When moisture is torture-API industry needs critical care
The pandemic has taught us over-reliance on any country for any key product could hamper its production and subsequently the supply chain. Being, a global supplier of generic drugs, India was largely dependent on China for last three decades. During the early 90s, China has emerged as API producer tapping the Indian market with cheaper products. Now, amid pandemic outburst, its time for India to revive or scale up API indigenous production.
API, Active Pharmaceutical Ingredient, which is key ingredient used to produce finished medicine actually a mixture of chemical compounds which cure the disease eg. API Paracetamol is the key ingredient for Crocin. In absence of API, medicine cannot meet the strict quality criteria. Thus, the quality of an API is crucial.
Top API imported from China:
- Anti-epileptic, and
- basic cancer products.
API is moisture sensitive
For API manufacturing, the recommended environmental control solutions should be used at all manufacturing stages. The relative humidity level in combination with temperature is utmost importance. High humidity level can adversely impact the physical properties of the API and in turn the pharmaceutical product. It can affect the chemical reactivity, and the shelf-life of the final pharmaceutical product. The excess humidity can lead to following problems:
- uneven distribution of ingredients
- bacterial contamination
- inconsistency and clogging
- caking and lumping during tablet compression
Thus, investments in advanced Dehumidification technologies are a prerequisite for API manufacturing. Dehumidification can help in achieving quality standards, API consistent production , stable, free-flowing materials for formulation, packaging, storage and transport. Bry-Air Dehumidifiers maintain ideal humidity level and a dry environment which prevents degradation, ensures safe and hygienic storage conditions and reduced rejects.
To read more on humidity control solutions for pharma industry click here