The pharmaceutical sector is constantly advancing, not only in the areas of pharmacology and research, but for products as a whole. Packaging is a central component of this development, as packaging not only protects drugs from possible contamination, but often plays a key 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 ready to be consumed by patients. Ensuring complete safety and quality in the pharmaceutical products you manufacture requires equipment with the right mix of speed, handling, and flexibility.
Gianmarco Pincelli, Technical Sales Manager for 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 business advantages that leak testing can offer.
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.
Single-dose vials 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 regulators. For example, injectable products must be tested for contaminants and package integrity, to ensure there is no oxygen inside the vial for products at risk of oxidation.
Generally, VDM testing is recommended for vials containing liquids. Those containing a powder or 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 pre-filled syringes can be tested like vials, their design is more intricate and sophisticated as compared to a traditional vial, with multiple sealing areas. In addition, the syringe plunger must be held in place during testing. This requires specific handling solutions that lock the plunger when the syringe is exposed to a vacuum.
Mainly used for liquid pharmaceuticals, flexible capsules are produced by a filling, forming and sealing process produced on a continuous automated system within a sterile and closed area, reducing human intervention. BFS vials can be tested by VDM, AVI and HGA, although HGA is not commonly used.
For maximum flexibility, the best testing machines are designed to integrate directly into the production line, testing 100% of batches with no operator intervention. Testing equipment may also work separate from the production line, using trays loaded on platforms that transport the products on the conveyor.
Flexibility in test equipment speed is also important. A machine capable of analyzing over 300 products per minute is generally considered high speed, although this varies according to the size of the product being tested. In case of small 2 ml vials, for example, up to 600 containers can be inspected per minute, while 100 ml vials can be tested at speeds up to 100-120 units per minute.
The main objective of all tests performed on pharmaceutical products is the protection of consumer health, guarded by various international regulatory organizations like the FDA.
By implementing inspections following industry standards, manufacturers can confirm they are placing safe products on the market and meeting auditors’ demands. Reliable high-speed leak testing can deliver even more benefits, in the form of data that can be used to increase both production efficiency and overall product quality in the future. This increased efficiency and consistent quality assurance translates to lasting brand integrity and increased profits.
Bonfiglioli Engineering has the technology and expertise to design a custom leak testing solution for your high-speed pharmaceutical operations. With refined handling capabilities suitable for the most delicate and precise packaging and flexible equipment that can perform a variety of non-destructive test methods with repeatable, reliable accuracy, Bonfiglioli Engineering has the leak testing solution you need to ensure the complete quality and safety of every pharmaceutical product that leaves your line. Contact us today to learn more about how we can deliver the ultimate leak testing solution for your business.