Patent US4828797A successfully refreshed from Google Patents.
US4828797A
Expired / Lapsed
US
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EO biological test pack
Assignee: Steris Inc
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Filing: 1986-06-24
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Granted: 1989-05-09
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Expires: 2006-06-24
Abstract
Abstract A 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. In addition, the tray contains a plastic syringe which holds a biological indicator. On top of the plastic syringe, absorbent paper is placed. The entire pack has a Tyvek sheet which seals it until it is used. The plastic tray is molded into a shape for holding the various items in particularly desirable locations. Accordingly, a disposable test pack which is uniformly manufactured and which should yield consistent results, is described. It can be used either as a general purpose routine test pack or as a validation challenge test pack.
Inventors
- 👤 Andrew A. Zwarun
- 👤 Steven T. Buglino
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-09 15:38
CPC Classifications
C; C12; C12Q; C12Q1/00; C12Q1/02; C12Q1/22; A; A61; A61L; A61L2/00; A61L2/26; A61L2/28
Claims Analysis
Total Claims: 7
Claim 1
Independent Claim
198 words
A biological test pack for use in ethylene oxide sterilization processes comprising: (a) a clear, colorless plastic tray including syringe holding means molded therein for holding a syringe containing a biological indicator; (b) indicator card holding means for holding an indicator card adjacent to the bottom of said tray in a position so that the indicator card is raised away from possible condensate and is visible from outside of said tray; (c) absorbent paper holding means for holding absorbent paper over said syringe; (d) a biological indicator of the type including a glassine enclosed or a self-contained biological indicator; (e) a syringe containing said biological indicator, said syringe being held in place within said tray by said syringe holding means; (f) 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 (g) absorbent paper held in place within said tray over said syringe by said absorbent paper holding means, whereby the combination creates a rate-limiting tortuous flow path; and (h) means for sealing the top of said tray until it is ready for use.
Claim 2
Dependent Claim
198 words
A biological test pack for use in ethylene oxide sterilization processes comprising: (a) a clear, colorless plastic tray including syringe holding means molded therein for holding a syringe containing a biological indicator; (b) indicator card holding means for holding an indicator card adjacent to the bottom of said tray in a position so that the indicator card is raised away from possible condensate and is visible from outside of said tray; (c) absorbent paper holding means for holding absorbent paper over said syringe; (d) a biological indicator of the type including a glassine enclosed or a self-contained biological indicator; (e) a syringe containing said biological indicator, said syringe being held in place within said tray by said syringe holding means; (f) 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 (g) absorbent paper held in place within said tray over said syringe by said absorbent paper holding means, whereby the combination creates a rate-limiting tortuous flow path; and (h) means for sealing the top of said tray until it is ready for use.
Claim 3
Dependent Claim
18 words
The biological test pack of claim 1 wherein said syringe holding means is molded into said plastic tray.
Claim 4
Dependent Claim
19 words
The biological test pack of claim 2 wherein said indicator card holding means is molded into said plastic tray.
Claim 5
Dependent Claim
19 words
The biological test pack of claim 3 wherein said absorbent paper holding means is molded into said plastic tray.
Claim 6
Dependent Claim
21 words
The biological test pack of claim 4 wherein said biological indicator is a self-contained biological indicator or glassine enclosed spore strip.
Claim 7
Dependent Claim
50 words
The biological test pack of claim 5 wherein said absorbent paper is comprised of a stack of individual sheets of absorbent paper wherein said paper has an amount and rate of moisture absorption substantially equal to an all-cotton surgical towel of the type used in a standard AAMI test pack.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1992-05-08 | 1992-11-07 | 1993-05-09 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1996-05-08 | 1996-11-07 | 1997-05-09 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2000-05-08 | 2000-11-07 | 2001-05-09 | $7700.00 | Window Closed / Lapsed |