Flexible containment solutions must work well for every stakeholder. With high potency active pharmaceutical ingredients (HPAPIs) come a heightened awareness of this requirement and the added burden of a higher level of regulatory oversight.
This paper describes how to understand punch length, how to measure it correctly, and how wear affects length and tablet consistency. It also addresses the importance of specifying cup-depth tolerances.
Frequently, companies have used fume hood exhaust to ventilate hood base cabinets. There is both the need for this practice and the designs for them are frequently not well thought-out.
This paper reviews why very bad things happen when either quantity or purity of Highly Potent Active Pharmaceuticals is not properly maintained during the compounding process. Additionally, when highly potent active pharma ingredients are not effectively contained, workers may be adversely affected.
When executed properly, HME advances poorly soluble compounds in the development pipeline, without adding delays, cost, or significant post-processing activities, and can scale to commercial manufacturing.
Understanding and being able to control granulation is essential to the production of high quality pharmaceuticals. Fluid bed granulation and melt granulation can be tightly regulated to produce uniform material with a specified particle size therefore affording superior process reproducibility and better process control than many other granulation techniques.
The enhanced precision used in 3D printing can drive efficiencies in early drug development by allowing more flexibility with dosage size and strengths, leading to a more effective use of costly resources.