Polymer analysis (getAlyser)
Analysis of spices (getAlyser)
Online NIR measurement (BlendAlyser)
Online NIR measurement (SentroProc)
Informationen in deutsch
Informations en franšais
Информация на русском языке
The blending of pharmaceutical ingredients is one of the critical processes during the production of pharmaceuticals. Product homogeneity and further processibility are depending on starting material and process conditions. Sample taking and analysis at the end of the process is most commonly used for quality control, but not providing process information.
Online monitoring of the blending process is allowing to increase process understanding, not restricted to the final product. It also allows to optimise blending time, thus assuring a homogenous blend and avoiding the risk of deblending due to too long blending time.
A first generation of NIR instruments is used and established for endpoint detection on blending processes. A number of systems are available but still there is potential for optimisation. Critical parameters are system size and weight as well as spectroscopic specifications. Ideally the systems should be compact, easy to handle and mountable on different blender systems. A light weighted systems avoids reduction of system workload. Battery power and wireless communication simplify system setup.
Insensitivity against movement and vibrations at the operating blender are required. Using a relatively low resolution as with the most Diode Array systems reduces sensitivity to peak variations or requires PLS modelling for improvement of sensitivity.getSys-BlendAlyser is a high performance system for blend uniformity incorporating a high resolution MEMS spectrometer based on tuneable laser technology. Key advantages of this system are an optical resolution of 1nm and excellent long term stability provided by internal wavelength and intensity standards. Due to the wavelength resolution it is possible to analyse content uniformity by pre-treated spectra rather than using PLS models.
The single packaged solution system has compact dimensions, is battery powered with the measurement triggered by a programmable 3D orientation measurement system and is ready for WLAN communication with 2 internal antennas for improved communication stability under moving conditions.
A service adapter enables the system to by serviced locally.
getSys-Blendalyser systems are easy to mount on a wide range of blender systems using a hygienic 4” tri-clamp connector.
getSys-Blendalyser is fully validated and comes with IQ/OQ documentation. The 21CFR part11 compliant software NovaPac
is installed on the system and includes validation routines to test against the USP1119 requirements.
End-point detection while production of mixture of materials
Prevention of deblending in process
Production of homogeneous blends
Control and monitoring of production processes
Additional quantitative analyses possible
Copyright (c) getAMO 2019