NIR/Raman Chamber Extension for Non-Destructive Sterile Container Testing
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Solution Overview
Problem
Existing methods for quality and identity control of pharmaceutical products in sterile containers require destructive sampling and specialized laboratory analysis, compromising sterility and being impractical for individual batch assessment.
Innovation Solution
A measurement chamber extension for NIR- or Raman-spectrophotometry that allows non-destructive identification and quantification of active pharmaceutical ingredients and contaminants within sterile containers like infusion bags and syringes by optimizing light path and using reflective materials to minimize interference.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a sample of pharmaceutical product is taken for analysis, then quality and identity control can be performed, but the sample destruction compromises sterility and prevents assessment of individual batches
Solution Approach 1:
The invention extracts only the necessary information (spectral data) from the pharmaceutical product without removing or destroying the product itself. The measurement chamber extension allows light to pass through the container walls to obtain spectral information while the product remains intact and sterile inside its original packaging.
Solution Approach 2:
The measurement chamber extension acts as an intermediary device between the spectrophotometer and the sealed container. It provides an optical path through the container walls without breaching the sterile seal, allowing indirect measurement that preserves sterility while enabling quality control.
2Measurement precision
If specialized laboratory analysis is used for pharmaceutical product characterization, then accurate identification and quantification can be achieved, but the complexity and requirement for trained personnel increases
Solution Approach 1:
The measurement chamber extension enables the spectrophotometer to perform measurements directly on sealed containers without requiring extraction to a laboratory setting. The device self-adjusts to account for container wall interference through calibration measurements, eliminating the need for complex laboratory preparation procedures.
Solution Approach 2:
The invention changes the measurement parameters by accounting for and compensating for the optical properties of container walls. Through calibration measurements on empty containers and mathematical correction of the spectral data, the system achieves accurate pharmaceutical product characterization despite the presence of container walls in the optical path.
3Reliability
If light passes through polymer container walls for measurement, then non-destructive analysis is possible, but interference from the container material affects measurement accuracy
Solution Approach 1:
The system performs preliminary calibration measurements on empty containers before measuring the actual pharmaceutical product. This preliminary action captures the spectral characteristics of the container walls alone, which are then subtracted from the product measurements to isolate and accurately identify the pharmaceutical components.
Solution Approach 2:
The measurement system uses feedback from calibration measurements to correct and improve the accuracy of subsequent product measurements. The spectral data from empty containers provides reference information that is continuously applied to compensate for container wall interference in all product measurements.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Enables reliable identification and quantification of pharmaceutical components without compromising sterility, allowing for rapid, accurate quality control of individual batches using commercially available spectrophotometers.
Implementation Method 1
measuring a transmission or a transflection of a measuring light beam (sample beam) of a NIR-spectrophotometer or a Raman-spectrophotometer which is directed through the polymer container
Implementation Method 2
measuring a transmission or a transflection of a measuring light beam (sample beam) of a NIR-spectrophotometer or a Raman-spectrophotometer which is directed through the polymer container
Data Source
Figure 1~2
Figure 3~4
Figure 5
AI summary
A measurement chamber extension (10) for a spectrophotometric characterization with a NIR- spectrophotometer (1) or a Raman-spectrophotometer (1) of a liquid (2) in a polymer container (3), wherein the measurement chamber extension (10) comprises: an adapter plate (11) having an adapter opening (I V); a container holder (7); and an optical element (5), selected from a mirror and a waveguide; wherein the adapter (11) is configured to cover in a light-tight manner the measurement chamber (20) of the NIR-spectrophotometer (1) or of the Raman-spectrophotometer (1) and the adapter opening (I V) is arranged to encompass a measurement window of the NIR- spectrophotometer (1) or Raman-spectrophotometer (1) to provide exposition of the liquid (2) to a measurement light beam emitted from the measurement chamber (20) of the NIR- spectrophotometer (1) or Raman-spectrophotometer (1) through the measurement window; wherein the container holder (7) is configured to allow a close placement of the optical element (5) adjacent to the polymer container (3) containing the liquid (2) providing a loss- free transmission or transflection of the measurement light beam from the optical element (5) to a detector of the NIR-spectrophotometer (1) or Raman-spectrophotometer (1); and wherein the container holder (7) comprises a clamp (13) which is configured to hold a tubular section (3a) of the polymer container (3) as to allow a reproducible measurement condition.