From raw material identification through the pharmaceutical manufacturing process, to finished and packaged pharmaceutical product inspection, our solutions employ proven technologies to help pharmaceutical and biopharmaceutical manufacturers save time, improve quality, optimize processes, protect brand integrity, and ensure patient safety.
Addressing challenges in pharmaceuticals where API solubility and processing stability, taste-masking, enterics, and specialized dosage forms are critical projects, our extruders and related analytical instrumentation provide the shortest path from feasibility studies to production in drug formulation and manufacturing.
Quickly and reliably move from feasibility studies to production
Our compounding and extrusion technologies are well proven to be valuable tools in creating novel drug formulations, and in the transition from inefficient batch processing to continuous manufacturing. Analysis of extruded formulations using a variety of techniques, including spectroscopic instrumentation, helps you optimize your API/excipient mix and extruder parameters by providing feedback that identifies a material or flags an unknown compound such as a contaminant or inclusion.
X-ray diffraction allows to ensure product safety with the ability to assess polymorphs and amorphous content, speed up analysis time for organic samples, and measure samples in reflection or transmission mode in the same configuration. XRD is a powerful technique to structurally characterize a pharmaceutical compound throughout the drug product pipeline.
Quickly and non-destructively characterize almost any material
XRF can be used as a fast and easy-to-use technique to analyze catalyst residues in APIs as a pre-screening step for ICP trace element analysis. Using XRF, researchers can achieve rapid material characterization and analysis to ensure product chemistry specifications are met.
As part of cGMP, many pharmaceutical manufacturers are adopting Process Analytical Technologies (PAT), Quality by Design (QbD), or Process Validation (PV) to provide continuous process verification and analysis. Analytical instruments may be used for at-line and in-process monitoring to bring the technology to the sample to speed up the analysis process and enable more flexibility from a smaller footprint.
cGMP and associated process monitoring standards require continuous process verification and analysis.
Real-time analysis and lab-quality results Real time off gas monitoring provides accurate measurement of respiratory gases which yields valuable information on how cells metabolize, while minimizing offline testing and without compromising the sterile environment. With advanced process mass spectrometers and Raman analyzers, pharmaceutical manufacturers can monitor and control multiple fermenters in real-time to ensure that each progresses according to the experiment design and produces optimum outcomes.
In fermentation and cell cultures, the sparge and vent gases can be frequently changing mixtures of varying compositions. The implementation of real-time gas analysis using mass spectrometry in these processes can help identify process deviations during bioreactor runs and evaluate batch to batch variation, within predefined specifications, for robust manufacturing.
Variables in respiratory gas can be analyzed and monitored in real time
Bioreactor monitoring Although the requirements of fermentation and cell culture processes provide challenges to the off-gas analyzer, our mass spectrometers and process Raman analyzer for bioreactor monitoring have already proved invaluable in improving understanding and increasing yields of fermentation and cell cultures.
Portable, handheld Raman spectrometers for pharmaceutical identification can obtain fast, accurate material verification in seconds anywhere in the plant. These technologies dramatically enhance the efficiency of critical quality control steps that prevent falsified and substandard medicines from entering the supply chain.
Identify and quantify raw materials, intermediates and finished products on site in seconds
Fast, accurate material verification Handheld Raman instruments enable quantitative methods for complex material analysis such as multiple component discrimination, API content quantification, and solvent quantitation. Designed for compliance with current good manufacturing practices (cGMP) and 21 CFR Part 11, these technologies can help you better understand the composition of your raw materials and achieve high quality pharmaceutical analysis to help ensure patient safety and brand integrity.
Pharmaceutical applications demand the highest standards of performance, hygiene and reliability. Our online product inspection systems for pharmaceutical and biotech applications enable detection of foreign object contamination and provide dynamic weighing of finished and packaged products for quality and consistency, protecting brand reputation, and helping to ensure consumer safety.
Online product inspection helps ensure quality, safety, and protects brand integrity
Quality assurance Our checkweighing, metal detection, and x-ray inspection systems -- designed specifically for pharmaceutical applications -- can detect incomplete packages at high speed through high accuracy dynamic weight check of packed and part-packed goods. They can also detect metallic and non-metallic contamination in both oral solid production and in liquid vial filling.
A key stage in many pharmaceutical processes is the complete or partial removal of a solvent or solvents from a product or intermediate. This solvent recovery process can occur in a variety of process vessels, including vacuum dryers, tray dryers and rotary dryers. Magnetic sector mass spectrometry is used to help monitor and control the solvent drying process with fast, precise, quantitative data.
Faster, more complete, lab quality online gas composition analysis
Accurate tracking of process dynamics Thermo Scientific process mass spectrometers can monitor up to 10 dryers, with a unique inlet that can switch between dryers at widely differing pressures and concentrations, and still provide reliable, stable solvent concentration data.
For Research Use Only. Not for use in diagnostic procedures.