Compressed air and nitrogen systems qualified
Ergopharm has qualified its compressed air and nitrogen systems, treating process gases that contact product or product-contact surfaces to the same standard applied to pharmaceutical water.
Process gases are the utility most often forgotten. Compressed air blows out a container immediately before filling; nitrogen displaces headspace oxygen in a sealed ampoule. Both touch the product or its immediate surfaces, and a system delivering oil mist, water or particles into that contact is a contamination route with no downstream step to catch it.
“The gas is only as clean as it is at the last inch before the product.”
Qualification establishes the required quality at the point of use rather than at the generator, and testing covers water content, oil content, particulate matter and microbial count. Point-of-use filtration is specified, with filter integrity confirmed on a defined schedule rather than assumed from installation.
Monitoring continues routinely on the same principle: samples are drawn where the gas meets the product, because that is the only place where its quality matters.
Key facts
- Scope
- Compressed air and nitrogen contacting product or surfaces
- Tested for
- Water, oil, particulates, microbial count
- Sampled at
- Point of use, not the generator
- Filtration
- Point-of-use filters with scheduled integrity testing