Rather than risking their reputations, pharmaceutical manufacturers are encouraged to invest in oil-free compressors that can achieve Class 0 contaminant-free compressed air

Compressed air is used extensively in various industries; however, for some sectors – such as the pharmaceutical industry – it is crucial for the compressed air to be completely free of contamination, including oil vapour, moisture and particulates.

Craig Swart, fleet manager at Rand-Air, explains: “Contaminant-free air is a requirement for the air supply in the clean rooms found in pharmaceutical manufacturing, where, for obvious reasons, exceptionally stringent hygiene regulations apply.” Ideally manufacturers should strive for a Class 0 – as defined under the ISO 8573-1:2010 standard for compressed air.

Under the standard, there are several purity classes, which look at particles, water and oil. Class 0 is the lowest or least contaminated level. According to the ISO standard, this class is achieved by ensuring the concentration of contaminant in the air is below Class 1. The specific level is determined by the equipment user and supplier.

Class 1 is achieved in the compressed air (per cubic metre) when:

• There are 20 000 particles or less from 0,1 to 0,5 µm in size;

• There are 400 particles or less from 0.5 to 1.0 µm in size;

• There are 10 particles or less;

• A pressure dew point of minus 70°C or less is achieved;

• There is no liquid water; and

• The concentration of total oil (liquid, aerosol and vapour) is
0.01 mg/m3 or less.

Achieving Class 0 compressed air can assist manufacturers in minimising the potential for compromised or damaged goods, expensive operational downtime and reputational damage.

To assist in achieving this level of contaminant-free compressed air, experts advise manufacturers to invest in oil-free compressors.

While there is a higher initial cost to oil-free compressors, there are fewer expensive filter replacements, less energy consumed, and no oil condensate treatment required. Rand-Air sources its oil-free compressors from Atlas Copco – the first compressor manufacturer to achieve ISO 8573-1 certification.

“Rand-Air has the right solution and is able to supply pharmaceutical manufacturer clean rooms with oil-free compressors with a TÜV Class 0 certification that meets the ISO 8573-1 standard,” Swart notes.

“With this assurance, pharmaceutical manufacturers can have peace of mind that they are guaranteed fully sterile and hygienic 100-percent oil-free compressed air,” he adds. TÜV provides independent certification.

The evolution of this stringent standard reflects the ever-increasing need for quality air for manufacturing processes and end products. As consumers demand better quality products, manufacturers need to take every precautionary method possible to ensure they offer the best product.

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