SILICOATING
Effect of Silicoating
Forming a thin film of silicon dioxide (SiO2) on the inner surface of glass container will strongly suppress the elution of metal derived from borosilicate glass and improve the stability of the contained medicines. Can be used safely for pharmaceuticals requiring pH control. Since the thin film keeps the medicine from direct contact with the inner surface of glass, silicoating is also expected to suppress flakes (delamination).
Shiotani Glass is capable of manufacture glass containers that meet the requirements of pharmacopoeias without applying silicoating. However, applying silicoating will suppress elution more strongly.
Processing Method
While silicoating gas is being supplied, the glass container is heated to form a thin film of silicon dioxide (SiO2) on the inner surface. Since the thin film forming technology is applied, the SiO2 film is formed by chemical reaction. This process is effective in suppressing delamination.
Superiority Shown by Data
Compared with general vials, silicoated vials demonstrate more stable and superior performance in suppressing pH fluctuation and metal elution.
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 Silicoating
Silicoating uses thin film forming technology to suppress metal ion elution. 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.
Silicoating was applied to this low pH vial to achieve the result of “Silicoated” 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.
