Description
BPG109 is a 56-page Best Practice Guide titled “Pharmaceutical Grade Compressed Air”, produced by the British Compressed Air Society (BCAS) for professionals working in the pharmaceutical manufacturing sector, including quality managers, engineers, and auditors responsible for product safety and compliance.
This guide outlines how to manage the purity of compressed air used in pharmaceutical applications, offering clear, usable recommendations where international guidance is often vague or lacking. It is designed to support Good Manufacturing Practice (GMP) and Pre-requisite Programmes (PRPs), providing a practical approach to identifying and mitigating the risks of contamination from compressed air.
BPG109 details the main sources of compressed air contamination, outlines key hazard control measures, and introduces air purity specifications based on the ISO 8573-1 standard. It explains how these can be applied at various points in the manufacturing process—whether the air comes into direct, in-direct or non-product contact with ingredients, equipment, or packaging. The guide also covers technologies for air purification, microbiological control, testing methods, and references parallel specifications including European Pharmacopoeia, ISO 14644-1, and FDA CFR Title 21.
With pharmaceutical product safety as its focus, this Best Practice Guide serves as a vital reference for manufacturers aiming to specify, verify and maintain pharmaceutical-grade compressed air systems that meet current industry expectations and regulatory requirements.
