JPS5997664A - Biological indicator and production thereof - Google Patents
Biological indicator and production thereofInfo
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- JPS5997664A JPS5997664A JP57207314A JP20731482A JPS5997664A JP S5997664 A JPS5997664 A JP S5997664A JP 57207314 A JP57207314 A JP 57207314A JP 20731482 A JP20731482 A JP 20731482A JP S5997664 A JPS5997664 A JP S5997664A
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Abstract
(57)【要約】本公報は電子出願前の出願データであるた
め要約のデータは記録されません。(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.
Description
【発明の詳細な説明】
１、発明の背景
技術分野
本発明は滅菌における生物学的インジケーターおよびそ
の製法に関するものである。DETAILED DESCRIPTION OF THE INVENTION 1. Background of the Invention Technical Field The present invention relates to a biological indicator for sterilization and a method for producing the same.
さらに詳しくは、バチルス サブチリス（Ｂａｃｉｌｌ
ｕｓ ５ｕｂｔｉｌｉｓ ） ｆ担体に担持させてなる
滅菌における一定したＤ値を有する生物学的インノケー
ターおよびその製法に関する。For more information, see Bacillus subtilis
The present invention relates to a biological innovator having a constant D value during sterilization, which is supported on a carrier (US 5ubtilis), and a method for producing the same.
医療器具等の滅菌は、高圧蒸気を使用するオートクレー
ブ滅菌法やエチレンオキサイドガス（ＥＯＧ ）を使用
するガス滅菌法により行なわれる。Sterilization of medical instruments and the like is performed by autoclave sterilization using high-pressure steam or gas sterilization using ethylene oxide gas (EOG).
その際、滅菌の程度を知るために生物学的インジケータ
ーが使用される。この生物学的インジケーターとしては
、濾紙上にバチルス サブチリス等の胞子の懸濁液を濾
紙−片当シの胞子数か１０〜１０６個となるように濾紙
に吸収させて、乾燥させたものがある。使用に際しては
、この濾紙片を被滅菌物とともに滅菌処理し、その後、
該濾紙片に付着した胞子を過当な培地で培養し、培養に
よって微生物が生育すれば滅菌が不充分であると判定さ
れ、微生物が生育しなければ滅菌が完全であると判定さ
れる。このような生物学的インジケーターにおいて指標
菌として使用される菌は、一定の滅菌条件下−では常に
一定数の菌が死滅するようなものでなければならない。Biological indicators are used to determine the degree of sterilization. This biological indicator is made by absorbing a suspension of spores such as Bacillus subtilis onto a filter paper so that the number of spores per piece of filter paper is 10 to 106, and then drying it. . Before use, this piece of filter paper is sterilized together with the object to be sterilized, and then
The spores attached to the filter paper pieces are cultured in an appropriate medium, and if microorganisms grow during the culture, it is determined that sterilization is insufficient, and if no microorganisms grow, it is determined that sterilization is complete. Bacteria used as indicator bacteria in such biological indicators must be such that a certain number of bacteria always die under certain sterilization conditions.
このような指標菌の力価を表わす数値としてＤ値（Ｄｅ
ｃｉｍａｌ ｒｅｄｕｃｔｉｏｎｖａｌｕｅ ）がある
。Ｄ値とは一定の滅菌条件下で最初の菌数の１／１０に
減少（９０係死滅）させるのに必要な時間を意味する。The D value (De
cimal reductionvalue). The D value means the time required to reduce the number of bacteria to 1/10 of the original number (90 times killed) under certain sterilization conditions.
そこで生物学的インジケーターの信頼度を高めるために
は、できるだけ・々うつきの少ないＤ値を与える生物学
的インジケーターが要求される。Therefore, in order to increase the reliability of a biological indicator, a biological indicator that provides a D value with as little bias as possible is required.
先行技術および問題点
従来、バチルス サブチリスは、エチレンオキサイドガ
ス滅菌法における指標菌として使用されているが、それ
を担持させた生物学的インジケーターのＤ値は必ずしも
一定ではなく、より ノｓ”ｌうつきの少ないものが要
望されていた。Prior Art and Problems Conventionally, Bacillus subtilis has been used as an indicator bacterium in ethylene oxide gas sterilization, but the D value of the biological indicator carrying it is not necessarily constant and is more There was a demand for something with less stickiness.
■１発明の目的
そこで本発明者等は、可及的に・ぐうつきの少ないＤ値
を有する生物学的インジケーターを提供すべく鋭意研究
を重ねた結果、本発明を完成させた。(1) Purpose of the Invention Therefore, the present inventors have completed the present invention as a result of extensive research in order to provide a biological indicator having a D value with as little dullness as possible.
即ち、本発明の目的は、次の各項記載の構成を有する生
物学的インジケーターおよびその製法によって達成され
る。That is, the object of the present invention is achieved by a biological indicator having the structure described in each of the following sections and a method for producing the same.
（１）バチルス サブチリス（Ｂａｃｉｌｌｕｓ ５ｕ
ｂｔｉｌｉｓ ）を担体に担持させてなる滅菌における
一定したＤ値を有する生物学的インジケーター。(1) Bacillus subtilis (Bacillus 5u)
1. A biological indicator having a constant D value during sterilization, which is obtained by supporting S. btilis on a carrier.
（２）前記り値が７．５５±１．２８分（９５チ信頼限
界）である第１項記載の生物学的インジケーター。(2) The biological indicator according to item 1, wherein the residual value is 7.55±1.28 minutes (95-chip confidence limit).
（３）前記り値が１．５７±１．２８分（−９５チ信頼
限界）である第１項記載の生物学的インジケーター。(3) The biological indicator according to item 1, wherein the residual value is 1.57±1.28 minutes (-95 confidence limit).
（４）前記り値が３．０３±１．２８分（９５チ信頼限
界）である第１項記載の生物学的インジケーター。(4) The biological indicator according to item 1, wherein the residual value is 3.03±1.28 minutes (95-chip confidence limit).
（５）前記担体が沢紙片である第１項乃至第４項のいず
れか゛の項に記載の生物学的インジケーター。(5) The biological indicator according to any one of items 1 to 4, wherein the carrier is a piece of paper.
（６）バチルス サブチリス（Ｂａｃｉｌｌｕｓ ５ｕ
ｂｔｉｌｉｓ ）の保存株をトリプトソイ寒天培地で増
菌培養し、得られた菌体を普通寒天培地に塗抹して培養
し、得られた菌体を適当な溶媒に懸濁させ、得られた菌
懸濁液を冷所に放置し、菌体の一定数を担体に担持させ
、次いでこれを乾燥させる滅菌における生物学的インジ
ケーターの製法において、増菌培養の温度および時間並
びに１５１体を担体に担持させた後の乾燥の温度および
時間を一定とすることを特徴とする滅菌における一定し
たＤ値を有する生物学的インジケーターの製法。(6) Bacillus subtilis (Bacillus 5u)
btilis) is enriched on a trypto-soy agar medium, the resulting bacterial cells are smeared onto an ordinary agar medium and cultured, the resulting bacterial cells are suspended in an appropriate solvent, and the resulting bacterial suspension is cultured. A method for producing a biological indicator in sterilization in which a suspension is left in a cool place, a certain number of bacterial cells are supported on a carrier, and then this is dried. A method for producing a biological indicator having a constant D value during sterilization, characterized in that the drying temperature and time after drying are constant.
（７ン 前記増菌培養の温度および時間を約３１℃で
約２４時間とし、懸濁溶媒として生理食塩水を使用し、
ツ燥の温度および時間を室温乃至約３７℃で約１週間と
することによ！ｌｌＤ値７．５５±１．２８分（９５係
信頼限界）を有する第６項記載の生物学的インジケータ
ーの製法。(7) The temperature and time of the enrichment culture were set at about 31°C for about 24 hours, using physiological saline as a suspension medium,
By setting the temperature and time of drying at room temperature to about 37°C for about one week! 7. A method for producing a biological indicator according to claim 6, having an LLD value of 7.55±1.28 minutes (95-fold confidence limit).
（８）前記増菌培養の温度および時間を約３７℃で約４
８時間とし、懸濁溶媒として０．１％可溶性澱粉液を使
用し、乾燥の温度および時間を室温乃至約３７℃で約１
週間とすることによｐＤ値１５７±１．２８分（９５襲
信頼限界）を有する第６項記載の生物学的インジケータ
ーの製法。(8) The temperature and time of the enrichment culture is about 37°C for about 4 hours.
8 hours, using 0.1% soluble starch solution as the suspending solvent, and drying temperature and time at room temperature to about 37°C for about 1 hour.
7. The method for producing the biological indicator according to item 6, which has a pD value of 157±1.28 minutes (95 times confidence limit) when measured in weeks.
（９）前記増菌培養の温度および時間を約３１℃で約２
４時間とし、懸濁溶媒として０１係可溶性澱粉液を使用
し、乾燥の温度および時間を室温乃至約３７℃で約１週
間とすることによりＤ値３．０３±１．２８分（９５チ
信頓限界）を有する第６項記載の生物学的インジケータ
ーの製法。(9) The temperature and time of the enrichment culture is about 31°C for about 2 hours.
By using the 01 soluble starch solution as the suspension solvent and the drying temperature and time at room temperature to about 37°C for about 1 week, the D value was 3.03±1.28 minutes (95% 7. The method for producing the biological indicator according to item 6, which has
ＩＩｌ、 発明の詳細な説明
本発明の生物学的インジケーターは、バチルスサブチリ
ス（Ｂａｃｉｌｌｕｓ ５ｕｂｔｉｌｕｓ ）の保存株
をトリプトソイ寒天培地で一定の温度および時間で増菌
培養し、得られた菌体を適当な一定の溶媒に懸濁させ、
得られた菌懸濁液を冷所（例えば４℃）に放置し、菌体
の一定数を担体に担持させ、次いで、これを一定の温度
および時間で乾燥させることによって製造される。IIl. Detailed Description of the Invention The biological indicator of the present invention is obtained by enriching and cultivating a stock strain of Bacillus subtilis on a trypto soy agar medium at a constant temperature and time, and incubating the resulting bacterial cells with an appropriate culture. Suspended in a certain solvent,
It is produced by leaving the obtained bacterial suspension in a cool place (for example, 4° C.) to support a certain number of bacterial cells on a carrier, and then drying this at a certain temperature and time.
上記製法において、増菌培養の温度および時間を約３１
℃で約２４時間とし、懸濁溶媒として生理食塩水を使用
し、乾燥の温度および時間を室温乃至約３７℃で約１週
間とすると、Ｄ値７，５５±１２８分（９５チ信頼限界
）を有する生物学的インジケーターが得られる。増菌培
養の温度および時間を約３７℃で約４８時間とし、懸濁
溶媒として０．１％可溶性澱粉液を使用し、乾燥の温度
および時間を室温乃至約３７℃で約１週間とすると、Ｄ
値１．５７±１．２８分（９５％信頼限界）を有する生
物学的インジケーターが得られる。In the above production method, the temperature and time for enrichment culture are approximately 31
℃ for about 24 hours, using physiological saline as the suspension medium, and drying temperature and time for about 1 week at room temperature to about 37℃, the D value is 7,55 ± 128 minutes (95 chi confidence limit). A biological indicator having the following properties is obtained. When the enrichment culture temperature and time are about 48 hours at about 37 ° C., 0.1% soluble starch solution is used as a suspending medium, and the drying temperature and time is about 1 week at room temperature to about 37 ° C. D
A biological indicator with a value of 1.57±1.28 minutes (95% confidence limits) is obtained.
増菌培養の温度および時間を約３１℃で約２４時間とし
、懸濁溶媒として０．１％可溶性澱粉液を使用し、乾燥
の温度および時間を室温乃至約３７℃で約１週間とする
ことによりＤ値３．０３±１．２８分（９５％信頼限界
）を有する生物学的インジケーターが得られる。本発明
において担体としては、ｐ紙の外、メンブランフィルタ
−、ガラスフィルター、ザイツフィルター等が使用され
る。The temperature and time for enrichment culture should be about 31°C for about 24 hours, 0.1% soluble starch solution should be used as the suspension medium, and the temperature and time for drying should be about 1 week at room temperature to about 37°C. gives a biological indicator with a D value of 3.03±1.28 minutes (95% confidence limits). In the present invention, as the carrier, in addition to P paper, membrane filters, glass filters, Seitz filters, etc. are used.
次に実施例を示して本発明をさらに具体的に説明する。Next, the present invention will be explained in more detail with reference to Examples.
実施例 。Example .
１ 実験材料および方法
（１）使用菌株
エチレンオキサイドガス滅菌用指標菌としてバチリス
サブチリス（Ｂａｃｉｌｌｕｓ ５ｕｂｔｉｌｉｓ ）
ＡＴＣＣ６６３３株を用いた。1 Experimental materials and methods (1) Bacterial strains used Bacillus as an indicator bacterium for ethylene oxide gas sterilization
Bacillus 5ubtilis
ATCC6633 strain was used.
（２）Ｐ紙片の付着菌数測定法
（１，０５％Ｔｗｅｅｎ ８０加生理食塩水を試験管に
と９．１２１℃、２０分間高圧蒸気滅菌したのち、生物
学的インジケーターを入れ、ホモジナイズする。得られ
た懸濁液を段階希釈し、トリシトソイ寒天培地と混釈し
、３７℃、２４時間培養後、生じたコロニー数を計測す
る。(2) Method for measuring the number of bacteria attached to P paper strips (1.05% Tween 80 saline is placed in a test tube and sterilized with high-pressure steam at 9.121°C for 20 minutes, then a biological indicator is added and homogenized. The obtained suspension is serially diluted, mixed with a trisitosoy agar medium, and after culturing at 37° C. for 24 hours, the number of colonies produced is counted.
（３）菌懸濁液の耐熱性試験法 ９０℃、２０分間処理し、上記菌数測定法に従かう。(3) Heat resistance test method for bacterial suspension Treat at 90°C for 20 minutes and follow the method for measuring the number of bacteria described above.
（４） エチレンオキサイドガス滅菌条件米国薬局方
第２０版（ＵＳＰＸＸ ）に従がい、温度５４℃、湿度
５０％ＲＨ，ガス濃度６００〃曖／ｐの条件で処理する
。(4) Ethylene oxide gas sterilization conditions According to the 20th edition of the United States Pharmacopoeia (USPXX), process at a temperature of 54° C., humidity of 50% RH, and gas concentration of 600 am/p.
（５）Ｄ値測定法
処理条件下で経時的に生残菌数を測定し、その生残曲線
より求めた。(5) D value measurement method The number of surviving bacteria was measured over time under treatment conditions and determined from the survival curve.
（６） 力 価
力価の標準値としては、ＵＳＰＸＸに従がい、エチレン
オキサイドガス滅菌用としてはＤ値３分を目安として用
いた。(6) Titer The standard value of titer was in accordance with USPXX, and a D value of 3 minutes was used as a guideline for sterilization with ethylene oxide gas.
（力 検討因子 インジケーターの調製手順は次の通りである。(Power consideration factor The procedure for preparing the indicator is as follows.
保存株ヲトリゾトンイ寒天培地で３７℃、２４時間前培
養後、普通寒天培地に塗抹して培養後、適切な溶媒にて
菌ｊけ濁液を調製し、冷所（４℃）に一定時間放置する
。得られた懸濁液の生菌数測定、耐熱性試験を実施後、
濾紙（商品名：東洋濾紙Ａｉｊ（５Ｘ３５％））に１０
６個／ペーノや−となるよう付着させ、１週間乾燥する
。この一連の操作の中で、普通寒天培地での培養時間、
及び温度、菌懸濁液の溶媒の種類、冷所放置時間、及び
乾燥温度の５因子をとり挙げＬ１６直交表に割りつけた
。溶媒の種類及び培養時間については、他因子との間の
交互作用も検討することにした。各因子は２水準を設定
し、その内容は次の通りである。After pre-culturing the stock stock on an agar medium at 37°C for 24 hours, smear it on an ordinary agar medium and culture it. Prepare a bacterial suspension with an appropriate solvent and leave it in a cool place (4°C) for a certain period of time. . After measuring the number of viable bacteria and conducting a heat resistance test on the resulting suspension,
10 on filter paper (product name: Toyo Roshi Aij (5X35%))
It is attached so that 6 pieces/peno or - are attached and dried for one week. In this series of operations, the culture time on ordinary agar medium,
The following five factors were selected and assigned to an L16 orthogonal array: temperature, type of solvent for the bacterial suspension, time for standing in a cold place, and drying temperature. Regarding the type of solvent and culture time, we decided to examine the interaction with other factors. Two levels are set for each factor, and the contents are as follows.
因子Ａ 懸濁液の種類：Ａ、：０．１％澱粉液Ａ２；生
理食塩液
Ｂ 培養時間 ： Ｂ、； ２４時間Ｂ２；４８時間
Ｃ冷所放置時間：Ｃ１；２４時間
Ｃ２；４８時間
Ｄ 培養温度 ：Ｄ、；３１℃
Ｄ２；３７℃
Ｅ 乾燥温度 ：Ｅ、；室温（２２℃）Ｅ２；３７℃
交互作用 ＡＸＢ、ＡＸＣ，ＡＸＤ、ＡＸＥ、ＢＸＣ。Factor A Suspension type: A,: 0.1% starch solution A2; Physiological saline solution B Culture time: B,; 24 hours B2; 48 hours C Cooling time: C1; 24 hours C2; 48 hours D Culture temperature: D; 31°C D2; 37°C E Drying temperature: E; room temperature (22°C) E2; 37°C Interaction AXB, AXC, AXD, AXE, BXC.
ＸＤ ２、実験結果 測定結果は、Ｄ値を計算して表−１にまとめた。XD 2. Experimental results The measurement results were summarized in Table 1 by calculating the D value.
得られた数値を用い七分散分析を行うと表−２の如くな
９、懸濁液の溶媒差（ト）、培養時間（Ｂ）、培養温度
（Ｄ）に有意差が認められ、交互作用としては、懸濁液
の溶媒差と乾燥温度との間、及び培養温度と時間との間
に有意差が認められた。これら、因子Ａ、Ｂ、Ｄについ
て相対的な水準間の差を示したものが図−１である。Using the obtained values, a seven variance analysis was performed, and as shown in Table 2, significant differences were observed in the suspension solvent difference (G), culture time (B), and culture temperature (D), indicating an interaction effect. As a result, significant differences were observed between the difference in the solvent of the suspension and the drying temperature, as well as between the culture temperature and time. Figure 1 shows the relative level differences for these factors A, B, and D.
、 ６
碧
叶ニ
ＩＶ、 発明の具体的効果
上に詳述したように、本発明によれば、バチルス サブ
チリスを担体に担持させてなる滅菌における一定したＤ
値を有する生物学的インジケーターおよびその製法が提
供される。, 6 Aoi Kano Ni IV, Specific Effects of the Invention As detailed above, according to the present invention, a constant D during sterilization is obtained by carrying Bacillus subtilis on a carrier.
Biological indicators having a value and methods for making the same are provided.
本発明によれば、さらに、上記り値がそれぞれ７．５５
±１２８分（９５％信頼限界、以下同じ）、１．５７±
１．２８分、３．０３±１．２８分である生物学的イン
ジケーターおよびその製法が提供される。According to the present invention, each of the above values is 7.55.
±128 minutes (95% confidence limit, same below), 1.57±
1.28 minutes, 3.03±1.28 minutes, and methods for making the same are provided.
特許出願人 テルモ株式会社
手 続 補 正 書く方式）
％式％
ｌ、事件の表示
昭和５７年特許＃１２０７３１４号
２ 発明の名称
生物学的イン７ケーターおよびその製法３、補正をする
者
！Ｓｆ件との関係 特許出願人
住所 東京都渋谷区幅ケ谷２丁目４４．’１９１号名称
テルモ株式会社
代表取締役 戸澤三Ｈ１゜
埋入 〒１０５
住所 東京都港区虎ノ門１丁目２番１６号渡辺ビル
電話（５９５）２３１１ｔ８（発送日 昭和５８年２月
２２日）
６．補正の対象
明細書の「発明の詳細な説明」および「図面の簡単な説
明」の欄並びに図面。Patent Applicant Terumo Corporation Procedures Amendment Writing Method) % Formula % l, Display of the Case 1982 Patent #1207314 2 Name of the Invention Biological Indicator 7 and its Manufacturing Process 3, Person Making the Amendment! Relationship with Case Sf Patent applicant address 2-44, Habagaya, Shibuya-ku, Tokyo. '191 Name Terumo Corporation Representative Director San H1゜ Tozawa Embedded 105 Address Watanabe Building, 1-2-16 Toranomon, Minato-ku, Tokyo
Telephone (595) 2311t8 (Shipping date: February 22, 1982) 6. The "Detailed Description of the Invention" and "Brief Description of the Drawings" columns and drawings of the specification to be amended.
７、補正の内容 別紙の通り。7. Contents of correction As per attached sheet.
１、明細書第１２頁第１１行の「図−１」を「第１図乃
至第３図」と訂正する。1. "Figure 1" on page 12, line 11 of the specification is corrected to "Figures 1 to 3."
２ 同第１５頁の図−１を全部削除する。2. Delete all of Figure 1 on page 15.
３、同第１６頁第９行目の次に以下の文章を挿入する。3. Insert the following sentence next to the 9th line of page 16.
「４、図面の簡単な説明
第１１、第２図およびＮＩＪ３図はそれぞれ溶媒差（因
子Ａ）、培養時間（因子Ｂ）および培養温度（因子Ｄ）
における水準間の差を示すグラフである。」
４、別紙の図面（第１図乃至第３［Δ）を明細書に添付
する。4. Brief explanation of the drawings 11. Fig. 2 and NIJ Fig. 3 show solvent difference (factor A), culture time (factor B), and culture temperature (factor D), respectively.
It is a graph showing the difference between levels in . ” 4. The attached drawings (Figures 1 to 3 [Δ)] are attached to the specification.
以−Ｌ
第１図
り一値（分） 山“”″′第２図 第
り一値（分） Ｄ−値（分）
９５ａ／ａ信頼限界
３図-L 1st value (minutes) 2nd value (minutes) D-value (minutes)
95a/a confidence limit diagram 3
Claims (1)
ｂｔｉｌｉｓ）を担体に担持させてなる滅菌における一
定したＤ値を有する生物学的インジケーター。 （２）前記り値が７．５５±１．２８分（９５チ信頼限
界）である特許請求の範囲第１項記載の生物学的インジ
ケーター。 （３）前記り値が１．５７±１．２８分（９５チ信頼限
界）である特許請求の範囲第１項記載の生物学的インジ
ケーター。 （４）前記り値が３．０３±１．２８分（９５％信頼限
界）である特許請求の範囲第１項記載の生物学的インジ
ケーター。 （５）前記担体が濾紙片である特許請求の範囲第１項乃
至第４項のいずれかの項に記載の生物学的インジケータ
ー。 の保存株をトリットソイ寒天培地で増菌培養し、得られ
た菌体を普通寒天培地に塗抹して培養し、得られた菌体
を適当な溶媒に懸濁させ、得られた菌懸濁液を冷所に放
置し、菌体の一定数を担体に担持させ、次いでこれを乾
燥させる滅菌における生物学的インジケーターの製法に
おいて、増菌培養の温度および時間、懸濁溶媒並びに菌
体を担体に担持させた後の乾燥の温度および時間を一定
とすることを特徴とする滅菌における一定したＤ値を有
する生物学的インジケーターの製法。 （７）前記増菌培養の温度および時間を約３１℃で約２
４時間とし、懸濁溶媒として生理食塩水を使用し、乾燥
の温度および時間を室温乃至約３７℃で約１週間とする
ことによりＤ値７．５５±１．２８分（９５％信頼限界
）を有する特許請求の範囲第６項記載の生物学的インジ
ケーターの製法。 （８） 前記増菌培養の温度および時間を約３７℃で
約４８時間とし、懸濁溶媒として０．１多可溶性澱粉液
を使用し、乾燥の温度および時間を室温乃至約３７℃で
約１週間とすることによりＤ値１．５７±１．２８分（
９５％信頼限界）を有する特許請求の範囲第６項記載の
生物学的インジケーターの製法。 （９）前記増菌培養の温度および時間を約３１℃で約２
４時間とし、懸濁溶媒として０．１％可溶性澱粉液を使
用し、乾燥の温度および時間を室温乃至約３７℃で約１
週間とすることによシＤ値３．０３±１．２８分（９５
％信頼限界）を有する特許請求の範囲第６項記載の生物
学的インジケーターの製法。[Claims] (1) Bacillus subtilis (Bacillus 5u)
1. A biological indicator having a constant D value during sterilization, which is made by supporting S. btilis) on a carrier. (2) The biological indicator according to claim 1, wherein the error value is 7.55±1.28 minutes (95-bit confidence limit). (3) The biological indicator according to claim 1, wherein the error value is 1.57±1.28 minutes (95-chip confidence limit). (4) The biological indicator according to claim 1, wherein the error value is 3.03±1.28 minutes (95% confidence limit). (5) The biological indicator according to any one of claims 1 to 4, wherein the carrier is a piece of filter paper. The stock strain is enriched and cultivated on a Tritto soy agar medium, the resulting bacterial cells are smeared onto an ordinary agar medium and cultured, and the resulting bacterial cells are suspended in an appropriate solvent to create a bacterial suspension. In the production method of biological indicators in sterilization, which involves leaving the cellulose in a cool place, allowing a certain number of bacterial cells to be carried on the carrier, and then drying the carrier, the temperature and time of the enrichment culture, the suspending solvent, and the bacterial cells on the carrier are determined. A method for producing a biological indicator having a constant D value during sterilization, which comprises keeping the drying temperature and time constant after loading. (7) The temperature and time of the enrichment culture is about 31°C for about 2 hours.
By using physiological saline as the suspension medium and drying temperature and time at room temperature to about 37°C for about 1 week, the D value was 7.55 ± 1.28 minutes (95% confidence limit). A method for producing a biological indicator according to claim 6. (8) The enrichment culture temperature and time were set at about 37°C for about 48 hours, a 0.1% soluble starch solution was used as the suspension solvent, and the drying temperature and time was set at about 1% at room temperature to about 37°C. By setting it as a week, the D value is 1.57 ± 1.28 minutes (
95% confidence limit). (9) The temperature and time of the enrichment culture is about 31°C for about 2 hours.
4 hours, using 0.1% soluble starch solution as the suspending solvent, and drying temperature and time at room temperature to about 37°C for about 1 hour.
Weekly D value 3.03±1.28 minutes (95
% confidence limit).
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP57207314A JPS5997664A (en) | 1982-11-26 | 1982-11-26 | Biological indicator and production thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP57207314A JPS5997664A (en) | 1982-11-26 | 1982-11-26 | Biological indicator and production thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPS5997664A true JPS5997664A (en) | 1984-06-05 |
| JPH0325160B2 JPH0325160B2 (en) | 1991-04-05 |
Family
ID=16537714
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP57207314A Granted JPS5997664A (en) | 1982-11-26 | 1982-11-26 | Biological indicator and production thereof |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JPS5997664A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS62130634U (en) * | 1986-02-10 | 1987-08-18 |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS5741920A (en) * | 1980-08-27 | 1982-03-09 | Mitsubishi Electric Corp | Manufacture of fiber-reinforced plastic product |
-
1982
- 1982-11-26 JP JP57207314A patent/JPS5997664A/en active Granted
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS5741920A (en) * | 1980-08-27 | 1982-03-09 | Mitsubishi Electric Corp | Manufacture of fiber-reinforced plastic product |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS62130634U (en) * | 1986-02-10 | 1987-08-18 | ||
| JPH0438835Y2 (en) * | 1986-02-10 | 1992-09-10 |
Also Published As
| Publication number | Publication date |
|---|---|
| JPH0325160B2 (en) | 1991-04-05 |
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