US3711378A - Microbiological-scaled sterility controls - Google Patents
Microbiological-scaled sterility controls Download PDFInfo
- Publication number
- US3711378A US3711378A US00857668A US3711378DA US3711378A US 3711378 A US3711378 A US 3711378A US 00857668 A US00857668 A US 00857668A US 3711378D A US3711378D A US 3711378DA US 3711378 A US3711378 A US 3711378A
- Authority
- US
- United States
- Prior art keywords
- strips
- sterilizing
- spore
- population
- sterility
- 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 - Lifetime
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Classifications
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
- C12Q1/02—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving viable microorganisms
- C12Q1/22—Testing for sterility conditions
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S435/00—Chemistry: molecular biology and microbiology
- Y10S435/805—Test papers
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S435/00—Chemistry: molecular biology and microbiology
- Y10S435/81—Packaged device or kit
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S435/00—Chemistry: molecular biology and microbiology
- Y10S435/8215—Microorganisms
- Y10S435/822—Microorganisms using bacteria or actinomycetales
- Y10S435/832—Bacillus
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S435/00—Chemistry: molecular biology and microbiology
- Y10S435/8215—Microorganisms
- Y10S435/822—Microorganisms using bacteria or actinomycetales
- Y10S435/832—Bacillus
- Y10S435/839—Bacillus subtilis
Definitions
- the sterility control is either exposed directly to the active elements of the sterilizing process or the control is placed in the load of materials to be sterilized. The strips are then removed and incubated and studied. The effectiveness of the cycle can be ⁇ concluded from the spore strip containing ⁇ the highest population on which the entire population is killed.
- This invention relates to sterility controls, and more particularly, to control devices for determining the effectiveness of a sterilizing cycle.
- Another object of the invention is to provide an improved control for determining the effectiveness of a sterilizing cycle.
- Another object of the invention is to provide an improved structure of a sterility control.
- Another object of the invention is to provide a sterility control, which is simple in construction, economical to manufacture, and simple and efliicient to use.
- Another object of the invention is to provide an improved method of controlling a sterilizing process in a sterilizer.
- a method which enables an operator or manufacturer of sterile disposables to evaluate the effectiveness and/or eiciency of the sterilizing process.
- this method it is possible to determine (1) whether the conditions of the process are capable of achieving sterility, (2) whether the Iconditions of the process will achieve sterility each time the process is conducted, and (3) whether some safety factor, such as increased exposure time or increased temperature, should be considered in order to attain sterility and/or reproducibility of results.
- the bacterial spore-impregnated strips employed in this method, are prepared in a manner similar to currently used spore strips with one exception.
- a total of seven spore strips are prepared as a set with each strip containing a different concentration or population of bacterial spores, i.e., the first strip will contain a population of 1 10z bacterial spores, the second strip will contain a population of 1 103 spores, and so on until the final or seventh strip will contain a population of 1 108 bacterial spores.
- the organism used in this method comprises albacterial sporeforming specie known to be resistant to the sterilizing process being used or tested.
- the bacterial specie used to test the eiiiciency of a steam sterilizing proc'- ess is usually Bacillus stearothermophilus, while Bacillus subtilis var. niger is more commonly employed to test the efiiciency of such sterilizing processes as dry heat or ethylene oxide.
- the microbiological-scaled sterility controls are exposed either directlyto the sterilization process or are placed in the load of materials to be sterilized.
- the sterilization process is conducted in the usual manner following which the sterility controls are removed from the sterilizing apparatus or the load, aseptically removed from their respective glassine envelopes and cultured in tubes of recommended bacteriological culture media.
- the tubes are then incubated at the optimum temperature of the test organism (usually stipulated on the glassine envelope) for a period of seven days. Results are recorded in terms of growth or no growth.
- the effectiveness and/or efficiency of the sterilizing process under the conditions employed can be determined.
- the sterilizing conditions used are capable of sterilizing materials containing microbial contamination levels up through 1 10 organisms. If successive tests produce the same result, it can be concluded that the conditions of the sterilizing process are reproducible and will provide consecutive sterilizing cycles. However, if the above results are not achieved in each successive cycle, it
- Test strips have been used for various purposes to indicate various intensities of process, for example, Pat. 3,245,- S82.l discloses a test strip for testing the phenylalanine in blood.
- FIG. 1 isfan isometric view of one embodiment of the invention.
- FIG. 2 is a top view of another embodiment of the invention.
- FIG. 3 is a cross-sectional view taken on line 3 3 of FIG-2. f
- FIG. 4 is a cross-sectional view taken on line 4--4 of FIG. 2.
- FIG. 5 is aview showing the embodiment of FIG. v2 folded.
- FIG. 6 is a view showing the embodiment of FIG. '2 formed into a roll.
- the glassine envelopes are indicated at 10. They are divided into containers 11, 12, 13, l14, 15, 16, 17, and 18 by they scored lines 19, 20,21, 22, 23, and 24.
- the material which makes up the envelope may be made of a sheet which is folded back on itself at and sealed along lines 26 and 27 by a suitable process.
- a spore carrier 28 will be enclosed in each compartment of the envelope.
- the spore carrier 28 will be specially prepared bacterial spore impregnated strips of lter paper, sealed in the glassine envelopes, and they will be exposed to the condition of sterilizing by placing the envelope 10 either rolled up, as shown in FIG. 6, or folded, as shown in FIG. 5, or lying at as shown in FIG. 2.
- a container 110 which is made of relatively rigid material and which has compartments 111, 112, 113, 114, 115, 116, 117.
- the compartments will each contain at least one bacterial sporey impregnated strip 118, 119, 120, 121, 122, 123, and 124.
- the strips will be made according to a well known process, such as for example shown in Pat. No.
- spore strips 118 through 124 will be impregnated with 1 1O2 bacterial spores, 1 103 bacterial spores, 1 104 bacterial spores, on through 1X1()8 bacterial spores, respectively.
- a scored liner 126 formed in the walls of the compartments, by which the upper ⁇ part 127 ofthe container may be removed. The spore strip may then be removed and incubated.
- the container 110 may be molded from a plastic material for example vinyl or polyethylene.
- a method of determining the etfectiveness of a sterilizing cycle comprising providing a set of at least seven spore carrying devices, each having a different sporev population, f
- saidspores are inoculated ⁇ with spores taken from the group of Bacillus stearothermophilus and Bacillus .subtilis var. niger. f
- a sterility control comprising a plurality of containers adapted to be disposed in a sterilizing chamber
- each said spore carrier being impregnated with a different population of spores
- the number of spores in each said population being equal to areal positive integer greater than zero raised to a real positive exponential integer, each said exponential power being different from the others, whereby the effectiveness of the cycle can be determined by observingsaid spore carrier having the largest number of said spores wherein all said spores are killed.
- each said strip being impregnated with a different population of spores from the other strips, the number of spores in each said population being equal to a real positive integer greater than zero raised to a real positive exponential integer, each said exponential power being different froml the others,
- said container with said spore strips being adapted to be placed in a sterilizing chamber during sterilizing cycle and said strips subsequently incubated and the strips having all spores thereon killed whereby the effectiveness of said cycle can be determined by observing the said strip having the largest number of said spores wherein all said spores are killed.
- said envelope being scored along a line adjacent on edge whereby the covercan be removed.
Abstract
Description
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US85766869A | 1969-09-15 | 1969-09-15 |
Publications (1)
Publication Number | Publication Date |
---|---|
US3711378A true US3711378A (en) | 1973-01-16 |
Family
ID=25326485
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US00857668A Expired - Lifetime US3711378A (en) | 1969-09-15 | 1969-09-15 | Microbiological-scaled sterility controls |
Country Status (2)
Country | Link |
---|---|
US (1) | US3711378A (en) |
CA (1) | CA940025A (en) |
Cited By (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
FR2350106A1 (en) * | 1976-05-03 | 1977-12-02 | Ethicon Inc | STEP BIOLOGICAL STERILITY CHECK SLIDE |
US4283498A (en) * | 1979-10-29 | 1981-08-11 | Schlesinger Joseph D | Biological specimen collection and transport system |
US4486387A (en) * | 1982-06-16 | 1984-12-04 | Propper Manufacturing Co., Inc. | Disposable prevacuum steam sterilizer test device |
US5552320A (en) * | 1993-08-09 | 1996-09-03 | Johnson & Johnson Medical, Inc. | Self-contained biological indicator |
US5750184A (en) * | 1995-12-19 | 1998-05-12 | Pharmaceutical Systems, Inc. | Unitary biological indicator for gaseous sterilants and process |
US5942408A (en) * | 1996-07-29 | 1999-08-24 | Christensen; Dennis E. | Process challenge device and method |
US20030064427A1 (en) * | 2001-09-15 | 2003-04-03 | Icf Technologies, Inc. | Kits and methods for determining the effectiveness of sterilization of disinfection processes |
US6653096B1 (en) * | 1996-07-29 | 2003-11-25 | Process Challenge Devices | Process challenge device and method |
-
1969
- 1969-09-15 US US00857668A patent/US3711378A/en not_active Expired - Lifetime
-
1970
- 1970-09-02 CA CA092,170A patent/CA940025A/en not_active Expired
Cited By (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
FR2350106A1 (en) * | 1976-05-03 | 1977-12-02 | Ethicon Inc | STEP BIOLOGICAL STERILITY CHECK SLIDE |
US4087326A (en) * | 1976-05-03 | 1978-05-02 | Ethicon, Inc. | Microbiological scaled sterility test strips and method |
US4283498A (en) * | 1979-10-29 | 1981-08-11 | Schlesinger Joseph D | Biological specimen collection and transport system |
US4486387A (en) * | 1982-06-16 | 1984-12-04 | Propper Manufacturing Co., Inc. | Disposable prevacuum steam sterilizer test device |
US5552320A (en) * | 1993-08-09 | 1996-09-03 | Johnson & Johnson Medical, Inc. | Self-contained biological indicator |
US5750184A (en) * | 1995-12-19 | 1998-05-12 | Pharmaceutical Systems, Inc. | Unitary biological indicator for gaseous sterilants and process |
US5942408A (en) * | 1996-07-29 | 1999-08-24 | Christensen; Dennis E. | Process challenge device and method |
US6653096B1 (en) * | 1996-07-29 | 2003-11-25 | Process Challenge Devices | Process challenge device and method |
US20030064427A1 (en) * | 2001-09-15 | 2003-04-03 | Icf Technologies, Inc. | Kits and methods for determining the effectiveness of sterilization of disinfection processes |
US7183048B2 (en) | 2001-09-15 | 2007-02-27 | Icf Technologies, Inc. | Kits and methods for determining the effectiveness of sterilization of disinfection processes |
Also Published As
Publication number | Publication date |
---|---|
CA940025A (en) | 1974-01-15 |
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Legal Events
Date | Code | Title | Description |
---|---|---|---|
AS | Assignment |
Owner name: MORGAN GUARANTY TRUST COMPANY,NEW YORK Free format text: SECURITY INTEREST;ASSIGNOR:AMERICAN STERILIZER COMPANY, A PA CORP.;REEL/FRAME:004765/0752 Effective date: 19870827 Owner name: MORGAN GUARANTY TRUST COMPANY, 23 WALL STREET, NEW Free format text: SECURITY INTEREST;ASSIGNOR:AMERICAN STERILIZER COMPANY, A PA CORP.;REEL/FRAME:004765/0752 Effective date: 19870827 |
|
AS | Assignment |
Owner name: AMERICAN STERILIZER COMPANY, ONE MELLON BANK CENTE Free format text: RELEASED BY SECURED PARTY;ASSIGNOR:MORGAN GUARANTY TRUST COMPANY OF NEW YORK;REEL/FRAME:005581/0543 Effective date: 19910130 |