发明名称 |
PROCESS FOR THE MANUFACTURE OF PREFILLED SYRINGES |
摘要 |
This invention relates to a process for manufacturing prefilled syringes where at least one of the syringe components is manufactured in at least a class 100 environment. The process includes the steps of manufacturing syringe components, such as the barrel and plunger substrate, within at least a class 100 and MCB-3 environment; manufacturing syringe components, such as the plunger cover and tip seal in an environment less clean than a class 100 environment; decontaminating the plunger cover and tip seal; lubricating at least one of the barrel, plunger substrate, plunger cover and tip seal; assembling the barrel and tip seal to form a barrel/tip seal combination; assembling the plunger cover and plunger substrate to form a plunger; filling the barrel/tip seal combination with a predetermined amount of fluid; and final assembling of the prefilled syringe by inserting the plunger into the barrel/tip seal combination. When the syringe components are manufactured at different locations, each component is tripled-bagged to maintain the component substantially free from contaminants, and transported to an assembly site where the components are unpackaged and assembled into the barrel/tip seal combination and plunger. When filling and final assembly of the barrel/tip seal combination takes place at a location separate from its assembly site, the barrel/tip seal combination is tripled-bagged to maintain it substantially free from contaminants, and transported to a filling and final assembling site for filling and final assembling into a prefilled syringe. |
申请公布号 |
EP0846072(A1) |
申请公布日期 |
1998.06.10 |
申请号 |
EP19960929717 |
申请日期 |
1996.08.20 |
申请人 |
MEDRAD, INC. |
发明人 |
REILLY, DAVID, M.;RHINEHART, EDWARD, J.;GELBLUM, EUGENE, A.;HITCHINS, MARK;ROBINSON, MICHELLE |
分类号 |
B65B3/00;(IPC1-7):B65B55/02 |
主分类号 |
B65B3/00 |
代理机构 |
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代理人 |
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主权项 |
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地址 |
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