Intact Analyzer 

InTact Analyzers offer pharmaceutical manufacturers - for the first time - a rapid, reliable test method covering the full array of solid dosage forms: layered, coated or cored tablets, capsules, caplets, geltabs and gelcaps.

The unique, patented InTact optical design operates in transmission mode. This sampling mode provides a representative whole body measurement of the dosage form; rather than only the outside layers as with reflectance measurements.

InTact Analyzers provide a non-destructive assay of individual solid dosage forms in less than one minute, even for multiple-constituent assays. The InTact results are precise and correlate extremely well with standard compendial test methods.

InTact analysis requires no crushing, grinding, dissolution, or other types of sample preparation. Unlike wet chemical analysis, no solvents or reagents are required with the InTact Analyzers.

InTact Analyzers will streamline solid dosage testing without compromising the results. They are a powerful QC tool for performing a range of tests such as identity, quality, assay, content uniformity, hardness, coating thickness and stability. The Intact Tablet Analyzer is designed for research and investigative work on single tablets; the InTact MultiTab Analyzer is optimized for batch and routine use.

FOSS InTact Analyzers are supplied with Vision Spectral Acquisition and Analysis Software for Windows. Vision is fully validated and year-2000 compliant. To help with cGMP regulations, FOSS and its global network of distributors offer extensive support programs.

The InTact Advantage:
True Transmission Measurements of Your Solid Dosage Forms

Features and Benefits

• Patented optical design ensures true transmission measurements (U.S. Pat. 5,760,399)

• Analyzes all types of solid dosage forms

• Satisfies USP batch compliance requirements

• Validated Vision ® spectral analysis software

• Analyzers for Method Development or Routine QC testing

• Global assistance and support for streamlined cGMP compliance

Tablet testing has traditionally been conducted by time consuming chemical and physical methods. In less than one minute FOSS Intact Analyzers can provide pharmaceutical manufacturers with information on tablet identity, potency, coating thickness and content uniformity. No crushing, grinding, dissolution or preparation is required. When combined with the Vision Software Package the new InTact Tablet Analyzers allow non chemists to obtain accurate test results.

Two systems are available. The standard InTact Single Tablet Analyzer system accepts single tablets and is suited to method development. The Intact MultiTab Analyzer includes an integral 30 place autosampler offering faster throughput with less manual effort. Both units are based on the FOSS scanning monochromator and InGaAs detector.

True Transmission for Optimal Results

Transmitting Near-Infrared (NIR) energy through the full thickness of a strongly light scattering, highly absorbing solid dosage form, without compromising analytical performance is a significant challenge for today’s NIR technology. Due to the optical properties of solid dosage forms, most of the incident energy is lost to scattering and absorption phenomena. To achieve suitable analytical performance, FOSS InTact Analyzers incorporate a patented optical design that optimizes signal coupling and eliminates stray light.

Optimal Signal Coupling

To maximize the coupling of NIR energy to the dosage form, InTact Analyzers use fiber optics to deliver pre-dispersed NIR energy from the monochromator. Sample heating is eliminated by interrogating the dosage form with monochromatic energy. To maximize sample illumination, a plano-convex lens focuses this energy onto the solid dosage form. With this unique coupling design, the InTact Analyzers’ performance is virtually independent of dosage form shape.

Optimal Signal Purity

To ensure true transmission spectra, InTact Analyzers block light leakage around the dosage form using a metal holder that closely fits the contour of the dosage form. Stray light or light leakage that could produce an undesired mixed-mode (i.e., combined transmission and reflectance) spectrum is further avoided using a lower aperture in the sample holder. This effective rejection of stray light allows reliable transmission measurements to be made at the high absorbance values encountered with solid dosage forms.

Optimal Signal Detection

To detect the energy transmitted through the dosage form, Intact Analyzers have a high-sensitivity Indium Gallium Arsenide (InGaAs) detector positioned immediately beneath the dosage form. The proximity of this location yields highly linear, low-noise transmission spectra.

Optimal Measurements

The InTact Analyzers’ working spectral region of 700-1500 nm allows measurements of most active and excipient compounds found in solid dosage forms. However, the resultant spectrum will have a very high absorbance and signal attenuation beyond 1500 nm. The unique InTact Analyzer design provides a highly linear spectrum that can be collected over a broad operating range (0-6 AU) with a wide photometric range (3 AU from baseline) to ensure analysis of a wide range of concentrations and a range of dosage form thicknesses.

The InTact Analyzers also benefit from using an automatic dynamic ranging (auto-gain) detector circuitry. This unique FOSS feature permits the use of ambient air as the reference material. Therefore, the need for maintaining separate physical references for different dosage forms is eliminated. Calibration trans-fer is also simplified as weak spectral features and sloping baselines attributed to physical reference materials are avoided.

Optimal Results

FOSS InTact Analyzers innovative optical design yields true transmission measurements of solid dosage forms to ensure confidence in the analytical result. Based on the reliable FOSS monochromator, the InTact Analyzers provide the highest signal-to-noise ratio, the lowest detection limits and the highest measurement precision.

The FOSS Advantage:
The Experience and Support for Validation and cGMP Compliance

Confidence in Results

In parallel testing, near-infrared (NIR) results routinely demonstrate excellent correlation and equivalency with compendial methods. NIR has been accepted as a general method by the European Pharmacopoeia, and as an alternative method in specific applications by both the U.S. Food and Drug Administration and the Canadian Health Protection Branch.

VISION: Validated NIR Software

FOSS’ Analyzers are supplied with VISION Spectral Analysis Software for Windows. VISION is fully validated NIR spectroscopic analysis software, and is year-2000 compliant. VISION was developed under the stringent "Life Cycle Method" as recommended by the U.S. Pharmaceutical Research and Manufacturers Association. This includes a rigorous documentation of the process covering such elements as functional requirement specification, architecture documentation, design documentation and proof of code reviews, among many others. VISION has been tested and audited to this standard.

Research and Method Development

The InTact Tablet Analyzer accepts one tablet at a time, and is intended for method development and laboratory investigative work. Methods developed using the InTact Tablet Analyzer can be transferred to the InTact MultiTab Analyzer for high throughput testing.

Routine Production and QC Testing

The InTact MultiTab Analyzer is designed to test solid dosage forms in standard batches of 10 and 20 tablets in accordance with current USP testing procedures. Up to 30 tablets may be processed in a single batch

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