Publication : Healthcare World
Dhirendra Choudhary, CEO, Bry-Air | Business World Healthcare World | December 12, 2021
Moisture or humidity is one of the major elements that affects and may spoil the manufacturing process, if not kept under control.
Quality air is indispensable for the pharmaceutical industry specifically so because it involves human well-being. Customers today are very demanding and want the best of medical and healthcare facilities available to them and it takes a lot of effort, strength, resources, and investments to build the products for pharmaceuticals. Like any other industry, pharmaceutical is also one of those industries where technology is embodied truly in the DNA which demands the best-in-class updated technologies and machinery to deliver a relevant and consistent quality of the product.
However, moisture or humidity is one of the major elements that affects and may spoil the manufacturing process, if not kept under control.
The exposure of pharmaceutical products to moisture can have severe imputation during manufacturing, which further impacts shelf life also. The ideal situation is to prevent unwanted moisture uptake or loss, at any stage of progression.
Moreover, factors such as temperature, humidity, air quality, can all have a significant impact on the final quality, and therefore impact the brand reputation and profitability too. Even the simplest form of the pharmaceutical manufacturing process can involve a range of steps before the finished product is packaged and finally reaches the consumer. In the pharma industry, there are a wide variety of drugs, injections, and other products that requires ideal RH conditions, storage in cool conditions, refrigeration plant is widely used, that needs to be carefully monitored and ensure that products are preserved at the right temperatures. Hence, that is the reason stocks are secured and stored in the appropriate environmental conditions.
However, the more modern and technical pharmaceutical processes, the more stringent is the demand for the controlled environment to deliver a consistent quality of product with a longer shelf life. In this article, we will throw light on the various critical areas where stringent environment control is required.
Powder milling: Atmospheric moisture is the natural enemy of many grinding and pulverizing operations. The contact of moisture traces in the air around, with the product, makes the material resilient and therefore difficult to grind. The material clings to the grinding machine and defies pneumatic conveying from one process to another.
Compounding of tablets: Basic operation of chemical and pharmaceutical industries is bringing together the constituents, under precise conditions, to form compounds. Unwanted moisture may impede desired reactions or cause the formation of undesirable end products. Many diagnostic products used in medicine today involve radioactive material that must be mixed or compounded in a humidity-controlled environment. Aspirin and many other complex diagnostic compounds are moisture reactive. It leads to poor product quality and shortened shelf life.
Soft gelatin capsule manufacturing: In soft gelatin manufacturing, warm liquid gelatin is spread over a slowly revolving stainless steel drum. A supply of chilled dry air congeals the gelatin as the drum rotates so that a tacky, elastic band rolls off the other end. This thin band is automatically formed into capsules filled with medicine. If the temperature and humidity are high, gelatin will start softening and prevent solidification. From the capsulating machines, the soft moist capsules are transferred to drying drums or chambers for rapid drying. The extent of moisture to be removed during drying depends on the size from which the moisture is to be removed. The moisture has to be removed gradually, to prevent superficial surface hardening. Drying at elevated temperatures will impair dried product quality.
Similarly, storage is also one of the important parameters which require a lot of attention, because a minor mistake can ruin the process. As per products, there is a different kind of storage, for example, most pharmaceutical powders are hygroscopic and moisture reactive. Maintaining low humidity in storage before manufacture, after manufacturing and in packaging, areas are of prime importance. While in capsule storage, the drug needs to be stored in a dry environment before packaging to prevent moisture regain and spoilage of the product. Other than this, Aluminium Foil Storage is extensively used in packaging tablets and capsules, is moisture sensitive in nature and needs to be stored in a humidity-controlled environment prior to being used for packaging.
To prevent pharmaceutical products from moisture, desiccant dehumidifiers are the perfect solution that removes the humidity from the air. It is used in various areas of the pharmaceutical industry.
