SiO2 Medical Products has developed a series of technical reports to help elaborate on relevant test findings and the subsequent benefits to our customers.
The objective of this study was to determine the effect of ionizing radiation on the color of COP vials. An evaluation of the color intensities produced by varying Electron Beam (E-beam) radiation doses was performed. A study was performed to determine the visual degree of color dissipation at different E-beam doses over the course of three months.
The effects of sterilization processes on Zeonex 690R COP were assessed by injection molding tensile bars and subjecting them to various sterilization conditions. Steam sterilization, ethylene oxide exposure and e-beam irradiation were utilized individually and in various combinations.
In 2015, SMP completed the process validation of the 6 mL vial. Shelf life stability studies were conducted with 6 mL vials manufactured from the validated process. The shelf life stability studies included both empty container and filled container shelf life. The data from the shelf life studies show that the SMP tri-layer coated 6 mL vials are stable throughout the shelf life.
Testing was conducted to measure the effectiveness of the SiO2 Medical Products, Inc. (SMP) coating system at blocking non-volatile extractables from the underlying plastic substrate from migrating into the liquid contained in the vial.
The objective of this study is to determine how well SiO₂ Medical Product’s (SMP) coated COP vials maintain water for injection (WFI) relative to standard borosilicate glass. A pH shift in WFI stored in glass containers has been observed. This study will determine the effect of SMP’s coated and uncoated vials on the pH of WFI stored in them.
SiO₂ Medical Products, Inc.’s (SMP) containers for parenteral medications stand out from all other polymer and glass containers for parenteral solutions on the market today for many reasons. This study was designed to determine relative dimensional stability of SMP injection molded articles over glass.
SiO₂ Medical Products, Inc. (SMP) 6 mL vials were filled with WFI and stored for various periods of time and temperature and tested for various characteristics that would indicate stability and suitability for use. Orthogonal testing indicated that the trilayer oxygen barrier coating resisted the challenge posed by the WFI.
Polymeric materials such as cyclic olefin polymers (COP) may be used for parenteral drug packaging because they possess high optical clarity, high strength and impact resistance, low extractables, dimensional consistency and a moisture vapor barrier. The robust mechanical properties of COP provide an impact and shatter resistant container that can tolerate severe handling without failure. While the polymer matrix is robust there is concern that the thin oxygen barrier film will yield and not protect the interior of the vial from oxygen ingress.