The pharmaceutical sector is constantly advancing, not only in the pharmacological and research fields, but for products as a whole. Packaging is the central component of this development, since it not only protects drugs from possible contamination, but often plays a central role in determining how the medicines are administered. This is particularly important in the case of single-dose pharmaceuticals that are sold pre-dosed and therefore ready to be consumed by patients.
Gianmarco Pincelli, Technical Sales Manager of Bonfiglioli Engineering, shares what is unique about packaging for single-dose drugs. He also explains the different types of tests used for these products and the advantages that these controls can offer the company implementing them.
Single-dose vials are available in a variety of sizes, typically ranging from 2 to 100 ml. They are usually sealed with a rubber stopper locked by a metal ring, and there may also be an additional plastic cover that is removed at the time of use.
Vials of this type can be inspected using Vacuum Decay Method (VDM), Visual Inspection (VI) or Headspace Gas Analysis (HGA) technologies, depending on the product and the type of test required by the regulator. Injectable products, for example, must be tested for contaminants and integrity, while there must be no oxygen inside the vial for products at risk of oxidation, and so on.
Generally, the vacuum test is recommended for vials containing liquids. Those containing a powder or a lyophilizate usually undergo pressure tests or NIR (Neural Infrared Analysis), a spectroscopic technique that checks the composition of the vial's content by striking it with a beam of infrared light and analyzing the changes in the emitted spectrum.
Although these can be tested like vials, the pre-filled syringe is more intricate and sophisticated as compared to a traditional vial, with multiple sealing areas that require integrity. The syringe plunger must be held in place during testing. This requires specific handling solutions related to the test chamber that lock the plunger when the syringe is exposed to a vacuum.
These flexible capsules mainly used for liquid containers in pharmaceuticals are produced by a filling, forming and sealing through a continuous automated system, within a sterile and closed area, reducing human intervention and can be tested by VDM, AVI and HGA, although HGA is not commonly used.
For maximum flexibility, the best testing machines are designed to operate directly on the production line, testing 100% of batches with no operator intervention, or to work in separate environments, using trays loaded on platforms that transport the products on the conveyor.
In terms of test cycle, a machine capable of analyzing over 300 products per minute is generally considered to be high speed, although this varies according to the size of the product to be checked. In case of small 2 ml vials, for example, up to 600 containers can be inspected per minute, while for 100 ml vials up to 100-120 units can be tested per minute.
The main objective of all tests performed on pharmaceutical products is to protect consumers’ health as required by various international regulatory organizations like the FDA.
By implementing inspections following industry standards, the manufacturer can ascertain it is placing safe products on the market, is meeting auditors’ demands and can obtain useful data to improve its activity, by increasing both efficiency and the quality of its products even in the future.
Therefore, high-speed testing equipment indirectly increases company profits by improving product quality and, therefore, providing sterile and safe medicinal.
Thanks to custom-built solutions and the implementation of handling and non-destructive testing technologies designed to meet customers’ needs, look to Bonfiglioli Engineering equipment for the guarantee of full recovery of tested products and compliant results. Pharmaceutical manufacturers can improve their production processes by delivering accurate and meticulous results in the shortest time possible and increasing business productivity.