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PHARMACEUTICAL PACKAGING OPC/CBR Ampoules presentation
PHARMACEUTICAL PACKAGING OPC/CBR Ampoules presentation
OPC and CBR break systems
SCHOTT AG
January 2009/OL
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Break system description
The One Point Cut principle (OPC)
After the forming process and before the annealing oven,
a small cut is applied with a carbide disc to theconstriction of the ampoule.
The depth of the cut must be constant and
dot
Chart 2
contro e very care u y to prevent t e ampou esfrom leaking and to ensure a regular break force.In the cut there are micro cracks which weakens theglass at this position
As the cut is very small and is not visible withoutmagnification, there is a small colored dot abovethe cut on the bulb of the ampoule which marks theposition of the cut.
cut
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Break system description
Color ring
The Color Break Ring principle (CBR)
The CBR ampoules have a ceramic color ring on the
constriction. This ring made of ceramic enamel and organicoil is applied after forming and before annealing theampoules. The ceramic enamel has a higher mean linearcoefficient of expansion than the glass.
Chart 3
In the annealing oven the organic oil decomposes and theenamel is melted onto the glass surface.After cooling down, due to the higher mean linear coefficientof expansion the enamel contracts more than the glass and
as it is fixed onto the glass surface, it produces micro crackson the surface which has contact with the glass and whichweakens the glass at this position.
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The 2 systems use the same break force test set-up
used for both systems
Chart 4
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OPC - ISO Breaking force
Nennvolumen
Nominal
Volume
ml
Auflageabstand
Length
Bruchkraft
Breaking Force
l
mm
l1
mm
l2
mm
Fmin
N
Fmax
N
1 - 3
36 18 18
25 65
5 30 70
10 - 30 60 22 38 30 80
Chart 5
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CBR - ISO Breaking force
Nennvolumen
Nominal
Volume
ml
Auflageabstand
Length
Bruchkraft
Breaking Force
l
mm
l1
mm
l2
mm
Fmin
N
Fmax
N
1 - 5 36 18 18 30 80
10
60 22 38
30 90
20 - 30 30 100
Chart 6
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Influence on the break force
The break force of Color Break Ampoules is -in addition to other
parameters dependent on the viscosity, the thickness of the enamelapplied and on the temperature profile of the annealing oven.As these three parameters are extremely difficult to control in technical
roduction there is alwa s a bi er s read of the mean value of the
Origins
Chart 7
break force of Color Break Ampoules than of OPC Ampoules.
As the influencing parameters for the break force of OPC Ampoules,which are the cut depth and the cut position into the constriction, are
easier to control, the standard deviation of the break force of OPCAmpoules is lower than that of Color Break Ampoules. The productionof OPC ampoules requires the use of sophisticated equipment.
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OPC values: Reduced distribution
within the ISO range (25 to 65 N)
Influence on the break force
Chart 8
Color Break values: Inflexible withinthe whole ISO range (30 to 80 N)
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Influence on particles
Hereafter are the limits defined for the test Particles at break on 100 ampoulesThe ampoules are broken, the particles are collected in a recipient and thenweighedThis test is only performed in case of doubt after the usual hand breaking test or
in case of bad aspect of the ringThese values are not contractual
Chart 9
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Lower mean value
Reduced standard deviation
OPC system properties support your move from
Color break to OPC providing:
Product safetyfor the end user
Chart 10
Better hand break quality
No enamel particle when opening
Less glass particles when opening
Product quality
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