JP2013094683A5

JP2013094683A5 -

Info

Publication number: JP2013094683A5
Application number: JP2011236542A
Authority: JP
Filing date: 2011-10-27
Publication date: 2014-02-27
Anticipated expiration: 2031-10-27

Description

例えば注射液の製造において、図５に示すようなバッチ方式の注射液製造システムが知られている。注射液製造システム９０は、調合タンク９１と、ポンプ９３ａ、９３ｂと、冷却器９４と、フィルター９５と、貯液タンク９６とを備える。注射液製造システム９０では、調合タンク９１は内部に撹拌機９２を有しており、まず、注射用水Ｗ９と注射液の原料Ｒ９とを調合タンク９１内にそれぞれ所定量入れ、撹拌機９２で注射液Ｍ９を調合する。その後その注射液Ｍ９をポンプ９３ａで冷却器９４及びフィルター９５を通過させて貯液タンク９６に送液する。その後貯液タンク９６内の注射液Ｓ９をポンプ９３ｂで充填機や所定の場所に送液する。このように、この注射液製造システム９０は、各工程（調合、濾過滅菌、輸送、充填等）毎に処理を完結させるため、品質の管理、洗浄、及び滅菌作業が比較的容易に実施できる利点がある。 For example, in the production of an injection solution, a batch-type injection solution production system as shown in FIG. 5 is known. The injection solution manufacturing system 90 includes a preparation tank 91, pumps 93 a and 93 b , a cooler 94, a filter 95, and a liquid storage tank 96. In the injection solution manufacturing system 90, the preparation tank 91 has a stirrer 92 therein. First, a predetermined amount of water for injection W9 and a raw material R9 for injection solution are respectively put into the preparation tank 91 and injected by the stirrer 92. Prepare liquid M9. Thereafter, the injection solution M9 is passed through the cooler 94 and the filter 95 by the pump 93a and sent to the liquid storage tank 96. Thereafter, the injection solution S9 in the liquid storage tank 96 is sent to the filling machine or a predetermined place by the pump 93b. Thus, since this injection solution manufacturing system 90 completes the process for each process (preparation, filtration sterilization, transportation, filling, etc.), the advantage that quality control, cleaning , and sterilization operations can be performed relatively easily. There is.

本発明に係る混合システムは、原料と希釈液とを調合して濃縮液を貯液する調合タンクと、第１の流量調整弁を有する第１のラインと、第２の流量調整弁を有する第２のラインと、第３のラインと、混合機と、を備え、前記第１のラインを介して前記調合タンク内の濃縮液が前記混合機に流入するように接続され、前記第２のラインを介して希釈液が前記混合機に流入するように接続され、前記混合機は、第１及び第２のラインから流入した濃縮液及び希釈液を連続的に混合して前記第３のラインに送液することを特徴とする。 The mixing system according to the present invention is a first tank having a first tank having a first flow rate adjusting valve, a second tank having a first flow rate adjusting valve, a mixing tank for mixing a raw material and a diluent and storing the concentrated liquid. and second line, the third line, and mixer, comprising a concentrate of the preparation tank through the first line is connected to flow into the mixer, the second line The diluting liquid is connected to the mixer through the mixer , and the mixer continuously mixes the concentrated liquid and the diluting liquid flowing in from the first and second lines to the third line. It is characterized by feeding.

混合システム３０では、原薬Ｒ２は調合タンク１１に輸送される。注射用水Ｗ２は、冷却器１４を介して混合機１７へ送液されるとともに、調合タンク１１にも送液される。調合タンク１１では、撹拌機１２で原薬Ｒ２と注射用水Ｗ２とを攪拌して高濃度薬液Ｃ２を調合する。そして、注射用水Ｗ２及び高濃度薬液Ｃ２をそれぞれ混合機１７に送液する。このとき、注射用水Ｗ２及び高濃度薬液Ｃ２の流量（流量計２１ａ、２１ｂ）がそれぞれ所定の流量値となるようにするとともに、注射用水Ｗ２及び高濃度薬液Ｃ２の圧力（圧力計２２ａ、２２ｂ）が等しくなるようにする。レギュレーター２３ａ、２３ｂは、各流量計２１ａ、２１ｂの数値を基にして予め設定された流量となるように流量調整弁１８ａ、１８ｂをそれぞれ調整する。混合機１７では、注射用水Ｗ２と高濃度薬液Ｃ２とが所定の割合で混合され、混合された混合液Ｍ２は、フィルター１５で濾過滅菌され、注射剤Ｓ２として貯液タンク１６に貯液される。その後注射剤Ｓ２は、図示しない充填機や輸送装置等の所定の場所に送液される。 In the mixing system 30, the drug substance R <b> 2 is transported to the preparation tank 11. The water for injection W <b> 2 is sent to the mixer 17 through the cooler 14 and is also sent to the preparation tank 11. In the preparation tank 11, the high-concentration drug solution C2 is prepared by stirring the drug substance R2 and the water for injection W2 with the agitator 12. Then, the water for injection W2 and the high-concentration drug solution C2 are fed to the mixer 17, respectively. At this time, the flow rates of the water for injection W2 and the high-concentration chemical solution C2 (flow meters 21a and 21b) are set to predetermined flow rates, respectively, and the pressures of the water for injection W2 and the high-concentration chemical solution C2 (pressure gauges 22a and 22b). To be equal. The regulators 23a and 23b respectively adjust the flow rate adjusting valves 18a and 18b so that the flow rates are set in advance based on the numerical values of the flow meters 21a and 21b. In mixer 17, and water for injection W2 and the high-concentration chemical solution C2 are mixed at a predetermined ratio, mixed mixture M 2 is filter sterilized with 15, is liquid storage in the liquid storage tank 16 as an injection S2 The Thereafter, the injection S2 is sent to a predetermined place such as a filling machine or a transport device (not shown).

Claims

A mixing system,
The mixing system includes:
A blending tank that blends the raw material and diluent and stores the concentrated liquid;
A first line having a first flow regulating valve;
A second line having a second flow regulating valve;
The third line;
And a mixer,
Concentrate of the preparation tank through the first line is connected to flow into the mixer,
A diluent is connected to flow into the mixer via the second line ;
The mixer, mixing system, characterized in that the concentrate and the diluent flowing from the first and second lines continuously mixed to feeding to the third line.

The mixing system according to claim 1 , wherein the mixing system includes a cooler in the second line.

The mixing system includes a pump in the first line.
The mixing system according to claim 1 or 2, characterized in that

The flow rate of the diluent in the second line is
75 to 90% of the total flow rate of the concentrated liquid of the first line and the diluted liquid of the second line sent to the mixer
The mixing system according to any one of claims 1 to 3, characterized in that:

Also further it comprising a pressure gauge any said first and second lines,
While making the flow rate of the concentrated solution and the diluted solution respectively a predetermined flow rate,
The mixing system according to any one of claims 1 to 4, wherein pressures of the concentrated liquid and the diluted liquid are made equal.

The mixing system according to any one of claims 1 to 5 , comprising a plurality of the first lines.

A fourth line having a meter for weighing powder ;
The fourth line, the powder mixing system according to any one of claims 1 to 6, characterized in that transport to the mixer to adjust the thus amount to the meter .