The Containment Performance Verification and Determination of Surrogate Particles

Several advances in medicines and medicinal values help in curing diseases and in improvement of health care systems. The biopharmaceutical industry is committed in ensuring that the medicine is useful to all patients. Success of the biopharmaceutical industry is highly depended on the invention and growth of medicines that can improve human health. Nowadays pharmaceutical industry is facing several key challenges. The workers in biopharmaceutical industry are exposed to surrogate powders and airborne dusts which contain harmful Active Pharmaceutical Ingredients (API). This paper proposed the surrogate powder application in testing the containment system performance. Materials such as lactose and mannitol are suggested as their physical characteristics such as compatibility, dustiness, adhesion, particle sizes and flow properties are reflecting those of active pharmaceutical ingredients. Moreover they are safe, highly pure and can be obtained at a reasonable cost. This paper is aimed at developing and validating an ion-chromatography based analytical technique for determining surrogate powders such as mannitol, sorbitol and glucose. Finally, a standardised approach is used for evaluating the containment performance of a planned system of dust collection that would help in making a new manufacturing area