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CA1170152A - Sterilization indicator - Google Patents

Sterilization indicator

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Publication number
CA1170152A
CA1170152A CA000394343A CA394343A CA1170152A CA 1170152 A CA1170152 A CA 1170152A CA 000394343 A CA000394343 A CA 000394343A CA 394343 A CA394343 A CA 394343A CA 1170152 A CA1170152 A CA 1170152A
Authority
CA
Canada
Prior art keywords
indicator
sterilizing
temperature
culture medium
recited
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.)
Expired
Application number
CA000394343A
Other languages
French (fr)
Inventor
Frank E. Halleck
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
American Sterilizer Co
Original Assignee
American Sterilizer Co
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by American Sterilizer Co filed Critical American Sterilizer Co
Priority to CA000394343A priority Critical patent/CA1170152A/en
Application granted granted Critical
Publication of CA1170152A publication Critical patent/CA1170152A/en
Expired legal-status Critical Current

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  • Apparatus For Disinfection Or Sterilisation (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)

Abstract

ABSTRACT
A sterilization indicator that yields immediate visual post sterilization evidence of attainment of sterilization parameters by the change of a chemical indicator and time verification of destruction of spores by subsequent culture and incubation of organisms.

Description

8 The invention relates to the development of a specialized sterilization 9 indicator thnt yields post sterilization evidence of attainment of certQin sterilizationll 10 parameters by: (1) the change of a chemical indicator to give immediate visual I
11 ¦ indication of achievement of the desired temperature, and (2) biological verificationl 12 of the destruction of the spores conta;ned therein by the subsequent incubation of ¦
13 these indicator organisms. The specification of the chemical indicator, or melt pellet¦
14 in the sealed glass vial is such that the change takes place after achieving the desired 15 sterilization temperature, i.e. 250 F (121 C), 270 F (132 C), or 285 F (141 C), for a 16 defined period of time, thereby providing visual evidence of achieving sterilization 17 temperature. The biological indicator ampule contains a growth promoting culture 18 medium with a pH indicator or a vital dye selected for the indicator organism and 19 spores of known heat resistance. Change of the pH indicator present in the culture 20 medium and turbidity of the media following incubation are evidence for non-sterility, 21 whereas no color change and lack of turbidity after incubation are evidence for sterility.
22 Three novel applications of this invention are as follows:
23 1. There are, at present, two generally known means for monitoring the 24 ¦ efficacy of a solution sterilization cycle, neither of which is easily carried out. The 26 1I first and most difficult would be seeding a solution to be sterilized with a known 26 l~ amount of spores, sterili~ing the container of solution, recovery and concentration of 27 ¦¦ the spores, and determination of the viability of the spores by various microbiological 28 ¦¦ means.
29 ¦~ 2. The second generally known method would be to fill a solution flask with 30 1 culture medium, seed the media with spores of a known resistance, sterilize the 31 1 container of medium and incubate the -solution flask to determine viability of the 32 ¦ spores following the sterilizati~n cycleO This method has ~he disadvantages of requiring
2 ~:

~ 170~2 1 immediate use of the culture medium to preclude the growth of adventitious¦
2 microorganisms and is costly due to the large quanti~ies of culture medium which~
3 ¦ must be used for such tests. Storage of this type of test container al~o presents al
4 1 I problem in incubation due to their bulk.
I This invention is applicable to monitoring steriliz~tion of solutions by 6 placement of the indicators directly in one or more of the containers of solution being 7 sterilized. Usually one or more of the indicators is employed to monitor a solution~
8 sterilization cycle. It provides a compact and easy-to-use sterilization indicator which j 9 can be evaluated at the point of use, thereby eliminating~ the involved procedures and 10 speeialized equipment required in the commonly used methods described abo~e.
11 3. There is presently no acceptable method for evaluating the efficacy of 12 a washer-sterilizer cycle, due to the filling of the sterilizer ~vith water, or water 13 sprays, during a portion o~ the washer-sterilizer cycle. Such action does destroy the 14 integrity of the packaging commonly used in spore strip type indicators, thus making~
15 them susceptible to post sterilization adventitious contamination and false sterilization 16 test results. The system disclosed herein allows the retention of the stability of the 17 biological and chemical indicator until the sterilization cycle is completed. Placement 18 ¦ of this combined indicator may be accomplished by various means of anchorage, i.e., 19 ¦ tape, clips, or implantation in goods.
20 ¦ Other prior art applications may also be applicable to such a combined and 21 biological system. Such applications might be placement in challenge packs or within 22 other portions of a sterilizer load or such indicators may be used in the evaluation of 23 a dry heat sterilization means.

25 l ' REFERENCE TO P~IOR ART
26 ¦ 1 United States Patent No. 2,854,384 shows a glass ampule conaining two 27 ~ compartments separated by an aperture partition. The aperture is closed by a meltable 28 plug. One compartment contains spores and ~e other contains a culture media.
29 During sterilizdtion, the plug melts and falls into the culture media allowing the spores 30 ¦ to enter the culture media for incubation.

31 Unitefl States Patent No. 3,440,144 discloses an apparatus for testing 32 sterilization including a bag containing a glass ampule with culture medium therein and i 3 ~1'7~ S~

1 a spore strip in the bag. After sterilization, the operator can breal~ the glass ampule~
2 allowing the culture medium to join the spores for incubation.
3 ¦ United States Patent No. 3,661,717 shows a unitary indieator much like the 4 ! preceding indicator.
United States Patent NoO 2,99g,306 shows a spore strip of a common variety.
6 None of the forementioned patents combine both an immediate visual 7 indicator and the confirming biological sterilization indicator.

9 OBJECTS OF T~IE INVENTION
It is ~n object of the present invention to provide an improved sterilization 11 indicator.
12 Another object of the invention is to provide a sterilization indicator that 13 is simple and efficient to use.
14 Another object of the invention is to provide a self-contained indicator system, which is capable of being evaluated and incubated at the point of use, thus 16 1 eliminating procedures requiring a laboratory and microbiologist.
17 Another object of the invention is to provide a sterilization indicator wherein 18 a chemical indicator is isolated from culture media in a sealed glass ampul~. The 19 chemical indicator changes when the ambient media has reached a predetermined temperature level and the media containing spores can be subsequently incubated,21 thereby giving proof positive of the success of the sterilization cycle.
2~ With the above and other objectives in view, the present invention consists 23 of the combination and arrangement of parts hereinafter more fully described, 24 ¦ I illustrated in the acccompanying drawing and more particularly pointed out in the ~5 l l appended claims, it being understood that changes may be made in the form, size, 26 ~ proportions and minor details of construction without departing from the spirit or 27 1 saerificing any of the advantages of the invention.
28 Construction of the indicator is not limited to the chemical indicator being 29 ~ located within the sealed ampule nor within the culture medium. Similar results may 30 1 also be realized by placement of the chemical indicator externally, either separated 31 or attached to the container of culture medium.

170~

2 Figure 1 is a side view of the sterilization ind;cator according to th 3 invention.
4 Figure 2 is a view of the sterilization indicator in a container of solutior to be sterilized.
6 Figure 3 is an enlarged view of the inner vial of the sterilization indicato 7 showing the meltable pellet therein.
8 Figure 4 ;s a view of another embodiment of the invention.
9 Figure 5 is a view of yet another embodiment of the invention.
Figure 6 is a view of another embodiment of the invention.
11 ¦ Figure 7 is a view of another embodiment of the invention. I
12~

14 Now, with more particular reference to the drawings and ~igure 2, th~
invention of the sterilizing indicator is supported in the container 10 which contain~
16 a solution 11 to be sterilized. The combination chemical and biological indicator 12 1q is suspended in the solution 11 by means of a cord 19 supported on the closed end 2C
18 of the combination chemical and biological indicator 12 and attached to the cap 17 19 of the container.
The chemical and biological indicator 12 is made up of an ampule 14, which 21 may be made of glass, sealed with an incubation medium 13 therein, which is a suitable 22 broth that may contain an indicator. E~amples of indicators are pH indicators such 23 as phenol red or brom cresol purple or vital dyes, such as triphenyl tetrazolium chloride.
24 The inner tube 15 is hollow and contains a melt pellet 16. The melt pellet 25 11 16 is loosely rec~eived on the inside of the tube. The melt pellet 16 is adapted to meltl 26 ~ at a predetermined temperature, for example, 250 F, 270 F, or 285 ~ or at some¦
27 I suitable temperature. The broth, or incubation medium, 13 will also contain spores ol 28 a predetermined variety, such as B. stearothermophilus or some other suitable spores.¦
29 The melt pellet 16 may be isolated ~ince it may contain chemical materials that might~
30 be inhibitory to the spores or cidal to the bacterial growth and, therefore, interfere¦

32 with the accuracy of the tests if they were not sealed up in the inner tube 15.
s q 1 ~ 5 ~, When the con~ainel l~ of solution to be ster~ ed is pl~ced in a ste~m 2 sterilizer or suitable thermal controlled chamber and brought up to temperature, and 3 ~ when the central part of the solution reaches a temperature at which the pellet lB
4 will melt, the pellet will melt and this will be visible from outside the container. If!
the melt pellet has not melted, the op~erator is immediately notified that the cycle¦
6 1 was not successful and can resterili~e the solution. Then, when the combination 7 ~ chemical and biological indicator 12 is removed from the container 10 and incubated, 8 if the spores are viable, the vital dye will visually turn color ~nd turbid. If a pH
9 1 indicator is used, viable spores will also cause the solution to change color. If at the 10 1 end of the incubation time, the spores are not viable, no change in clarity, no change 11 ¦ in vital dye or color change will occur and a successful cycle is proven.
12 ¦ The biological test indicator could be used in a washer-sterilizer or other 13 apparatus when it is desirable to get a preliminary indication of the success of a 14 sterilizing cycle. If the pellet is melted, the operator knows immediately that the 15 challenge part of the load has reached sterili~ing temperature and can incubate the 16 indicator to verify the success of the cycle. If the pellet is not melted, the load 17 ¦ can immediately be resterilized.
18 I In the embodiment of the invention shown in Figure 4, we show a biological 1~ I indicator 112, which may be suspended in a solution, such as the solution 11 in Figure 20 ¦ 2. The chemical indicator 112 is made up of an ampule 114, which may be made of 21 I glass, sealed at 120 with an incubation medium 113 therein. This incubation medium 22 ¦~ may be a suitable broth that may contain an indicator. The indicator may be a pH
23 1 indicator, triphenyl tetrazolium chloride or other suitable indicator. The melt pellet 24 jl 116 is adapted to melt at a predetermined temperature, for example, 150 F., 270 F., 25 11 or 285 F. indicating that sueh temperature h~ been reached. The broth or incubation 26 j medium 113 will contain spores of a suitable variety.
27 I Referring to the embodiment of Figure 5, this embodiment of the biological 28 ~ chemical indicator 212 has an upper closed end 220 and contains a broth or incubation 29 medium 213 and a melt pellet 216 is supported inside the container 214.
Referring to the embodiment of the invention of Figure 6, the chemical ~1 biological indicator 312 shows a container 314 contalning a broth 313 and having al 32 suitable temperature indicating material 316 thereinO This could be a filter paper with i O l S 2 1 a temperature sensitive material painted onto it or it could be a material that melts 2 at the predetermined temperature. The ~enclosure 317 separates the material 316 from~
3 the broth 313.
4 In the embodiment of the invention shown in Figure 7, we show the chemical¦
and biological indicator 412 containing the incubation medium 413 inside of the outer~
6 ~ container 414. The container 416 is af Eixed to the outside surface of the container ¦
7 414 and the temperature indicator 417 is housed in the container 416. When the ~
8 temperature surrounding the container 414 reaches a predetermined temperature, thel 9 indicator material 417 wiU so in~licate.
The foregoing specification sets forth the invention in its preferred, practical~
11 forms but the structure shown is capable of modification within a range of equivalents¦
12 without departing from the invention which is to be understood is broadly novel as is¦
13 commensurate with the appended claims.

l8 2a~

31 l

Claims (19)

The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows:
1. A sterilizing indicator comprising, a transparent container, said container containing a liquid culture medium containing viable spores, a temperature indicator, said temperature indicator being substantially surrounded in said liquid culture medium, said temperature indicator being adapted to change in appearance when it reaches a predetermined temperature to indicate whether the temperature has reached said predetermined temperature for a predetermined time, said culture media having indicating means to indicate whether viable spores are present therein when said culture media is incubated.
2. A sterilizing indicator comprising an outer transparent ampule, said outer ampule containing a liquid culture medium containing living spores, an inner ampule in said outer ampule, said inner ampule containing a temperature indicator therein, said inner ampule being sealed whereby said temperature indicator is isolated from said liquid culture medium, said temperature indicator being adapted to change in appearance at a predetermined temperature to indicate whether the temperature of said liquid medium inside said inner ampule and in said liquid medium has reached said predetermined temperature, said liquid culture medium having indicating means therein to indicate whether viable spores are present therein when said culture media is incubated after said outer ampule has been exposed to sterilizing conditions.
3. The sterilizing indicator recited in Claim 1 wherein said indicating means comprises, a pH indicator.
4. The sterilizing indicator recited in Claim 2 wherein said indicating means comprises, a pH indicator.
5. The sterilizing indicator recited in Claim 1 wherein said indicating means comprises, triphenyl tetrazolium chloride.
6. The sterlizing indicator recited in Claim 1 wherein said culture medium contains material that is adapted to have a cloudy appearance as a result of being incubated with said viable spores therein.
7. The sterilizing indicator recited in Claim 6 wherein said culture medium contains material that is adapted to have a cloudy appearance as a result of being incubated with viable spores therein.
8. The sterilizing indicator recited in Claim 7 wherein said viable spores comprise, bacillus stearothermophilus.
9. The sterilizing indicator recited in Claim 8 wherein said viable spores comprise, aerobic or anaerobic spore formers.
10. The sterilizing indicator recited in Claim 9 wherein said viable spores comprise, bacillus stearothermophilus.
11. The sterilizing indicator recited in Claim 10 wherein said viable spores are taken from the group of Bacillus stearothermophilus, Clostridium sporogenes, Clostridium thermosacharolyticum, Bacillus subtilus, or Putrefactive anaerobe 3679.
12. The sterilizing indicator recited in Claim 11 wherein said viable spores comprise, aerobic or anaerobic spore formers.
13. The sterilizing indicator recited in Claim 2 wherein said viable spores are taken from the group of Bacillus stearothermophilus, Clostridium sporogenes, clostridium thermosacharolyticum, Bacillus subtilus, and Putrefactive anaerobe 3679.
14. The sterilizing indicator recited in Claim 1 wherein said temperature indicator is made up of a material that is non-toxic to said spores.
15. The sterilizing indicator recited in Claim 2 wherein said inner ampule is substantially submerged in said culture medium.
16. A method of testing a moist environment in a container to determine if a sterilizing procedure has been successful comprising, placing in said container a transparent ampule containing a liquid culture medium and spores in said culture medium and a sealed tube containing a melt pellet in said culture medium adapted to melt at a predetermined temperature, exposing said container to sterilizing conditions of temperature and time, if said pellet has melted, incubating said vial for a predetermined time whereby said liquid indicates that said spores have been killed and said procedure has been successful.
17. A method of testing a moist environment in a container to determine if a sterilizing procedure in said container has been successful comprising, placing in said container an ampule containing a liquid culture medium and spores in said culture medium, a temperature indicator disposed in said liquid culture medium adapted to change in appearance at a predetermined temperature in said container, exposing said container to sterilizing conditions of temperature and time, observing said temperature indicator and if said chemical indicator has changed, incubating said ampule for a predetermined time whereby said liquid indicates whether said spores have been killed and said procedure has been successful.
18. The method recited in Claim 17 wherein said temperature indicator comprises, a meltable pellet.
19. The method recited in Claim 18 wherein said indicator is a pellet placed inside said ampule in said culture medium.
CA000394343A 1982-01-18 1982-01-18 Sterilization indicator Expired CA1170152A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA000394343A CA1170152A (en) 1982-01-18 1982-01-18 Sterilization indicator

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CA000394343A CA1170152A (en) 1982-01-18 1982-01-18 Sterilization indicator

Publications (1)

Publication Number Publication Date
CA1170152A true CA1170152A (en) 1984-07-03

Family

ID=4121843

Family Applications (1)

Application Number Title Priority Date Filing Date
CA000394343A Expired CA1170152A (en) 1982-01-18 1982-01-18 Sterilization indicator

Country Status (1)

Country Link
CA (1) CA1170152A (en)

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