Importance of quality compressed air for complying with GMP in pharma industry

About Author: Deepesh Upadhyay, Asst. Vice President, Delair India leads the Sales & Business Development of the company. Coming with more than two decades of experience in the industry, he has extensive expertise in leading Industrial Sales & Services along with Dealer Management and Customer Relationship Management.

The Indian pharma industry is at a very interesting cusp of development. Recognized across the globe as the ‘pharmacy of the world,’ the country is a major exporter of pharmaceutical products to more than 200 countries across the globe. Therefore, in order to maintain the supremacy of Indian pharma products, there is an incessant need to continuously innovate and upgrade the manufacturing process to curate the highest quality products that are at par with global standards.

Along similar lines, the recent guidelines issued by the government aimed at promoting Good Manufacturing Practices (GMP) can be considered a breakthrough step in fortifying the reputation of Indian pharmaceutical products in the international market. Complying with the new guidelines, it is the need of the hour that pharma manufacturers ensure the production of safe, effective, and high-quality drugs. To achieve the result, the industry needs to practice robust quality control of the pharma products.

In order to meet the strict hygiene standards, the manufacturers should proactively mitigate the moisture menace severely plaguing the industry. Here, it is important to understand that the pharmaceutical industry is highly dependent on compressed air for a wide range of pneumatic processes that are required during the processing, manufacturing, and packaging of pharmaceutical products. As a result, the industry should deploy quality compressed air, free from even the slightest trace of moisture and any form of contaminants, to comply with the Food and Drug Administration (FDA) recommendation. Hence, quality compressed air plays a crucial role in abiding by the hygiene standards to produce drugs and medicines of the highest quality.

Gauging the wide range of applications compressed air finds in manufacturing, from mixing and granulation to drying, pressing, coating, packaging, and many more critical applications, it comes in contact with pharmaceutical products at every stage of manufacturing. In the production of tablets and capsules, compressed air gives the right texture, colour and flavour to the product. Hence, the requirement for compressed air is inevitable in the pharmaceutical industry, right from mixing powder to producing granules for tablet pressing, it is even required during coating or encapsulation. In addition to this, in liquid medicine, it maintains the accurate balance of ingredients and ensures the precise measurement of each formula. Consequently, it is also important for the production of ointments, creams, gels, and syrups.

However, in the entire process, moisture in the compressed air acts as a major deterrent for the pharmaceutical industry, especially in tablet manufacturing. It comes with a destructive ability to interfere with the tablet compression and tablet coating process. Here, the powdered material is compressed into a tablet under high pressure in completely dry state. This is because the various materials used in medicines are highly hygroscopic in nature, which in the presence of moisture, can give rise to the lumping and caking of powder. Consequently, this can invariably lead to failure of the entire tableting process and in the worst case is also responsible for the decomposition of the drug, ultimately resulting in decreased medicinal value of the drug.

Apart from this, at the time of spray coating the tablets, compressed air laden with moisture can severely alter the color, smell, and taste of pharmaceutical products. It can account for blisters in the tablets responsible for their breakage as well. Moisture even raises the issue of uneven coating which renders inferior quality products due to non-uniform coating. All the factors together can result in the revocation of entire batches of tablets from the market, ultimately incurring huge loss on the industry.

In addition to producing tablets of inferior quality, moisture in the compressed air causes the malfunctioning of the pneumatic tools and machines which are used for manufacturing. Moisture gives rise to corrosion of pipes, pneumatic operated cylinders, zig & fixtures and other components that interfere with the smooth completion of the operations. As a result of corrosion, pneumatic valves and cylinders function sluggishly and inconsistently. The situation becomes even worse in cold weather when freezing issues arise. All of this can take a toll on the pharmaceutical company as it prolongs the downtime of pneumatic machines, leading to high maintenance costs.

Therefore, to keep the moisture menace in check, the pharmaceutical industry should always supply compressed air of the highest quality that is free from contaminants such as moisture/water, oil vapors, dust particles, or any form of solid contaminants. To achieve this, the industry should employ compressed air dryers to treat the compressed air thoroughly to enable seamless completion of various pneumatic processes.

The dryers are well equipped with desiccant-based drying technology for driving processes requiring dry compressed air with the best atmospheric dew point temperature of (-40°C) to (-70°C) max. The desiccant on pressure swing principle/purge air regenerates the desiccant bed by adsorbing and desorbing the water vapor.

Therefore, looking at the rising demand for pharma products across the world, the country needs to scale its production both quantitatively and qualitatively to meet the domestic and international demand projected in the market.

**Views expressed by the author are his own.