Chemical indicator sheets and packaging bags for sterilization made with the use of the same

• US 6,267,242 B1
• Filed: 10/18/1999
• Issued: 07/31/2001
• Est. Priority Date: 04/17/1997
• Status: Expired due to Term

• Current Assignee: Fujimori Kogyo Company Limited, Johnson & Johnson Medical KK (Johnson & Johnson)
• Original Assignee: Johnson & Johnson Medical KK (Johnson & Johnson)
• Inventors: Sagara, Makoto, Nagata, Masanori, Sutoh, Teiko
• Primary Examiner(s): LUONG, SHIAN TINH NHAN
• Application Number:
  US09/403,358
• Time in Patent Office: 652 Days
• Field of Search: 206/459.1, 206/438, 422/28, 422/61, 422/119, 422/56, 422/57, 422/58, 436/135, 428/35.2
• US Class Current: 206/459.1
• CPC Class Codes: A61L 2/28 Devices for testing the effectiveness or completeness of sterilisation, e.g. indicators which change colour apparatus involving enzymes or microorganisms C12M1/34; methods involving enzymes or microorganisms C12Q1/00
• CPC Class Codes: G01N 31/22 using chemical indicators G01N31/02 takes precedence
• CPC Class Codes: G01N 31/226 for investigating the degree of sterilisation
• CPC Class Codes: G01N 31/228 for peroxides
• CPC Class Codes: Y10T 428/1334 Nonself-supporting tubular film or bag [e.g., pouch, envelope, packet, etc.]
• CPC Class Codes: Y10T 436/206664 Ozone or peroxide

Abstract

This invention provides a sheet which has a chemical indicator, in particular, a composition layer for use as an indicator in hydrogen peroxide plasma sterilization, and further provides a packaging bag for said sterilization with use of such an indicator. Said composition layer comprises both a dye which can change color when contacted with hydrogen peroxide vapor or plasma derived from hydrogen peroxide, and a certain organic amine compound.

Claims

1. A sheet used for monitoring the efficacy of a hydrogen peroxide plasma sterilization treatment, said sheet comprising an indicator-function layer, said indicator-function layer comprising:

a dye which can change color when contacted with at least one substance selected from the group consisting of hydrogen peroxide and plasma derived from hydrogen peroxide,

an organic amine compound which does not evaporate under ambient conditions,

at least one aliphatic alcohol, and

a synthetic resin which is soluble in said alcohol.

2. The sheet of claim 1, further comprising an overcoat layer which is provided on said indicator-function layer.

4. The sheet of claim 1 wherein the aliphatic alcohol(s) is C_3-5 alcohol(s) and wherein the synthetic resin is polyamide resin.

3. A sheet used for monitoring the efficacy of a hydrogen peroxide plasma sterilization treatment, said sheet comprising:

an indicator-function layer comprising;

a dye which can change color when contacted with at least one substance selected from the group consisting of hydrogen peroxide and plasma derived from hydrogen peroxide;

an organic amine compound which does not evaporate under ambient conditions;

at least one aliphatic alcohol;

a synthetic resin which is soluble in said alcohol; and

an overcoat layer which is provided on said indicator-function layer, said overcoat layer comprising;

at least one aliphatic alcohol,

a synthetic resin which is soluble in said alcohol,

ultraviolet light absorber, and

waxes.

5. A packaging bag for sterilizing its contents with hydrogen peroxide plasma, wherein there is deposited, on at least a part of said packaging bag, a composition layer for use as a chemical indicator which comprises both a dye which can change its color when contacted with at least one substance selected from the group consisting of hydrogen peroxide and plasma derived from hydrogen peroxide, and an organic amine compound which does not evaporate under ambient conditions, and wherein at least a part of said packaging bag is made of breathing sheet.

6. The packaging bag of claim 5 wherein the composition layer for use as a chemical indicator further contains aliphatic alcohol(s) and a synthetic resin which is soluble in said alcohol(s) as well.

7. The packaging bag of claim 5 wherein the composition layer for use as a chemical indicator is deposited in the form of a thin layer on one side of the breathing sheet.

8. The packaging bag of any one of claims 5 wherein the breathing sheet is made of nonwoven fabric produced from high-density polyethylene or polypropylene.