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PHARMACEUTICALS

100% QUALITY CONTROL AND PRODUCT SAFETY BY ANALYZING THE ENTIRE PRODUCT STREAM

To achieve real-time product release, a continuous quality check and production optimization is required at each stage of the manufacturing process. This ensures that all final release criteria are met.

Only a fully integrated control strategy, which demands the implementation of real-time process analyzers and control tools, can provide real-time knowledge of any changes in the many manufacture processing steps. Alarms and automatic feedbacks to production processes are an integral part of this strategy.

EVK’s HELIOS Analyzer is a new tool available which can measure, analyze and steer production processes ranging from laboratory environments to industrial manufacturing:

PRODUCT IDENTIFICATION

Pharmaceutical applications of HELIOS Analyzer, such as quality control of tablet manufacturing, have been demonstrated by the Research Center for Pharmaceutical Engineering (RCPE, Austria). HELIOS Analyzer can check tablet integrity pre- and post-packaging

CHEMICAL COMPOSITION

In both food and pharmaceutical sectors, the primary quality criterion is chemical composition. Checking and verifying the chemical integrity of each product item, whether it be vials, pills, grapes or potatoes, is possible with HELIOS Analyzer. Spatially resolved Active Pharmaceutical Ingredient distribution maps can be analyzed, classified if necessary, and sent instantly for real-time process control.

The picture below shows clockwise from top left the chemical mapping of tablet API content for 1%, 5%, 11% and 15% nominal concentrations, as well as agglomerated API spots (courtesy of RCPE, Austria)

SPATIAL DISTRIBUTION HOMOGENEITY

EVK’s HELIOS Analyzer has been developed to analyze and quantify how well chemicals are distributed on a substrate. Sample classification, based on customer-specific thresholds, will quickly bin samples into “good” and “reject” categories.

The picture below shows: the visible image of substrate (left), false color rendering of HSI image shows distribution of API (middle) and classified sub-regions of sample where grid is tailored to customer-specific product size (right).

DRYING PROCESSES

Drying can be a critical step in some manufacturing and testing processes such as deposition on a substrate or desiccation for dry matter content analysis of food. HELIOS Analyzer can perform both, without disruption to the manufacturing process and in real-time to steer pharmaceutical processes to maximize profit. For instance, the development of production processes  is important for final product quality. The HELIOS Analyzer supports this development process and measures the dry matter content in the lab and provides the result in false color rendering:

LAYER THICKNESS

HELIOS Analyzer can also be configured to measure API coating layer thickness. The NIR and SWIR spectral ranges even make it possible to measure certain opaque materials.