Air Compressors for the Pharmaceutical Industry

In the production of your product, compressed air is not just another utility: it is an ingredient. When it comes into contact with your products, the quality of compressed air has a direct impact on product safety and regulatory compliance. Failed compressed air systems can lead to product contamination, production shutdowns, and significant financial losses. That’s why, for Plant Managers, Quality Assurance leads, and Compliance Officers, the control of compressed air is a primary aspect of any GMP strategy.

We go through the fundamentals of designing, operating, and maintaining a GMP-compliant compressed air system for pharmaceutical manufacturing in Scotland.

The Risks of Contamination in Pharmaceutical Production

The compressed air process pulls in and concentrates contaminants from the air. Without the right purification system, these contaminants are sent straight into your sensitive production areas.

The primary risks include:

Solid Particulates: Dust and rust will contaminate the product and clog pneumatic equipment.
Water: Humidity condenses into water and vapour, encouraging mould and bacteria to grow in pipework and spoiling moisture-sensitive products.
Oil: Hydrocarbon vapours present in the outside air can degrade formulations. Even with an oil-free compressor, these will be drawn in. This means you need to filter them out downstream.
Microorganisms: Bacteria and spores are sucked into the system and can multiply. They can then be blown directly into sterile processes.

A simple precaution is to position your compressor’s air intake away from loading bays and exhausts. This reduces the load of contaminants right from the start. Contaminated air can spoil products, damage equipment, and even cause MHRA audit failures.

Meeting UK Regulatory & Compliance Standards

A compliant system must meet both product quality rules (GMP) and workplace safety laws (PSSR).

ISO 8573-1 and the Class 0 Standard

The global standard for air purity is ISO 8573-1:2010. It classifies air based on the presence of particles, water, and oil. For the pharmaceutical industry, the highest standard is Class 0.

Crucially, Class 0 doesn’t mean zero contamination. It’s an air quality standard stricter than Class 1, achieved with certified oil-free technology to eliminate contamination risk at the source.

GMP, MHRA, and Validation

Compressed air is a critical utility under UK Good Manufacturing Practice (GMP). The MHRA expects you to conduct risk assessments to demonstrate that your air quality is suitable for each application.

Part of this is developing a site-wide Contamination Control Strategy (CCS). EU GMP Annex 15 also requires complete qualification documentation for your system. This ensures your system is:

IQ (Installation Qualification): Installed correctly.
Operational Qualification (OQ): Operates within established limits.
PQ (Performance Qualification): Performs reliably under real production conditions.

Pressure Systems Safety Regulations (PSSR) 2000

Separate from product quality, PSSR 2000 is a UK safety law to prevent injury from high-pressure systems. It legally requires you to have a Written Scheme of Examination (WSE) prepared by a ‘competent person’. This document schedules safety inspections for components like air receivers and valves.

Engineered for Purity: The Right Compressor Technology

A compliant system starts with the right core technology and a complete air treatment train.

Why Oil-Free is the Only Option

Using oil-lubricated compressors carries an unacceptable risk. A single filter failure could release oil into your production environment with potential losses exceeding £100,000 for a single contaminated batch.

Certified Class 0 Oil-Free Air Compressors are engineered to prevent oil from ever entering the compression chamber. It’s why our engineers at Design Air (Scotland) exclusively install systems like the Atlas Copco ZR/ZT series for critical pharmaceutical applications.

The Complete Air Treatment Train

Generating pure air is a multi-step process. A correctly specified system includes:

Aftercooler & Water Separator: To cool the air and remove bulk water.
Desiccant Dryer: Essential for achieving a low dew point (down to-40°C or -70°C) to prevent microbial growth.
Multi-Stage Filtration: Includes a coalescing filter for aerosols and a critical activated carbon filter to remove hydrocarbon vapours pulled in from the outside air.
Sterile Filters: A final point-of-use filter for aseptic applications.

For rapid scale-ups, the Atlas Copco AIRCUBE offers a fully containerised, plug-and-play compressor room built to these standards.

Need help designing a compliant system? Contact our team today for a pharmaceutical-grade air assessment.

Driving Efficiency with Smart Technology

A modern compressed air system is a smart asset that helps you hit sustainability and Pharma 4.0 goals.

Reducing Energy Costs and Carbon Footprint

Variable Speed Drive (VSD) compressors can reduce energy consumption by up to 35% by matching motor speed to your exact air demand. In addition, up to 94% of the energy a compressor uses is converted to heat. A heat recovery system can capture this to produce hot water for other plant processes, cutting your fuel bills and carbon footprint.

Pharma 4.0 Readiness with SMARTLINK

Atlas Copco’s SMARTLINK remote monitoring system provides real-time data on pressure, flow, and energy usage.

Predictive Maintenance: Identifies potential issues before they cause breakdowns, preventing unplanned downtime.
Compliance & Data Integrity: Creates a traceable, time-stamped record of air quality for GMP audit logs.
Energy Management: Helps you optimise system performance and supports compliance with ISO 50001.

Your Local Partner for Compliance & Performance

Based in Airdrie, Design Air (Scotland) is positioned to serve the country’s key life science hubs, from the Edinburgh BioQuarter to advanced manufacturing centres across the Central Belt. As Scotland’s Premier Atlas Copco distributor, we offer complete services from start to finish.

Our services include:

Expert Consultation: We conduct a comprehensive Compressed Air System Audit to assess risks and determine the optimal air purity for each application.
GMP-Compliant Installation: Our engineers provide complete system installation and validation.
Air Quality Validation: We offer a scheduled ISO 8573 Air Quality Test service to give you proof of compliance when you need it.
PSSR 2000 Compliance: Our team can act as the ‘competent person’ to create and manage your legally required WSE.
Proactive Maintenance: Our tailored Compressor Service Plans use only genuine OEM parts to maintain your system’s validated status. We also provide On-Site Nitrogen Generation for blanketing and purging.

For expert compressed air assistance, to ensure your pharma operations are backed up by a dependable, efficient, fully-compliant compressed air supply, talk to the experts at Design Air (Scotland) Ltd.

Contact our team today to discuss your needs or schedule a comprehensive site audit.