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Advanced technologies applied throughout the pharmaceutical and biotech manufacturing process for meaningful operational improvements

Thermo Fisher Scientific continues to be your most trusted industry partner in developing and applying technologies that improve pharmaceutical manufacturing processes.  Our technologies are delivered as business solutions with a focus on gaining operational efficiencies, improving product quality and safety, and ultimately, improving the profitability of your operations. 


Checkweighing

Checkweighing systems weigh and count products in motion and reject products that are off specification, helping to ensure final product consistency, quality, and brand integrity.  Checkweighing systems are installed online and operate at high speed and high accuracy.  As a package moves from the customer’s outfeed onto the checkweigher infeed, the package is weighed on a weigh cell of the weigh table.  The package then moves onto the outfeed of the checkweigher to be accepted or rejected according to the checkweigher settings. 

 

The VersaRx checkweigher is designed specifically for the pharmaceutical industry and are compatible with oral solid and liquid vial packaging operations. 

Versa Rx Checkweigher

Meet the high-performance standards of the pharmaceutical industry with the Thermo Scientific Versa Rx Pharmaceutical Checkweigher. With high-accuracy—within ±50mg at 3 sigma and speeds up to 650ppm—the Versa Rx Pharma checkweigher is Ideal for a variety of products (blister packs, cartons, plastic bottles, glass bottles, pouches and small aerosols). 21 CFR Part 11 compliance option. OIML MID approved.

Global Versa GP Pharmaceutical Checkweigher

The Thermo Scientific Global Versa GP Checkweigher is a versatile, general purpose checkweigher that scans at line speeds up to 350 packages per minute without ever sacrificing accuracy. The Versa GP Checkweigher comes with a compact cantilever construction for height adjustment and is ideal for packages up to 3 kilograms (6.6 pounds).

Global VersaWeigh Checkweigher

The Global VersaWeigh is a general purpose checkweigher designed to provide superior levels of quality control in the pharmaceutical packaging environment. It is a highly reliable, easy-to-use and easy-to-maintain system that complies with Good Manufacturing Practice (GMP) guidelines.


Extrusion and compounding

Twin-screw extruders are extremely efficient mixers used for continuous compounding and granulation of pharmaceutical ingredients. Using two intermeshing screws with a segmented profile, twin-screw extrusion provides a flexible process with a high degree of customizability. A twin-screw extruder allows users to conduct dry, melt, or wet granulation, as well as wet extrusion and hot-melt extrusion (HME) all with the same instrument.

HME is ideal for pharmaceutical products as it is a solvent- and dust-free continuous process with remarkably few processing steps and high reproducibility in a small footprint. It is one of the chief methods of producing amorphous solid dispersions (ASD), competing with the likes of pharmaceutical spray drying. The primary reason for ASD manufacturing is to increase the bioavailability of drug products, as most drug products in the R&D pipeline suffer from poor water solubility. Hot-melt extrusion can resolve this issue. 

 

Key applications of twin-screw extrusion include mixing of drug molecules with pharmaceutical polymers for solubility and stability improvement, the preparation of enteric dosages or controlled release dosages, and the creation of novel forms.

Pharma mini HME Micro Compounder

The Thermo Scientific Pharma mini HME is a GMP compliant conical micro compounder for Hot Melt Extrusion in research and development in the pharmaceutical industry. This product allows users to identify the right drug candidates for hot melt extrusion by compounding as little as three grams of material.

Pharma 11 Twin-screw Extruder

Perform material- and labor-effective extrusion with the Thermo Scientific Pharma 11 Twin-screw Extruder, which requires only a small amount of active pharmaceutical ingredient, operating at throughput levels as low as 20g/h. The parallel 11mm twin screws and compact design of the Pharma 11 Twin-screw Extruder is fully scalable with Thermo Scientific stand-alone pharmaceutical compounding systems. Together, you can obtain process-relevant results or even perform small scale production.

Pharma 16 Twin-screw Extruder

Rapidly develop pharmaceutical formulations and adopt continuous processing methods using the Thermo Scientific Pharma 16 Twin-Screw Extruder.  The Pharma 16 Twin-Screw Extruder can switch between continuous hot melt extrusion (HME) or wet granulation (TSG) with ease. Ideal for pilot-scale, continuous HME or TSG processes used for research, development or production in the pharmaceutical industry.


Metal detection

Pharmaceutical manufacturers must meet the US Federal Drug Administration's (FDA) stringent requirements for validated production. As quality and safety controls are critical, metal detectors are used to find small particles of ferrous and non-ferrous metals and stainless steel that may have been introduced by broken machinery, loose screws, or in raw materials that contaminate the product.

Metal detectors use coils wound on a non-metallic frame connected to a high-frequency radio transmitter. When a particle of metal passes through the coils, the high frequency field is disturbed under one coil, changing the voltage by a few microvolts. The output is used to detect metal.

 

To improve sensitivity and enable the detection of many metal types and smaller sizes, we offer multiscan technology. Metal detectors with multiscan technology utilize up to five completely adjustable frequencies to find metal types and sizes previously undetectable. Using a true broad-spectrum approach reduces the probability of an escape by many orders of magnitude.

The multicoil design provides for multiple detection coils inside of the detector, each with adjustable frequencies.  As the product passes through the coils, contaminants of various types and sizes can be detected as they create disturbances in the different frequencies monitored by the coils. Multiscan technology allows a single metal detector to achieve the effectiveness and sensitivity that would previously require several machines operating in-line.

APEX 500 Rx Pharmaceutical Metal Detector

Achieve cost-effective, industry-leading sensitivity in the most demanding pharmaceutical environments while meeting the US Federal Drug Administration's (FDA) stringent requirements for validated production. The APEX 500 Rx Pharmaceutical Metal Detector is a mobile, versatile and reliable solution for tablet presses, capsule filling, and deduster applications. Equipped with a multi-coil design that isn't impacted by product effects or environmental changes.


NIR spectroscopy

NIR (near-infrared) spectroscopy is a proven technology that delivers clear results for pharmaceutical applications. This spectroscopic method, based on overtones and combinations of bond vibrations in molecules, uses the near-infrared region of the electromagnetic spectrum.

 

In NIR spectroscopy, the unknown substance is illuminated with a broad-spectrum (many wavelengths or frequencies) of near infrared light, which can be absorbed, transmitted, reflected or scattered by the sample of interest. The illumination is typically in the wavelength range of 0.8 to 2.5 microns (800 to 2500nm). The light intensity as a function of wavelength is measured before and after interacting with the sample, and the diffuse reflectance, a combination of absorbance and scattering, caused by the sample is calculated.

NIR can typically penetrate much further into a sample than FTIR, and unlike Raman, is not affected by fluorescence. Thus, although NIR spectroscopy is not as chemically specific as Raman or FTIR, it can be very useful in probing bulk material with little or no sample preparation.

Antaris MX FT-NIR Process Analyzer

This easy-to-use NIR analyzer allows a single process to be monitored at multiple points or multiple processes to be monitored simultaneously. It enables you to optimize your QC testing while remotely monitoring the process using fiber optic simultaneous multiplexing technology and integrated communication for real-time feedback.  It also eliminates removing the probe from the process stream for background collection or qualification.

Antaris II FT-NIR Analyzer

Easily implement laboratory-based FT-NIR performance in a ready-for-plant package.  This analyzer provides robust and reliable data collection for at-line, online, and in-line analysis. You can customize an Antaris II FT-NIR Analyzer for specific applications or choose the Antaris II MDS Method Development Sampling System, which includes transmission, fiber-optic and integrating sphere diffuse reflection analysis all in one turnkey system.


Process mass spectrometry

Controlling manufacturing by testing and measuring during the processing of critical quality and performance attributes of raw and in-process materials helps ensure final product quality. Real time off-gas monitoring provides insightful data that can be used to determine metabolism. Process mass spectrometers can help track fermentation and cell culture processes in real time and help produce quantitative solvent drying data to optimize the drying process. Process gas analysis technologies deliver lab-quality online gas composition analysis and help maximize product yield and profitability.

Prima PRO Process Mass Spectrometer

Prima PRO Process Mass Spectrometer is an online mass spectrometer and process gas analyzer that provides fast, accurate, comprehensive gas analysis.  Engineered to meet a number of challenging process applications in the biotechnology industry, it delivers fast, complete, lab quality online gas composition analysis and features a rugged, fault-tolerant design that ensures availability that exceeds 99.7%.  

Prima BT Bench Top Process Mass Spectrometer

With the Thermo Scientific Prima BT gas analysis mass spectrometer, you can gather respiratory gas data from multiple fermenters and bioreactors with a single analyzer, packaged ideally for development laboratories. This real time process gas analyzer is a precise, multi-stream magnetic sector mass spectrometer. Use this solution to monitor fermentations and cell cultures as part of your PAT implementation strategy, building a platform to reduce off-line testing while improving process understanding.


Raman spectroscopy

Raman spectroscopy is a molecular analysis technique that has been effectively deployed by the pharmaceutical and biotech industry to identify and quantify unknown materials. Using this technology, an unknown sample of material is illuminated with monochromatic (single wavelength or single frequency) laser light, which can be absorbed, transmitted, reflected, or scattered by the sample. Light scattered from the sample is due to either elastic collisions of the light with the sample's molecules (Rayleigh scatter) or inelastic collisions (Raman scatter). Whereas Rayleigh scattered light has the same frequency (wavelength) of the incident laser light, Raman scattered light returns from the sample at different frequencies corresponding to the vibrational frequencies of the bonds of the molecules in the sample.

Since Raman spectroscopy uses lasers with wavelengths in the UV-visible region (400-700 nm), glass and quartz containers do not interfere with the Raman reading, allowing users to verify the identity of packaged materials.

 

Our handheld Raman analyzers include state-of-the-art optics paired with a patented multivariate residual analysis that offers an effective chemometric solution for material identification, with two spectral pre-processing options. The analyzer’s non-destructive point-and-shoot sampling principle facilitates rapid verification of a broad range of chemical compounds, including cellulose-based products.  These portable devices allow for efficient and effective analysis on site, and anywhere in the plant.

TruScan RM Handheld Raman Analyzer

The Thermo Scientific TruScan RM Handheld Raman Analyzer helps pharmaceutical and biotechnology manufacturers ensure the quality of materials - from incoming raw material through finished product. These Raman analyzers deliver reliable material identity verification through sealed packaging in seconds, right at the point-of-need. 

TruTools

Thermo Scientific TruTools is an add-on chemometrics software package that runs on the TruScan RM Handheld Raman Analyzer. TruTools provides a platform to implement customized chemometric models including PCA, PLS-DA, PCR and PLS algorithms onboard the handheld device. This solution allows method developers to implement advanced preprocessing of spectra, identification of qualitative differences between samples, and facilitate quantitative sample determination.

MarqMetrix All-In-One Process Raman Analyzer

The Thermo Scientific MarqMetrix All-In-One Process Raman Analyzer is a compact, easy-to-use, reliable, and affordable system that leverages the power of Raman spectroscopy to measure key variables in a process so that they may be controlled. Conduct real-time, non-destructive, and immediate analysis without sample preparation; the analyzer easily integrates into your existing processes and eliminates the need for costly technical expertise.

DXR3 SmartRaman Spectrometer

Bring high-performance, dedicated bulk Raman sample analysis to your fast-paced lab. Designed for busy multi-purpose analytical labs, the DXR3 SmartRaman Spectrometer provides comprehensive, reproducible, and accurate results in a dependable, low-maintenance platform.

DXR3 Flex Raman Spectrometer

Accelerate your research with a compact Raman spectrometer specifically designed for integration with other analytical techniques. Coupling the DXR3 Flex Raman Spectrometer with other techniques eliminates the need for multiple measurements and assumptions, helping you get fast answers.

DXR3 Raman Microscope

Benefit from this research-grade microscope offering superior combination of performance and ease-of-use. The DXR3 Raman Microscope provides high spatial resolution point & shoot Raman microscopy for the most demanding analytical tasks.


UV-Visible spectroscopy (UV-Vis)

UV-Visible spectroscopy is a well-established analytical technique used in the pharmaceutical industry for testing in the research and quality control stages of drug development. UV-Vis spectrophotometers can provide highly accurate measurements and meet all USP and EP performance characteristics.   

 

In simple terms, spectrophotometers enable photometric comparisons of relative light intensities across the ultraviolet and visible spectrums. When samples are irradiated with light, they selectively absorb incident light at specific wavelengths. The wavelength with the highest absorbance (λmax) is typically used as the analytical wavelength and expressed in nanometers (nm). Absorbance measurements are simple to take and are used to generate spectrum curves. Absorption can provide direct and indirect options for calculating concentration.

Evolution Pro UV-Vis Spectrophotometer

Our next generation Evolution UV-Vis Spectrophotometers combine reliable and versatile hardware with easy-to-learn, easy-to-use Thermo Scientific Insight Pro Software. Together they will meet the diverse needs your organization requires from an analytical tool.


X-ray fluorescence (XRF)

X-ray fluorescence spectroscopy (XRF) is a non-destructive analytical technique used to determine the elemental composition of materials. XRF analyzers work by measuring the fluorescent (or secondary) X-rays emitted from a sample when excited by a primary X-ray source. Each element present in a sample produces a set of characteristic fluorescent X-rays, or “unique fingerprints.” These fingerprints are distinct for each element, making XRF analysis an excellent tool for quantitative and qualitative measurements of materials.

IonicX Portable XRF Analyzer

The Thermo Scientific IonicX Portable XRF Analyzer enables pharmaceutical and biopharmaceutical manufacturers to identify ionic salts in seconds with minimal sample preparation. It provides fast and accurate ionic salt raw material identity verification and high sample throughput.  This non-destructive, non-contact portable XRF analyzer for ionic salts also cuts testing time and expense by replacing time-consuming, resource-intensive wet chemistry and benchtop methods. The IonicX complies with 21 CFR Part 11, offering user access control, audit trails, electronic signatures, and full synchronization capabilities for proper storage of all electronic records.

ARL QUANT'X EDXRF Spectrometer

The Thermo Scientific ARL QUANT'X EDXRF Spectrometer provides major, minor, and trace element quantification. It offers the ultimate in performance, versatility and reliability of elemental analysis. Its compact desktop design, close-coupled optics, and advanced electrically cooled detectors allow for excellent analytical precision in a wide dynamic range from ppm to percent elemental concentrations.


X-ray detection and inspection systems

X-ray inspection systems are based on the density of the product and the contaminant. As an X-ray penetrates a pharmaceutical package, it loses some of its energy. A dense area, such as a contaminant, will reduce the energy even further. As the X-ray exits the product, it reaches a detector. The detector then converts the energy signal into a grayscale image of the pharmaceutical product. Foreign matter appears as a darker shade of grey and helps identify foreign contaminants.

 

X-ray inspection systems in the life science manufacturing industry do not use radioactive materials to generate X-rays; instead, they use high voltage X-ray tubes to generate power. When the tube is turned off, no X-ray energy is emitted.

NextGuard X-Ray Detection Systems

The Thermo Scientific NextGuard conveyor X-ray detection system offers enhanced capabilities to inspect packaged products for missing pieces or components, under and over-fills, and other quality problems with easily customizable vision software. Our easy-to-use X-ray inspection system provides complete protection from metal, glass, and other dense foreign objects.

X-ray diffraction

X-ray diffraction (XRD) is among the most effective non-destructive tools for identifying and characterizing polycrystalline materials with respect to their crystallography, polymorphic structures, phases and crystallinity changes.

 

Thermo Scientific powder X-ray diffractometers are delivered under the trusted ARL EQUINOX product line, featuring both compact benchtop and full-scale XRD solutions.

 

According to your needs, various attachments are used with our ARL EQUINOX powder X-ray diffractometers for making acquisitions in real time thanks to fast detectors.

ARL EQUINOX 100 X-ray Diffractometer

The Thermo Scientific ARL EQUINOX 100 is the perfect instrument for fast acquisitions when space becomes a priority, thanks to its fully integrated water-cooling system and its plugging into a standard electrical power outlet. With its excellent performance, it is perfectly designed for a cost-effective solution for routine QC/QA in industrial labs or structural and phase analysis in R&D laboratory or teaching.

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