XNEXT

Pharma Safety

Non-conformity and chemical contamination detection

Pharma Safety

FOR A HEALTHIER LIFE

XSpectra® technology: the new generation of X-ray inspection systems also applies to pharma safety. An higher standard can be set to pharma production.

 

Year by year, an increasing attention is paid to the quality of pharmaceutical production. European and North American Regulations, in particular, raise continuously the level of quality required to allow the commercialization of drugs. This fact forces the pharmaceutical companies to look for new technologies to fulfill the requirements. The growing production demands higher attention on two possible big areas of problems, both harmful for the end-users: a) non-conformities generally related to the drugs containers, b) non-conformities in the chemical composition of the drugs themselves. Chemical contamination can have three different possible origins: 1) extrinsic: all the particles that don’t belong to the pharma itself or to the package, but are rather unexpected; 2) intrinsic: all the particles coming from sources that relate to pharma production itself or to the package but shouldn’t be in the final product; 2) inherent: all the particles that are expected to be there but in a lower quantity or concentration.

 

Up to today, the technologies employed in Quality Control procedures in the Pharma industry can be divided in two main groups: visible inspection techniques and X ray inspection techniques. Both have advantages and disadvantages and in the actual drugs production they are complementary and both necessary. Visible techniques can be used to find each kind of non-transparent foreign bodies, if the container is transparent and the liquid drugs, too. They can be used even to highlight each possible external non-conformity of the container. But when the drugs are non-transparent or the containers are non-transparent and the defect is hidden, visible techniques are ineffective. This main group comprises two possible ways of implementation: human inspection by eyes and electronic cameras inspection, with software algorithms. In the first situation, the expertise of the human operator to discover even new foreign bodies or container defects cannot be beaten by imaging algorithms. But the total production cannot be checked. Only a small sample is analyzed and the whole inspection depends on the effective human level of precision over many hours of work. The electronic cameras respond to the need of complete production line automation (Industry 4.0 paradigm) and can completely overcome the limits of human operators. The production rate can be very high and the controls are effective on 100% of the samples. The limit is intrinsic of visible light: it can’t penetrate opaque objects. Another main limit is the impossibility to detect and categorize new kind of defects to which the algorithms weren’t trained for, in advance. The second main group of technologies concerns the implementation of X ray inspection systems. XRF ( X ray fluorescence ) and X ray diffractometry are two powerful techniques that can provide precious information about the chemical composition of the samples, mainly in powder batches. These information can be at the molecule structure level. On the other side, the complexity of the instruments and even their very slow speed necessary for the analysis relegates them to the laboratory environment. By the end, a highly technical skilled personnel is required to obtain a top performance from these complex methods.  

 

In this scenario, our innovative inspection system XSpectra® emerges and gives the possibility to go another step further, joining different technologies and their benefits. Its increased sensitivity gives the possibility to detect low density foreign bodies, impossible to be found until today. Its ability to collect the spectrum of each material inspected allows to identify the unique atomic number, in other worlds, the intrinsic chemical composition of the substances scanned. It is like taking their fingerprint and use it to distinguish the foreign bodies hidden inside the foodstuff. All these capabilities will be possible in real time on the whole pharma production.