vials made of coc polymer - adelphi · • tested in accordance with ep, jp and usp class vi (dmf...
TRANSCRIPT
Special SolutionsSCHOTT Type I plus® – SCHOTT TopLyo™ – SCHOTT TopPac®
Vials made of COC polymerAn excellent alternative to glass
SCHOTT TopPac® vials offer the highest purity and transparency comparable
to glass. Due to excellent barrier properties, high chemical resistance and
breakage resistance, COC vials are an excellent alternative to glass especially
for emergency drugs, vaccines, diagnostic products and contrast media.
They have a superior moisture barrier compared to HDPE or PP and can be
sterilized. COC could also be used for containers in drug delivery systems
such as needle-free injectors or inhalers.
The outstanding property profile of COC – compared to other plastics or
glass – offers innovative new packaging options.
TOPAS®¹ is an advanced cyclic olefin copolymer (COC). The production of
TOPAS® granulate is a strictly controlled process based on metallocene
technology. It provides a 100% uniform material with excellent chemical
and physical properties, suitable for the long-term storage of parenterals.
• Transparentwithaglass-likeappearance
• Break-resistantandlight-weight
• Excellentbarrierproperties
• Noionorheavymetalrelease
• Non-pyrogenic
• Lowerparticlelevelthanglass
• Differentsterilizationmethodspossible,e.g.gammairradiation
• TestedinaccordancewithEP,JPandUSPclassVI(DMF12132)
COC – a high-tech polymer
Long shelf life of COC vials due to low water vapor permeability
• SCHOTTTopPac® vials are available from
2ml,6ml,10ml,20ml,50ml,to100ml.
• CompliancewithEP,USPandJP
Product Portfolio:
COC Properties Unit Test TOPAS® TOPAS® TOPAS®
Method 8007 6013 6015
Heat deflection °C ISO 75 75 130 150temperature HDT/B part 1 and 2at 0.45 MPa
Water vapor permeability g x mm DIN 53122 0.023 0.035 0.035(23°C; 85% r.h.) m² x d
Water absorption % ISO 62 <0.01 <0.01 <0.01(water immerson at 23°C)
Density g/cm³ ISO 1183 1.02 1.02 1.02Tensile strength N/mm² ISO 527 66 66 66 part 1 and 2
Impact strength (Charpy) kJ/m² ISO 179/1eU 20 15 15
Light transmission % ASTM D 1003 92 92 92
Pharmaceutical Systems SCHOTT forma vitrum agSt.Josefen-Strasse20CH-9001 St. GallenSwitzerlandPhone: +41712741600Fax: [email protected]/pharmaceutical_systems
Water vapor permeability: comparison of different polymers measured at 40°C/90 % rh.
0,0 0,5 1,0 1,5 2,0 2,5 3,0 3,5 4,0
TOPAS® 0,1
PP 0.5
PVC 1.2
PC 4.0
g x mm
m² x d
¹TOPAS® is a registered trademark of TOPAS Advanced Polymers GmbH.
10.0
9/p
rinte
d in
Sw
itzer
land
Folder_TopLyo.indd 1-3 22.09.09 18:37
SCHOTT Type I plus® is particularly suitable for products where conventional
packaging of pharmaceutical Type I glass has reached its limits, such as:
• Lowconcentratedproteinswithdenaturationtendencies
• Productsthataresensitivetoalkalinity
(Na+releaseisdecreasedbyafactorof350)
• Formulationsthatreactwithleachables(e.g.Al3+, Ca2+,Fe3+,Fe2+,Ba2+)
• PreparationsthatcannottolerateashiftofpHvalue(e.g.waterforinjection)
• Radioactivediagnosticsthatadsorbtotheglasssurface
SCHOTT Type I plus® vials are characterized by the purity and inertness of
a quartz-like inner surface (100% SiO2coating),athicknessof100–200nm
andpharmaceuticalpropertiesaccordingtoEP,USPandJP.Thesevialswith
excellent barrier properties can be washed, autoclaved, sterilized, depyro-
genated, filled, closed and inspected just like standard containers.
SCHOTT TopLyo™ vials improve the freeze drying process and consequently
the results. The ultra-thin hydrophobic layer (40-100 nm and transparent)
along with the optimized geometry of the vials prevent the collapse of the
lyophilization cake and almost completely reduce the residual volume.
The geometric design is dimensioned for an enhanced thermal transfer
and a dramatic reduction of glass breakage.
Containers for demanding formulationsInvisible but noticeable inner layer
The performance bonus for modern pharmaceuticals
The development of increasingly more sensitive pharmaceutical products,
lower concentrations of active components and short development times
are making new demands on pharmaceutical packaging.
With its vast experience in coating technologies, SCHOTT presents two
products designed for current applications:
SCHOTT Type I plus® is the vial which drastically reduces interactions bet-
ween your drug and the container surface. As a result, loss of pharmaceutical
ingredient activity due to leachables from the glass is significantly decreased.
The benefit is packaging that offers security and stability for your product.
SCHOTT TopLyo™ has distinct properties that make freeze drying more
efficient. Due to the combination of the hydrophic inner layer and the
optimized geometry, the optical quality of the lyophilization-cakes stays
intact which ensures the functionality of the drug. Also, the risk of glass
breakage during freeze drying is minimized. The advantage is easy to see:
a more effective process combined with lower risks equals cost reductions.
Coating designed to support your products
Technology proven a million times overSCHOTT PI-Coating® – assurance through single station coating
SiO
2Si
O2
pureoxygen
water
CH3
SiO
O2
O2
O2
e-
e-
SiO
SiO
2. Activation of the inner surface by pure oxygen
1. Washing process
5. Formation of
the layer
3. Introduction of the SiO2
coating gas
4. Start of the plasma
reaction
SiO2 SiO2
20
40
60
80
100
0 h 3 h 24 h 336 h 672 h
Significant advantages to the pharmaceutical and biotech industriesSafety all around
All coated vials are designed to answer the
increasing requirements for safety and stability
of drugs (e.g. no loss of activity due to adsorp-
tion).TheSCHOTTFiolax® Type I glass used
is in accordance with all pharmacopoeias.
A covalent bond is formed between the glass
matrix and the layers of SCHOTT Type l plus®
and SCHOTT TopLyo™ to guarantee the
inertness and purity of the inner surface. The
chemically uniform coating is stable for phar-
maceutical procedures and the production
of these vials is 100% system- and process-
compatible.Therefore,aDMFreferenceis
available. We are sure that you will find the
packaging solutions described in this brochure
to be well suited for your sophisticated prepa-
rations and new drug developments.
Microwave
Layer
Layer
• Schott Type I plus® • Standard vials
Prot
ein
conc
entr
atio
n [%
]
Microwave
PICVD (Plasma Impulse Chemical Vapour Deposition) coating technology was developed by SCHOTT
Loss of active component due to adsorption on the example of a nicotinic acetylcholine receptor in SCHOTT Type I plus® and standard vials.Source: Dr. André Schrattenholz, Johannes Gutenberg-University, Mainz, Medical School, Institute of Physiological Chemistry and Pathobiochemistry.
The coating technology PICVD (Plasma Impulse Chemical Vapor Deposition) was developed by SCHOTT. It is a validated
process that is proven a million times over. A three-stage inspection (100% on-site inspection of each reactor, an inspection
of the process parameters and monitoring the system) enables 100% pharmaceutical quality.
Folder_TopLyo.indd 4-6 22.09.09 18:38
SCHOTT Type I plus® is particularly suitable for products where conventional
packaging of pharmaceutical Type I glass has reached its limits, such as:
• Lowconcentratedproteinswithdenaturationtendencies
• Productsthataresensitivetoalkalinity
(Na+releaseisdecreasedbyafactorof350)
• Formulationsthatreactwithleachables(e.g.Al3+, Ca2+,Fe3+,Fe2+,Ba2+)
• PreparationsthatcannottolerateashiftofpHvalue(e.g.waterforinjection)
• Radioactivediagnosticsthatadsorbtotheglasssurface
SCHOTT Type I plus® vials are characterized by the purity and inertness of
a quartz-like inner surface (100% SiO2coating),athicknessof100–200nm
andpharmaceuticalpropertiesaccordingtoEP,USPandJP.Thesevialswith
excellent barrier properties can be washed, autoclaved, sterilized, depyro-
genated, filled, closed and inspected just like standard containers.
SCHOTT TopLyo™ vials improve the freeze drying process and consequently
the results. The ultra-thin hydrophobic layer (40-100 nm and transparent)
along with the optimized geometry of the vials prevent the collapse of the
lyophilization cake and almost completely reduce the residual volume.
The geometric design is dimensioned for an enhanced thermal transfer
and a dramatic reduction of glass breakage.
Containers for demanding formulationsInvisible but noticeable inner layer
The performance bonus for modern pharmaceuticals
The development of increasingly more sensitive pharmaceutical products,
lower concentrations of active components and short development times
are making new demands on pharmaceutical packaging.
With its vast experience in coating technologies, SCHOTT presents two
products designed for current applications:
SCHOTT Type I plus® is the vial which drastically reduces interactions bet-
ween your drug and the container surface. As a result, loss of pharmaceutical
ingredient activity due to leachables from the glass is significantly decreased.
The benefit is packaging that offers security and stability for your product.
SCHOTT TopLyo™ has distinct properties that make freeze drying more
efficient. Due to the combination of the hydrophic inner layer and the
optimized geometry, the optical quality of the lyophilization-cakes stays
intact which ensures the functionality of the drug. Also, the risk of glass
breakage during freeze drying is minimized. The advantage is easy to see:
a more effective process combined with lower risks equals cost reductions.
Coating designed to support your products
Technology proven a million times overSCHOTT PI-Coating® – assurance through single station coating
SiO
2Si
O2
pureoxygen
water
CH3
SiO
O2
O2
O2
e-
e-
SiO
SiO
2. Activation of the inner surface by pure oxygen
1. Washing process
5. Formation of
the layer
3. Introduction of the SiO2
coating gas
4. Start of the plasma
reaction
SiO2 SiO2
20
40
60
80
100
0 h 3 h 24 h 336 h 672 h
Significant advantages to the pharmaceutical and biotech industriesSafety all around
All coated vials are designed to answer the
increasing requirements for safety and stability
of drugs (e.g. no loss of activity due to adsorp-
tion).TheSCHOTTFiolax® Type I glass used
is in accordance with all pharmacopoeias.
A covalent bond is formed between the glass
matrix and the layers of SCHOTT Type l plus®
and SCHOTT TopLyo™ to guarantee the
inertness and purity of the inner surface. The
chemically uniform coating is stable for phar-
maceutical procedures and the production
of these vials is 100% system- and process-
compatible.Therefore,aDMFreferenceis
available. We are sure that you will find the
packaging solutions described in this brochure
to be well suited for your sophisticated prepa-
rations and new drug developments.
Microwave
Layer
Layer
• Schott Type I plus® • Standard vials
Prot
ein
conc
entr
atio
n [%
]
Microwave
PICVD (Plasma Impulse Chemical Vapour Deposition) coating technology was developed by SCHOTT
Loss of active component due to adsorption on the example of a nicotinic acetylcholine receptor in SCHOTT Type I plus® and standard vials.Source: Dr. André Schrattenholz, Johannes Gutenberg-University, Mainz, Medical School, Institute of Physiological Chemistry and Pathobiochemistry.
The coating technology PICVD (Plasma Impulse Chemical Vapor Deposition) was developed by SCHOTT. It is a validated
process that is proven a million times over. A three-stage inspection (100% on-site inspection of each reactor, an inspection
of the process parameters and monitoring the system) enables 100% pharmaceutical quality.
Folder_TopLyo.indd 4-6 22.09.09 18:38
SCHOTT Type I plus® is particularly suitable for products where conventional
packaging of pharmaceutical Type I glass has reached its limits, such as:
• Lowconcentratedproteinswithdenaturationtendencies
• Productsthataresensitivetoalkalinity
(Na+releaseisdecreasedbyafactorof350)
• Formulationsthatreactwithleachables(e.g.Al3+, Ca2+,Fe3+,Fe2+,Ba2+)
• PreparationsthatcannottolerateashiftofpHvalue(e.g.waterforinjection)
• Radioactivediagnosticsthatadsorbtotheglasssurface
SCHOTT Type I plus® vials are characterized by the purity and inertness of
a quartz-like inner surface (100% SiO2coating),athicknessof100–200nm
andpharmaceuticalpropertiesaccordingtoEP,USPandJP.Thesevialswith
excellent barrier properties can be washed, autoclaved, sterilized, depyro-
genated, filled, closed and inspected just like standard containers.
SCHOTT TopLyo™ vials improve the freeze drying process and consequently
the results. The ultra-thin hydrophobic layer (40-100 nm and transparent)
along with the optimized geometry of the vials prevent the collapse of the
lyophilization cake and almost completely reduce the residual volume.
The geometric design is dimensioned for an enhanced thermal transfer
and a dramatic reduction of glass breakage.
Containers for demanding formulationsInvisible but noticeable inner layer
The performance bonus for modern pharmaceuticals
The development of increasingly more sensitive pharmaceutical products,
lower concentrations of active components and short development times
are making new demands on pharmaceutical packaging.
With its vast experience in coating technologies, SCHOTT presents two
products designed for current applications:
SCHOTT Type I plus® is the vial which drastically reduces interactions bet-
ween your drug and the container surface. As a result, loss of pharmaceutical
ingredient activity due to leachables from the glass is significantly decreased.
The benefit is packaging that offers security and stability for your product.
SCHOTT TopLyo™ has distinct properties that make freeze drying more
efficient. Due to the combination of the hydrophic inner layer and the
optimized geometry, the optical quality of the lyophilization-cakes stays
intact which ensures the functionality of the drug. Also, the risk of glass
breakage during freeze drying is minimized. The advantage is easy to see:
a more effective process combined with lower risks equals cost reductions.
Coating designed to support your products
Technology proven a million times overSCHOTT PI-Coating® – assurance through single station coating
SiO
2Si
O2
pureoxygen
water
CH3
SiO
O2
O2
O2
e-
e-
SiO
SiO
2. Activation of the inner surface by pure oxygen
1. Washing process
5. Formation of
the layer
3. Introduction of the SiO2
coating gas
4. Start of the plasma
reaction
SiO2 SiO2
20
40
60
80
100
0 h 3 h 24 h 336 h 672 h
Significant advantages to the pharmaceutical and biotech industriesSafety all around
All coated vials are designed to answer the
increasing requirements for safety and stability
of drugs (e.g. no loss of activity due to adsorp-
tion).TheSCHOTTFiolax® Type I glass used
is in accordance with all pharmacopoeias.
A covalent bond is formed between the glass
matrix and the layers of SCHOTT Type l plus®
and SCHOTT TopLyo™ to guarantee the
inertness and purity of the inner surface. The
chemically uniform coating is stable for phar-
maceutical procedures and the production
of these vials is 100% system- and process-
compatible.Therefore,aDMFreferenceis
available. We are sure that you will find the
packaging solutions described in this brochure
to be well suited for your sophisticated prepa-
rations and new drug developments.
Microwave
Layer
Layer
• Schott Type I plus® • Standard vials
Prot
ein
conc
entr
atio
n [%
]
Microwave
PICVD (Plasma Impulse Chemical Vapour Deposition) coating technology was developed by SCHOTT
Loss of active component due to adsorption on the example of a nicotinic acetylcholine receptor in SCHOTT Type I plus® and standard vials.Source: Dr. André Schrattenholz, Johannes Gutenberg-University, Mainz, Medical School, Institute of Physiological Chemistry and Pathobiochemistry.
The coating technology PICVD (Plasma Impulse Chemical Vapor Deposition) was developed by SCHOTT. It is a validated
process that is proven a million times over. A three-stage inspection (100% on-site inspection of each reactor, an inspection
of the process parameters and monitoring the system) enables 100% pharmaceutical quality.
Folder_TopLyo.indd 4-6 22.09.09 18:38
Special SolutionsSCHOTT Type I plus® – SCHOTT TopLyo™ – SCHOTT TopPac®
Vials made of COC polymerAn excellent alternative to glass
SCHOTT TopPac® vials offer the highest purity and transparency comparable
to glass. Due to excellent barrier properties, high chemical resistance and
breakage resistance, COC vials are an excellent alternative to glass especially
for emergency drugs, vaccines, diagnostic products and contrast media.
They have a superior moisture barrier compared to HDPE or PP and can be
sterilized. COC could also be used for containers in drug delivery systems
such as needle-free injectors or inhalers.
The outstanding property profile of COC – compared to other plastics or
glass – offers innovative new packaging options.
TOPAS®¹ is an advanced cyclic olefin copolymer (COC). The production of
TOPAS® granulate is a strictly controlled process based on metallocene
technology. It provides a 100% uniform material with excellent chemical
and physical properties, suitable for the long-term storage of parenterals.
• Transparentwithaglass-likeappearance
• Break-resistantandlight-weight
• Excellentbarrierproperties
• Noionorheavymetalrelease
• Non-pyrogenic
• Lowerparticlelevelthanglass
• Differentsterilizationmethodspossible,e.g.gammairradiation
• TestedinaccordancewithEP,JPandUSPclassVI(DMF12132)
COC – a high-tech polymer
Long shelf life of COC vials due to low water vapor permeability
• SCHOTTTopPac® vials are available from
2ml,6ml,10ml,20ml,50ml,to100ml.
• CompliancewithEP,USPandJP
Product Portfolio:
COC Properties Unit Test TOPAS® TOPAS® TOPAS®
Method 8007 6013 6015
Heat deflection °C ISO 75 75 130 150temperature HDT/B part 1 and 2at 0.45 MPa
Water vapor permeability g x mm DIN 53122 0.023 0.035 0.035(23°C; 85% r.h.) m² x d
Water absorption % ISO 62 <0.01 <0.01 <0.01(water immerson at 23°C)
Density g/cm³ ISO 1183 1.02 1.02 1.02Tensile strength N/mm² ISO 527 66 66 66 part 1 and 2
Impact strength (Charpy) kJ/m² ISO 179/1eU 20 15 15
Light transmission % ASTM D 1003 92 92 92
Pharmaceutical Systems SCHOTT forma vitrum agSt.Josefen-Strasse20CH-9001 St. GallenSwitzerlandPhone: +41712741600Fax: [email protected]/pharmaceutical_systems
Water vapor permeability: comparison of different polymers measured at 40°C/90 % rh.
0,0 0,5 1,0 1,5 2,0 2,5 3,0 3,5 4,0
TOPAS® 0,1
PP 0.5
PVC 1.2
PC 4.0
g x mm
m² x d
¹TOPAS® is a registered trademark of TOPAS Advanced Polymers GmbH.
10.0
9/p
rinte
d in
Sw
itzer
land
Folder_TopLyo.indd 1-3 22.09.09 18:37
Special SolutionsSCHOTT Type I plus® – SCHOTT TopLyo™ – SCHOTT TopPac®
Vials made of COC polymerAn excellent alternative to glass
SCHOTT TopPac® vials offer the highest purity and transparency comparable
to glass. Due to excellent barrier properties, high chemical resistance and
breakage resistance, COC vials are an excellent alternative to glass especially
for emergency drugs, vaccines, diagnostic products and contrast media.
They have a superior moisture barrier compared to HDPE or PP and can be
sterilized. COC could also be used for containers in drug delivery systems
such as needle-free injectors or inhalers.
The outstanding property profile of COC – compared to other plastics or
glass – offers innovative new packaging options.
TOPAS®¹ is an advanced cyclic olefin copolymer (COC). The production of
TOPAS® granulate is a strictly controlled process based on metallocene
technology. It provides a 100% uniform material with excellent chemical
and physical properties, suitable for the long-term storage of parenterals.
• Transparentwithaglass-likeappearance
• Break-resistantandlight-weight
• Excellentbarrierproperties
• Noionorheavymetalrelease
• Non-pyrogenic
• Lowerparticlelevelthanglass
• Differentsterilizationmethodspossible,e.g.gammairradiation
• TestedinaccordancewithEP,JPandUSPclassVI(DMF12132)
COC – a high-tech polymer
Long shelf life of COC vials due to low water vapor permeability
• SCHOTTTopPac® vials are available from
2ml,6ml,10ml,20ml,50ml,to100ml.
• CompliancewithEP,USPandJP
Product Portfolio:
COC Properties Unit Test TOPAS® TOPAS® TOPAS®
Method 8007 6013 6015
Heat deflection °C ISO 75 75 130 150temperature HDT/B part 1 and 2at 0.45 MPa
Water vapor permeability g x mm DIN 53122 0.023 0.035 0.035(23°C; 85% r.h.) m² x d
Water absorption % ISO 62 <0.01 <0.01 <0.01(water immerson at 23°C)
Density g/cm³ ISO 1183 1.02 1.02 1.02Tensile strength N/mm² ISO 527 66 66 66 part 1 and 2
Impact strength (Charpy) kJ/m² ISO 179/1eU 20 15 15
Light transmission % ASTM D 1003 92 92 92
Pharmaceutical Systems SCHOTT forma vitrum agSt.Josefen-Strasse20CH-9001 St. GallenSwitzerlandPhone: +41712741600Fax: [email protected]/pharmaceutical_systems
Water vapor permeability: comparison of different polymers measured at 40°C/90 % rh.
0,0 0,5 1,0 1,5 2,0 2,5 3,0 3,5 4,0
TOPAS® 0,1
PP 0.5
PVC 1.2
PC 4.0
g x mm
m² x d
¹TOPAS® is a registered trademark of TOPAS Advanced Polymers GmbH.
10.0
9/p
rinte
d in
Sw
itzer
land
Folder_TopLyo.indd 1-3 22.09.09 18:37