Absence of viable and non-viable contamination is considered a critical quality attribute due to its potential to dramatically impact, directly or indirectly, the safety and/or the efficacy of the drug product. Moreover, compressed gases can be viewed as critical utilities in pharmaceutical Industry when either in direct product contact or directly entered into the clean room environment.
Particle Measuring Systems offer a wide range of solutions, compliant to the latest ISO/GMP requirements, to ensure the contamination control in critical environments including the monitoring of compressed gases.
Knowledge / Papers
Compressed Gases: An Important Component of an Environmental Monitoring Program in a Pharmaceutical Manufacturing Environment
The testing and monitoring of compressed air and other process gases such as gaseous and liquid nitrogen, oxygen, argon, and carbon dioxide that come into direct contact with pharmaceutical drugs during the manufacturing process is vital to assuring the quality and safety of these products.
Compressed gases are broadly used in medicinal production facilities. A variety of different gases can be introduced into the process at various stages of a product’s manufacture for different reasons. The cleanliness of compressed gases used during the pharmaceutical manufacturing process is a very important quality factor because in many instances, the gas comes into contact with the medicinal product.
This FAQ paper is a follow up to the webinar, “Effective Compressed Gas Contamination Monitoring:
Particles and Microbials”.