Aug 2, 2023

Flawless compressed air: Essential in the Pharmaceutical Industry

From the operation of equipment to the transport of materials, compressed air in the pharmaceutical sector is paramount. Furthermore, it is crucial to understand that compressed air quality is essential to ensure the safe production of medicines and meet regulatory standards. In this article, we will explore why compressed air quality is vitally important in the pharmaceutical sector, how it can be measured and the consequences of poor compressed air quality in this sensitive industry.
Any contaminants present in compressed air, such as particles, moisture or oil, can affect the stability, efficacy and safety of pharmaceutical products. Failure to meet quality standards can lead to degradation of medicines, resulting in financial losses and, more seriously, health risks to patients.
Regulatory agencies impose strict regulations to ensure the quality and safety of pharmaceutical products. These regulations include specific requirements for the quality of compressed air used in critical areas, such as cleanrooms and manufacturing areas. Compliance with these standards is essential to avoid regulatory sanctions, ensure product quality and customer satisfaction.
Rafael Torres Martinez, Director of RP Mechatronics, explains more about the importance of quality compressed air in this sector.

What are the main challenges industries face when trying to comply with compressed air quality standards?

Meeting compressed air quality standards in the pharmaceutical industry can be a significant challenge due to the critical and sensitive nature of the products being manufactured. For example, the control of contaminants, such as particulates, oil and moisture, can affect the quality of pharmaceutical products. It is also necessary to implement a regular monitoring and maintenance programme to ensure the integrity of the compressed air system. The latter is closely linked to ensuring compliance with ISO standards, which requires planning and adaptation.

What are the key criteria that must be met to ensure compressed air quality according to ISO standards?

ISO 8573-1 and ISO 8573-7 are the most relevant standards for compressed air quality in the pharmaceutical sector. Key criteria include:
ISO 8573-1: This standard specifies limits for the maximum allowable amount of particles, water and oil in compressed air in different quality classes (Class 0 to Class 9). The lower the class number, the higher the purity of the compressed air.
ISO 8573-7: This standard focuses on microbiological contamination testing, which is critical in pharmaceutical environments, and sets limits for microorganisms present in compressed air.

What are the main contaminants in compressed air and how can they affect human health and equipment performance in an industrial environment?

The most common contaminants in compressed air include particulates, water, oil, micro-organisms and chemicals. These contaminants can have serious consequences in the pharmaceutical sector, both on patient health and industrial equipment.
Filters and Separators: The installation of suitable filters and separators helps to remove particles and oil, ensuring greater compressed air purity.
Dryers and Desiccants: This equipment is used to remove moisture from compressed air, preventing corrosion and the growth of micro-organisms.
Contamination Analysis: Periodic analysis can be performed to measure the quality of compressed air and detect the presence of contaminants.

What are the economic and efficiency benefits of maintaining optimal compressed air quality compared to a poor compressed air system?

Maintaining optimal compressed air quality provides numerous benefits such as optimal product quality, process efficiency by reducing downtime and economic savings in maintenance.