2023-11-23

The global pharmaceutical sector is renowned for its stringent regulations and high standards. Every pharmaceutical company adheres to strict guidelines, such as Good Manufacturing Practice (GMP), the European Pharmacopoeia, Food and Drug Administration (FDA), or International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). These regulations ensure the quality, safety, and efficacy of pharmaceutical products.

In 2021, India's domestic pharmaceutical market experienced remarkable growth, with an annual rate of 17.7 percent, surpassing the 13.7 percent recorded in July 2020. The Indian pharmaceutical industry is projected to expand its market size to USD 65 billion by 2024, a substantial increase from its valuation of USD 42 billion in July 2022. This exponential growth positions India as a prominent player in the global pharmaceutical market.

Moreover, the Indian pharmaceutical sector has made significant contributions during the COVID-19 pandemic by offering cost-effective global healthcare solutions during health emergencies. This track record of success has led to the anticipation that the pharmaceutical market revenue in India will reach USD 130 billion by 2030.

Quality of Air is Critical

Compressed air is a cornerstone utility in the pharmaceutical industry. Quality of air plays a vital role in the processing of ingredients and the instrumentation side. The applications of compressed air in the pharmaceutical industry are diverse. 

• Nitrogen Generation: Filtered oil free compressed air is used to produce Nitrogen, which is then used in the packaging process, blanketing coating applications, or purging of equipment.
• Process Air: Compressed air comes into direct contact with products during various processes, such as jet milling, fluid bed mixing and blending, fermenters, or tablet coating.
• Cleaning: Compressed air is used for cleaning and purging equipment between different batches of production. 
• Product Moving: Compressed air is utilised for moving products or facilitating the filling process.
• Instrumentation Air: Pneumatic systems in production lines also rely on compressed air for their operation. 

Any form of contaminants in the air can disrupt the functionality of the pneumatic systems and potentially lead to production quality issues. This will occur if the process air comes in direct contact with the product. Depending on the production layout, during blow-off from a pneumatic system, air may come into contact with the product. In order to prevent contamination of the final product, the air needs to be as clean as possible. With increasingly stringent quality control requirements and growing regulatory standards, the pharmaceutical industry must prioritise the quality of compressed air used in its production facilities.

Compressed Air Quality

All air compressors draw in atmospheric air, compress it to the required pressure, and deliver it to the point of application. Atmospheric air can contain various contaminants, including particulates, moisture, solvents, oil, and pollen. These can seriously hamper end products if they are not filtered properly. 

ISO 8573 is a globally recognized standard for compressed air quality measurement. Almost all pharmaceutical companies demand compressed air quality in compliance with Class Zero per ISO 8573-1, which stipulates the absence of oil, and ISO 8573-7, which specifies the absence of microbiological contaminants.

Even a minute trace of oil in the air lines can lead to product contamination and impurities, damaging a drug manufacturer's reputation. Therefore, there is a growing demand for high-quality, efficient, and reliable compressed air systems.

Safety and Risk Analysis

The criticality of compressed air applications in any pharma Industry must be carefully accessed before setting up the compressed air system. Key considerations include:

• Intended use: Will the air be used for breathing applications?
• Application Scope: Will the air be used for instrumentation, process, or both? If only instrumentation, the blow-off layout is very important. 
• Volume and Pressure Requirements: Determining the total quantity and pressure of compressed air needed.
• Product Sensitivity: Assessing whether the product being produced is sterile or sensitive to specific parameters.
• Regulatory Compliance: Understanding the regulatory or statutory requirements for utilities, including compressed air.
• Environmental Contaminants: Identifying any other potential contaminants in the operating environment.
• Moisture Control: Establishing acceptable moisture levels for critical applications in the system.

Compressed Air Purification

It is imperative that all contaminants are removed from compressed air before it is used in the end application. It involves carefully evaluating the entire system, as discussed in the above section, the right type of compressor in the system, and selecting the right systems both upstream and downstream of the compressor.

Oil free air compressors are designed fundamentally to avoid additional oil particles or aerosols via the compressor lubricants.

The atmospheric air is the source of contamination. To maintain air quality, the environment inside the compressor room should ideally be free of contaminants. However, in practical situations, this may only sometimes be feasible. In such cases, chemical filters, high dust filters, or pre-filters should be used on the upstream side of the compressor.

Compressed air treatment systems on the downstream side of the compressor are tailored to meet specific air quality requirements, flow rates, pressures, temperatures, desired dew points, and the location of the compressed air system in relation to its applications.

Lower Life Cycle Cost of Operation

The life cycle cost of compressors has three critical components:

• Initial investment cost
• Power Cost of running the compressor
• Maintenance and consumables

Oil-flooded compressors with downstream filters might appeal to be a very cost-effective solution in the beginning. A lot of times, ‘oil-less’ or ‘technical oil-free’ air is perceived to be ‘oil-free’ air. This is not true. Even with the best of filtration on the downstream side of compressors, the air quality will not exceed Class 1, which is not completely oil-free. They also call for a lot of maintenance over their life cycle – oil filters, oil change, oil separators, downstream side filters, oil-water separators, and non-lube modules. Hence, it is important that while making a compressor selection, one must not focus on just initial investment but consider all the above factors involved coupled with air quality requirements.

Oil-free compressors, coupled with efficient control systems, not only improve air quality but also reduce the overall cost of compressed air in pharmaceutical manufacturing. This shift transforms compressed air from a cost driver into a source of cost efficiency and aligns with corporate responsibility, including minimising environmental impact.

Air compressors deployed in pharmaceutical industry should be of oil-free nature with good downstream side air dryers and filters. Moisture in air can lead to unwanted viable particulates and impact drug quality. Hence, the pharmaceutical industry prefers to have a PDP of -20C to -40C. Hence, it is always recommended to go with Desiccant dryers, which can consistently deliver lower dew points than refrigerated dryers. 

In conclusion, compressed air quality is of paramount importance in the pharmaceutical industry. Properly purified compressed air ensures product integrity, compliance with stringent regulations, and reliable operations. Therefore, pharmaceutical companies must partner with air compressor manufacturers to select the right products, maintain statutory compliance, and achieve a lower life cycle cost of operation, all while meeting the ever-increasing quality demands of the industry. By addressing these critical aspects, the pharmaceutical industry can continue to thrive and contribute to global healthcare solutions.