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One more step for a better health
Increasing attention is paid every year to the quality of pharmaceutical products. European and North American regulations, in particular, continue to raise quality levels required for drug commercialisation. The rise in the production demands further attention be paid to two potential issues, both harmful for patients:
1. non-conformities in drug containers
2. non-conformities in the drugs themselves.
Chemical contamination can have three different possible origins:
Extrinsic: all the particles that do not belong to the drug itself or to the package, but that are rather unexpected;
Intrinsic: all the particles that arise from sources related to the pharma production itself or to the package, but that should not be in the final product;
Inherent: all the particles that are expected to be present but in a lower quantity or concentration. This compels pharmaceutical companies to look for new technologies capable of responding to these requirements.
Shortcomings Of Current Inspection Methods
In the pharma industry the quality control procedures can be divided into two types of technology:
1- Visual inspection techniques
2- X-ray inspection techniques
They both have pros and cons, and they are currently complementary and both necessary.
Current Detection Systems
PROS
CONS
VISUAL INSPECTION TECHNIQUES
* when using human visual inspection
* when using electronic camera inspection
PRO
Effective in detecting non-transparent foreign bodies, if containers and drugs are transparent. Possibility to discover new foreign bodies or container defects thanks to human expertise. Controls on the entire production line.
CONS
Ineffective in case of non-transparent drugs or containers. Analysis of small samples. Quality control dependent on potential human errors. Impossibility to detect and classify new defect types.
CONVENTIONAL X-RAY SYSTEMS (X-RAY FLUORESCENCE - XRF AND X-RAY DIFFRACTION - XRD)
PRO
Valuable information about the chemical properties of the samples tested.
CONS
Complexity of the instruments involved. Very slow inspection process, therefore rather suitable for laboratory environments. Need for highly skilled technical staff.
Why XSpectra® Is A Must-Have Solution?
Given the current situation, our innovative inspection XSpectra® makes it possible to go the extra mile, combining different technologies and their benefits. It thus provides for a complete and fast inspection, and identifies defects and contaminants non-detectable by the current technologies.
One more step for a better health
The XSpectra® technology can take quality and safety in the pharma production to the next level.
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Xnext Eu fundend No 849381
Xnext has received funding from the European Union’s Horizon 2020 Research and Innovation Programme under grant agreement N° 849381