If your specification requires a breakdown of oil mist from particulate a 48 hour turnaround is required to meet this specification.