SULFUR TREATMENT
Effect of Sulfur Treatment
Aqueous ammonium sulfate solution is poured into vials. The vials are heated at the annealing process to cause the generated sulfurous acid gas to react with alkaline metal derived from borosilicate glass. By doing so, alkaline components are selectively removed from the inner surface. Sulfur treatment can be used safely for vials for medicines that may cause alkaline pH shift or react with alkaline metals.
Shiotani Glass vials demonstrate low metal elution characteristics that meet the requirements of pharmacopoeias without applying sulfur treatment. However, applying sulfur treatment will suppress elution more strongly.
Processing Method
Aqueous ammonium sulfate solution is poured into primary processed vials. The vias undergo the annealing process to cause reaction with alkaline metals. Low metal elution is achieved by selectively reacting with or extracting alkaline components from the inner surface of vials.
Sulfur treated vials will have a surface layer with higher silica content, which reduces alkaline metal elution.
Superiority Shown by Data
Compared with unprocessed general vial, the sulfur treated vial shows metal elution suppression performance second-best to silicoated vial. Sulfur treatment is effective especially for vials for medicines that may cause alkaline pH shift or react with alkaline metals.
View information about silicoating
Comparison of Na⁺ Ion Elution
- Test condition: 2, 10, and 20 mL vials manufactured by Shiotani Glass are filled with distilled water and autoclaved at 121℃ for 60 minutes to measure Na+ ion elution.
- Atomic absorption spectrophotometer owned by our Quality Control Section was used for measurement.
Elution Suppression Level by Sulfur Treatment
Sulfur treatment is applied to intentionally change the compositional distribution of the inner surface of glass. The low pH vial shown in the graph below is a so-called primary processed vial (special process has not yet been applied), but is superior to general vial in suppressing metal elution. Sulfur treatment was applied to this low pH vial to achieve the result of “Sulfur treated” vial here.
- Test condition: 2, 10, and 20 mL vials manufactured by Shiotani Glass are filled with distilled water and autoclaved at 121℃ for 60 minutes to measure Na+ ion elution.
- Atomic absorption spectrophotometer owned by our Quality Control Section was used for measurement.
OTHER SPECIAL PROCESSES
Low Elution Vials (SE, LE, LE+)
Inner surface of vial is cleaned before annealing in order to remove alkaline. Elution suppression levels can be selected according to your needs.
NEW TECHNOLOGY
Inner surface of vial is cleaned before annealing in order to remove alkaline. Elution suppression levels can be selected according to your needs.
Silicoating
Suppresses metal elution most of all special processes. It deposits silica film on the inner surface of vial to prevent metal elution.
Suppresses metal elution most of all special processes. It deposits silica film on the inner surface of vial to prevent metal elution.
Sulfur Treatment
Sprays aqueous ammonium sulfate solution into vials at a manufacturing process and heats it to cause reaction, thus achieving low metal elution.
Sprays aqueous ammonium sulfate solution into vials at a manufacturing process and heats it to cause reaction, thus achieving low metal elution.
