Billions of patients worldwide benefit from a diverse range of medical devices. The global medical device market in 2011 was approximately $300 billion and is predicted to grow by 4% per year to reach over $400 billion by 2018. Specifically, the European medical device market is estimated to make up 30% of global sales (i.e. $100 billion) and is second only to the US which makes up 40% of the market.
A medical device is an implant, implement, instrument, apparatus, in vitro reagent or other similar article that can diagnose, prevent, monitor, treat and alleviate disease.
During a manufacturing process unexpected and unknown impurities may arise in a sample. It is important that such impurities are isolated and identified.
In an industry that is seeing increasing levels of outsourcing, the contract research organisation (CRO) needs to have proven experience in both the pragmatism and flexibility of method development and a regulatory background in validation.
Oral dosage forms remain one of the most flexible and effective treatments available to patients. Dissolution testing is a requirement for all solid oral dosage forms and is used throughout the development life-cycle for product release and stability testing. It is a pivotal analytical test used for detecting physical changes in an active pharmaceutical ingredient and formulated product
Sometimes it's the smallest details that have the biggest impact on pharmaceutical performance. That's certainly true when it comes down to the properties of particles and their impact on pharmaceutical performance. Subtle changes in particle size, shape and distribution can have a major impact on pharmaceutical solubility, stability and efficacy.
Cross contamination must be avoided in the pharmaceutical industry at all costs. Successful cleaning validation ensures that patients are not put at risk due to cross contamination. The process can be divided into a number of sections each of which must be fully understood. Areas of concern must be addressed to ensure a successful outcome across the entire process.