Application
range

Types of
OSeeT systems

Direct vs indirect
measurements

OSeeT
software

OSeeT

OSeeT – Optical Coherence Tomography for the in-line and at-line monitoring of pharmaceutical products and their critical quality attributes.

OSeeT is the only existing technology that allows rapid (even in-line/real-time) monitoring of coating quality without calibration and multivariate data analysis for transparent and semi-transparent materials.

OSeeT provides direct information about multiple quality attributes of layers in pharmaceutical products (e.g. coating thickness) and is a link to related critical quality attributes (e.g. API release in dissolution).

OSeeT can also provide indirect information (for scattering materials) from the penetration depth of light into the sample which can be linked e.g. to dissolution behavior or compression force.

Working
principle

• OCT is based on (coherence gated) interferometry.
• Light is split in reference and probe path.
• Optics of the sample arm focus light and define lateral (=surface) resolution in focus.
• Interference of light reflected back from both paths.
• Spectrometer (grating, high-speed CMOS sensor).
• Depth-information is generated from interference by non- linear Fourier-transformation (nu-FFT).
• Depth scan measurement rate: 130 – 250 kHz (depending on OSeeT system version).
• Direct thickness measurement (optical path length).
• Each interferogram -> one depth reading (“A-scan”, 1D). A-scan rate: 130kHz-250kHz max.
• Multiple A-scans -> cross-sectional image (“B-scan”, 2D). Requires moving of objects or a scanning sensor beam.

Gallery/Use cases/installation examples

OSeeT Pharma 1D with Sampling device

Gallery/Use cases/Installation examples

OSeeT Pharma 1D with Sampling device

Fluid bed probe installed in-line

Gallery/Use cases/Installation examples

Fluid bed probe installed in-line

Pan coated probe installed in-line

Gallery/Use cases/Installation examples

Pan coated probe installed in-line

Pan coater probe

Gallery/Use cases/Installation examples

Pan coater probe

Probe installed in Oral Film production machine

Gallery/Use cases/Installation examples

Probe installed in Oral Film production machine

OSeeT image showing the coating and the laser drilled hole in Oros tablet

Gallery/Use cases/Installation examples

OSeeT image showing the coating and the laser drilled hole in Oros tablet

Sampling device SDP2.1 for measuring at-line pellets, tablets, capsules

Gallery/Use cases/Installation examples

Sampling device SDP2.1 for measuring at-line pellets, tablets, capsules

Sampling device SD1 for measuring at-line tablets, capsules mimic a tablet coater

Gallery/Use cases/Installation examples

Sampling device SD1 for measuring at-line tablets, capsules mimic a tablet coater

OSeeT image of pellets at-line

Gallery/Use cases/Installation examples

OSeeT image of pellets at-line

Screen shot visualisation of a complete coating process

Gallery/Use cases/Installation examples

Screen shot visualisation of a complete coating process

Screen shot visualisation of a trend of a complete coating process

Gallery/Use cases/Installation examples

Screen shot visualisation of a trend of a complete coating process

OSeeT image of Multi-layer pellets with UHR -OSeeT

Gallery/Use cases/Installation examples

OSeeT image of Multi-layer pellets with UHR -OSeeT

OSeeT image of 6 microns coating layer with UHR-OSeeT

Gallery/Use cases/Installation examples

OSeeT image of 6 microns coating layer with UHR-OSeeT

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    Application range of OSeeT

    OSeeT was originally developed for direct measurement of transparent and semi-transparent materials. High concentrations of pigments in the coating formulation (i.e., titanium dioxide or iron oxide) are scattering the light beam and therefore limiting the direct insight into the material. By establishing advanced image analysis metrics, a second stream of OSeeT software has been developed to evaluate coatings with highly scattering pigments as well as uncoated dosage forms (beta version).

    Application range of OSeeT (in the pharmaceutical field)

    Transparent or semi-transparent coated products

    OSeDirect measurement of coating thickness, roughness, homogeneity for:
    • Tablets and capsules at-line and in-line
    • Pellets at-line and in-line
    • Co-extruded dosage forms
    • Thin drug layer of transdermal patches and oral films

    Uncoated products

    Indirect measurement of uncoated samples and correlation with critical quality attributes (e.g. dissolution or tablet hardness) – beta version of the software

    Non-transparent coated products

    Indirect measurement of the thickness of scattering coatings (beta version) and correlation with critical quality attributes (e.g. dissolution) – beta version of the software

    Types of OSeeT systems and probe heads

    Depending on the intended application, there are different systems or combinations of OseeT systems and probe heads available.

    Base Unit

    Use Case

    Specification

    Image

    HW 1.5

    Mainly tablets

    • Axial resolution: 4 µm

    • Minimum coating thickness for automatic evaluation: 12 µm

    HW 2.0

    Samples with layer thicknesses between 12 µm and 150 µm (in certain cases up to 400 µm or more possible)

    Suitable dosage forms: tablets, pellets, polymer films, co-extrudates, transdermal patches

    • Axial resolution: 3.7 µm

    • Minimum coating thickness for automatic evaluation: 12 µm

    Compared to HW 1.5:

    • Improved image quality

    • Faster acquisition rate

    • Stronger PC components

    UHR OCT

    Pellets with very thin coating layers starting from about 4.5 µm

    (UHR OCT is not recommended for tablets and coatings thicker than about 50 µm)

    • Axial Resolution: 1.5 µm

    • Minimum coating thickness for automatic evaluation: 4.5 µm

    Sampling Device

    Use Case

    Characteristics

    Image

    SDP

    At-line measurements mainly with pellets or tablets

    • Samples stay static and are not mechanically stressed during measurement

    • Samples can be measured in desired and specified positions

    • Only one tablet necessary to perform a measurement (but not limited to one – there can also be many samples)

    • Exchangeable discs available for different products/sizes

    SDT

    At-line measurement of tablets in a little perforated drum, mimicking an in-line coating process movement of the samples

    • Movement of samples as in a drum coater

    • Larger sample set can be evaluated at once compared to SDP

    • Measurements from different positions of the tablet are evaluated at the same time and give information about the whole batch’s variation with only one measurement

    • Min. 100 ml (ca. 100 tablets) of samples required

    • Depending on characteristics of coating, samples might be damaged during longer measurement periods

    Probe

    Use Case

    In-line installation

    Image

    Pan Probe

    Monitoring of drum coating processes, co-extrudates, films, patches

    • e.g. mounted below the drum of a pan coater with perforated drum

    Fluid Bed Monitoring Probe

    In-line monitoring for coating processes of pellets and other multi-particulates

    • Directly attached to a fluid bed coater window/port

    • Probe interface includes a funnel to guide pellets in front of the sensor (pellets need to be measured at a certain distance and a suitable velocity)

    Direct vs indirect measurements

     Direct measurements with standard OseeT softwareIndirect measurements with new development software
    Typical use casemonitoring of transparent or semi-transparent coatings without scattering pigmentsmonitoring of scattering coatings (containing e.g. TiO₂, Fe₂O₃ etc.), uncoated products investigation, correlation of compression force to dissolution
    Coating layersvisible in OseeT imagesnot visible in OseeT images
    Calibration and correlationnot necessary – initial results are available right after the first measurementsA model needs to be created to correlate light penetration depth with the desired parameters (coating thickness, compression force, dissolution time)
    Evaluationbased on visible interfaces between coating and corebased on penetration depth of light into the sample
    Example OCT images

    Images fromWolfgang et al., Ascertain a minimum coating thickness for acid protection of enteric coatings by means of optical coherence tomography (2022)Elisabeth Fink, Elen Gartshein, Johannes G. Khinast. Extending the Use of Optical Coherence Tomography to Scattering Coatings Containing Pigments

    Comment regarding direct measurement imgs: Imgs are from following time points: 65, 130, 240 min. Include the time points on the images on the HP as on the images of the indirect measurements

    Samples measured at 3 different time points of a coating process.
    Evaluated area shown in color.

    OSeeT Software

    A simple and User Friendly OSeeT software, monitors the growth of the coating thickness and other characteristics throughout the whole process or at-line measurement. Each black spot on the chart corresponds to one thickness evaluation. Individual evaluations can be reviewed clicking on the black spots.

    Screenshot of the Results tab in our OSeeT Pharma 1D software at the end of a coating process