Badalli İkon

Ampoules

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AMPOULES

Ampoules manufactured from Type I Borosilicate Glass with high chemical resistance, in accordance with ISO 9187-1 or customer requirements, ensure the safe storage of a wide variety of pharmaceuticals and medical products.

The medical ampoules we manufacture from Type I Borosilicate Glass are produced in accordance with ISO 9187-1 and ISO 9187-2 standards with high dimensional and cosmetic control precision, and are packaged in an ISO 8 class area.

Review the Dimensions of Ampoules Manufactured According to ISO 9187-1
For product safety, 100% dimensional inspections are carried out with camera control systems, and the products also undergo strict cosmetic inspection.
Ampoules manufactured according to ISO 9187-1 are produced as open-mouth Form B and Form C, and as closed Form D.
Ampoules offer a wide product portfolio for volumes ranging from 1 to 30 ml.
Ampoules can be manufactured in colorless/transparent or colored/amber glass.
Printing, CBR, CDR, and OPC applications can be applied to ampoules.
In addition to the ISO 9187-1 standard, production can also be carried out in line with customer product requirements.
The products are packaged in polypropylene boxes and lids within an ISO 8 class clean area and delivered to the customer. Upon request, the boxes are shrink-wrapped together with the product.
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Printings on Ampoules

Text printing of drug contents and logo printing can be applied on ampoules using ceramic paint in various colors.
For easy identification of ampoules and the medicine inside, identification code rings can be applied on the ampoule using ceramic paints in various colors.
CBR application is applied to ampoules for easy breaking.

Ampoule Breaking Systems

Three different breaking systems are applied to ampoules to facilitate safe breaking during use.

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OPC (One Point Cut): Single-point breaking

A very small notch is made on the ampoule constriction with a cutting disk, and a dot is applied a few millimeters above to indicate the breaking point. These ampoules are easy to break and generate fewer glass particles during breaking.

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CBR (Color Break Ring): Break Ring

Around the ampoule constriction, a 360° ring of ceramic paint is applied, creating micro GER to weaken the ampoule surface.

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SCO (Scoring): Creating a Cutting Line

A shallow cutting line is drawn on the glass around the constriction of the ampoule using a cutting disc.

Technical Diagram of Medical Ampoule

Source: Injection equipment for medical use
Part 1: Ampoules for injectables (ISO 9187-1:2010)

Source: Injection equipment for medical use
Part 2: One-point-cut (OPC) ampoules (ISO 9187-2:2010)

TYPE - B AMPOULE DIMENSIONS
AMPOULE NOMINAL VOLUME – ml (Type – B)
Definition Unit of Measurement123510202530
Body Diameterd1mm10,75 ±0,1510,75 ±0,1512,75 ±0,1514,75 ±0,1517,75 ±0,2022,5 ±0,2522,5 ±0,2522,5 ±0,25
Constriction Diameterd2mm6,5 ±0,56,5 ±0,56,5 ±0,57 ±0,57,5 ±0,58,5 ±0,58,5 ±0,58,5 ±0,5
Ampoule Diameterd3mm8,5 ±0,58,5 ±0,58,5 ±0,59 ±0,59,5 ±0,512 ±112 ±112 ±1
Classification Diameterd4mm6 ±0,356 ±0,356 ±0,357 ±0,357,1 ±0,357,8 ±0,57,8 ±0,57,8 ±0,5
Edge Diameter – Type Bd7mm8 ±18 ±18 ±19 ±19,5 ±111 ±111 ±111 ±1
Full Length – Tip Bh1mm60 ±172 ±175 ±183 ±1102 ±1113 ±1128 ±1143 ±1
Capacity Heighth4mm25,5 ±0,537,5 ±0,539,5 ±0,546,5 ±0,562 ±176 ±1,391 ±1,3106 ±1,3
Shut-off Point Heighth5mm47 ±257 ±262 ±268 ±287 ±2100 ±2115 ±2130 ±2
Body Shoulder Height – Minh6mm2133354155658095
Bottom Radiusrmm111,51,522,52,52,5
Punt Depthemm1 ±0,51 ±0,51 ±0,51 ±0,51,25 ±0,751,5 ±11,5 ±11,5 ±1
Wall Thicknessw1mm0,5 ±0,30,5 ±0,30,5 ±0,30,55 ±0,30,6 ±0,40,7 ±0,40,7 ±0,40,7 ±0,4
Glass Wall Thickness at the Sealing Linew2mm0,37 ±0,50,37 ±0,50,37 ±0,50,40 ±0,50,47 ±0,50,50 ±0,50,50 ±0,50,50 ±0,5
Bottom Glass Thickness – Minw3mm0,30,30,30,40,40,50,50,5
Neck Constriction Wall Thicknessw4mm0,7 ±0,10,7 ±0,10,7 ±0,10,7 ±0,150,8 ±0,151 ±0,21 ±0,21 ±0,2
Technical Diagram of Medical Ampoule

Source: Injection equipment for medical use
Part 1: Ampoules for injectables (ISO 9187-1:2010)

Source: Injection equipment for medical use
Part 2: One-point-cut (OPC) ampoules (ISO 9187-2:2010)

TYPE - C AMPOULE DIMENSIONS
AMPOULE NOMINAL VOLUME – ml (Type – C)
Definition Unit of Measurement123510202530
Body Diameterd1mm10,75 ±0,1510,75 ±0,1512,75 ±0,1514,75 ±0,1517,75 ±0,2022,5 ±0,2522,5 ±0,2522,5 ±0,25
Constriction Diameterd2mm6,5 ±0,56,5 ±0,56,5 ±0,57 ±0,57,5 ±0,58,5 ±0,58,5 ±0,58,5 ±0,5
Ampoule Diameterd3mm8,5 ±0,58,5 ±0,58,5 ±0,59 ±0,59,5 ±0,512 ±112 ±112 ±1
Classification Diameterd4mm6 ±0,356 ±0,356 ±0,357 ±0,357,1 ±0,357,8 ±0,57,8 ±0,57,8 ±0,5
Mouth Diameter – Type Cd5mm9 ±0,89 ±0,810,7 ±0,812,2 ±113 ±114 ±114 ±114 ±1
Overall Length – Type Ch2mm67 ±179 ±182 ±190 ±1109 ±1120 ±1,5135 ±1,5150 ±1,5
Capacity Heighth4mm25,5 ±0,537,5 ±0,539,5 ±0,546,5 ±0,562 ±176 ±1,391 ±1,3106 ±1,3
Shut-off Point Heighth5mm47 ±257 ±262 ±268 ±287 ±2100 ±2115 ±2130 ±2
Body Shoulder Height – Minh6mm2133354155658095
Bottom Radiusrmm111,51,522,52,52,5
Punt Depthemm1 ±0,51 ±0,51 ±0,51 ±0,51,25 ±0,751,5 ±11,5 ±11,5 ±1
Wall Thicknessw1mm0,5 ±0,30,5 ±0,30,5 ±0,30,55 ±0,30,6 ±0,40,7 ±0,40,7 ±0,40,7 ±0,4
Glass Wall Thickness at the Sealing Linew2mm0,37 ±0,50,37 ±0,50,37 ±0,50,40 ±0,50,47 ±0,50,50 ±0,50,50 ±0,50,50 ±0,5
Bottom Glass Thickness – Minw3mm0,30,30,30,40,40,50,50,5
Neck Constriction Wall Thicknessw4mm0,7 ±0,10,7 ±0,10,7 ±0,10,7 ±0,150,8 ±0,151 ±0,21 ±0,21 ±0,2
Technical Diagram of Medical Ampoule

Source: Injection equipment for medical use
Part 1: Ampoules for injectables (ISO 9187-1:2010)

Source: Injection equipment for medical use
Part 2: One-point-cut (OPC) ampoules (ISO 9187-2:2010)

TYPE - D AMPOULE DIMENSIONS
AMPOULE NOMINAL VOLUME – ml (Type – D)
Definition Unit of Measurement 12351020
Body Diametermmd110,75 ±0,1510,75 ±0,1512,75 ±0,1514,75 ±0,1517,75 ±0,2022,5 ±0,25
Constriction Diametermmd26,5 ±0,56,5 ±0,56,5 ±0,57 ±0,57,5 ±0,58,5 ±0,5
Ampoule Diametermmd38,5 ±0,58,5 ±0,58,5 ±0,59 ±0,59,5 ±0,512 ±1
Classification Diametermmd46 ±0,356 ±0,356 ±0,357 ±0,357,1 ±0,357,8 ±0,5
Ampoule Domemmd610 ±110 ±110,5 ±112 ±113,5 ±113,5 ±1
Overall Length – Type Dmmh370 ±183 ±189 ±195 ±1112 ±1126 ±1
Capacity Heightmmh425,5 ±0,537,5 ±0,539,5 ±0,546,5 ±0,562 ±176 ±1,3
Filling Point Heightmmh547 ±257 ±262 ±268 ±287 ±2100 ±2
Body Shoulder Height – Minmmh6213335415565
Bottom Radiusmmr111,51,522,5
Punt Depthmme1 ±0,51 ±0,51 ±0,51 ±0,51,25 ±0,751,5 ±1
Wall Thicknessmmw10,5 ±0,30,5 ±0,30,5 ±0,30,55 ±0,30,6 ±0,40,7 ±0,4
Glass Wall Thickness at the Sealing Linemmw20,37 ±0,50,37 ±0,50,37 ±0,50,40 ±0,50,47 ±0,50,50 ±0,5
Bottom Glass Thickness – Minmmw30,30,30,30,40,40,5
Neck Constriction Wall Thicknessmmw40,7 ±0,10,7 ±0,10,7 ±0,10,7 ±0,150,8 ±0,151 ±0,2
Glass Thickness of the Dome Sectionmmw50,1–0,250,1–0,250,1–0,250,1–0,250,1–0,250,1–0,30
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