MXPA97009191A - Methods and indicators of sterilization - Google Patents

Abstract

The present invention relates to a sterilization indicator, characterized in that it comprises: two reinforcement ribbons or strips, each of the reinforcement ribbons have opposite sides and a pressure sensitive adhesive, water dispersible, moisture resistant, on at least one of the opposite sides, and a sterilization indicator tape attached to one end of each of the reinforcement tapes and the method for its manufacture.

Description

METHODS AND INDICATORS OF STERILIZATION Field of the Invention This invention relates to sterilization indicators, and more particularly to sterilization indicator tapes that utilize pressure-sensitive, water-dispersible adhesives for the closure of reusable casings in the. which a sterilization indicator strip is easily removable from the sterilization indicator, and the methods for using same.

Background of the Invention A variety of products such as gowns, sheets, cloths, instruments, etc. which are required during surgery or other aseptic procedures, are used daily in the normal operation of hospitals, clinics and the like. Where such products are not pre-packed in a sterile condition, it is necessary that the hospital or clinic sterilize them before using them. In addition, where these products are not disposable, and are used more than once, they must be cleaned and otherwise REP: 26134 prepared for subsequent use. Before such use, however, it is essential that such products be sterilized. Due to the volume of materials involved, it is often necessary to sterilize and store these products for later use. Accordingly, a process has been developed where such products, after cleaning, laundry and the like, are packaged in fabric sterilization casings and the wrapped package is then sterilized and stored for subsequent use. As may be apparent, there is a potential danger in such a procedure. There is a package insert of non-sterilized packages that are mixed with the sterilized packages when they are stored for use. To prevent unsterilized products from being used by the physician or the person attending, various types of sterility indicators have been developed, which are coupled to or incorporated into the wrapped sterilization package. This allows a user to immediately determine if a particular package has been passed through the sterilizer. Such indicators of sterilization, in many cases, have been placed in a package wrapped or coupled to the package wrapped. The most convenient way to apply such sterilization indicators, however, is to have the indicator carried by indicator tapes with pressure-sensitive adhesive, used to hold the fabric wrapper in a closed position before, during and after sterilization. the products enclosed. Various pressure sensitive adhesives have been used - with tape reinforcements, including appropriate means that change color to indicate whether the package has been exposed to sterilization conditions. Examples of pressure sensitive adhesives used with such indicator tapes include natural, water-insoluble, rubber-based adhesives, natural rubber and synthetic rubber blend adhesives, styrene-isoprene-styrene block copolymers, with thickener resins , vinyl ethers, and high molecular weight acrylate copolymers having minimal amounts of plasticizing monomers included therein. See for example US Patents Nos. 2,889,799, 3,067,057, 3,078,182, 3,311,084 and 4,188,437. Typically, these indicator tapes use a reinforcement of paper, cloth or film, and an adhesive chemical that is resistant to softening after exposure to sterilization conditions (including heat, steam or other chemical methods). The fabric sterilization wraps can be discarded or preserved after use. If they are preserved, dirty cloth wrappings can usually be cleaned by washing in soapy water, such as an aqueous alkali solution. These wraps will then be reused. The expense of some cloth wrappings, such as synthetic treated wraps and untreated wraps, demands that the closure tapes and sterilization indicators do not damage the wrapping after use. The various indicator tapes referred to above are not formulated to be dispensed during cleaning, and in fact if they are not manually removed before laundry, they can permanently damage a sterilization casing. Specifically, the heat and chemicals associated with laundry and the drying of the sterilization casings will cause the pressure sensitive adhesives, used with the indicator tapes, to be transferred to the fabric of the garment casings, and with this permanently damage the sterilization wrapping.

In addition, in the various indicator tapes referred to above, there is the potential that the indicator portion of the indicator tape sterilization, which typically contains heavy metals, be discharged into the waste stream, but is removed earlier. of the laundry. The water-dispersible, pressure-sensitive adhesives have been made and used for papermaking and printing operations, which require splicing the end of one paper strip at the beginning of the other strip. For example, U.S. Patent Nos. 3,865,770, 4,413,080, 4,569,960, 3,441,430 and 2,838,421 describe such water-dispersible pressure sensitive adhesives, and / or the water-splicing tapes given therefrom. Additional examples of water-soluble or water-dispersible pressure sensitive adhesive compositions, and / or tapes made therefrom, can be found in U.S. Patent Nos. 4,413,082, 4,341,680, 4,388,432, 3,890,292, 3,763,117, 3,152,940, 3,096,202, and European Patent Publications Nos. 0 352 442 and 0 297 451. In addition, US Patent No. 5,125,995 discloses a water-dispersible pressure sensitive adhesive, which can be sterilized in an autoclave, on a dispersible reinforcement for Use as a means to attach clothing to clothing or clothing to the skin in areas where high amounts of fluid may be present. U.S. Patent No. 5,460,880 provides a sterilization indicator tape, which utilizes a water-dispersible, pressure sensitive adhesive. These indicator tapes include a non-water dispersible reinforcement, which includes on it a sterilization indicator and a water-dispersible, moisture-dispersible, pressure-sensitive adhesive coating on at least one of the two opposite sides of the reinforcement not dispersible in water. Such construction allows the laundry of the sterilization wraps, without having to remove the indicator tape before the laundry. The tapes are capable of keeping a package wrapped of articles in a closed position during sterilization, and normal handling pre- and post-sterilization. The pressure-sensitive adhesive, water-dispersible, on the indicator tapes, however, will be dispersed after immersion in the aqueous, alkaline laundry solutions during the laundry, while the tape reinforcement containing the sterilization indicator, such as an indicator tape, it remains in contact. Although this type of sterilization indicator tape allows the sterilization wraps to be laundered without removal of the indicator tape, the sterilization indicator material (which typically contains heavy materials) is introduced into the laundry process and potentially into the stream of waste. The non-water dispersible reinforcement containing the indicator portion of the sterilization remains intact, and must be collected from the laundry equipment after the laundry procedure. After the laundry, the tape can be collected and discarded. To date, there are no tapes that use an indicator portion which is easily removable before the laundry, from a sterilization wrap. Thus, the present indicator tapes containing portions indicative of sterilization, must be collected from the industrial laundry equipment after the laundry of the sterilization casings.

BRIEF DESCRIPTION OF THE INVENTION The present invention provides a solution to the problems presented by the sterilization indicator tapes known in the art. The sterilization indicator of the present invention is capable of maintaining a cluster of wrapped items in a closed position during sterilization, and normal pre- and post-sterilization handling, but the indicator portion of the indicator tape sterilization is easily removable from the sterilization wrap before the wrap laundry. In preferred embodiments, the present invention provides an indicator of sterilization in which the portion remaining after removal of the indicator portion of the sterilization is completely dispersed after the laundry, thereby eliminating the need to collect any material afterwards. of the laundry. The easy removal of the indicator portion of the sterilization from a sterilization indicator tape prior to laundry means that the indicator portion, which typically contains heavy metals, will not be introduced into the laundry process of the sterilization envelope used, and with this eliminates the potential that the indicator portion of the indicator tape sterilization will be discharged into the waste stream. The present invention provides a sterilization indicator which includes at least one reinforcing strip having opposite sides and a moisture-dispersible, water-dispersible portion sensitive adhesive on at least one of the opposite sides of the strip of reinforcement. A sterilization indicator strip or tape is attached to the reinforcing strip or strips, such that the sterilization indicator strip or tape can be easily removed from the sterilization indicator. The reinforcing tapes are preferably water dispersible, but may be non-water dispersible. The sterilization indicators of the present invention can have any of several preferred configurations. In one embodiment, two reinforcement tapes and a sterilization indicating tape are provided followed at one end of each of the two reinforcement tapes. In yet another embodiment a reinforcing tape is provided, and a sterilization indicator tape is attached to one end of the reinforcement tape. In yet another embodiment, a reinforcing tape is provided which has one or more openings. The openings may be in general in the intermediate portions of the reinforcing tape or near one end of the reinforcing tape. A sterilization indicator tape is attached to one side of the reinforcement tape, which has the pressure sensitive, water dispersible, moisture resistant adhesive, such that the sterilization indicator tape is observed through the opening or openings in the reinforcement tapes. The sterilization indicator tape preferably comprises an indicator ink in combination with a binder, printed on a non-water dispersible reinforcement, the indicator ink is capable of undergoing a color change when exposed to the sterilization conditions. The sterilization indicator tape can be attached to the reinforcing tape or tapes by adhering the sterilization indicator tape or a portion or portions thereof, to the side of the reinforcing tape or tapes having the adhesive sensitive thereto. The pressure, or dispersible in water, resistant to moisture. The reinforcing tape used in the sterilization indicator of the present invention may be water dispersible or non-water dispersible. In the embodiments of the claimed invention in which the reinforcing tapes are non-water dispersible, such reinforcement tapes can include a woven reinforcement, a non-woven reinforcement, a fabric reinforcement, a film reinforcement, a paper reinforcement, a sheet reinforcement or combinations thereof. The indicator ink used in the sterilization indicator tape may be a steam sterilization indicating ink, an ink indicating sterilization by ethylene oxide or combinations thereof. In a preferred embodiment, an ink indicating the sterilization of lead-sulfur carbonate is used. In preferred embodiments, the binder used in the sterilization indicator tape of the present invention, is an acrylate binder. In the preferred embodiments of the present invention, the moisture-dispersible, water-dispersible pressure-sensitive adhesive is a composition that is dispersible at an alkaline pH but not at an acidic or neutral pH. Preferably, the adhesive contains a polymer formed from one of the monomers A, B and C and less than about 0.1 part of plasticizer per part of polymer. The monomer "A" is preferably a hydrophobic monomer selected from the group consisting of an acrylic or methacrylic ester of a non-tertiary alcohol having from 2 to 14 carbon atoms. Preferably, monomer "A" comprises from 50 to 80% by weight of the polymer. The monomer "B" is preferably a monomer selected from the group consisting of β-carboxyethyl acrylate, the β-carboxyethyl acrylate salt, vinyl carboxylic acid, the vinyl carboxylic acid salt, and mixtures thereof. Preferably, the monomer "B" comprises from 10 to 30% by weight of the polymer, and the polymer carboxylic acid groups are neutralized with from about 0.5 to about 2 equivalents of an alkali metal hydroxide per carboxylic acid group. When the monomer "B" comprises a mixture of the β-carboxyethyl acrylate and the vinyl carboxylic acid, the β-carboxyethyl acrylate preferably comprises at least 10% by weight of the polymer. The monomer "C" is preferably a macromolecular monomer dispersible in water, which has the formula X-Y-Z. "X" is a copolymerizable portion with "A" and "B"; "Y" is a divalent linking group which joins "X" to "Z"; and "Z" is a water dispersible group which contains at least two units which are essentially non-reactive under the copolymerization conditions initiated by free radicals, used to form the polymer. Preferably, the monomer "C" comprises from 10 to 30% by weight of the polymer. The sterilization indicators of the present invention are capable of maintaining a cluster or wrapped package of articles, in a closed position during sterilization and normal pre- and post-sterilization handling. The pressure sensitive adhesive shows sufficient adhesion to keep the cluster wrapped in items in a closed position during sterilization and normal pre- and post-sterilization handling. The reinforcing tape or tapes used in the present invention show sufficient strength, so that they will not tear or break during sterilization and normal pre- and post-sterilization handling. In the sterilization indicators of the present invention, the sterilization indicator tape is easily removable before laundry. Because there are preferably no adhesives on the sterilization indicator tape, it can easily be torn from the rest of the sterilization indicator, before laundry. The sterilization indicator tape will not be introduced into the laundry process, and therefore has no potential to enter the waste stream. As preferred, if a water-dispersible reinforcement tape is used, the reinforcement tape or tapes are left on a sterilization wrap before the laundry will be dispersed directly during the laundry, eliminating the need to collect material from the laundry equipment afterwards. of the laundry. In the embodiments of the present invention, wherein the sterilization indicator tape is affixed to one end of one or more reinforcement ribbons, the reinforcement ribbons can be pierced at or near the end to which the indicator tape is attached. sterilization. In the embodiments of the present invention, where the sterilization indicator tape is attached to a reinforcing tape having openings therethrough, the reinforcing tape can be perforated near the sterilization indicator tape. Such perforation allows even easier removal of the sterilization indicator tape before the wrapping laundry. The invention also provides a method for making a sterilization indicator, which includes the following steps: the provision of at least one reinforcing tape having opposite ends and sides, and a sterilization indicator tape which includes a indicator ink in combination with a binder printed on a reinforcement or liner; the coating of a water-dispersible pressure sensitive adhesive resistant to moisture on one of the opposite sides of the reinforcing tape or tapes; and fixing the sterilization indicator tape to one end of the tape? reinforcement ribbons. In preferred embodiments, the method may comprise a step for drilling the reinforcing tape or tapes near the end of the reinforcing tape to which the sterilization indicator tape is attached. The present invention also provides a method for making a sterilization indicator, which includes the steps of providing a reinforcing tape having opposite ends and sides, and having at least one opening through the reinforcing tape. , and a sterilization indicating tape which includes an indicator ink in combination with a binder printed on a reinforcement; the coating of a moisture-dispersible water-dispersible pressure-sensitive adhesive on one of the opposite sides of the reinforcement; and fixing the sterilization indicator tape to the reinforcement tape, such that the indicator tape of the sterilization is observable through the opening or openings. Finally, the present invention provides a method for using a sterilization indicator as a wrapping closure that includes the following steps: the provision of an indicator that includes at least one reinforcing tape having opposite sides, and a sensitive adhesive. the pressure, water-dispersible, moisture resistant, coated on one of the opposite sides on the reinforcement tape, the reinforcing tape having a strip or tape indicating the sterilization fixed thereto; the application of the indicator to a sterilization envelope containing a cluster or package of articles, such that the package will remain substantially closed during sterilization and normal handling before and after sterilization. The method of using the sterilization indicator as a wrapping can further comprise removing the sterilization indicator tape from the sterilization wrapping prior to the laundry of the wrapping. In preferred embodiments, the reinforcement tape is perforated, allowing it to be easily removed before the laundry of the sterilization wrap.

Definitions For the purposes of this invention: "Normal handling and pre- and post-sterilization" refers to the handling of wrapped packages or clusters that would likely occur in the day-to-day operation of hospitals, clinics, laundries and the like. This may include loading the packages in and out of the sterilizers, placing the packages in storage and moving the packages throughout and between the institutions. "Sterilization wrap" or "wrap" refers to a covering, typically made of cloth, used to wrap an article or articles to be sterilized by steam, gas, etc., and can in fact be formed by the outer side of a item to be sterilized. Preferably, but not necessarily, the sterilization wrap is reusable. The fabric or clothing is defined in its broadest sense as the fabric or material formed by weaving, knitting, knitting, knitting, binding, crocheting, interlocking, braiding, blowing, melting, or stringing filaments. or synthetic or natural fibers. Non-limiting examples of the fabric include woven and knitted fabrics, knitted or non-woven, used as wraps for sterilization.

Brief Description of the Drawings The invention can be further illustrated with reference to the accompanying drawings in which: The Figures Id are perspective views of various embodiments of the sterilization indicator according to the present invention.

Detailed description Figures 1-Id illustrate preferred embodiments of the sterilization indicator according to the present invention. With reference to FIG. 1, two reinforcing tapes 12 each have opposite sides and a water-dispersible pressure-sensitive adhesive 13, resistant to moisture on at least one of the opposite sides. Preferably, the reinforcing tapes 12 are water dispersible, but may also be non-water dispersible. The sterilization indicator tape 14 is fixed to one end of each of the reinforcement tapes 12. The sterilization indicating tape 14 is preferably fixed to one end of each of the reinforcement tapes 12, by adhesion of the sterilization indicator tape 14 on one side of the reinforcement tape 12, having pressure sensitive adhesive, water dispersible, moisture resistant, coated thereon. The sterilization indicating tape 14 preferably includes a sterilization indicating ink, in combination with a binder printed on a non-water dispersible reinforcement. The indicator ink is capable of undergoing a color change when exposed to sterilization conditions. While the indicator 14 of the sterilization is shown printed in a diagonal pattern in Figure la, it will be appreciated that any pattern and / or variations in the total surface area covered by the printed sterilization indicator ribbon 14 could be encompassed. Optionally, and preferably, perforations 16 can be provided in the reinforcement tapes 12 at or near the ends of the reinforcement tape 12 to which the sterilization indicator tape is attached. The perforations 16 allow easy removal of the indicator sterilization indicator tape from the sterilization 10, prior to the laundry of a sterilization casing packaged with the sterilization indicator of the present invention. Figure Ib shows yet another embodiment of the sterilization indicator 20 of the present invention. In this embodiment, a simple reinforcing tape 22 is provided having a pressure sensitive, water dispersible, moisture resistant adhesive 23 thereon, which is similar to the reinforcement tapes described with reference to the Figure the. The sterilization indicator tape 24 is fixed to one end of the reinforcing tape 22, in a manner similar to that described with reference to Figure la. Holes 26 may optionally be provided on the reinforcement tape 22, at or near the end to which the sterilization indicator tape is attached, for easy removal. Figure 1c shows another preferred embodiment of the sterilization indicator 30 of the present invention. A reinforcing tape 32 similar in construction to the reinforcing tapes described above is provided with reference to Figures la and Ib. The reinforcing tapes 32 have one or more openings 38. While the reinforcing tapes 32 shown in Figure 1c show a plurality of openings, it will be appreciated that the reinforcing tape 32 may be provided with a single opening or a plurality of openings . A sterilization indicating tape 34, similar to that described above with reference to Figures la and Ib, is attached to one side of the reinforcement tape 32 having the water-dispersible, pressure-sensitive adhesive 33, resistant to humidity, on this one. The sterilization indicator tape 34 is attached to the reinforcement tape 32, such that the sterilization indicator tape 34 is observable through the opening or openings 38 in the reinforcement tape 32. The perforations 36 may optionally be provided in the reinforcing tape 32, near the ends of the sterilization indicator tape 34, to allow easy removal of the sterilization indicator tape 34. FIG. Id shows another preferred embodiment of the indicator 40 of the sterilization of the present invention . In this embodiment, a reinforcement tape 42 having an opening or openings 48 is provided near one end of the reinforcement tape 42. A sterilization indicator tape 44 is attached to one side of the reinforcement tape 42 having the reinforcement tape. pressure sensitive adhesive 43, dispersible in water, resistant to moisture, on it. The tape 44 of the sterilization indicator is attached to the reinforcement tape 42 such that the tape 44 of the sterilization indicator is observable through the opening or apertures 48 in the reinforcement tape 42. Perforations 46 can be provided to allow the easy removal of the sterilization indicator tape 44, from the sterilization indicator. The sterilization indicators of the present invention utilize a water-dispersible, water-dispersible pressure sensitive adhesive on at least one side of the reinforcing tape. In this regard, it is preferred that the water dispersible adhesive comprises an acrylate-based adhesive copolymer. In a preferred embodiment, the acrylate-based adhesive copolymer is comprised of three monomers "A", "B" and "C", and less than about 0.1 part of plasticizer per part of polymer. "A" is preferably a hydrophobic monomer selected from the group consisting of an acrylic or methacrylic ester of a non-tertiary alcohol having from 2 to 14 carbon atoms. In preferred embodiments, monomer A comprises from about 50 to about 80% by weight of the polymer. Among the esters of acrylic acid of the non-tertiary alkyl alcohols, the preferred one is butyl acrylate. Monomer B is preferably selected from the group consisting of β-carboxyethylacrylate or the β-carboxyethyl acrylate salt, vinyl carboxylic acid, the vinyl carboxylic acid salt, and mixtures thereof. Preferably, monomer B comprises from 10 to 30% by weight of the polymer. The carboxylic acid groups of the polymer are neutralized with from about 0.5 to about 2 equivalents of an alkali metal hydroxide per carboxylic acid group. When the monomer B comprises a mixture of β-carboxyethyl acrylate and vinyl carboxylic acid, the β-carboxyethyl acrylate preferably comprises at least 10% by weight of the polymer. Monomer C is preferably a macromolecular monomer, dispersible in water, which has the formula X-Y-Z. "X" is a copolymerizable portion with A and B; "Y" is a divalent linking group which joins X to "Z"; and "Z" is a water dispersible group containing at least two units that are essentially non-reactive under the copolymerization conditions initiated by free radicals, used to form the polymer. The monomer C preferably comprises from 10 to 30% by weight of the polymer.

The moisture-dispersible, water-dispersible, pressure-sensitive adhesives preferred for use in the indicators of sterilization of the present invention, and the methods for preparing such adhesives are fully described and detailed in US Patent No. 4,397, 614, assigned to 3M. The reinforcement tapes used in the sterilization indicators of the present invention are preferably water dispersible reinforcements. Water-dispersible reinforcements include those materials that are completely soluble in water or alkali, as well as materials that break into small particles or fibers that are capable of being supported in a liquid medium. Fully soluble materials include, but are not limited to, water-soluble polymers such as polyvinyl alcohol of varying degrees of hydrolysis, or alkali-soluble polymers, such as those available from Belland AG, Biberist, Switzerland. The materials that will be dispersed into fibers or particles capable of being washed with a stream of waste water, include untreated papers or fabrics, such as those papers identified as Crystex tissue from Crystal Papel Co. , or the compressed paper or compressed, untreated paper of International Paper (Springhill Form Bond MP 3800). In untreated matte paper, such as paper with a basis weight of 47.2 kg / m2, by Moisinee Corporation, Mosinee, Wl also possesses the desired dispersion capacity attributes after agitation and laundry. Combinations of these materials could also be used, for example, sizes adjusted with polyvinyl alcohol. The reinforcing tapes can also be non-dispersible in water. Non-water dispersible reinforcements can be made from any film, paper or other non-water dispersible sheet material physically capable of withstanding the conditions of a sterilization cycle given by steam and / or ethylene oxide. Non-limiting examples of other suitable reinforcements include polymeric reinforcements such as polyfinefin-based film reinforcements (e.g., polyethylene reinforcements, polyester reinforcements and isotactic polypropylene reinforcements as described in U.S. Patent No. 4,898,762; paper reinforcements saturated with latex, metal reinforcements, woven reinforcements, and non-woven reinforcements-Non-dispersible reinforcements in water could also include papers treated with binders and / or moisture-resistant additives, to make the reinforcement non-dispersible in water. The sterilization indicator tapes of the present invention preferably comprise an indicator ink in combination with a binder printed on a non-water dispersible reinforcement Suitable non-water dispersible reinforcements for the sterilization indicator tape include non-dispersible reinforcements in water described above. Binding of the sterilization indicator tape is coated with an ink capable of changing the color after exposure to the given conditions of a sterilization cycle. Virtually any indicator ink can be used with the reinforcements of the sterilization indicator tapes of the present invention, as long as the components of the adhesive ink do not react to cause the premature development of the color of the indicator ink, in the adhesion areas between the sterilization indicator tape and the reinforcement tapes. Thus, sterilization indicator inks, such as lead-sulfur carbonate indicator inks, inks indicating sterilization by ethylene oxide, or both types of indicator inks, can be printed on the non-water dispersible reinforcement . See, for example, US Patent No. 3,667,916. Non-limiting examples of suitable inks according to the present invention are described in U.S. Patent Nos. 3,386,807; 3,098,754; 3,360,337 3, 360,338 3,360,339; 3,862,824; 3,523,011; 4,382,063 3,258,312 3,627,469; 3,852,034; 4,015,937; 4,094,642 4,168,779 5,064,576; British Patents Nos. 1,478,553 and 1,370,470; and EPO Publication No. 0,282,178.

The preferred ink for a steam sterilizer is a lead-sulfur carbonate system in a binder system, gravure in lines on the brown paper reinforcement. Preferably, the ink system comprises 38% binder, 23% sulfur, 15% lacquer thinner, 23% lead carbonate, and 1% clay (available as "BENTONE" 38, LM Chemicals, Hightstown, NJ ).

Virtually any binder can be used with the indicator inks of the present invention, as long as the binder is able to maintain the ink used on the reinforcement during laundry. In this way, the binder and the ink must be compatible. The preferred binder system is 24% nitrocellulose-ethyl alcohol (Hercules Inc., Wilmington, DE); 3% phenol-formaldehyde resin (BECKCITE® 24-102, BTL Specialty Resins, Toledo, OH); 9% tricresol phosphate; 14% butyl alcohol; 27% xylene and 23% butyl acetate.

The brown paper printed with ink is then reinforced using a vulcanized system of natural wood rubber turpentine, coated on paper. Preferably, the rubber system comprises 23% natural rubber (Goodyear Tire &Rubber Co., Akron, OH); 6% zinc oxide (Sher in Williams, Cleveland, OH); 3% titanium dioxide (Type A-140, New Jersey Zinc Co., Palmerotn, PA); 29% wood turpentine resin (TENEX © 36-710, Reichold Chemicals Inc., Oakbrook, IL); 2% calcium lithium pigment (Hercules Inc., Wilmington, DE); and 37% mineral alcohol. The preferred vulcanizer used to crosslink the rubber system is 40% white mineral oil (Type # 31 USP; AMOCO Chemical Corp., Chicago, IL); 15% tetramethyltirum disulfide accelerator (RT Vanderbit Co., Norwalk, CT); and 45% ortho-pentamethylethiuram sulfate (RT Vanderbilt Co.).

The printed sterilization indicator tape is then treated to decrease the penetration of paper moisture. Preferably, an acrylate polymer solution is used. The preferred solution is 19% butyl alcohol, 0.2% phosphoric acid, 9% urea, 0.8% aqueous ammonia, 31% formaldehyde, 6% isopropyl alcohol, 10% acrylic polymer (ELVACITE® 2044; DuPont Nemours, Wilmington, DE); 9% butanol and 15% xylene.

The tapes are preferably manufactured on tape reels for continuous feeding for application to the fabric sterilization casings.

The construction of the sterilization indicators of the present invention allows easy removal of the sterilization indicator tape from a sterilization wrap, prior to the laundry of a used sterilization wrap. This advantage is achieved by fixing the sterilization indicator tape to the reinforcement tape, such that it can be easily removed before laundry. The sterilization indicator tape, which does not contain a coated adhesive on it, can easily be torn or torn before laundry. In the preferred embodiments, where perforations are provided, it has been even easier to remove the indicator tape from the sterilization.

The sterilization indicators of the present invention serve strictly for an indicator that a wrapped package has been sterilized, for example, by coupling the sterilization indicator to the outer side of the wrapped package. However, it is preferred that the indicators of the sterilization of the present invention serve a dual purpose. Specifically, it is preferred that the indicator tapes be used to keep the package wrapped in a closed position, and also provide a means for indicating the termination of a sterilization cycle. Whether they are used for a single or double purpose, the water-dispersible, pressure-sensitive adhesives used in the sterilization indicator reinforcing tapes of the present invention are dispersed when submerged in aqueous alkaline solutions in less than about 40-60 minutes. In the preferred embodiments of the present invention where a water dispersible reinforcing tape is used, the reinforcing tape will also be dispersed under these laundry conditions.

Since the sterilization indicator tape has been removed before the laundry, nothing is left to collect from the laundry equipment. Where a nondispersible reinforcing strip or strips is used, the non-dispersible reinforcing tapes remain after the washing cycle, and can be collected in the laundry equipment after washing. In both embodiments, the dispersion of the additive causes the sterilization indicator to separate from the envelope of the washed sterilization. There is no damage to the wrapping caused by, for example, the adhesive residue, the damage of which could necessitate premature disposal of the wrapping. In addition, potentially contaminating sterilization indicator tapes are not introduced into the wash cycle, and thus have no potential to be discharged into the waste stream. The reinforcement tapes are dispersed or collected, not damaging the garments or the environment.

In addition, the water-dispersible pressure sensitive adhesive used over the sterilization indicators of the present invention resists moisture and heat generated during use as a sterilization wrap closure, and thereby prevents loss of adherence to the time of sterilization. Even if some transfer of the adhesive occurs to the wrapping fabric, the dispersion capacity of the adhesive ensures that the wrapping will not suffer any permanent damage.

Another advantage of the invention is that the indicators of the sterilization reduce the time for the processing of the washed goods. Specifically, the inspection for the sterilization tape or the adhesive residue does not need to take place since the pressure sensitive adhesive will be dispersed in the wash cycle.

A further advantage of the present invention is that the indicator tape of the water-dispersible pressure sensitive adhesive is that it reveals tampering or tampering. Once the tape is detached from a sterilized wrapper, it can not be readied because the adhesive remains on the wrapper, thus indicating that the sterility has been compromised.

While the description of the preferred embodiments and parameters of the present invention are provided herein, it will be appreciated that the scope of the invention is not limited thereto, and that other embodiments of the present invention are within the scope of the claims. annexes. Reference is made to the following claims for an understanding of the scope of the present invention. It is noted that in relation to this date, the best method known to the applicant to carry out the aforementioned invention is that which is clear from the present description of the invention.

Having described the invention as above, property is claimed as contained in the following:

Claims (22)

1. A sterilization indicator, characterized in that it comprises: two reinforcement ribbons or strips, each of the reinforcement ribbons have opposite sides and a water-dispersible, moisture-dispersible pressure sensitive adhesive on at least one of the sides opposites; and a sterilization indicator tape attached to one end of each of the reinforcement tapes.

2. The indicator according to claim 1, characterized in that the reinforcing tapes are water dispersible.

3. The indicator according to claim 1, characterized in that the reinforcing tapes are not water dispersible.

4. The indicator according to claim 3, characterized in that the reinforcing tapes are selected from the group consisting of woven reinforcements, nonwoven reinforcements, fabric reinforcements, film reinforcements, paper reinforcements and mechanical reinforcements.

5. The indicator according to claim 1, characterized in that the sterilization indicator tape comprises an indicator ink in combination with a binder printed on a non-water dispersible reinforcement, the indicator ink is capable of undergoing a color change when exposed to sterilization conditions.

6. The indicator according to claim 5, characterized in that the indicator ink is selected from the group consisting of steam sterilization indicator inks, ethylene oxide sterilization indicating inks, or a combination of a sterilization indicating ink by steam, and an ink indicating sterilization by ethylene oxide.

7. The indicator according to claim 6, characterized in that the ink indicating the steam sterilization comprises a lead-sulfur carbonate indicator ink.

8. The indicator according to claim 5, characterized in that the binder comprises an acrylate binder.

9. The indicator according to claim 1, characterized in that the water-sensitive, moisture-dispersible pressure-sensitive adhesive comprises a composition that is dispersible at an alkaline pH, but not at an acidic or neutral pH, comprising: a polymer formed of the monomers A, B and C wherein A is a hydrophobic monomer selected from the group consisting of an acrylic or methacrylic ester of a non-tertiary alcohol having from 2 to 14 carbon atoms, wherein A comprises 50 to 80% by weight of the polymer. B is a monomer selected from the group consisting of β-carboxyethylacrylate, the β-carboxyethyl acrylate salt, vinyl carboxylic acid, the vinyl carboxylic acid salt, and mixtures thereof, wherein B comprises from 10 to 30% in polymer weight, wherein the carboxylic acid groups of the polymer have been neutralized with from about 0.5 to about 2 equivalents of an alkali metal hydroxide per carboxylic acid group, and wherein, when the mixture of the β-carboxyethyl acrylate and the vinyl carboxylic acid, β-carboxyethyl acrylate is used comprises at least 10% by weight of the polymer, and C is a macromolecular water dispersible monomer, which has the formula XYZ, wherein X is a portion copolymerizable with A and B; And it's a divalent linking group which links X to Z; and Z is a water dispersible group which contains at least two units, which are essentially non-reactive under the copolymerization conditions initiated by free radicals, used to form the polymer, and wherein C comprises from 10 to 30% by weight of the polymer, and less than about 0.1 part of the plasticizer by the polymer.

10. The indicator according to claim 1, characterized in that the indicator is capable of maintaining a package wrapped of articles in a closed position during sterilization and normal handling before and after sterilization.

11. The indicator according to claim 1, characterized in that the pressure sensitive adhesive shows sufficient adhesion to keep the package wrapped of articles in a closed position during sterilization and normal handling before and after sterilization.

12. The indicator according to claim 1, characterized in that the reinforcing tapes show sufficient strength, so that they will not tear or break during sterilization and pre- and post-sterilization handling.

13. The indicator according to claim 1, characterized in that the reinforcing tapes are perforated at or near the end to which the sterilization indicator tape is attached.

14. An indicator of sterilization, characterized in that it comprises: a reinforcing tape having opposite sides and a water-dispersible, pressure-sensitive adhesive, resistant to moisture on at least one of the opposite sides; and a sterilization indicator tape attached to one end of the reinforcement tape.

15. An indicator of sterilization, characterized in that it comprises: a reinforcing tape having opposite sides and a water-dispersible, pressure-sensitive adhesive, resistant to moisture on at least one of the opposite sides, the reinforcing tape has one or more openings; and a sterilization indicator tape attached to the reinforcement tape such that the sterilization indicator tape is observable through one or more openings.

16. A method for manufacturing a sterilization indicator, characterized in that it comprises: the provision of at least one reinforcing tape having opposite ends and sides; the provision of a sterilization indicator tape, the sterilization indicator tape comprises an indicator ink in combination with a binder printed on a reinforcement; the coating of a moisture-dispersible water-dispersible pressure sensitive adhesive on one of the opposite sides of at least one reinforcing tape; and securing the sterilization indicator tape to one end of at least one reinforcement tape.

17. The method according to claim 16, further characterized in that it comprises the step of drilling at least one reinforcing tape near the end to which the sterilization indicator tape is attached.

18. The method according to claim 16, characterized in that the method comprises the provision of two reinforcing tapes, and wherein the fixing step comprises attaching the indicator reinforcement of the sterilization to one end of each of the two reinforcement tapes. .

19. A method for using a sterilization indicator as a closure for wrapping, characterized in that it comprises: the provision of an indicator comprising at least one reinforcing tape having opposite sides and a water-dispersible, pressure-sensitive adhesive, resistant to moisture, coated on one of the opposite sides, at least one reinforcement tape has a sterilization indicator tape attached to one end thereof, and the application of the indicator to a sterilization envelope containing a package or cluster of articles, such that the package will remain substantially closed during sterilization and normal handling before and after sterilization.

20. The method according to claim 19, further characterized in that it comprises removing the indicator tape from the sterilization of the sterilization casing, before washing the sterilization casing.

21. The method according to claim 19, characterized in that at least one indicator reinforcing tape is perforated near the end to which the sterilization indicator tape is attached.

22. A method for manufacturing a sterilization indicator, characterized in that it comprises: the provision of a reinforcing tape having opposite sides and at least one opening; the provision of a sterilization indicator tape, the sterilization indicator tape comprising an indicator ink in combination with a binder printed on a reinforcement; the coating of a moisture sensitive, water dispersible pressure sensitive adhesive on one of the opposite sides of the reinforcement; and attaching the sterilization indicator tape to the reinforcement tape such that the sterilization indicator tape is observable through at least one aperture. SUMMARY OF THE INVENTION Sterilization indicators are described using water-dispersible, pressure-sensitive adhesives, resistant to moisture. The indicators of the sterilization comprise at least one reinforcing strip or strip, preferably water-dispersible, which is coated on at least one side with a water-dispersible, moisture-sensitive pressure-sensitive adhesive. A sterilization indicator tape is attached to the reinforcement tape, is easily removable or removable from the sterilization indicator. The indicator tapes are useful for maintaining a sterilization casing containing articles to be sterilized, in a closed position during sterilization, and normal handling pre- and post-sterilization, while also providing the means for indicating the wrapped items have passed through a sterilization cycle. After use, the sterilization indicator tape is easily removed, and the adhesives covering the indicators of the sterilization, and preferably also the reinforcing tapes, are dispersed in aqueous alkaline solution, such as that found in commercial laundries. . Methods for the development and use of sterilization indicators are also provided.