The Problem
Many quality assurance steps in pharmaceutical manufacturing are currently limited to the analytical testing of samples in the laboratory. These sample-based tests range from the identity testing of starting materials upon delivery to in-process controls (IPC) and final release checks. This approach carries the inherent risk that batch defects or deviations may only be detected belatedly, potentially leading to increased rejection rates (reject quantities), significant costs, and potential supply chain issues.
The Solution
From Spectroscopic Lab Sample to 100% Testing in Ongoing Production
Our process spectrometers are flexible analytical tools for the reliable identification and quantification of optically active substances – directly in the production line. They enable the transition from traditional sample control in the Quality Control (QC) Laboratory to 100% control in the running production process. Whether it involves desired active ingredients or unwanted impurities: We make concentration variations visible before they lead to a batch deviation.
Our modular system for your application offers the following key features:
- Individual Calibration and Validation: Each system is calibrated and validated according to the specific product/batch and the analytical purpose. The hardware, consisting of a transmitter and receiver unit, is precisely adapted to the measuring geometry and the primary container (e.g., vial, ampoule).
- Broad Detection Spectrum (Multidetection): Detection occurs via fluorescence or absorption, even for multiple wavelengths simultaneously. This offers maximum flexibility for a wide variety of substances and formulations. Furthermore, the multidetection capability allows the compensation and suppression of influences from the primary packaging materials.
- Direct Process Integration (Inline Analysis): The product container (e.g., vial) is guided through our system. Depending on the light sensitivity of the substances, the contained sample is illuminated for an ultra-short duration using LED or scattered laser light, and the data is immediately evaluated.
- Maximum Measurement Speed: A complete measurement per unit (sample) is typically completed in under 10 milliseconds and is optimized for the cycle time of high-speed filling lines.
- Increased Process Reliability: Inline measurement ensures continuous quality control without production interruption – a significant contribution to Good Manufacturing Practice (GMP) compliance.
Your Advantage
With our process spectrometers, you receive a validated, customized analytical tool that integrates seamlessly into your production environment and automation.
Your Advantages at a Glance:
- Ensuring Product Quality (Quality Assurance, QA)
- Minimizing Rejects and Rework
- Increasing Overall Equipment Effectiveness (OEE)
This is achieved in real-time and with the highest analytical precision.
Application Examples
Specific application examples for our process spectrometers from the last 25 years, illustrating the range of applications, include the detection of:
- Fluorescein (also in opaque plastic containers, among others)
- α-Tocopherol
- Retinol
- Mycotoxin