最新型压片技术的应用
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新型压片机的开发目的之一:
1. 荷尔蒙、抗癌药等有毒产片。 2. 提高效率:减少批次更换的时间-同品种更换、不同品种更换,
20%
GEA Pharma Systems
Courtoy – Product & Service Range
GEA Pharma Systems
密封连接点
GEA Pharma Systems
新型压片机的开发目的之三 更多的压片控制参数:预压力、预压有效时间—压片发热、难压品 种
GEA Pharma Systems
Courtoy – Product & Service Range
新型压片机的开发目的之四:
1. 微丸压片:溶出 物料分层、破丸率
-主压力-传统/GEA;
2. 口含片:崩解时间控制;
deformation properties选择塑形/弹性好的包衣材
-Using suitable excipients with good cushioning
properties that mix homogenously with the pellets
(compaction forces have to be absorbed mainly by the excipients so that the single units remain virtually intact) 使 用 耐压效果好的辅料同时混合均匀(丸粒不会受损)
GEA Pharma Systems
Dual Control: weight & hardness control 1. 预压控制片重:线性
控制(70s,核材料)
2. 10分钟之内解决 3. 兼顾放大
GEA Pharma Systems
Dual Control: weight & hardness control
equipment
• Internal system validation and acceptance testing
with customers
• On-site services: installation, IQ/OQ, training,
process validation and production start-up assistance
-Using an optimal pellet/excipient ratio优化配方比率
(pellet-pellet contact has to be avoided, at least 30% to 50% of excipient is required to fill the inter -pellet space为避免微丸 直接接触,建议至少30%至50%的辅料)
Introduction:
GEA-Courtoy nv-3rd Generation Tablet Press
GEA Pharma Systems
Tablet Press Review
第一代压片机-20s ;
第二代压片机-30s ~90s ;
90s出现不同方向:简化,专用;
第三代压片机:代表人物之一Courtoy;
15
GEA Pharma Systems
Courtoy – Product & Service Range
物料分层:粒径差、密度差;物料传输
GEA Pharma Systems
Courtoy – Product & Service Range
物料分层:粒径差、密度差;物料传输
GEA Pharma Systems
MODUL™ P
MODUL™ S
MODUL™ D
GEA Pharma Systems
The MODUL™ series
• For development & clinical
trials production
• Full instrumentation • 6 different compression
-荷尔蒙、抗癌药等有毒产片 品种快速更换
-简化压片控制-预压/片重、主压/硬度
-更多的压片控制参数:压片发热、难压品种
-缓控释:微丸压片
口含片
GEA Pharma Systems
Courtoy – Product & Service Range
Pharmaceutical Rotary Tablet Presses 三个系列压片机
There are five general mechanisms of segregation:分层原因
• percolation segregation 下移分层 • elutriation segregation 上移分层 • projection segregation 抛洒分层 • feed or heap segregation 装料分层 • shear segregation 移动分层
第二代 压片机
第三代 压片机
R series
Exchangeable Turret
MODUL™ series
PERFORMA™ series
Exchangeable Compression Module GEEAxPchhaarnmgaeaSbylseteDmei s
Courtoy – Product & Service Range
Courtoy – Product & Service Range
物料分层:粒径差、密度差;物料传输
G A Pharma Systems
Courtoy – Product & Service Range
物料分层:粒径差、密度差;物料传输
GEA Pharma Systems
The MODUL™ series
• Spare part management. • Multilingual telephone, e-mail and
on-site support.
• In-house machine evaluation trials
and process development.
• Factory acceptance testing and ini tial
and repair work.
GEA Pharma Systems
Courtoy – Operations
R&D, Project Engineering, Manufacturing & Support
The day-to-day running of our business involves:
BB 31 223.000
BBS 35 320.000
GEA Pharma Systems
The MODUL™ series
D
S
31 186.000
B 38 274.000
BB 46 331.000
BBS 52 374.000
GEA Pharma Systems
The MODUL™ series
• After-sales services: repair, PM, troubleshooting,
process optimization
GEA Pharma Systems
in-house training.
• Full on-ຫໍສະໝຸດ Baiduite installation, start-up a nd
commissioning.
• Detailed training programmes for
operators and maintenance person nel.
• On-site preventative maintenance
modes
• PAT-enabling • Available since January
2007
• Batches of 1kg or more • Single Punch Production • Single Tablet Production
D
P
21 126.000
B 26 187.000
密封连接点
GEA Pharma Systems
剪断
GEA Pharma Systems
Courtoy – Product & Service Range
新型压片机的开发目的 之二:
1. 简化压片控制-预压控制
片重、主压控制硬度
W
x S
d
GEA Pharma Systems
Achieving equal force: the air compensator
GEA Pharma Systems
Courtoy – Product & Service Range
物料分层:粒径差、密度差;物料传输
The tendency of powder to segregate increases when there is a large difference in form, size and/or density of the particles 颗粒形状,尺寸和密 度差异导致分层.
• Development: mechanical, electrical, software and
documentation (all in-house)
• Project management & engineering of customized
solutions
• Purchasing, subcontracting and in-house machining • Machine assembling and integration of peripheral
D
D
53 540.000
B 67 722.000
BB 81 875.000
BBS 89 1.069.000
GEA Pharma Systems
Courtoy – Product & Service Range
Spares and Service
Our dedicated, highly skilled Courtoy Customer Care team offers:
GEA Pharma Systems
Courtoy – Product & Service Range
Damage to the pellet coating can be minimized by optimizing the formulation通过优化配方减少包衣层损 伤
-Selecting a pellet coating with optimal elastic/plastic
1. 荷尔蒙、抗癌药等有毒产片。 2. 提高效率:减少批次更换的时间-同品种更换、不同品种更换,
20%
GEA Pharma Systems
Courtoy – Product & Service Range
GEA Pharma Systems
密封连接点
GEA Pharma Systems
新型压片机的开发目的之三 更多的压片控制参数:预压力、预压有效时间—压片发热、难压品 种
GEA Pharma Systems
Courtoy – Product & Service Range
新型压片机的开发目的之四:
1. 微丸压片:溶出 物料分层、破丸率
-主压力-传统/GEA;
2. 口含片:崩解时间控制;
deformation properties选择塑形/弹性好的包衣材
-Using suitable excipients with good cushioning
properties that mix homogenously with the pellets
(compaction forces have to be absorbed mainly by the excipients so that the single units remain virtually intact) 使 用 耐压效果好的辅料同时混合均匀(丸粒不会受损)
GEA Pharma Systems
Dual Control: weight & hardness control 1. 预压控制片重:线性
控制(70s,核材料)
2. 10分钟之内解决 3. 兼顾放大
GEA Pharma Systems
Dual Control: weight & hardness control
equipment
• Internal system validation and acceptance testing
with customers
• On-site services: installation, IQ/OQ, training,
process validation and production start-up assistance
-Using an optimal pellet/excipient ratio优化配方比率
(pellet-pellet contact has to be avoided, at least 30% to 50% of excipient is required to fill the inter -pellet space为避免微丸 直接接触,建议至少30%至50%的辅料)
Introduction:
GEA-Courtoy nv-3rd Generation Tablet Press
GEA Pharma Systems
Tablet Press Review
第一代压片机-20s ;
第二代压片机-30s ~90s ;
90s出现不同方向:简化,专用;
第三代压片机:代表人物之一Courtoy;
15
GEA Pharma Systems
Courtoy – Product & Service Range
物料分层:粒径差、密度差;物料传输
GEA Pharma Systems
Courtoy – Product & Service Range
物料分层:粒径差、密度差;物料传输
GEA Pharma Systems
MODUL™ P
MODUL™ S
MODUL™ D
GEA Pharma Systems
The MODUL™ series
• For development & clinical
trials production
• Full instrumentation • 6 different compression
-荷尔蒙、抗癌药等有毒产片 品种快速更换
-简化压片控制-预压/片重、主压/硬度
-更多的压片控制参数:压片发热、难压品种
-缓控释:微丸压片
口含片
GEA Pharma Systems
Courtoy – Product & Service Range
Pharmaceutical Rotary Tablet Presses 三个系列压片机
There are five general mechanisms of segregation:分层原因
• percolation segregation 下移分层 • elutriation segregation 上移分层 • projection segregation 抛洒分层 • feed or heap segregation 装料分层 • shear segregation 移动分层
第二代 压片机
第三代 压片机
R series
Exchangeable Turret
MODUL™ series
PERFORMA™ series
Exchangeable Compression Module GEEAxPchhaarnmgaeaSbylseteDmei s
Courtoy – Product & Service Range
Courtoy – Product & Service Range
物料分层:粒径差、密度差;物料传输
G A Pharma Systems
Courtoy – Product & Service Range
物料分层:粒径差、密度差;物料传输
GEA Pharma Systems
The MODUL™ series
• Spare part management. • Multilingual telephone, e-mail and
on-site support.
• In-house machine evaluation trials
and process development.
• Factory acceptance testing and ini tial
and repair work.
GEA Pharma Systems
Courtoy – Operations
R&D, Project Engineering, Manufacturing & Support
The day-to-day running of our business involves:
BB 31 223.000
BBS 35 320.000
GEA Pharma Systems
The MODUL™ series
D
S
31 186.000
B 38 274.000
BB 46 331.000
BBS 52 374.000
GEA Pharma Systems
The MODUL™ series
• After-sales services: repair, PM, troubleshooting,
process optimization
GEA Pharma Systems
in-house training.
• Full on-ຫໍສະໝຸດ Baiduite installation, start-up a nd
commissioning.
• Detailed training programmes for
operators and maintenance person nel.
• On-site preventative maintenance
modes
• PAT-enabling • Available since January
2007
• Batches of 1kg or more • Single Punch Production • Single Tablet Production
D
P
21 126.000
B 26 187.000
密封连接点
GEA Pharma Systems
剪断
GEA Pharma Systems
Courtoy – Product & Service Range
新型压片机的开发目的 之二:
1. 简化压片控制-预压控制
片重、主压控制硬度
W
x S
d
GEA Pharma Systems
Achieving equal force: the air compensator
GEA Pharma Systems
Courtoy – Product & Service Range
物料分层:粒径差、密度差;物料传输
The tendency of powder to segregate increases when there is a large difference in form, size and/or density of the particles 颗粒形状,尺寸和密 度差异导致分层.
• Development: mechanical, electrical, software and
documentation (all in-house)
• Project management & engineering of customized
solutions
• Purchasing, subcontracting and in-house machining • Machine assembling and integration of peripheral
D
D
53 540.000
B 67 722.000
BB 81 875.000
BBS 89 1.069.000
GEA Pharma Systems
Courtoy – Product & Service Range
Spares and Service
Our dedicated, highly skilled Courtoy Customer Care team offers:
GEA Pharma Systems
Courtoy – Product & Service Range
Damage to the pellet coating can be minimized by optimizing the formulation通过优化配方减少包衣层损 伤
-Selecting a pellet coating with optimal elastic/plastic