Capsule Dosage Uniformity
FDA requirements for capsule dosage uniformity requires an accurate evaluation of the net weight and API concentration. Dosage real time analyzer and in-line analysis provides significant financial benefits due to faster process development and understanding, better QC, less laboratory analysis, shorter production times and increased safety.
SAM-SPEC, a patented NIR-SRS optical technology, provides the solutions to pharmaceutical API content uniformity test for capsules.
Quantification of Vitamins in a Blend in Solution
Vitamins are essential elements for our bodies which are present in many areas of industry. In the pharmaceutical industry, they are often combined with formulations containing active pharmaceutical ingredients to achieve optimum efficacy.
Asuryan’s versatility offers sensitivity and measurement accuracy covering diverse products and concentrations thanks to its adaptability. The system can make prediction of several ingredients of interest within a complex blend with quick and reliable measurement by means of chemometrics.
Blend Uniformity Monitoring
Failing a mixing process can cost a high amount of money due large batch losses. At the same time designing a mixing process is complicated due to the influence of several factors, such as blade shape and speed, reactor shape, product viscosity, scale up effect, etc. SAM-SPEC Mix provides a Real time Multipoint Monitoring for mixing liquids and solids as well. The product is assessed in real-time and in-line at different depths and positions. The validation of mean particles size, segregation, chemical concentration uniformity, turbidity is therefore completely controlled and mapped.
Powder Blend Homogeneity
To improve understanding of the blending process and optimize its control, thorough characterization of the distribution of the active pharmaceutical ingredients within the overall blend is essential. HypeReal is a Near Infrared Chemical Imaging (NIR-CI) system that combines digital imaging and optical spectroscopy to collect and process together all the information provided by the image generated. By moving the hyperspectral camera underneath the powder and processing all the spectral and spatial information thus obtained, the pharmaceutical ingredients can be identified. Their spatial distribution enables you to ensure the blend is homogeneous and free of contaminants.
Residual Moisture Content of Lyophilized Products
Freeze-drying or lyophilization is a process used to dehydrate and hence improve the conservation of a wide range of materials, including pharmaceuticals and biopharmaceuticals. R&D laboratories generally work on lyophilization of small quantities of the product (small vials or 96-well plates).
HypeReal is a unique inspection solution capable of quickly testing a wide variety of lyophilized products via non-contact measurements from below the sample. HypeReal’s technology is the ideal tool for quick, non-destructive testing of lyophilized products.
Protein Analysis
Proteins, which are highly reactive molecules, are present in small quantities, so they require a spectroscopy method suitable for such low concentrations.
Visible-UV spectroscopy is an analytical method focusing on the electronic transitions of the products of interest. This type of spectroscopy offers very high sensitivity (up to 10 to 100 times that of NIR or Raman spectroscopy). Due to its high sensitivity, UV spectroscopy is ideal for protein analysis.
Asuryan is capable of measure your product in less than 50ms. It offers excellent stability thanks to simultaneous measurement of the source’s spectrum. Several spectrometers can be integrated into Asuryan to perform measurements on several key phases of the process (dilution, filling, etc.), thus giving an immediate snapshot of your whole process. This flexibility proves essential in processes manufacturing or consuming high added-value or very varied products.
Upstream/Downstream Bio-Process Monitoring
The biotech process relies on living organisms and is far more complex to understand than conventional chemistry. The ability to develop a robust and reproducible bio-process with high productivity is highly desirable.
Viserion® Raman Analyzer will improve financial performance with faster process development times and enhanced process understanding using a QbD approach. It enables a significant reduction of laboratory analyses, fast in-situ analysis of critical process parameters and attributes, and yield optimization. Viserion® is capable of predicting the concentrations of glucose, lactate, glutamine, alcohol, etc. with high accuracy.
Cleaning In Place (CIP) and Sterilization In Place (SIP)
The SPOT4Line multi-parameter analysis provides precise measurements concerning the physical and chemical composition of the liquid, including the turbidity, the color and the temperature. By detecting each CIP phase precisely, the SPOT4Line LED spectrometer can help you save up to 15% on cleaning time.
In-line Color Analysis
To consumers’ eyes, color is a sign of quality. Determination of color and its stability are two key factors to control in the food industry such as fermentation process. Continuous in-line monitoring helps to reduce sampling operations and analyses in the laboratory. The detection instrument must be capable of providing real-time supervision with quick, precise, reproducible results.
Specially designed for measuring liquids in-line, SPOT4Line is the first spectrometer offering a comprehensive solution for simultaneous measurement of critical parameters such as the color, turbidity and detection of impurities.
Chemical Composition Analysis
Visible-UV spectroscopy is an analytical method focusing on the electronic transitions of the products of interest. Asuryan offers very high sensitivity for chemical composition analysis even with very low concentrations.
Intralipid Globule Size and Form of Crystals
Asuryan is capable of using SAM-Flex multi-angle measuring sensors or SAM-Spec multipoint sensors. These technologies extract more information in complex media (emulsions, suspensions, powders, etc.) by measuring the average globule size and globule density. The different spectra help to improve separation of the information on the milieu from the data on the products in suspension.
