Tracking Polymorph & Crystal Morphology with High Throughput Raman for Process Understanding & Control
Crystallisation is a commonly used process for solid-dose manufacturing. To improve the biological performance and economic benefits of a crystallisation process, proper process control is necessary. However, crystallisation can be difficult to control due to the complex relationship between thermodynamic and kinetic factors and processes such as nucleation, growth, and agglomeration. A thorough understanding of the process is required, which can be done through modelling, design of experiment stress testing and the use of process analytical technologies (PAT).
Raman Spectroscopy has been shown to be a ubiquitous PAT technology ranging in application from the large molecule to monitor the small molecule space. By coupling the Hyperflux Pro Plus Process Raman Spectrometer to a high-quality complementary tool such as Crystalline Parallel Crystalliser from Technobis Crystallisation Systems, it is possible to monitor your crystallisation process and accelerate the development of drug products to market.
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Take The Headache Out Of Your Raw Material Identification
If you work within the pharmaceutical industry, then you know that strict regulatory guidelines govern Quality Analysis and Quality Control. In order to maintain compliance, these regulations often dictate that certain measures or process improvements must be implemented. Keeping pharmaceuticals at peak quality means consistent and rigorous analysis at all stages of the manufacturing and distribution process. Without maintaining strict quality control procedures, companies risk product inefficiencies and heavy fines for non compliance.
3 Reasons Why Progeny is Different to Other Handheld Raman Spectrometers
The Raman effect, also known as Raman scattering, was discovered back in 1928 by CV Raman. The Indian physicist observed that when light traverses an object, a small part of that light changes frequency. By small, we really mean tiny – only about 1 part in 100,000 is affected by this. However, this tiny amount of scattered light can reveal a great deal. When the light changes frequency, it creates a specific pattern depending on the molecular makeup of the substance it hits. CV Raman went on to win a Nobel prize for his observations.
How Technology is Improving Quality Control Processes
Good Manufacturing Practice, or GMP for short, is a legal requirement for the pharmaceutical industry. It exists to ensure that drugs, vaccines and other pharmaceuticals are safe for use and are being produced to a high quality. This is extremely important when considering some of the high profile cases of drugs causing more harm than good, such as the Thalidomide tragedy in the 1960s. As the pharmaceutical industry is constantly researching and developing new remedies and cures, the GMP regulations help to safeguard against future similar incidents. Although GMP regulations can sometimes cause headaches for pharmaceutical companies, their application has been made easier thanks to advances in technology. One area where technology has been improving quality control processes is in temperature monitoring.
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