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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
For Research Use Only. Not for use in diagnostic procedures.