高压气体污染监测
监测高压气体中的粒子和微生物
在许多工业生产中，无论是直接与产品接触还是直接进入洁净室环境，压缩气体都是非常重要的。
包括制药行业中活性微生物与非活性粒子的监测，以及电子行业中惰性气体（监测精度为10nm）和腐蚀性气体（监测精度为100nm）的监测。
制药生产环境控制是良好生产规范(GMP)的关键要素。洁净室、限制进入隔离系统(RABS)和隔离器中的颗粒和微生物的监测指标详见下表。
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 Gas Microbial Monitoring in Aseptic Manufacturing
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.
Sampling High-Pressure Gases
This paper describes fundamental relationships between air or gas volume, pressure, and flow, and how these relationships affect particle counting.
Compressed Gas Contamination Monitoring: Particles & Microbials Questions & Answers
This FAQ paper is a follow up to the webinar, “Effective Compressed Gas Contamination Monitoring:
Particles and Microbials”.HPD III High Pressure Diffuser
The HPD III Aerosol Monitoring Accessory is compatible with non-toxic, non-flammable gases such as Clean Dry Air (CDA), Argon, and Nitrogen.
