The importance of Quality Control in the Pharmaceutical Primary Packaging Industry

Pharma Companies are amongst the most demanding ones when it comes to Quality Control. This is true for drugs and chemical substances due to regulations and safety rules, but is of critical importance when it comes to packaging too.

The Industry has set high-standard requirements for vial, ampoules, cartridges and bottles in plastic or glass. The geometry of these containers is very important for multiple reasons such as correct filling, fitting seal closure, fluent movement on the production line and aesthetic appearance.

A strict Quality Control procedure not only helps in certifiying the good quality of the product and has an impact on the brand but is also necessary to optimize the production process. Producers of vials and ampoules are very careful about getting the correct shape of the product not only to avoid claims, but first and foremost, to avoid time losses in the downstream lines.

Traditional measuring methods with calipers and other manual instruments have proved to be too subjective and not repetitive enough to guarantee a stable measurement and control. They require a great amount of time and human resources, thus they are very high in cost.

Due to the human influence on measurements, there is a high risk of confusion and mistakes. The process itself is not regular, since the operators have to manually write the results and then insert them on the company sistem. There is an high chance of mistakes and no traceability of the items, resulting in very poor Quality Check results.

To solve this problem, many vials producers have developed in-line control systems to check their products, but this has turned out to be an incomplete solution. While giving an advantage on the time side, In-line processes are not precise enough to assure top-quality standards.

Inline systems are often not accurate enough and check only one diameter of the bottles and vials, while a 360° check would be required. Many times the temperature of the material is not stable enough to ensure that the dimension measured in line will be the same off line.

SmartVision, an Italian company leader in manufacturing metrology instruments, has developed specific solutions to overcome these limits with a series of products meant to perform automatic and accurate measurements in few seconds, with no human influence and ready traceability.

Smart_Projector Pharma has been recognized as the leader instrument for Primary Pharmaceutical Packaging quality control. Smart_Projector Pharma is a 2D digital profile projector, designed to perform a complete contactless analysis of parts such as bottles, vials, syringes, ampoules and cartridges, even if transparent.

The innovative Smart_Rotating_Robot, designed to extend the Smart_Projector Pharma’s range of application, allows control quality check to cylindrical parts and any other item that needs to be examined on different projection planes all over the circumference.