LOW
ELUTION
GLASS
VIALS
LOW
ELUTION
GLASS
VIALS
ADVANCED VIAL TECHNOLOGIES
SE Vial
LE Vial
LE+Vial
ADVANCED VIAL
TECHNOLOGIES
New inner surface cleaning and treatment techniques greatly reduce metal ion elution
Thanks to epoch-making new inner surface cleaning and treatment techniques, our new vials demonstrate metal ion elution suppression in long-term stability testing, which is far better than that of CGMP-certified vial. This also ensures supply of reliable products having less variations in quality, with ordinary lead time. Furthermore, these techniques are effective also for reducing protein absorption and delamination.
Highlights of Low Elution
Vial Manufacturing
At Shiotani Glass, low elution vials are manufactured by the processes of forming, organic acid cleaning, RO water cleaning, and silica film forming integrated into a single line.
Selectable elution levels
Our newly-designed manufacturing line is provided with three special processes, consisting of two types of cleaning: “organic acid cleaning” and “RO water cleaning”, plus “silica film forming”. This allows you to select alkaline elution level according to the type of medicine.
Roles of special processes
Organic acid cleaning
Sprays organic acid into vials being rotated to flow out eluted alkaline, and removes it by suction.
RO water cleaning
Sprays RO water (purified water) into vials being rotated to flow out eluted alkaline, and removes it by suction.
Silica film forming
After cleaning, silica components are sprayed into vials, followed by annealing to form silica film.
Using the following combinations of special processes, vials of different elution levels can be manufactured.
RO water cleaning = SE vial
Organic acid cleaning + RO water cleaning = LE vial
Organic acid cleaning + RO water rinsing + Silica film forming = LE+ vial
Product Specification
3 types of new vials that further reduce metal ion elution are now available.
| Products | Our New Technology (Advanced Processing Method) | Results Obtained Through Testing |
|---|---|---|
| SE Vial（Stable Elution） | The inner surface of the container is washed with RO water to remove the accumulations of alkali borate. | Accumulations of alkali borate are reduced by an average of 70%, leading to greater elution stability. |
| LE Vial（Lower Elution） | The inner surface of the container is washed with highly safe organic acid and rinsed with RO water. | The elution rate of LE Vials are 23% lower than SE Vials and 78% lower than that of the average comparable vial on the market. |
| LE＋Vial（Lower Elution Plus） | Same manufacturing process as LE Vials, a silica film is deposited on the inner surface of the container to inhibit further elution of metal ions. | The elution rate of LE Plus Vials are 44% lower than LE Vials, and are appropriate for clients seeking the highest possible control of metal ion elution on the market. |
| Products | SE Vial（Stable Elution） | Our New Technology (Advanced Processing Method) | The inner surface of the container is washed with RO water to remove the accumulations of alkali borate. | Results Obtained Through Testing | Accumulations of alkali borate are reduced by an average of 70%, leading to greater elution stability. |
|---|
| Products | LE Vial（Lower Elution） | Our New Technology (Advanced Processing Method) | The inner surface of the container is washed with highly safe organic acid and rinsed with RO water. | Results Obtained Through Testing | The elution rate of LE Vials are 23% lower than SE Vials and 78% lower than that of the average comparable vial on the market. |
|---|
| Products | LE＋Vial（Lower Elution Plus） | Our New Technology (Advanced Processing Method) | Same manufacturing process as LE Vials, a silica film is deposited on the inner surface of the container to inhibit further elution of metal ions. | Results Obtained Through Testing | The elution rate of LE Plus Vials are 44% lower than LE Vials, and are appropriate for clients seeking the highest possible control of metal ion elution on the market. |
|---|
USP41 <660> 3mL vial hydrolytic resistance
by surface glass test
3mL vial long-term stability test
Test Result by using WFI ICP-MS
(Inductively Coupled Plasma-Mass Spectrometry)
Bovine serum albumin protein adsorption quantification result (50μg/mL)
Available Vial Sizes
Vials from 2R to 30R are available. For sizes not listed in the table below, consult with our Sales Department.
| ISO Standard Vials | Volume | 2R | 3R | 4R | 6R | 8R | 10R | 15R | 20R | 25R | 30R |
|---|---|---|---|---|---|---|---|---|---|---|---|
| OD（φ） | 16 | 16 | 16 | 22 | 22 | 24 | 24 | 30 | 30 | 30 | |
| Overall Height（mm） | 35 | 40 | 45 | 40 | 45 | 45 | 60 | 55 | 65 | 75 |