Avoid Glass Particles With High-Tech Polymers And Coated Glass Vials

Recently, the US Food and Drug Administration (FDA) addressed a warning to a US pharmaceuticals company, when third-party manufactured glass vials were found to contain glass particles upon inspection. Schott Pharmaceutical Packaging Division, part of the multinational technology-based Schott group, offers several different high-quality alternatives to the conventional primary pharmaceutical glass packaging. Schott has extensive knowledge and experience when it comes to glass particles that can form during the production process and how these can be limited. Contributory factors include temperature and speed during glass formation, and also the adjustment of the burners. The glass composition of the raw material also has a significant impact. The high-quality Fiolax glass tube, for instance, has a superior hydrolytic resistance compared to similar products on the market.

Pharmaceutical companies have the option of switching to the high-tech Polymer COC in order to completely avoid the risk of glass particles. Schott TopPac® products made from COC offer a number of advantages: they are break-resistant and contain no ions or heavy metals. However, they may not be the perfect solution for all applications, due to their inferior oxygen barrier properties in comparison to glass, which is very important for the stability of drugs.

In addition, polymers cannot withstand heat sterilisation.

Customers who demand the advantages of glass, but would like to be fully protected against glass particles at the same time may want to consider the Schott Type I plus® products. The inner surface of these vials is coated with an ultra-thin silicon dioxide coating, a technique called Plasma Impulse Chemical Vapor Deposition (PICVD) that was developed by Schott. Product advantages include a more homogeneous surface, better barrier properties and higher chemical stability of the active pharmaceutical ingredient.