The pharmaceutical sector is among the most highly regulated industries. For good reason. The products manufactured in pharmaceutical plants can ease suffering and save lives. To do so, however, their production must meet stringent quality standards. And that begins with very clean compressed air. Pneumatech offers a complete range of solutions to achieve the compressed air quality standards pharmaceutical companies must meet.
Compressed air plays a crucial role in virtually every phase of the production of pharmaceuticals. Just consider the laboratories in which they are developed, the extruders and bottling plants, tablet presses and packaging machines. Compressed air really can be found everywhere in the production process.
In many applications, such as mixing and granulation, drying, pressing, coating and packaging, this compressed air comes into direct contact with the pharmaceuticals. When that happens, the air has to meet certain quality standards, or you risk contaminating your pharmaceuticals.
All untreated compressed air contains contaminants, which can be divided into 3 categories: moisture, particles, and traces of oil. It would be disastrous for this untreated air to get in direct contact with pharmaceutical products.
That is why the treatment of the air is a top priority – not only to protect your products but also your equipment.
Fortunately, different technologies are available to ensure that the air meets the stringent air quality requirements of the pharmaceutical industry:
ISO 8573-1:2010 is the international standard that categorizes compressed air quality. Pharmaceutical processes typically require class 1.2.1 or 1.3.1.
Purity class |
Solid particles |
Water |
Total oil |
|||
Number of particles per m3 |
Pressure dewpoint |
Concentration |
||||
0.1 < d ≤ 0.5 μm** |
0.5 < d ≤ 1.0 μm** |
1.0 < d ≤ 5.0 μm** |
°C |
°F |
mg/m3 |
|
0 |
As specified by the equipment user or supplier and more stringent than Class 1. |
|||||
1 |
≤ 20000 |
≤ 400 |
≤ 10 |
≤ -70 |
≤ -94 |
≤ 0.01 |
2 |
≤ 400000 |
≤ 6000 |
≤ 100 |
≤ -40 |
≤ -40 |
≤ 0.1 |
3 |
- |
≤ 90000 |
≤ 1000 |
≤ -20 |
≤ -4 |
≤ 1 |
4 |
- |
- |
≤ 10000 |
≤ 3 |
≤ 37.4 |
≤ 5 |
5 |
- |
- |
≤ 100000 |
≤ 7 |
≤ 44.6 |
- |
6 |
≤ 5 mg/m3 |
≤ 10 |
≤ 50 |
- |
ISO 8573-1 does not define values for germs/micro-organisms. However, germ-free compressed air is extremely important for pharmaceutical manufacturing processes. That's because germs and micro-organisms can compromise products and endanger the health of the consumer. It is therefore important to remove them from compressed air using specialized technologies such as sterile filters.
Meeting the compressed air quality standards pharmaceutical companies must comply with requires the right dryer. The Pneumatech PB is that adsorption dryer:
As the leader in compressed air quality, Pneumatech offers a complete range of air treatment equipment. This includes all types of dryers, filters, drains and (oil-)water separators. That means you can get top-quality, fully compatible air solutions from one single source.
Need help with the compressed air quality standards pharmaceutical companies like yours must meet? Contact us today. Our experts are ready to provide you with the right information, support, and solutions.