Compressed Air Testing Pharmaceutical Manufacturing
Compressed air serves a crucial role in manufacturing. Considered the fourth utility, alongside water, electricity, and gas, compressed air powers vital equipment, control valves, and packaging lines.
According to the Department of Energy, over 70% of all manufacturing businesses in the US use compressed air in their production.
In the pharmaceutical and medical instrument sector, pneumatic-powered systems assist with product handling and may come into direct contact with the products.
Because of this close interaction, strict standards have been established to ensure compressed air remains free from harmful contaminants. All manufacturers are expected to meet these regulatory requirements.
Here’s everything you need to know about compressed air testing for pharmaceutical manufacturing processes.
What Is Compressed Air Testing in Pharmaceutical Manufacturing?
Compressed air testing is a standardized process in which technicians from accredited laboratories analyze the purity of air being used in manufacturing. These evaluations are generally required for facilities that produce products that may impact product quality and human health.
In the pharmaceutical sector, compressed air is generally tested for oil, particulates, microorganisms, toxic gases, and moisture to ensure they remain at safe, acceptable levels.
This is because pneumatic systems in these facilities are often involved in formulation and packaging. Impurities in these stages can adversely affect sensitive equipment and the end product. Even the smallest trace of contaminants can raise serious compliance breaches and legal consequences. Not to mention costly system failures.
Regular air testing helps identify contamination risks and prevent them from turning into a major headache.
Why Is Compressed Air Purity Critical in Pharma Facilities?
Pharma facilities may rely on compressed air for various production processes, including tablet coating and drying, filling and packaging, and end product conveying.
Because most of the items they produce are consumed, injected, or applied directly to the human body, maintaining clean, high-quality compressed air is essential to protect drug integrity and consumer health.
Microbial, Moisture, and Oil Contamination Risks
Oil contamination is a common issue in many production facilities. These issues often occur when compressor lubricants leak due to improper maintenance and invade other systems.
If left alone, oil aerosols harm nearby equipment, impact product quality, and compromise consumer safety.
Moisture is similarly prevalent and problematic.
Without sufficient air dryers, vapor can accumulate in piping systems, creating conditions for microorganisms to thrive. Bacteria, viruses, and fungi may reach sensitive production areas, posing health hazards.
Particulate Matter and Drug Quality Risks
In addition to oil and moisture, particulate impurities can just as easily enter pneumatic systems without proper safeguards.
Cytotoxic dust, dirt, and rust from corrosion can endanger workers and degrade the quality of compressed air.
Moreover, air containing these impurities can result in cross-contamination, with airborne dust migrating between systems and ruining batches of pharma products.
The International Organization for Standardization (ISO) imposes rigid standards for the acceptable number and size of permissible airborne particulates in pharmaceutical environments.
Frequent testing validates compliance with relevant regulations and that filtration systems are working as intended.
Compressed Air Standards for Pharmaceutical Manufacturing
Facilities that produce drugs and medical instruments follow strict guidelines mandated by several local and international regulatory bodies.
ISO 8573 Purity Standards
The ISO 8537 series is an internationally accepted standard in compressed air analysis in various industries, including pharma firms.
ISO 8537 1 provides guidelines and classifies purity levels for major contaminants, namely:
- Water or moisture
- Oil and hydrocarbon
- Gaseous impurities
- Microbial content
- Solid particulates
Different classes of ISO purity standards may apply to different stages of production. But they generally require low oil concentrations, strict particulate control, and low dew points.
Due to the nature of their products, pharmaceutical manufacturers must target higher levels of purity in their pneumatic systems. Even higher (Class 0) if compressed air is utilized closely with drug production.
The ISO 8537 also recommends practical methodologies for testing air quality for specific contaminants.
USP and cGMP Compliance Requirements
In the US, pharmaceutical manufacturers must comply with the requirements set by the United States Pharmacopeia (USP) for quality assurance.
Additionally, companies must follow the current Good Manufacturing Practice (cGMP).
USP guidelines focus on preventing contamination and environmental control. cGMP also places a high emphasis on quality compressed air and considers it a critical utility that should be closely monitored.
Companies in the drug production sector are expected to conduct risk assessments, validate compressed air systems, perform routine checks, and keep written records, among others.
FDA Expectations for Compressed Air Systems
Besides the USP, the US Food and Drug Administration (FDA) directs pharmaceutical firms to maintain compliant pneumatic systems.
During FDA inspections, inspectors may look for evidence that facilities are aware of where compressed air contacts with products and can identify risks.
Filtration and drying systems may be checked. Moreover, they may demand documentation for routine maintenance, validation, and air quality testing activities.
What Pharmaceutical Compressed Air Testing Includes
Depending on the type of contaminant, accredited laboratories have several testing instruments and methodologies.
Moisture and Dew Point Testing
Moisture and dew point testing are key steps in verifying air purity.
Measuring the moisture levels gives you an idea of the amount of vapor inside compressed air systems. Dew point testing, on the other hand, determines the temperature at which vapor condenses into water.
To do these tests, technicians primarily use hygrometers, spectroscopy, and detection cubes.
If the moisture content and dew point values exceed acceptable levels, the experts may recommend installing desiccant and membrane dryers.
Oil Mist and Hydrocarbon Detection
The second part of the ISO 8537 details how to measure oil aerosols and hydrocarbons in compressed air systems.
Air samples are passed through specialized membranes to capture oil residues. Infrared spectrometry is then used to determine the severity of oil contamination.
Particulate and Particle Count Analysis
Specialists test whether the particulate count and size in pneumatic systems remain compliant with ISO and USP standards. They do this using a laser particle counter or microscopic filter collection.
Microscopic filtering is more labor-intensive and requires special membranes to detect particulates. Laser counters are automated and ideal for rapid analysis.
Microbial and Toxic Gas Testing
This test evaluates whether bacteria, viruses, fungi, yeast, molds, and other microorganisms are present in compressed air.
To find out, technicians take a sample of compressed air near a point of use, often using agar plates. The sample is then incubated in a laboratory for microbiological testing.
Some facilities may also be required to conduct toxic gas testing to detect traces of hazardous gases, such as carbon monoxide and sulfur dioxide.
Pressure and Flow Rate Verification
Too much or insufficient compressed air flow can lead to systems lagging and, worse, failing.
Air pressure (PSI) and flow rate (CFM) are vital testing metrics for detecting leaks and ensuring pneumatic devices are in optimal condition. Routine checks of these parameters may help prolong equipment life.
How Compressed Air Validation Is Performed
Validation is a key part of compliance in the pharmaceutical sector, proving that compressed air systems are clean and functioning within the set standards.
Installation and Operational Qualification
Under ISO 8573, validating air purity for pharma companies usually begins with installation qualification (IQ) and operational qualification (OQ).
IQ verifies that the compressed air system physically matches design specifications, while OQ confirms that everything, from the pipes to the dryers, filters, and compressors, is operating as it should.
Performance Qualification and Revalidation
The quality of compressed air is evaluated during performance qualification (PQ). During testing, the pneumatic system must demonstrate consistent performance in real manufacturing scenarios.
Pharmaceutical companies should also revalidate results through routine checks and prove continued compliance.
Compressed Air Compliance and Testing Frequency
Monitoring and testing compressed air quality must be performed routinely. How often you’ll need to test for compliance can vary by industry.
How Often Pharmaceutical Facilities Should Test
Due to the stringent safety regulations for pharmaceutical facilities, testing should be performed more frequently than in other manufacturers.
While neither the ISO, USP, nor the FDA mandates a specific number, it may be a good idea to conduct compressed air testing semi-annually or quarterly.
What Happens When Systems Fail Compliance
Failing a compressed air quality test can lead to batch product rejections and regulatory sanctions. In the worst case, some facilities may damage their reputation and be forced to halt production.