CA2057372A1 - Eo biological test pack - Google Patents
Eo biological test packInfo
- Publication number
- CA2057372A1 CA2057372A1 CA002057372A CA2057372A CA2057372A1 CA 2057372 A1 CA2057372 A1 CA 2057372A1 CA 002057372 A CA002057372 A CA 002057372A CA 2057372 A CA2057372 A CA 2057372A CA 2057372 A1 CA2057372 A1 CA 2057372A1
- Authority
- CA
- Canada
- Prior art keywords
- syringe
- tray
- indicator
- biological
- test pack
- 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.)
- Abandoned
Links
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
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N31/00—Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroup; Apparatus specially adapted for such methods
- G01N31/22—Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroup; Apparatus specially adapted for such methods using chemical indicators
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- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Health & Medical Sciences (AREA)
- Organic Chemistry (AREA)
- Analytical Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- General Health & Medical Sciences (AREA)
- Zoology (AREA)
- Immunology (AREA)
- Wood Science & Technology (AREA)
- Biophysics (AREA)
- Physics & Mathematics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Public Health (AREA)
- Biotechnology (AREA)
- Microbiology (AREA)
- Epidemiology (AREA)
- Pathology (AREA)
- General Physics & Mathematics (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Engineering & Computer Science (AREA)
- Genetics & Genomics (AREA)
- Apparatus For Disinfection Or Sterilisation (AREA)
- Packages (AREA)
- Investigating Or Analyzing Non-Biological Materials By The Use Of Chemical Means (AREA)
Abstract
ABSTRACT OF THE DISCLOSURE
A disposable biological test pack adapted for use in testing the efficacy of an ethylene oxide sterilization process is described. The test pack is a clear plastic tray containing an sterilization sensitive ink which has been imprinted on a card which faces out of the bottom of the plastic tray. The tray contains a plastic syringe which holds a biological indicator and an absorptive material adapted to absorb moisture and ethylene oxide with the syringe. The ratio of the volume of absorptive material in the syringe to the volume of the syringe is comparable to the ratios of prior art test packs which were of much larger construction.
A disposable biological test pack adapted for use in testing the efficacy of an ethylene oxide sterilization process is described. The test pack is a clear plastic tray containing an sterilization sensitive ink which has been imprinted on a card which faces out of the bottom of the plastic tray. The tray contains a plastic syringe which holds a biological indicator and an absorptive material adapted to absorb moisture and ethylene oxide with the syringe. The ratio of the volume of absorptive material in the syringe to the volume of the syringe is comparable to the ratios of prior art test packs which were of much larger construction.
Description
2~ f372 EO BIOLOGICAL T~ST PACR
BAC~GRO~ND_OF T~E INVENTION
FI~D O~ T~E INV~NTION
The present inventlon relate to a biological test pack of the type used in hospitAl sterilization procedures.
In particular, the Lnvention relates to a biological test pack o~ the type used in ethylen~ oxide (EO) sterilization procedures.
~ ESCRIPTION OF THE P~EQR A~
Ethylene oxide gas is commonly us~d in sterilizing _tems for use in health care facilities. A common method of testing for the ef~icacy o~ the EO sterilization proces3 is to includa a biological indica~or in the load being steri~iz2d. A biologicz~l indicator i~ a suspQnsion of a large number of bacterial spore~ that has been dried on a carrier, e.g., paper, and then inserted into a package, such a~ a glassine envelope or a plastic vial. The spore suspension is typically comprised of a bacterial species that is very resistant to EO. For example, Bacillu~ subtilis may be used, 20~7372 and it may be present on the carrier in large numbers.
Accord mgly, the spore suspension acts as an indicator for the effectiveness of the EO sterilization process. If large numbers of a very EO resistant organism are placed in a load, and i~ the sterilizatlon process kills those resistant spores, then it is reasonable to conclude that the EO
sterilization process was ef~ective.
Since most items that are beLng EO sterilized are held in some sort of packaging whlch is intended to maintain the sterility of the contents of the pack until the time of their use, it is prudent to enclose the biological Lndicator inside similar packaging in order to egualize the challenge of k ~ ing the spores on the biological indicator.
In order to standardize the packaging challenge, the Association ~or the Advancement o~ Medical Instrumentation (AAMI) ha~ issued an AA~I ~ecommended Practice entitled "Good Hospital Practice: Per~ormance Evaluation oS Ethylene Oxide Sterilizer3 -- Ethylena Oxlde TQst Packs". That document recommends the use of a standardized routlne test pack for general purpose EO sterllizers in which the biological indicator as well as a chemical indlcator can be positioned, and also the use o~ a more resistant challenge pack for newly in~talled EO sterilizer~. The recommended standard challenge test packs consist o~ a plastic syringe enclosing a biological indicator, the syringe being wrapped in a properly-sized 2Q~7~2 cotton towel, and this entire assembly enclosed inside a wrapping or pouch.
The makmg of an EO test pack is often a tedious process, as the test packs are laborious to construct, and not all of the necessary materials and components may be present at the in~tltution. In addition, there is no standardized method of manuf acturing or selecting the components.
Compounding this problem is the fact that the surgical (huckaback) towel component of the test pack, which acts as a heat sink and moisture absorber in the te~t pack, ls inherently susc~ptible to variation, because surgical towels are subject to large changes in their characteristics. For example, after each succQ~sive laundering, a surgical towel 108e8 some of its flber content and thus its capacity to provide a heat and moisture challenge. I~ it is laundQred and then ironed, the towel may be so dry that it proYides too much o~ a challenge to moistuxe absorption.
In order t:o minimiz~ the above prGblems, an improved E0 mdicator tQst pack haa b~n developed and is dascribed in U.S. Patent 4,828,797 (Zwarun et al.), as~igned to the assignea hereof. This patQnt is incorporatad by re~erenca herQin and disclos~ a test pack which yields the same rate of survlval or death of a biological indlcator as doQs the AAMI-described pack, but which is fully disposable.
This test pack is of standardized construction and eliminates variation~ from pack to pack by being preloaded with an appropriate biological indicator to eliminate labor required for a~sembly. The pack behaves in a manner which is equivalent to the biological indicator tes~ pack recommended by AAMI for routme use in general purpose E0 sterilizers.
While the aforementioned te~t pack constitutes a signiflcant advance over the prior art, some improvements have been discovered. For example, the volume of materials used in this test pack required that the pack be fairly large to accommodate the quantity of blotter paper necessary to absorb the humidity and ethylene oxide to a sufficient degree to create a challenge equal to a huckaback towel. It has been found that by decreasing the size o~ the tray holding the test pack components wh~le substltuting an alternative absorptive material for the blotter paper an equivalent amount of absorption of humidity and ethylene oxide could be achieved al~o while providing a tortuou~ path. D~pendiny upon the ef~iciency o~ the alternative absorptive material, the entire test pack could be made in a range of selected smaller size~
because tha relative ratio o~ tho volume of blotter paper to the total volume Or th~ original tr~y could be made equal to the ratio of the volu~le of the altorn~tlv~ absorptive materlal to the volu~o of the enclo ur~ containing this material.
In the previous test pack, the syringe was situated within a tray which also contained tha blotter paper and wa~
covered by a permeable membrane. The relationship between the tray volum2 and the syringe and the mass and volume of the 2~7~7~
blotter paper in the tray created the appropriate challenge that was equivalent to the AAMI described test pack. In this prior art device the volume of the syringe itself was not critical in relation to the volume of the tray. In the present invention, the volume of the tray is st ~ irrelevant so long aR there i5 no impediment to the transfer of ethylene oxide through the tray cover. However, it has been found that an absorptive material, when inserted into the chamber of the standard syringe maintains the same relationship to the relevant volume in~ide the syringe as did the blotter paper to the relevant volume Ln~ide the prior art tray. That is, the absorptivQ material used in the present Lnvention i5 about 97%
smaller in volume than the previous blotter paper and is placed inside the syringe, the volum~ of which i~ about 96%
smaller than the volume of th~ tray. The absorption of humidity achieved by this amount o~ absorptive material i5 esssntlally the same a~ th~ ab~orption achieved by the blotter paper u~ed in the previous ver~ion (i.Q. about ~-10% by weight of the absorptivR material). In ef~ect, the invention enables a much smaller volume to ~e used to produce the equivalent challenge.
It is accordingly an ob~ect of this invention to produce a standard ethylene oxlde te~t pack in smaller sizea than tho e previously available.
2 ~ 7 2 It is yet another object of this invention to produce a standard ethylene oxide test pack able to achieve the results of previously known te~t packs while being constructed m a more simplified manner.
SIJMXARY OF T~l: INVENTION
These and other objects of the invention are achieved by the preferred embodiment thereof which is a standard, disposable ethylene oxide biological test pack comprising: (a) a clear, colorles~ plastic tray including syringe holding means molded therein for holding a syringe containing a biological indicator: (b) indicator card holding mean associated with said tray for holding an indicator card ad~acen~ to tha bottom of said tray in a po6ition in which said Lndicator card is raised away from po~ible condensate and is vi6ible fro~ outside o~ said tray; (c) a syringe containing a biological indicator of the type Lncluding a glassine enclosed or a sel~-contained biological indicator, ~aid syrinqe b~ing held in place wlthin said tray by said syringe holding m~ans; (d) an indicator card having a sterilization s~nsitiv~ mk i~printed thereon, said indicator card bemg held m sald tray by said indicator card holding mQans with said ink imprint ~acing out of said tray; and (e) an absorb0nt member situated within said syringe ad~acent the opening thereof, whereby tha combination creates a 2~372 rate-limiting tortuous opening; and (f) means for sealing the top of said tray until it is ready for use.
BRIEF DESCRIPTION_OF T~g DRA~INGS
Figure 1 is a top view of the tray of the test pack of the present invention;
Flgure 2 is a side view of the syringe included in the test pack of the present invention: and Flgure 3 is a sida ViQW of the test pack of Figure 1 including the syrmge of Flgure 2.
~SC~Ip~E~ON OF T~E P~F~ED ~O~I~ENT
R~ferrmg generally to Figures 1-3, the test pack 10 of the present invention is constructed of a clear plastic blister tray 12 which i~ s~aled with a peel off lid 14, compri~ed of Tyvek in the preferred embodlment of the invention. Alternati.vely, a paper lld can be used. The structure o~ the invention i3 sim~lar in many respects to the test pack of aforementioned U.S. Patent 4,828,797. This patent i5 incorporat:ed by re~erence to disclose various structural features not specifically mentioned herein~
In~ide the blister tray 12 is a indicator caxd 16 that is placed on raised bumps 18 on the bottom o~ the blister tray 12 in order to prevent any potential condensate from
BAC~GRO~ND_OF T~E INVENTION
FI~D O~ T~E INV~NTION
The present inventlon relate to a biological test pack of the type used in hospitAl sterilization procedures.
In particular, the Lnvention relates to a biological test pack o~ the type used in ethylen~ oxide (EO) sterilization procedures.
~ ESCRIPTION OF THE P~EQR A~
Ethylene oxide gas is commonly us~d in sterilizing _tems for use in health care facilities. A common method of testing for the ef~icacy o~ the EO sterilization proces3 is to includa a biological indica~or in the load being steri~iz2d. A biologicz~l indicator i~ a suspQnsion of a large number of bacterial spore~ that has been dried on a carrier, e.g., paper, and then inserted into a package, such a~ a glassine envelope or a plastic vial. The spore suspension is typically comprised of a bacterial species that is very resistant to EO. For example, Bacillu~ subtilis may be used, 20~7372 and it may be present on the carrier in large numbers.
Accord mgly, the spore suspension acts as an indicator for the effectiveness of the EO sterilization process. If large numbers of a very EO resistant organism are placed in a load, and i~ the sterilizatlon process kills those resistant spores, then it is reasonable to conclude that the EO
sterilization process was ef~ective.
Since most items that are beLng EO sterilized are held in some sort of packaging whlch is intended to maintain the sterility of the contents of the pack until the time of their use, it is prudent to enclose the biological Lndicator inside similar packaging in order to egualize the challenge of k ~ ing the spores on the biological indicator.
In order to standardize the packaging challenge, the Association ~or the Advancement o~ Medical Instrumentation (AAMI) ha~ issued an AA~I ~ecommended Practice entitled "Good Hospital Practice: Per~ormance Evaluation oS Ethylene Oxide Sterilizer3 -- Ethylena Oxlde TQst Packs". That document recommends the use of a standardized routlne test pack for general purpose EO sterllizers in which the biological indicator as well as a chemical indlcator can be positioned, and also the use o~ a more resistant challenge pack for newly in~talled EO sterilizer~. The recommended standard challenge test packs consist o~ a plastic syringe enclosing a biological indicator, the syringe being wrapped in a properly-sized 2Q~7~2 cotton towel, and this entire assembly enclosed inside a wrapping or pouch.
The makmg of an EO test pack is often a tedious process, as the test packs are laborious to construct, and not all of the necessary materials and components may be present at the in~tltution. In addition, there is no standardized method of manuf acturing or selecting the components.
Compounding this problem is the fact that the surgical (huckaback) towel component of the test pack, which acts as a heat sink and moisture absorber in the te~t pack, ls inherently susc~ptible to variation, because surgical towels are subject to large changes in their characteristics. For example, after each succQ~sive laundering, a surgical towel 108e8 some of its flber content and thus its capacity to provide a heat and moisture challenge. I~ it is laundQred and then ironed, the towel may be so dry that it proYides too much o~ a challenge to moistuxe absorption.
In order t:o minimiz~ the above prGblems, an improved E0 mdicator tQst pack haa b~n developed and is dascribed in U.S. Patent 4,828,797 (Zwarun et al.), as~igned to the assignea hereof. This patQnt is incorporatad by re~erenca herQin and disclos~ a test pack which yields the same rate of survlval or death of a biological indlcator as doQs the AAMI-described pack, but which is fully disposable.
This test pack is of standardized construction and eliminates variation~ from pack to pack by being preloaded with an appropriate biological indicator to eliminate labor required for a~sembly. The pack behaves in a manner which is equivalent to the biological indicator tes~ pack recommended by AAMI for routme use in general purpose E0 sterilizers.
While the aforementioned te~t pack constitutes a signiflcant advance over the prior art, some improvements have been discovered. For example, the volume of materials used in this test pack required that the pack be fairly large to accommodate the quantity of blotter paper necessary to absorb the humidity and ethylene oxide to a sufficient degree to create a challenge equal to a huckaback towel. It has been found that by decreasing the size o~ the tray holding the test pack components wh~le substltuting an alternative absorptive material for the blotter paper an equivalent amount of absorption of humidity and ethylene oxide could be achieved al~o while providing a tortuou~ path. D~pendiny upon the ef~iciency o~ the alternative absorptive material, the entire test pack could be made in a range of selected smaller size~
because tha relative ratio o~ tho volume of blotter paper to the total volume Or th~ original tr~y could be made equal to the ratio of the volu~le of the altorn~tlv~ absorptive materlal to the volu~o of the enclo ur~ containing this material.
In the previous test pack, the syringe was situated within a tray which also contained tha blotter paper and wa~
covered by a permeable membrane. The relationship between the tray volum2 and the syringe and the mass and volume of the 2~7~7~
blotter paper in the tray created the appropriate challenge that was equivalent to the AAMI described test pack. In this prior art device the volume of the syringe itself was not critical in relation to the volume of the tray. In the present invention, the volume of the tray is st ~ irrelevant so long aR there i5 no impediment to the transfer of ethylene oxide through the tray cover. However, it has been found that an absorptive material, when inserted into the chamber of the standard syringe maintains the same relationship to the relevant volume in~ide the syringe as did the blotter paper to the relevant volume Ln~ide the prior art tray. That is, the absorptivQ material used in the present Lnvention i5 about 97%
smaller in volume than the previous blotter paper and is placed inside the syringe, the volum~ of which i~ about 96%
smaller than the volume of th~ tray. The absorption of humidity achieved by this amount o~ absorptive material i5 esssntlally the same a~ th~ ab~orption achieved by the blotter paper u~ed in the previous ver~ion (i.Q. about ~-10% by weight of the absorptivR material). In ef~ect, the invention enables a much smaller volume to ~e used to produce the equivalent challenge.
It is accordingly an ob~ect of this invention to produce a standard ethylene oxlde te~t pack in smaller sizea than tho e previously available.
2 ~ 7 2 It is yet another object of this invention to produce a standard ethylene oxide test pack able to achieve the results of previously known te~t packs while being constructed m a more simplified manner.
SIJMXARY OF T~l: INVENTION
These and other objects of the invention are achieved by the preferred embodiment thereof which is a standard, disposable ethylene oxide biological test pack comprising: (a) a clear, colorles~ plastic tray including syringe holding means molded therein for holding a syringe containing a biological indicator: (b) indicator card holding mean associated with said tray for holding an indicator card ad~acen~ to tha bottom of said tray in a po6ition in which said Lndicator card is raised away from po~ible condensate and is vi6ible fro~ outside o~ said tray; (c) a syringe containing a biological indicator of the type Lncluding a glassine enclosed or a sel~-contained biological indicator, ~aid syrinqe b~ing held in place wlthin said tray by said syringe holding m~ans; (d) an indicator card having a sterilization s~nsitiv~ mk i~printed thereon, said indicator card bemg held m sald tray by said indicator card holding mQans with said ink imprint ~acing out of said tray; and (e) an absorb0nt member situated within said syringe ad~acent the opening thereof, whereby tha combination creates a 2~372 rate-limiting tortuous opening; and (f) means for sealing the top of said tray until it is ready for use.
BRIEF DESCRIPTION_OF T~g DRA~INGS
Figure 1 is a top view of the tray of the test pack of the present invention;
Flgure 2 is a side view of the syringe included in the test pack of the present invention: and Flgure 3 is a sida ViQW of the test pack of Figure 1 including the syrmge of Flgure 2.
~SC~Ip~E~ON OF T~E P~F~ED ~O~I~ENT
R~ferrmg generally to Figures 1-3, the test pack 10 of the present invention is constructed of a clear plastic blister tray 12 which i~ s~aled with a peel off lid 14, compri~ed of Tyvek in the preferred embodlment of the invention. Alternati.vely, a paper lld can be used. The structure o~ the invention i3 sim~lar in many respects to the test pack of aforementioned U.S. Patent 4,828,797. This patent i5 incorporat:ed by re~erence to disclose various structural features not specifically mentioned herein~
In~ide the blister tray 12 is a indicator caxd 16 that is placed on raised bumps 18 on the bottom o~ the blister tray 12 in order to prevent any potential condensate from
3 7 2 damaging the indicator card 162 The indicator card 16 is printed with an E0-sensitive Lnk so it serves as both an internal indicator of the sterilization process and as a record keeping card on which the results of the biological indicator test can be recorded. The m dicatsr card 16 can then be stored with a record keeping system a~ter it has been exposed.
Above the indicator card 16 and resting in a premolded seat in tray 12 i9 the plastic syringe 22 that contains the biological indicator 20, which may be an envelope-enclosed spore strip or a self-contained biological lndicator of the type known in thh art or of the type refsrred to in a~orementioned U.S. Patent No. 4,R28,797.
Raplacing the absorbQnt paper of the test pac~
shown in aforementloned U.S. Patent No. 4,828,797 is a~sorbent plug 30 which is positloned within syringe 22 adjacent the s~all opening 32 in the end of th~ syringe. It w ~ be understood that the ratio of the volume of absorbent plug 30 to the volume of the interior o~ syringe 22 is comparable to the ratlo o~ the volumQ o~ the absorbQnt paper of the test pack of U.S. Patent: No. 4,828,797 to the volume of the interior of the tray o~ that te~t pack. The partlcular type of absorptive material cho~en for use in the invention must have characteristic~ such that it i5 able to function withm the lesser volume of tray 12 to perform a function similar to that of the prior art test pack. Any suitable absorptiv~
~737 ~
materi~l may be used provided its efficiency per unit w2ight is, in the new, smaller tray, equivalent to that of the blotter paper used in the previous pack. For example, the amount of blotter paper necessary to achieve th~ same function if placed within the volume of the syringe would not leave enough room in ~he syringe for the biological test pack indicator. The particular absorptive material used in the preferred embodiment is a closed cell reticulated (sponge) foam known as Prestofoam #725 available from the Presto Manufacturing Co., 2 FranklLn Avenue, Brooklyn, New York.
The new te~t pack is smaller t~an previous devices and consequently, more inexpensive, more e~icient because it reduces wa~te (due to th~ nall~r volume of material to be discarded) and requires less storage space (hecause its volum~
18 slgni~icantly s~allar than the pr~vious pack).
The AAMI standard~ requlre that a biological indicator bQ placed inside a syri~g~. However, depending upon the blologlcal indlcator di~erent size~ of syringes may be used. In tha preferred embodiment shown in the drawings, the type o~ biological indicator used raquires tha use o~ a 20cc (internal volume) syringe.
Wh1le a syr~nge is not abcolutely n~cessary to the Lnvention, it is an acceptable easily recognized structure in the marketplace. It is certainly possible to create a dlfferently shaped structure to replacQ the standard syringe and yet maintain the AA~I challenge.
~737 ~
It w;ll be undorstood by thos~ sk ~ ed in the art that numerous other modifications and improvements may be made to the preferred embodiment of ~he invention disclosed herein without departing from the spirit and scope thereof.
Above the indicator card 16 and resting in a premolded seat in tray 12 i9 the plastic syringe 22 that contains the biological indicator 20, which may be an envelope-enclosed spore strip or a self-contained biological lndicator of the type known in thh art or of the type refsrred to in a~orementioned U.S. Patent No. 4,R28,797.
Raplacing the absorbQnt paper of the test pac~
shown in aforementloned U.S. Patent No. 4,828,797 is a~sorbent plug 30 which is positloned within syringe 22 adjacent the s~all opening 32 in the end of th~ syringe. It w ~ be understood that the ratio of the volume of absorbent plug 30 to the volume of the interior o~ syringe 22 is comparable to the ratlo o~ the volumQ o~ the absorbQnt paper of the test pack of U.S. Patent: No. 4,828,797 to the volume of the interior of the tray o~ that te~t pack. The partlcular type of absorptive material cho~en for use in the invention must have characteristic~ such that it i5 able to function withm the lesser volume of tray 12 to perform a function similar to that of the prior art test pack. Any suitable absorptiv~
~737 ~
materi~l may be used provided its efficiency per unit w2ight is, in the new, smaller tray, equivalent to that of the blotter paper used in the previous pack. For example, the amount of blotter paper necessary to achieve th~ same function if placed within the volume of the syringe would not leave enough room in ~he syringe for the biological test pack indicator. The particular absorptive material used in the preferred embodiment is a closed cell reticulated (sponge) foam known as Prestofoam #725 available from the Presto Manufacturing Co., 2 FranklLn Avenue, Brooklyn, New York.
The new te~t pack is smaller t~an previous devices and consequently, more inexpensive, more e~icient because it reduces wa~te (due to th~ nall~r volume of material to be discarded) and requires less storage space (hecause its volum~
18 slgni~icantly s~allar than the pr~vious pack).
The AAMI standard~ requlre that a biological indicator bQ placed inside a syri~g~. However, depending upon the blologlcal indlcator di~erent size~ of syringes may be used. In tha preferred embodiment shown in the drawings, the type o~ biological indicator used raquires tha use o~ a 20cc (internal volume) syringe.
Wh1le a syr~nge is not abcolutely n~cessary to the Lnvention, it is an acceptable easily recognized structure in the marketplace. It is certainly possible to create a dlfferently shaped structure to replacQ the standard syringe and yet maintain the AA~I challenge.
~737 ~
It w;ll be undorstood by thos~ sk ~ ed in the art that numerous other modifications and improvements may be made to the preferred embodiment of ~he invention disclosed herein without departing from the spirit and scope thereof.
Claims (3)
1. A biological test pack for use in ethylene oxide sterilization processes comprising:
(a) a tray including syringe holding means molded therein for holding a syringe containing a biological indicator;
(b) indicator card holding means associated with said tray for holding an indicator card adjacent to the bottom of said tray in a position in which said indicator card is raised away from possible condensate and is visible from outside of said tray;
(c) a syringe containing a biological indicator of the type including a glassine enclosed or a self-contained biological indicator, said syringe being held in place within said tray by said syringe holding means;
(d) an indicator card having a sterilization sensitive ink imprinted thereon, said indicator card being held in said tray by said indicator card holding means with said ink imprint facing out of said tray; and (e) an absorbent member situated within said syringe adjacent the opening thereof; and (f) means for sealing the top of said tray until it is ready for use.
(a) a tray including syringe holding means molded therein for holding a syringe containing a biological indicator;
(b) indicator card holding means associated with said tray for holding an indicator card adjacent to the bottom of said tray in a position in which said indicator card is raised away from possible condensate and is visible from outside of said tray;
(c) a syringe containing a biological indicator of the type including a glassine enclosed or a self-contained biological indicator, said syringe being held in place within said tray by said syringe holding means;
(d) an indicator card having a sterilization sensitive ink imprinted thereon, said indicator card being held in said tray by said indicator card holding means with said ink imprint facing out of said tray; and (e) an absorbent member situated within said syringe adjacent the opening thereof; and (f) means for sealing the top of said tray until it is ready for use.
2. The biological test pack of Claim 1 wherein said absorbent member comprises an open-celled foam.
3. An article for biologically challenging the efficacy of ethylene oxide sterilization processes comprising:
(a) a syringe containing a biological indicator of the type including a glassine enclosed or a self-contained biological indicator; and (b) an absorbent member situated within said syringe adjacent the opening thereof.
(a) a syringe containing a biological indicator of the type including a glassine enclosed or a self-contained biological indicator; and (b) an absorbent member situated within said syringe adjacent the opening thereof.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US63130790A | 1990-12-21 | 1990-12-21 | |
| US07/631,307 | 1990-12-21 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2057372A1 true CA2057372A1 (en) | 1992-06-22 |
Family
ID=24530645
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002057372A Abandoned CA2057372A1 (en) | 1990-12-21 | 1991-12-10 | Eo biological test pack |
Country Status (6)
| Country | Link |
|---|---|
| JP (1) | JPH04295369A (en) |
| AU (1) | AU8991491A (en) |
| CA (1) | CA2057372A1 (en) |
| DE (1) | DE4142397A1 (en) |
| FR (1) | FR2670799A1 (en) |
| GB (1) | GB2251069A (en) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| BR9403188A (en) * | 1993-08-09 | 1995-04-11 | Johnson & Johnson | Sterility indicator and test package |
| EP1466986A1 (en) * | 2003-04-09 | 2004-10-13 | Herbener, Heinz-Gerd | Method for testing the efficacy of gassterilisation, especially sterilisation with ethyleneoxide |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4528268A (en) * | 1981-12-31 | 1985-07-09 | H. W. Andersen Products Inc. | Apparatus and method for testing the sufficiency of sterilization |
| US4743537A (en) * | 1986-01-21 | 1988-05-10 | Castle Company | Biological indicator for sterilization processes |
| US4828797A (en) * | 1986-06-24 | 1989-05-09 | Edward Weck Incorporated | EO biological test pack |
| AU7336187A (en) * | 1986-06-30 | 1988-01-07 | Surgicot, Inc. | Steam test pack |
-
1991
- 1991-12-06 GB GB9126012A patent/GB2251069A/en not_active Withdrawn
- 1991-12-10 CA CA002057372A patent/CA2057372A1/en not_active Abandoned
- 1991-12-17 FR FR9115629A patent/FR2670799A1/en not_active Withdrawn
- 1991-12-20 DE DE19914142397 patent/DE4142397A1/en not_active Withdrawn
- 1991-12-20 AU AU89914/91A patent/AU8991491A/en not_active Abandoned
- 1991-12-20 JP JP3338433A patent/JPH04295369A/en active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| GB9126012D0 (en) | 1992-02-05 |
| FR2670799A1 (en) | 1992-06-26 |
| JPH04295369A (en) | 1992-10-20 |
| AU8991491A (en) | 1992-06-25 |
| GB2251069A (en) | 1992-06-24 |
| DE4142397A1 (en) | 1992-07-09 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FZDE | Discontinued | ||
| FZDE | Discontinued |
Effective date: 19940612 |