JPH078296A - Method for controlling, confirming and testing bacterium, culture medium and container used therefor - Google Patents
Method for controlling, confirming and testing bacterium, culture medium and container used thereforInfo
- Publication number
- JPH078296A JPH078296A JP5154996A JP15499693A JPH078296A JP H078296 A JPH078296 A JP H078296A JP 5154996 A JP5154996 A JP 5154996A JP 15499693 A JP15499693 A JP 15499693A JP H078296 A JPH078296 A JP H078296A
- Authority
- JP
- Japan
- Prior art keywords
- container
- filling
- medium
- bacterial
- test
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
- 238000012360 testing method Methods 0.000 title claims abstract description 51
- 238000000034 method Methods 0.000 title claims abstract description 42
- 239000001963 growth medium Substances 0.000 title claims abstract description 11
- 241000894006 Bacteria Species 0.000 title claims description 20
- 238000011049 filling Methods 0.000 claims abstract description 62
- 230000001580 bacterial effect Effects 0.000 claims abstract description 61
- 230000008569 process Effects 0.000 claims abstract description 33
- 238000011109 contamination Methods 0.000 claims abstract description 30
- 230000008859 change Effects 0.000 claims abstract description 11
- 238000007789 sealing Methods 0.000 claims abstract description 11
- 239000002609 medium Substances 0.000 claims description 62
- 238000012790 confirmation Methods 0.000 claims description 26
- 238000010998 test method Methods 0.000 claims description 9
- 238000005070 sampling Methods 0.000 abstract description 9
- 230000000721 bacterilogical effect Effects 0.000 abstract 4
- 239000007788 liquid Substances 0.000 description 43
- 238000007689 inspection Methods 0.000 description 35
- 238000004519 manufacturing process Methods 0.000 description 25
- 230000036512 infertility Effects 0.000 description 21
- 238000012371 Aseptic Filling Methods 0.000 description 16
- 230000001954 sterilising effect Effects 0.000 description 10
- 239000000463 material Substances 0.000 description 9
- 230000008439 repair process Effects 0.000 description 8
- 238000004659 sterilization and disinfection Methods 0.000 description 8
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 7
- 229920001817 Agar Polymers 0.000 description 5
- MHAJPDPJQMAIIY-UHFFFAOYSA-N Hydrogen peroxide Chemical compound OO MHAJPDPJQMAIIY-UHFFFAOYSA-N 0.000 description 5
- 239000008272 agar Substances 0.000 description 5
- 230000000844 anti-bacterial effect Effects 0.000 description 5
- 238000002156 mixing Methods 0.000 description 5
- 239000000047 product Substances 0.000 description 5
- 239000002994 raw material Substances 0.000 description 5
- 238000009826 distribution Methods 0.000 description 4
- 235000013305 food Nutrition 0.000 description 4
- 239000003381 stabilizer Substances 0.000 description 4
- 241000588724 Escherichia coli Species 0.000 description 3
- 229920000161 Locust bean gum Polymers 0.000 description 3
- 239000001888 Peptone Substances 0.000 description 3
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 3
- 230000009471 action Effects 0.000 description 3
- 239000007640 basal medium Substances 0.000 description 3
- 239000006071 cream Substances 0.000 description 3
- 235000010420 locust bean gum Nutrition 0.000 description 3
- 239000000711 locust bean gum Substances 0.000 description 3
- 238000012423 maintenance Methods 0.000 description 3
- 239000000843 powder Substances 0.000 description 3
- 238000002360 preparation method Methods 0.000 description 3
- 239000007787 solid Substances 0.000 description 3
- 229920002907 Guar gum Polymers 0.000 description 2
- 108010080698 Peptones Proteins 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- 238000007796 conventional method Methods 0.000 description 2
- 238000001816 cooling Methods 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 239000000499 gel Substances 0.000 description 2
- 239000000665 guar gum Substances 0.000 description 2
- 235000010417 guar gum Nutrition 0.000 description 2
- 229960002154 guar gum Drugs 0.000 description 2
- 239000012263 liquid product Substances 0.000 description 2
- 239000000203 mixture Substances 0.000 description 2
- 235000019319 peptone Nutrition 0.000 description 2
- 238000004080 punching Methods 0.000 description 2
- 230000000007 visual effect Effects 0.000 description 2
- 238000005406 washing Methods 0.000 description 2
- 238000003466 welding Methods 0.000 description 2
- 241000196324 Embryophyta Species 0.000 description 1
- 108010010803 Gelatin Proteins 0.000 description 1
- 229920000569 Gum karaya Polymers 0.000 description 1
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 description 1
- 241000934878 Sterculia Species 0.000 description 1
- 229920001615 Tragacanth Polymers 0.000 description 1
- 239000012615 aggregate Substances 0.000 description 1
- 239000000305 astragalus gummifer gum Substances 0.000 description 1
- 239000003899 bactericide agent Substances 0.000 description 1
- 230000003385 bacteriostatic effect Effects 0.000 description 1
- 229940041514 candida albicans extract Drugs 0.000 description 1
- 238000005119 centrifugation Methods 0.000 description 1
- 238000012258 culturing Methods 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 239000000839 emulsion Substances 0.000 description 1
- 230000001747 exhibiting effect Effects 0.000 description 1
- 238000000605 extraction Methods 0.000 description 1
- 238000005429 filling process Methods 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 239000006260 foam Substances 0.000 description 1
- 239000011888 foil Substances 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 235000015203 fruit juice Nutrition 0.000 description 1
- 235000013376 functional food Nutrition 0.000 description 1
- 239000008273 gelatin Substances 0.000 description 1
- 229920000159 gelatin Polymers 0.000 description 1
- 235000019322 gelatine Nutrition 0.000 description 1
- 235000011852 gelatine desserts Nutrition 0.000 description 1
- 239000008103 glucose Substances 0.000 description 1
- 229920005669 high impact polystyrene Polymers 0.000 description 1
- 239000004797 high-impact polystyrene Substances 0.000 description 1
- 238000011081 inoculation Methods 0.000 description 1
- 235000010494 karaya gum Nutrition 0.000 description 1
- 239000000231 karaya gum Substances 0.000 description 1
- 229940039371 karaya gum Drugs 0.000 description 1
- 239000008101 lactose Substances 0.000 description 1
- 230000000813 microbial effect Effects 0.000 description 1
- 239000008267 milk Substances 0.000 description 1
- 235000013336 milk Nutrition 0.000 description 1
- 210000004080 milk Anatomy 0.000 description 1
- 235000020124 milk-based beverage Nutrition 0.000 description 1
- 230000003287 optical effect Effects 0.000 description 1
- 239000005022 packaging material Substances 0.000 description 1
- 239000013630 prepared media Substances 0.000 description 1
- 238000004886 process control Methods 0.000 description 1
- 239000008213 purified water Substances 0.000 description 1
- 238000005057 refrigeration Methods 0.000 description 1
- 150000003839 salts Chemical class 0.000 description 1
- 238000004088 simulation Methods 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 239000002562 thickening agent Substances 0.000 description 1
- 239000012780 transparent material Substances 0.000 description 1
- 239000000230 xanthan gum Substances 0.000 description 1
- 235000010493 xanthan gum Nutrition 0.000 description 1
- 229920001285 xanthan gum Polymers 0.000 description 1
- 229940082509 xanthan gum Drugs 0.000 description 1
- 239000012138 yeast extract Substances 0.000 description 1
Landscapes
- Apparatus Associated With Microorganisms And Enzymes (AREA)
- Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
Abstract
Description
【０００１】[0001]
【産業上の利用分野】本発明は、無菌性充填等の細菌汚
染を制御して内容物を容器に充填する工程における該工
程の細菌制御確認試験法に関し、特に、製造プラントの
納入時もしくは始動時または装置の修理・補修等の保守
点検後に行う細菌制御状況の確認作業の簡素化を図る細
菌制御確認試験法、それに用いる培地および容器に関す
る。BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a bacterial control confirmation test method in a process of controlling bacterial contamination such as aseptic filling to fill a container with contents, and particularly, at the time of delivery or start of a manufacturing plant. The present invention relates to a bacterial control confirmation test method for simplifying the confirmation work of the bacterial control status performed at the time of or after the maintenance / inspection such as the repair / repair of the device, the medium and the container used therefor.
【０００２】[0002]
【従来の技術】コーヒー用ポーションパック等、容器充
填後に滅菌または殺菌処理されずに常温・冷蔵流通に付
される内容物の充填は、無菌充填等の細菌汚染を制御し
た充填手段が採用されている。無菌充填の場合、通常、
滅菌機、ライン、サージタンク、アセプテック充填機無
菌室、充填ノズルに至るまでの全工程で無菌性が達成さ
れなければならないので、製造プラントの納入時もしく
は始動時または装置の修理・補修等の保守点検後に無菌
性の確認を実施し製造工程の無菌性を確保しておく必要
がある。2. Description of the Related Art The filling of contents such as potion packs for coffee that are not sterilized or sterilized after being filled in a container and are subjected to normal temperature / refrigeration distribution is performed by using a filling means such as aseptic filling that controls bacterial contamination. There is. For aseptic filling, usually
Since sterility must be achieved in all processes from the sterilizer, line, surge tank, aseptic filling machine aseptic room and filling nozzle, maintenance at the time of delivery or startup of the manufacturing plant or repair / repair of equipment etc. It is necessary to confirm sterility after inspection to ensure sterility in the manufacturing process.
【０００３】また、無菌充填に限らず、大腸菌等の特定
の細菌の汚染排除を目的とした充填においても上記工程
における細菌汚染制御を実施する必要がある。In addition to aseptic filling, it is necessary to control bacterial contamination in the above steps not only in aseptic filling but also in filling for the purpose of eliminating contamination of specific bacteria such as Escherichia coli.
【０００４】かかる工程の細菌制御状態を本生産前に確
認する手段の一つは、実際に製品として容器に充填され
る内容液（実液という。）を用いて本生産と同様にして
充填しこれを抜き取り検査（培養検査）するものであ
る。この方法は本生産と同様の条件で工程の細菌制御が
確認できるので一見検査精度が高いようであるが、しか
し、この方法では、検査精度を高めるためには大量の実
液サンプルを採取しなければならず、かつ、細菌検査に
おいては採取サンプルを開封し別に用意した細菌検査用
培地に一定の試料を移し培養試験に供するため、検査労
力が多大であるばかりか、代表サンプル採取の困難性や
二次汚染の可能性があり、現実には検査精度、信頼性が
低く、従って、実液充填で工程の細菌制御が一応確認さ
れても本生産の稼動時間を長くできない（１回の稼動時
間は１時間程度）という問題点がある。One of the means for confirming the bacterial control state of such a process before the main production is to fill the container in the same manner as the main production by using the content liquid (referred to as actual liquid) actually filled in the container as a product. This is a sampling inspection (culture inspection). This method seems to have a high inspection accuracy because bacterial control of the process can be confirmed under the same conditions as in this production, but with this method, a large amount of actual liquid sample must be collected in order to improve the inspection accuracy. In addition, in the bacterial test, the sample to be collected is opened, and a certain sample is transferred to a separately prepared bacterial test medium for use in the culture test. There is a possibility of secondary contamination, and in reality the inspection accuracy and reliability are low. Therefore, even if bacterial control of the process is confirmed once by actual liquid filling, the operating time of the main production cannot be extended (one operating time Is about 1 hour).
【０００５】無菌充填の場合に限らず、細菌汚染を制御
する工程においては工程管理上、実液充填による細菌検
査を実施し汚染の有無を確認する必要があり、同様の問
題点を有する。Not only in the case of aseptic filling, but in the process of controlling bacterial contamination, it is necessary to carry out a bacterial test by actual liquid filling to confirm the presence or absence of contamination in the process control, and there are similar problems.
【０００６】[0006]
【発明が解決しようとする課題】本発明は、上述の従来
技術の有する問題点に鑑み、製造プラントの納入時もし
くは始動時または装置の修理・補修等の保守点検後に細
菌非汚染の確認を必要とする工程における実液検査に伴
うサンプリングおよび細菌非汚染確認作業の煩雑性、検
査精度の不完全性等の問題点を解決し、実液検査に代え
特定の検査用培地による検査を可能とすることでサンプ
リング作業の大幅な軽減および検査精度の向上を図り、
また、特定の検査用容器を用いることにより工程の細菌
汚染確認作業を大幅に迅速化することを目的とする。In view of the above-mentioned problems of the prior art, the present invention requires confirmation of bacterial non-contamination at the time of delivery or start of a manufacturing plant or after maintenance / inspection such as repair / repair of equipment. Solve problems such as the complexity of sampling and bacterial non-contamination confirmation work, incompleteness of inspection accuracy, etc. in the actual liquid inspection in the process to be performed, and enable inspection with a specific inspection medium instead of the actual liquid inspection By doing so, we aim to greatly reduce sampling work and improve inspection accuracy,
Another object is to significantly speed up the process of confirming bacterial contamination in the process by using a specific inspection container.
【０００７】また、本発明の他の目的は、前記目的を達
成するための検査用培地および検査用容器を提供するこ
とである。Another object of the present invention is to provide a test medium and a test container for achieving the above object.
【０００８】[0008]
【課題を解決するための手段】かかる目的を達成する本
発明は、充填機から内容物を容器に充填し密閉する工程
の細菌制御確認試験において、該内容物に代えてそれと
同等の流動性を有する細菌検査用培地を工程に導入して
容器に充填密閉し、該培地の澄明度変化により細菌汚染
を検出することで前記工程の細菌制御状態を検証するこ
とを特徴をする細菌制御確認試験法である。この方法に
より、サンプル採取時の二次汚染が防止でき実液充填と
同じ条件で工程の細菌汚染検査が可能となるので、サン
プリング作業が大幅に軽減されかつ検査精度も向上す
る。Means for Solving the Problems The present invention which achieves the above object, in a bacterial control confirmation test in the step of filling a container with a content from a filling machine and sealing the container, replaces the content with a fluidity equivalent to that. Bacterial control confirmation test method characterized by verifying the bacterial control state of the process by introducing a bacterial test medium having the method into a process, filling and sealing the container, and detecting bacterial contamination by a change in the clarity of the medium. Is. By this method, secondary contamination at the time of sample collection can be prevented and the bacterial contamination inspection of the process can be performed under the same conditions as the actual liquid filling, so that the sampling work can be significantly reduced and the inspection accuracy can be improved.
【０００９】また、本発明は、細菌検査用培地を充填し
密閉した容器の少なくとも一部が透明であることを特徴
とする上記細菌制御確認試験法である。この方法によ
り、培地充填後、容器を開封せず外部から目視等により
容易に培地の澄明度変化を判定できるので、細菌汚染確
認作業を大幅に迅速化でき、更に、充填中や搬送中の容
器内の液揺れや液漏れを観察することができる。Further, the present invention is the above-mentioned bacteria control confirmation test method, characterized in that at least a part of a container filled with a culture medium for bacteria test and sealed is transparent. By this method, after the medium is filled, the change in the clarity of the medium can be easily judged from the outside without opening the container, and thus the bacterial contamination confirmation work can be significantly speeded up. It is possible to observe liquid shaking and liquid leakage inside.
【００１０】更に、本発明は、上記細菌制御確認試験法
に用いる、内容物と同等の流動性を有する細菌検査用培
地であり、また、細菌検査用培地を充填密封した少なく
とも一部が透明である容器である。かかる培地は、内容
物と同等の流動性を有しているので、充填時に培地液が
飛散したりカップシールが不可能となることが防止でき
る。Further, the present invention is a bacterial test medium having the same fluidity as the contents, which is used in the above-mentioned bacterial control confirmation test method, and is at least partially transparent and filled with the bacterial test medium. It is a container. Since such a medium has fluidity equivalent to that of the contents, it is possible to prevent the medium liquid from splashing or the cup sealing becoming impossible at the time of filling.
【００１１】以下、本発明を詳述する。The present invention will be described in detail below.
【００１２】本発明において、充填機から内容物を容器
に充填し密閉する工程とは、密閉された容器内の充填物
の生菌数が一定以下、好ましくは生菌数ゼロに調整され
るように、内容物を充填機から容器に充填する段階で該
内容物の細菌汚染を制御して充填密閉する工程であっ
て、製造プラントの納入時もしくは始動時または装置の
修理・補修時等の保守点検後に細菌非汚染の確認が必要
となる工程をいう。細菌汚染の制御には、内容物を無菌
にする制御の他、大腸菌を陰性とし、一般細菌の汚染を
一定水準以下にするための制御も包含される。容器への
充填密閉後の処理は特に限定されないが、通常は、充填
密閉後には滅菌、殺菌処理が施されない工程が対象とな
る。制御の対象となる細菌の種類の別は問わない。細菌
制御の手段は、加熱滅菌・殺菌、遠心分離・フィルター
による除菌、殺菌剤・静菌剤の使用等、特に限定されな
い。また、上述工程には、細菌汚染制御に係わる全ての
工程が包含され、一般には、内容物の滅菌・殺菌・静菌
工程から、充填機に至るまでのライン〜タンク、充填機
から容器に充填され密閉されるまでの全工程を包含す
る。例えば、無菌充填の場合では、サージタンク、バッ
ファータンク、充填小タンク、アセプテック充填機無菌
室入口〜出口までの工程を包含するものである。内容物
は充填後の内容物の性状は問わず充填時に流動性があ
り、充填後の流通過程が冷蔵または常温であり流通また
は保存中の細菌増殖が問題となる食品類、機能性食品
類、医薬品類等であり、特に限定されない。ソルーショ
ン、サスペンション、エマルジョン、泡、ゲル、それら
の集合物、糸状、帯状ゲル集合物等の状態の食品類、医
薬品類等が包含される。充填後に内容物が固化し流通時
点では固体であってもよい。例えば、ポーションパック
滅菌手段等の無菌性の充填が要求される食品類、牛乳、
乳飲料、果汁等の大腸菌群陰性となる充填が要求される
食品類、医薬用ドリンク、医療用アンプル、医療用点滴
液等を挙げることができる。In the present invention, the step of filling and sealing the contents from the filling machine into the container means that the number of viable cells in the closed container is adjusted to a certain level or less, preferably to zero. In the step of filling the contents from the filling machine into the container, the process of controlling the bacterial contamination of the contents and filling and sealing the contents, at the time of delivery or start of the manufacturing plant or at the time of repair / repair of the equipment. The process that requires confirmation of non-contamination of bacteria after inspection. The control of bacterial contamination includes not only control of making contents sterilized but also control of making Escherichia coli negative and keeping the contamination of general bacteria below a certain level. The treatment after filling and sealing the container is not particularly limited, but usually, a process in which sterilization or sterilization treatment is not performed after the filling and sealing is targeted. The type of bacteria to be controlled does not matter. The means for controlling bacteria is not particularly limited, such as heat sterilization / sterilization, centrifugation / bacterial sterilization, use of bactericide / bacteriostat, and the like. In addition, the above-mentioned process includes all processes related to bacterial contamination control, and in general, the line from the sterilization / sterilization / bacteriostatic process of the contents to the filling machine, the tank to the filling machine, and the filling machine to fill the container. It includes all steps until it is sealed. For example, in the case of aseptic filling, it includes the steps from surge tank, buffer tank, small filling tank, aseptic filling machine aseptic chamber inlet to outlet. The contents are fluid at the time of filling regardless of the properties of the contents after filling, foods that functionally cause bacterial growth during distribution or storage when the distribution process after filling is refrigerated or at room temperature, functional foods, It is a drug or the like and is not particularly limited. Solutions, suspensions, emulsions, foams, gels, aggregates thereof, foods in the form of thread-like, band-like gel aggregates, pharmaceuticals and the like are included. The contents solidify after filling and may be solid at the time of distribution. For example, foods, milk, etc. that require aseptic filling such as potion pack sterilization means.
Examples thereof include milk drinks, fruit juices, and other foods that are required to be negative for coliform bacteria, medical drinks, medical ampoules, medical drip solutions, and the like.
【００１３】内容物の流動性は、内容物が通常はノズル
により容器内に充填されることからノズル充填が可能な
程度の流動性であり、特に限定されることなく用いる充
填機等により適宜調整されるものである。The fluidity of the content is such that the content is usually filled in the container by a nozzle and thus the nozzle can be filled, and is not particularly limited, and is appropriately adjusted by a filling machine used. It is what is done.
【００１４】本発明の細菌制御確認試験とは、例えば製
造プラント納入時もしくは始動時、装置の設置時、装置
の補修もしくは改造時、部品の交換時、製造条件の変更
時または微生物的トラブルの発生時等であって、実液に
よる実際の製造を行う前（直前に限定されない）または
行った後（直後に限定されない）に実施するが、本生産
における細菌制御の確保を検証するのに必要な場合には
いつでも実施することができる。The bacterial control confirmation test of the present invention means, for example, when a manufacturing plant is delivered or started, when a device is installed, when a device is repaired or remodeled, when parts are replaced, when manufacturing conditions are changed, or when microbial trouble occurs. For example, before (not limited to immediately before) or after (not immediately after) the actual production with the actual liquid, but it is necessary to verify the bacterial control in this production. In case it can be done at any time.
【００１５】本発明においては細菌検査用培地の流動性
は該内容物のものと同程度に調整される。培地が内容物
と同等の流動性を有することにより、内容物充填時と同
様に同じ条件下で培地を容器に充填できるので、細菌汚
染制御状態を的確に反映する検査用サンプルを量目のバ
ラツキなく採取することができる。細菌検査用培地が内
容物と同等の流動性を有するとは、完全同一の流動性を
有することが必要である意味ではなく、該培地を内容物
に代えて充填した場合に培地が飛散したりカップシール
不全とならず細菌制御状態の確保が可能となる程度に同
一性のある流動性であって、かかる機能、作用が発揮さ
れる流動性を意味する。流動性はレオロジー的に粘性と
弾性で規定できるが、これらの性質も上記充填の際の機
能、作用が発揮される範囲にあれば特に規定されない。
一つの目安としては粘度７０〜２５０ｃｐｓ程度に相当
する流動性が、上記の機能、作用を発揮させる上で一般
に好ましい。また、充填時の切れの点で一般的には曳糸
性は小さい方が好ましいが、製造対象となる内容物が曳
糸性の大きいものである場合ではそれと同程度の曳糸性
を有するとよい。In the present invention, the fluidity of the bacterial test medium is adjusted to the same level as that of the contents. Since the medium has the same fluidity as the contents, the medium can be filled in the container under the same conditions as when filling the contents, so that the amount of test sample that accurately reflects the bacterial contamination control state can be varied. Can be collected without. The fact that the culture medium for bacterial test has the same fluidity as the content does not mean that it has exactly the same fluidity, and the medium may scatter when the medium is filled in place of the content. It means the fluidity that has the same degree of fluidity to the extent that it is possible to ensure a bacterial control state without causing cup seal failure, and exerting such functions and actions. The fluidity can be defined rheologically by viscosity and elasticity, but these properties are not particularly defined as long as the function and action at the time of filling are exhibited.
As one measure, a fluidity corresponding to a viscosity of about 70 to 250 cps is generally preferable in order to exert the above functions and actions. In addition, in terms of breakage during filling, it is generally preferable that the spinnability is small, but in the case where the content to be manufactured is highly spinnable, it is considered that the spinnability is about the same. Good.
【００１６】本発明で用いる細菌検査用培地としては、
上述した通り所定の流動性を有していることの他に好ま
しくは、透明性に優れ、抗菌性がないこと等の特性を具
備しているものがよい。培地が透明であれば細菌汚染サ
ンプルの検出が極めて容易になり、また培地に抗菌性が
あれば細菌汚染が生じていても的確に検出できない場合
があるからである。培地は充填時には流動性を示す液体
であるが、充填後は固化しても支障はない。但し、充填
後も液体状であれば、充填時ばかりでなく搬送中の容器
内での液揺れや液漏れの状態の把握が目視にて確認でき
るので、漏洩等のトラブル対策の原因究明に役立てるこ
とができる。尚、液体培地では固体培地と異なり寒天等
の固化剤を含有していないので通常は白濁等は問題とな
らないが、本発明においては粘度を増大させた液体培地
を用いるので、安定剤や増粘剤を用いる必要があり、透
明性や抗菌性の課題が解決されなければらならい。従来
寒天培地の白濁を防止するために寒天に代えてキサンタ
ンガムとローカストビーンガムとを併用する技術（特開
昭６２ー１８６７８４号公報）等があるが、粘度が比較
的高い液体培地については殆ど知られていない。The bacterial test medium used in the present invention includes:
In addition to having the predetermined fluidity as described above, it is preferable that it has characteristics such as excellent transparency and no antibacterial property. This is because if the medium is transparent, it becomes extremely easy to detect a sample contaminated with bacteria, and if the medium has antibacterial properties, it may not be accurately detected even if bacterial contamination occurs. The medium is a liquid that exhibits fluidity when filled, but there is no problem even if it solidifies after filling. However, if it is still liquid after filling, it is possible to visually confirm the state of liquid shaking and liquid leakage not only during filling but also during transport, which is useful for investigating the cause of trouble measures such as leakage. be able to. Unlike the solid medium, the liquid medium does not contain a solidifying agent such as agar so that white turbidity or the like is not a problem, but in the present invention, since the liquid medium having an increased viscosity is used, a stabilizer or thickener is used. It is necessary to use an agent, and the problems of transparency and antibacterial property must be solved. Conventionally, there is a technique of using xanthan gum and locust bean gum in combination in place of agar in order to prevent cloudiness of the agar medium (Japanese Patent Laid-Open No. 186784/1987), but most of liquid medium with relatively high viscosity is known. Has not been done.
【００１７】本発明で用いる細菌検査用培地は、基本的
に基礎培地と安定剤からなる。基礎培地は制御対象とな
る細菌の培養に適するものを適宜選択することができ、
例えば、細菌用基礎培地であるブイヨン培地、大腸菌群
検査用の乳糖ブイヨン培地、ＢＧＬＢ培地、ペプトン、
肉汁培地等を用いることができ、上述の観点から好まし
くはペプトン等である。安定剤としては、少なくとも温
水可溶であり、溶液に透明性があり、熱安定性があり、
少量で安定した粘度を呈するものがよく、例えば、ロー
カストビーンガム、グァガム、トラガントガム、カラヤ
ガム等を用いることができるが、前述の観点、即ち透明
性および非抗菌性等から好ましくは精製ローカストビー
ンガム、精製グァガムである。また、実液の流動性によ
っては寒天、ゼラチン等も用いることができる。The bacterial test medium used in the present invention basically comprises a basal medium and a stabilizer. As the basal medium, one suitable for culturing the bacteria to be controlled can be appropriately selected,
For example, broth medium which is a basal medium for bacteria, lactose broth medium for coliform bacteria test, BGLB medium, peptone,
A broth medium or the like can be used, and from the above viewpoint, peptone or the like is preferable. As the stabilizer, at least hot water-soluble, the solution is transparent, has thermal stability,
Those exhibiting a stable viscosity in a small amount are good, for example, locust bean gum, guar gum, tragacanth gum, karaya gum and the like can be used, but from the above-mentioned viewpoint, that is, transparency and non-antibacterial property, preferably locust bean gum, It is a purified guar gum. In addition, agar, gelatin or the like can be used depending on the fluidity of the actual liquid.
【００１８】一般細菌の検査用培地の配合としては例え
ば次のようなものである。 （配合比） ・精製食塩 ０．５％ ・酵母エキス ０．３％ ・ペプトン １．０％ ・ブドウ糖 ０．５％ ・安定剤 ０．５〜０．６％ ・精製水 ９７．１〜９７．２％ （ｐＨ６．５〜６．８） （粘度７０〜１７０ｃｐｓ） 培地の調製は、原材料を粉粉混合してこれに加温した水
を加え充分分散、溶解した後、滅菌すればよい。この調
製工程は、内容物の製造工程とは別個に実施してもよい
が、好ましくは実液充填工程の混合ライン、タンク、滅
菌機等を利用すると設備の簡略化を図ることができる。The formulation of the test medium for general bacteria is, for example, as follows. (Blending ratio) -Purified salt 0.5% -Yeast extract 0.3% -Peptone 1.0% -Glucose 0.5% -Stabilizer 0.5-0.6% -Purified water 97.1-97. 2% (pH 6.5 to 6.8) (viscosity 70 to 170 cps) The medium may be prepared by mixing the raw materials with powder and adding warm water to the mixture to sufficiently disperse and dissolve it, and then sterilize it. This preparation step may be carried out separately from the manufacturing step of the contents, but it is preferable to use a mixing line, tank, sterilizer and the like in the actual liquid filling step to simplify the equipment.
【００１９】次に、本発明で細菌検査用に用いる容器と
しては、原則的には内容物充填に用いる容器即ち実液充
填の容器をそのまま適用することができる。実液充填の
容器を適用することにより、充填工程の製造ラインをそ
のまま使うことができるので、検査資材、設備の簡略化
および労力の軽減を図ることができ、また細菌制御状態
の確認を的確に行うことができる。更に、容器内での液
揺れ等の状態を実液の場合のシュミレーションとして的
確に把握できる。容器は１部材からなるものでも、蓋部
材と本体（底部材）の２部材やそれ以上の数の部材から
なるものであってもよい。Next, in principle, the container used for filling the contents, that is, the container filled with the actual liquid can be directly applied as the container used for the bacteria test in the present invention. By applying a container filled with actual liquid, the manufacturing line of the filling process can be used as it is, so it is possible to simplify the inspection materials and equipment and reduce labor, and to accurately check the bacterial control state. It can be carried out. Furthermore, the state of liquid shaking in the container can be accurately grasped as a simulation in the case of an actual liquid. The container may be composed of one member, two members of a lid member and a main body (bottom member), or more members.
【００２０】検査用の容器は好ましくは少なくともその
一部が透明である。透明であると、容器を開封すること
なく内部の培地の性状を外部からの目視観察により容易
に検査できるので、検査効率の大幅な向上を図ることが
できる。例えば、透明な底部分を形成し、それにフィル
ム状の不透明蓋材を熱溶着させた実液用容器の場合は、
これをそのまま検査用容器として用いることにより、透
明な底部分を通して内部の培地を容易に観察することが
でき、また充填中、搬送中の内部の液状態を観察するこ
ともできる。５〜１０ｍｌ容量程度のアセプティクポー
ションパックの場合は一般に底部分が、ＰＥＴ／ＯＰＳ
等の不透明材料であり、蓋部分はＰＥＴ／Ａｌ箔等の不
透明材料であるので、そのままでは検査用容器として用
いた場合、容器内部の観察を外部からできない。蓋部分
を検査時に開封して内部の澄明度を検査すればよいが、
開封の手間を省くためには容器の一部は透明であった方
が好ましい。無菌充填の場合は通常無菌室内で容器の滅
菌、成形加工も実施するので底部分を検査用のものと交
換すると作業上煩雑になるので、その場合は蓋部分の材
料を透明材料とする方が選択の幅が広く作業工程上の制
約も少なく好ましい。透明蓋材としては、好ましくは無
菌室内の滅菌手段である例えば過酸化水素（Ｈ2Ｏ2）に
よる滅菌が可能で、底部分へのシール性および底部分へ
溶着後打ち抜きが容易であるものである。溶着後の打ち
抜きは実液充填の場合に用いる装置をそのまま用いるこ
とができると設備上好都合である。透明蓋部材としは、
ＰＥＴ／ＯＰＳ等を用いることができる。The test container is preferably at least partially transparent. If transparent, the properties of the inner culture medium can be easily inspected by visual observation from the outside without opening the container, so that the inspection efficiency can be greatly improved. For example, in the case of a container for actual liquid in which a transparent bottom portion is formed and a film-like opaque lid material is heat-welded to it,
By using this as an inspection container as it is, it is possible to easily observe the medium inside through the transparent bottom portion, and it is also possible to observe the liquid state inside during filling and transportation. In the case of an aseptic potion pack with a volume of 5 to 10 ml, the bottom is generally PET / OPS.
Since the lid is an opaque material such as PET / Al foil, the inside of the container cannot be observed from the outside when used as an inspection container as it is. You can open the lid part at the time of inspection and inspect the internal clarity,
In order to save the trouble of opening, it is preferable that a part of the container is transparent. In the case of aseptic filling, the container is usually sterilized and molded in a sterile room. Replacing the bottom part with an inspection part complicates the work.In that case, use a transparent material for the lid part. The range of selection is wide and there are few restrictions on the working process, which is preferable. The transparent lid material is preferably one that can be sterilized by sterilizing means in a sterile room, for example, hydrogen peroxide (H 2 O 2 ), and has a sealing property to the bottom portion and easy punching after welding to the bottom portion. is there. For punching after welding, it is convenient in terms of equipment that the device used for filling actual liquid can be used as it is. As a transparent lid member,
PET / OPS or the like can be used.
【００２１】検査用容器の大きさ等は、実液容器のそれ
と同等であるが、例えば、内容量５ｍｌ、容器の厚み５
５０〜６００μｍ（蓋の厚み２５〜３０μｍ）程度が一
般的である。The size of the inspection container is the same as that of the actual liquid container, but for example, the internal volume is 5 ml and the container thickness is 5
It is generally about 50 to 600 μm (the thickness of the lid is 25 to 30 μm).
【００２２】[0022]
【作用】本発明は例えば次のように作用する（無菌充填
の場合）。The present invention functions as follows (in the case of aseptic filling).
【００２３】検査用培地の原料を全て秤量し粉粉混合
し、調合水の内一部（約３０％）の温湯（５０〜６０
℃）を用いて原料を例えばデスパーミルにて溶解後、例
えば直接ＴＫタンクに導入し、一方残りの調合水（約７
０℃）をデスパーミルからＴＫタンクに導入してＴＫホ
モミキサー高速回転で全体を均一に混合する（約２５分
間）。ｐＨ調整し、直接滅菌機（１５０℃で４秒程度）
で滅菌後、例えばプレート冷却部で冷却する（約１０
℃）。All the raw materials of the culture medium for inspection are weighed and mixed with powder, and a part of the prepared water (about 30%) in hot water (50 to 60) is mixed.
℃) is used to dissolve the raw material in, for example, Despermill, and then directly introduced into, for example, a TK tank, while
(0 ° C.) is introduced into the TK tank from the Despermill, and the whole is uniformly mixed by a TK homomixer high speed rotation (about 25 minutes). Adjust pH and sterilize directly (at 150 ° C for about 4 seconds)
After sterilizing with, for example, cool with a plate cooling unit (about 10
C).
【００２４】このもの（一回の検査で必要な量）を、実
液充填ラインである例えばサージタンク〜バファータン
ク〜充填小タンクの経路を経て無菌充填室に導入する。
無菌室内は過酸化水素で滅菌されており、検査用容器
（蓋部材および底部材）も同様に滅菌されている。連続
充填を開始しクッションタンク内のエア−圧等を利用し
て培地を容器を形成した底部材内へ充填する（内容物も
同等の流動性のため該エア−圧を利用した充填が可能と
なる）。充填に供するサンプル数は無菌性判断を精度高
く行うために必要な数であり、例えばノズル７０個のも
のでは１００〜３００ショット（７０００〜２１０００
個）程度のサンプリングを実施するとよい（従来法では
非現実的であったサンプル数も容易に処理できる）。底
部材の底面等にはノズル番号等が印示されていてサンプ
ルを同定することができる。充填後に透明蓋部材を容器
を形成した底部材上面にヒートシールにより溶着し、容
器を密閉した後、無菌室から搬出して検査に都合のよい
形態とする。回収したサンプルは３０℃のインキュベー
ターで５日間（汚染の程度によっては１〜２日間でもよ
い。）培養し培地の澄明度の変化を容器の蓋を開封する
ことなく目視により外部からの観察により判定する。判
定の結果、無菌性に問題があると認められた場合は、そ
のサンプルに対応するロット、ノズル等の実液製品は品
質上問題が発生すると推定することができる。このよう
にすれば、無菌性の確認の際容器を開封したり、別に用
意した培地に実液製品を接種する必要はない。This product (the amount required for one inspection) is introduced into the aseptic filling chamber through the actual liquid filling line, for example, the surge tank-buffer tank-filling small tank path.
The sterile chamber is sterilized with hydrogen peroxide, and the inspection containers (lid member and bottom member) are similarly sterilized. The continuous filling is started and the medium is filled into the bottom member forming the container by using the air-pressure in the cushion tank (the contents can also be filled using the air-pressure because of the same fluidity). Become). The number of samples to be filled is the number required to perform sterility determination with high accuracy. For example, with 70 nozzles, 100 to 300 shots (7000 to 21000).
It is better to carry out sampling of about (number of samples) (the number of samples, which was unrealistic in the conventional method, can be easily processed). Nozzle numbers and the like are marked on the bottom surface and the like of the bottom member so that the sample can be identified. After filling, the transparent lid member is heat-sealed to the upper surface of the bottom member forming the container, the container is sealed, and then the container is taken out of the aseptic chamber into a form convenient for inspection. The collected sample is cultivated in an incubator at 30 ° C for 5 days (1-2 days depending on the degree of contamination.) The change in the clarity of the medium is judged by visual observation from the outside without opening the lid of the container. To do. If it is determined that there is a problem in sterility as a result of the determination, it can be estimated that a quality problem occurs in the actual liquid product such as the lot or nozzle corresponding to the sample. In this way, it is not necessary to open the container or inoculate the separately prepared medium with the actual liquid product when confirming sterility.
【００２５】ここで、培地の澄明度変化とは培地全体の
平均的澄明度変化のみならず１つのコロニーの発生等局
所的な澄明度変化も含むものである。澄明度変化は目視
のみならず種々光学的測定機器による自動検出によって
も判定できる。Here, the change in the clearness of the medium includes not only the change in the average clearness of the entire medium but also the change in the local clearness such as the occurrence of one colony. The change in clarity can be judged not only visually but also by automatic detection by various optical measuring instruments.
【００２６】検査用培地を充填したサンプルを回収した
後に、滅菌機、ライン、アセプティクサージタンク（サ
ージタンク〜バファータンク〜充填小タンク）、ノズル
等から検査用培地を除去するため、精製滅菌水をライン
中に装填して液抜きをし、更に充分な洗浄を行うことが
重要で、この洗浄により検査用培地は完全に工程内から
除去される。そして上記で培養したサンプルの無菌性の
判定を確認した後、実液による本生産を実施する。また
本生産の細菌制御確認試験は、製造条件の変更等のため
に実液を充填終了後に実施することも可能である。この
場合は精製滅菌水をライン中に装填して実液を抜き取
り、更に充分な洗浄を実施して実液と検査用培地とを完
全に遮断することが検査精度を高める上で重要である。
実液を工程内から除去した後は、検査用培地を実液ライ
ンに導入して検査用容器に充填し、サンプルを培養して
無菌性を判定する。After collecting the sample filled with the test medium, the test medium is removed from the sterilizer, line, aseptic surge tank (surge tank-buffer tank-filling small tank), nozzle, etc. It is important to load in the line to drain the liquid, and to perform sufficient washing, and this washing completely removes the test medium from the process. Then, after confirming the determination of sterility of the above-cultured sample, the actual production with the actual liquid is carried out. In addition, the bacterial control confirmation test of this production can also be carried out after completion of filling with the actual liquid for the purpose of changing the production conditions and the like. In this case, it is important in order to improve the inspection accuracy that the purified sterilized water is loaded into the line, the actual liquid is extracted, and further sufficiently washed to completely shut off the actual liquid and the test medium.
After the actual liquid is removed from the process, the inspection medium is introduced into the actual liquid line and filled in the inspection container, and the sample is cultured to determine sterility.
【００２７】従来の実液充填による抜き取りによる検査
等では多大な労力を要する割には無菌性の判定の信頼性
が低かった。このため例えば製造プラントを新規に設置
した場合には、数日間〜数十日間も費やして細菌制御確
認試験を実施し、プラントの無菌性を確認してから本格
的な生産に入る必要があった。本発明の方法によれば、
簡便な方法にもかかわらず極めて高い精度で工程の無菌
性の確認が可能であるため、細菌制御確認試験の所要時
間を大幅に削減でき、かつ信頼性の向上も図ることがで
きる。In the conventional inspection such as sampling by filling with the actual liquid, the reliability of the determination of sterility was low in spite of requiring a lot of labor. Therefore, for example, when a new manufacturing plant is installed, it is necessary to spend several days to several tens of days to carry out a bacterial control confirmation test and confirm the sterility of the plant before starting full-scale production. . According to the method of the present invention,
Since the sterility of the process can be confirmed with extremely high accuracy in spite of the simple method, the time required for the bacteria control confirmation test can be significantly reduced and the reliability can be improved.
【００２８】尚、菌付きペーパー等を検査用培地と併用
して無菌性確認検査を実施し無菌性の判断をより完全な
ものにすることもできる。It is also possible to carry out a sterility confirmation test by using a paper with bacteria and the like in combination with a test medium to make the sterility judgment more complete.
【００２９】また、無菌充填以外の場合でも細菌制御を
実施している工程においては上述の処理を適用すること
ができる。Further, even in the case other than aseptic filling, the above-mentioned treatment can be applied in the step of controlling bacteria.
【００３０】[0030]
【実施例】以下、本発明を実施例により更に説明する。EXAMPLES The present invention will be further described below with reference to examples.
【００３１】（充填ラインおよび包材）コーヒー用ポー
ションクリーム（５ｍｌ）の連続無菌充填ラインにおい
て無菌性確認試験を実施した。充填ノズルは７０本セッ
トされており、ラインの生産能力は１０２，０００個／
ｈである。底材は不透明ＨＩＰＳであり無菌チャンバー
内でプレス成形され、一方蓋材は透明ＰＥＴ／ＯＰＳフ
ィルム（ＰＥＴ１６μｍ／ＯＰＳ２５μｍ）でありチャ
ンバー内で内容物が底部材（容器）に充填された後、底
部材の上面にヒートシールされる。それぞれの部材は使
用に供される前に無菌チャンバー内で過酸化水素により
滅菌される。尚、本生産のときの蓋材は不透明ＰＥＴ／
Ａｌフィルムである。また１ポーション毎の培地の充填
量は５ｍｌとした。 （培地の調製）培地の配合比は次に示す通りであった。(Filling line and packaging material) A sterility confirmation test was carried out in a continuous aseptic filling line for potion cream for coffee (5 ml). 70 filling nozzles are set, and the production capacity of the line is 102,000 /
h. The bottom material is opaque HIPS and is press-molded in a sterile chamber, while the lid material is a transparent PET / OPS film (PET 16 μm / OPS 25 μm) and the bottom member (container) is filled with the contents in the chamber and then the bottom member Is heat-sealed to the top surface of. Each component is sterilized with hydrogen peroxide in a sterile chamber before being put to use. The lid material used in this production is opaque PET /
It is an Al film. The filling amount of the medium for each portion was 5 ml. (Preparation of medium) The mixing ratio of the medium was as shown below.
【００３２】[0032]
【表１】 上記配合比に基づき調合での仕込み量が１，０００ｋｇ
となるように原料を全て秤量し、粉粉混合して、次に調
合水の内、約３０％の温湯（５０〜６０℃）を使用し、
デスパーミルにて原料を溶解し、これを直接ＴＫタンク
に入れ、一方残りの調合水（約７０℃）はデスパーミル
から該ＴＫタンクに入れた。ＴＫホモミキサー高速回転
で２５分間溶解し、４％水酸化ナトリウムによりｐＨを
６．８に調整した後、培地の滅菌を直接滅菌機にて実施
し（１５０℃、４秒）、その後プレート冷却部で１０℃
に冷却した。このものの粘度は１２６ｃｐｓ（Ｂ型粘度
計）で、コーヒー用ポーションクリームの粘度１５０〜
２５０ｃｐｓと同程度であり、ノズルからの充填状態も
該クリームのそれと類似していた。 （無菌性確認試験） 実液を用いた製品抜き取り（従来法） 比較のため実液を用いて充填、製造された製品を定期的
（１回／２時間）に採取（７０個×３回）し、このもの
を開封し別に用意した固体寒天培地に一定量を接種し培
養試験に付した後、無菌性の判定を行った。 培地充填（本発明） 本生産前に、タンク中の培地を無菌室へ導入し、本生産
と同様の条件で容器への充填を実施した。採取したサン
プルはその後培養試験に付し濁りの有無を判定した。１
回の本製造当りのサンプル採取数は１１，１３０個（１
５９ショット×７０充填ノズル）とした。 （無菌性確認試験結果）上記で採取したサンプルのお
よびについて完全無菌性の確認に要した人および時間
をつぎの表に示す。[Table 1] Based on the above blending ratio, the amount of preparation is 1,000 kg
So that all the raw materials are weighed and mixed with powder, and then using hot water (50-60 ° C) of about 30% in the prepared water,
The raw materials were melted in a Despermill, and this was put directly into the TK tank, while the rest of the prepared water (about 70 ° C.) was put into the TK tank from the Despermill. TK homomixer was rotated at high speed for 25 minutes, pH was adjusted to 6.8 with 4% sodium hydroxide, and the medium was sterilized directly with a sterilizer (150 ° C, 4 seconds), and then the plate cooling unit. At 10 ° C
Cooled to. The viscosity of this product is 126 cps (B type viscometer), and the viscosity of potion cream for coffee is 150-
It was about the same as 250 cps, and the filling state from the nozzle was similar to that of the cream. (Sterility confirmation test) Extraction of product using actual liquid (conventional method) For comparison, products manufactured by filling with actual liquid are sampled periodically (1 time / 2 hours) (70 pieces x 3 times) Then, this was opened, a fixed amount of solid agar medium prepared separately was inoculated and subjected to a culture test, and then sterility was determined. Medium Filling (Invention) Before the main production, the medium in the tank was introduced into a sterile room, and the container was filled under the same conditions as in the main production. The collected sample was then subjected to a culture test to determine the presence of turbidity. 1
The number of samples taken per book production is 11,130 (1
59 shots × 70 filling nozzles). (Results of sterility confirmation test) The following table shows the persons and the time required to confirm the complete sterility of the samples collected above.
【００３３】[0033]
【表２】 表に明らかなように、透明蓋材を用い容器への培地充填
を実施した本発明では、抜き取り試験と異なり蓋材の開
封が不要でかつ別培地への接種も不要となり、目視にて
大量のサンプルの完全無菌性の確認が容易にできるの
で、労力の大幅な低減を図ることができた。[Table 2] As is clear from the table, in the present invention in which the container was filled with the medium using the transparent lid material, unlike the sampling test, it was not necessary to open the lid material and the inoculation to another medium was unnecessary, and a large amount of the Since the complete sterility of the sample can be easily confirmed, the labor can be greatly reduced.
【００３４】[0034]
【発明の効果】以上説明したように、細菌汚染の制御を
必要とする工程において、内容物に代えてそれと同等の
流動性を有する細菌検査用培地を工程に導入して容器に
充填密閉し、該培地の澄明度変化により細菌汚染を検出
しこれにより該工程の細菌制御状態を検証することによ
り、サンプル採取時の二次汚染が防止でき実液充填と同
じ条件で工程の細菌汚染検査が可能となるので、サンプ
リング作業が大幅に軽減されかつ検査精度も向上した。
また、検査用容器を少なくとも一部が透明である容器と
したことにより、培地充填後、容器を開封せず外部から
目視により容易に培地の澄明度変化を判定できるので、
細菌汚染確認作業を大幅に迅速化でき、更に充填時や搬
送時の液状態の把握が可能となった。上記検査用培地は
内容物と同等の流動性を有しているので、充填時に培地
液が飛散したりカップシール不可能となることが防止で
きた。これらの効果は、大腸菌を陰性とし一般細菌数を
一定水準以下にする工程に適用する場合にも有効である
が、特に全ての工程において無菌性が保証されなければ
ならない無菌性充填の場合に顕著であり、ポーションパ
ック充填等の無菌性確認作業が確実化かつ簡便化でき
た。As described above, in a process requiring control of bacterial contamination, instead of the contents, a bacterial test medium having fluidity equivalent to that is introduced into the process, and the container is filled and sealed. By detecting bacterial contamination by changing the clarity of the medium and verifying the bacterial control state of the process by this, secondary contamination at the time of sample collection can be prevented and bacterial contamination inspection of the process can be performed under the same conditions as actual liquid filling Therefore, the sampling work is greatly reduced and the inspection accuracy is improved.
Further, by making the test container at least partially transparent, after filling the medium, it is possible to easily determine the change in the clarity of the medium visually from the outside without opening the container,
Bacterial contamination confirmation work has been greatly speeded up, and it has become possible to grasp the liquid state during filling and transportation. Since the above test medium has the same fluidity as that of the contents, it was possible to prevent the medium liquid from scattering or becoming impossible to cup-seal at the time of filling. These effects are also effective when applied to the process of making Escherichia coli negative and keeping the number of general bacteria below a certain level, but especially in the case of aseptic filling where sterility must be guaranteed in all processes. As a result, the sterility confirmation work such as filling of the potion pack could be confirmed and simplified.
───────────────────────────────────────────────────── フロントページの続き (72)発明者 酒井 建次 埼玉県南埼玉郡宮代町中央２−19−８ ─────────────────────────────────────────────────── ─── Continuation of front page (72) Inventor Kenji Sakai 2-19-8 Chuo, Miyashiro-cho, Minamisaitama-gun, Saitama Prefecture
Claims (4)
る工程の細菌制御確認試験において、該内容物に代えて
それと同等の流動性を有する細菌検査用培地を工程に導
入して容器に充填密閉し、該培地の澄明度変化により細
菌汚染を検出することで前記工程の細菌制御状態を検証
することを特徴とする細菌制御確認試験法。1. In a bacterium control confirmation test of a process of filling a container with a content from a filling machine and sealing the container, instead of the content, a bacterial test medium having a fluidity equivalent to that is introduced into the process and put in a container. A bacterial control confirmation test method comprising filling and sealing, and verifying the bacterial control state in the above step by detecting bacterial contamination by a change in the clarity of the medium.
少なくとも一部が透明であることを特徴とする請求項１
に記載の細菌制御確認試験法。2. A container which is filled with a culture medium for bacterial tests and which is sealed is at least partially transparent.
The bacterial control confirmation test method described in 1.
る、内容物と同等の流動性を有する細菌検査用培地。3. A culture medium for bacterial test, which has the same fluidity as the content, which is used in the bacterial control confirmation test method according to claim 1.
る、細菌検査用培地を充填密封した少なくとも一部が透
明である容器。4. A container which is used in the bacterial control confirmation test method according to claim 2 and which is filled and sealed with a bacterial test medium and is at least partially transparent.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP15499693A JP3210142B2 (en) | 1993-06-25 | 1993-06-25 | Bacterial control confirmation test method, medium used for it |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP15499693A JP3210142B2 (en) | 1993-06-25 | 1993-06-25 | Bacterial control confirmation test method, medium used for it |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPH078296A true JPH078296A (en) | 1995-01-13 |
| JP3210142B2 JP3210142B2 (en) | 2001-09-17 |
Family
ID=15596429
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP15499693A Expired - Fee Related JP3210142B2 (en) | 1993-06-25 | 1993-06-25 | Bacterial control confirmation test method, medium used for it |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JP3210142B2 (en) |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2017186090A (en) * | 2017-06-29 | 2017-10-12 | 大日本印刷株式会社 | Initial bacterial growth confirmation method in content filling system |
| JP2017186093A (en) * | 2017-06-29 | 2017-10-12 | 大日本印刷株式会社 | Initial bacterial growth confirmation method in content filling system |
| JP2019147630A (en) * | 2019-06-14 | 2019-09-05 | 大日本印刷株式会社 | Initial bacterial growth confirmation method in content filling system |
| EP3428077A4 (en) * | 2016-03-08 | 2019-09-11 | Dai Nippon Printing Co., Ltd. | Method for confirming initial bacteria in content filling system, content filling system verification method, and culture medium |
-
1993
- 1993-06-25 JP JP15499693A patent/JP3210142B2/en not_active Expired - Fee Related
Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP3428077A4 (en) * | 2016-03-08 | 2019-09-11 | Dai Nippon Printing Co., Ltd. | Method for confirming initial bacteria in content filling system, content filling system verification method, and culture medium |
| US10875756B2 (en) | 2016-03-08 | 2020-12-29 | Dai Nippon Printing Co., Ltd. | Initial bacteria confirmation method in content filling system, method for verifying content filling system, and culture medium |
| EP3919395A1 (en) * | 2016-03-08 | 2021-12-08 | Dai Nippon Printing Co., Ltd. | Initial bacteria confirmation method in content filling system, method for verifying content filling system, and culture method |
| EP4212442A1 (en) * | 2016-03-08 | 2023-07-19 | Dai Nippon Printing Co., Ltd. | Initial bacteria confirmation method in content filling system |
| JP2017186090A (en) * | 2017-06-29 | 2017-10-12 | 大日本印刷株式会社 | Initial bacterial growth confirmation method in content filling system |
| JP2017186093A (en) * | 2017-06-29 | 2017-10-12 | 大日本印刷株式会社 | Initial bacterial growth confirmation method in content filling system |
| JP2019147630A (en) * | 2019-06-14 | 2019-09-05 | 大日本印刷株式会社 | Initial bacterial growth confirmation method in content filling system |
Also Published As
| Publication number | Publication date |
|---|---|
| JP3210142B2 (en) | 2001-09-17 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| US6303363B1 (en) | Method for culturing microorganisms in prefilled flexible containers | |
| CN105462824B (en) | Improvements in the use of blood culture media platforms in commercial sterility testing | |
| JPH078296A (en) | Method for controlling, confirming and testing bacterium, culture medium and container used therefor | |
| CN105219634B (en) | The more ring test pieces of microbial rapid detection, aseptic culture medium and preparation method thereof | |
| EP3714897B1 (en) | Artificial sputum, method of producing an artificial sputum | |
| CN102356777A (en) | Production method of honey yoghurt | |
| Ahvenainen et al. | The effect of microhole size and foodstuff on the microbial integrity of aseptic plastic cups | |
| JP5015522B2 (en) | Microbiological testing method for food and drink | |
| Entis | Food microbiology: the laboratory | |
| CN108414763B (en) | Chlortetracycline hydrochloride bacterial endotoxin detection equipment and method | |
| JP2001114339A (en) | Sterilized culture medium packaging product | |
| JP3921049B2 (en) | Production method of instant medium containing agar | |
| CN104531830B (en) | A kind of resistance bacterium property detection method of film dressing class product in humid conditions | |
| AU2003252835B2 (en) | Method for culturing microorganisms in prefilled flexible containers | |
| JP2004229587A (en) | Method for inspecting microorganism | |
| SU955570A1 (en) | Method for preparing vaccine against trichophytosis of cattle | |
| Petrus et al. | Testing a small scale aseptic system for milk in plastic bottles | |
| Halls | Media Fills and Their Applications | |
| Chauhan et al. | Microbiological Methods for Pharmaceutical Analysis | |
| CN107245511A (en) | The method of bottle placer sterile system challenge experiment | |
| MENTIOHIED | TO BE CONSIDERED WHEN INSPECTING PREMISES WHERE P00D IS HANDLED, PRO | |
| JPS6211089A (en) | Method of preparing medium for microorganism | |
| Aaron | Lethality of various F0 values on spores of putrefactive anaerobe 3679 and thermophils in chocolate milk drink | |
| Moore et al. | Laboratory manual in general and pathogenic bacteriology and immunity | |
| CN101845389A (en) | Method for producing bottles for testing total number of bacteria in drinking water |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| LAPS | Cancellation because of no payment of annual fees |