Alcon plastic sterilization containers

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A second notch may be formed in that portion of the heat-sealed portion of the second packaging material which corresponds to the first notch. The first and second packaging materials may then be opened along the first and second notches.

The present inventors have made extensive studies in an attempt to develop a method for manufacturing a plastic container containing an infusion solution which does not allow deterioration of the infusion solution either during or after sterilization and which maintains the sterile condition of the container outer surface over a long period of time. As a result of such studies, the present inventors have reached the following conclusions. First, if a plastic container containing an infusion solution is first packaged, and is then subjected to autoclaving sterilization, contact of the containers with the outer atmosphere e.

Finally, if the container is further packaged with the second packaging material having a high oxygen gas impermeability after cooling, the infusion solution may be kept without deteriorating for a longer period of time. Based on these findings, the present invention has been established. As has been described earlier, the container containing an infusion solution manufactured according to the present invention is subjected to autoclaving sterilization.

For this reason, the container must be made of a flexible plastic material which has a heat resistance able to withstand the heat of autoclaving sterilization that is, is not subject to melting, deformation, deterioration, degradation, etc. The plastic container is preferably manufactured by heat sealing, especially, by high-frequency induction heating of plastic sheets or a flat tube. Therefore, the plastic material for the plastic container preferably has high-frequency sealability.

In addition, the plastic material is preferably transparent or semitransparent in order to allow visual observation of the infusion solution through the container wall. Examples of a plastic material which satisfies these conditions include polyvinyl chloride, a cross-linked ethylene-vinyl acetate copolymer, and a high-density polyethylene. The infusion solution may be prepared by a conventional method. The infusion solution may alternatively be a blood storing liquid. The first packaging material for packing the plastic container holding the infusion solution before autoclaving sterilization must have gas permeability during autoclaving sterilization and must satisfy similar requirements to those of the plastic material of the container.

The first packaging material is a plastic material which has gas oxygen gas and steam permeability during autoclaving sterilization. Accordingly, oxygen which may have remained inside the plastic container or between the plastic container and the first packaging material may be exhausted into the sterilizing atmosphere with a low oxygen partial pressure through the first packaging material during autoclaving sterilization.

Simultaneously, sterilization of the container can be satisfactorily performed by the introduction of high-temperature steam through the first packaging material. Even if the water content of the infusion solution is transferred to the surface of the plastic container through its wall, it is subsequently transferred to the surface of the first packaging material through its wall during cooling. Thus, water may not remain in the space between the plastic container and the first packaging material.

It is noted that the first packaging material preferably exhibits a high gas impermeability at the ambient temperatures. Preferred examples of the first packaging material include single-layer film, e.

The first packaging material may comprise a plurality of separate films; packing is preferably performed by deep draw vacuum forming. The second packaging material for further packaging the plastic container containing the infusion solution is preferably a material which has a high oxygen gas impermeability. In addition, the second packaging material preferably has good heat sealability.

Examples of such a material for the second packaging material include laminate films including a polyvinyl alcohol or aluminum layer. Since hydroxyl groups of polyvinyl alcohol are bonded with each other through hydrogen bonding, polyvinyl alcohol exhibits an extremely high impermeability barrier property to oxygen gas. In order to improve heat sealability of a polyvinyl alcohol film, it preferably has as an inner layer a plastic film having heat sealability such as a non-stretched polypropylene CPP film.

In order to eliminate the adverse effects of water content in the external atmosphere on the polyvinyl alcohol film, the film preferably has another plastic film laminated thereon as an outer layer. Examples of such an outer layer include a biaxially stretched polypropylene OPP film, a polyester film, a biaxially stretched nylon film, and a polyvinylidene chloride film.

Examples of the laminate film having an aluminum film include a polyester film, a polypropylene film and a high-density polyethylene film each laminated with an outer aluminum layer.

The method of the present invention will now be described in more detail with reference to the accompanying drawings. Referring to FIG. The bag 11 may be prepared by, for example, superposing two suitable plastic sheets on top of each other and heat-sealing a periphery 12 of the laminate film. An infusion solution port 13 is formed at one end of the bag 11 to communicate with the interior thereof, through which the infusion solution 16 is supplied. The bag 11 may have a relatively wide sealed portion 14 at its other end.

A suspension hole 15 for suspending the bag 11 from a suitable support member can be formed at this sealed portion After the infusion solution 16 is supplied into the bag 11, the bag 11 is sealed with a sealing member 17 by heat sealing, high-frequency welding or the like. The bag 11 now containing the infusion solution 16 is packed inside the first packaging material 18, and is preferably vacuum-packed therein.

The first packaging material 18 is applied by, for example, superposing two plastic films sandwiching the bag 11 therebetween and sealing a periphery of the two films to form a heat-sealed portion At least one notch 20 is preferably formed at at least one edge of the heat-sealed portion Subsequently, the packaged plastic bag containing the infusion solution as shown in Fig. Autoclaving sterilization can be performed by an apparatus 30 as shown in FIG.

The apparatus 30 has an autoclave 31 to perform sterilization. One end of the autoclave 31 is connected to a steam source such as a boiler 32 through a line 35 via a valve A source 33 of a gas which is inert to the infusion solution, preferably nitrogen gas, is connected to the other end of the autoclave 31 through a line 37, a valve 40, an inert gas reservoir 34, a line 36 and a valve The reservoir 34 may be omitted in which case, the line 36 and the valve 39 may also be omitted.

An exhaust valve 42 is also connected to the autoclave A cooling water source 43 is also connected to the autoclave 31 through a line 44 and a valve In order to perform autoclaving sterilization, a plurality of packaged plastic bags containing the infusion solution are first placed in the autoclave Steam is introduced into the autoclave 31 from the boiler 32 for a predetermined time interval e.

The exhaust valve 42 is then closed. Steam at a predetermined temperature is further introduced into the autoclave 31 from the boiler 32 to a saturation level in order to perform sterilization. The sterilization time is 10 to 40 minutes.

The gauge pressure in the autoclave during sterilization is about 1. In order to obtain this pressure during sterilization, the inert gas is introduced into the autoclave 31 in a suitable amount from the source 33 through the valve After sterilization, cooling water is introduced in a suitable amount from the cooling water source 43 into the autoclave 31 to sufficiently cool the infusion solution held in the bag.

Packaging with the second packaging material is preferably performed as soon as the bag is taken out from the autoclave If the second packaging material 21 is a laminate film having a polyvinyl alcohol film, the bag must be sufficiently cooled e. In any case, the pressure in the autoclave 31 is relatively abruptly decreased, whereas the infusion solution does not cool so quickly. Therefore the bag may be damaged or broken by the pressure of the still hot infusion solution.

In order to prevent this, the sterilization pressure in the autoclave 31 must be substantially maintained during cooling. In order to accomplish this, the inert gas is introduced from the source 33 into the autoclave 31 according to the present invention. After the infusion solution is sufficiently cooled, the gas inside the autoclave 31 is exhausted through the exhaust valve 42 to the normal pressure.

After the infusion solution is sufficiently cooled, the bag is taken out of the autoclave 31 and is wiped or dried to remove any water on the surface of the first packaging material The bag is then further packaged with the second packaging material. Packaging with the second packaging material 21 is preferably performed in an atmosphere containing substantially no oxygen to allow substantially no oxygen to be trapped inside the second packaging material.

Packaging with the second packaging material is, therefore, preferably performed by vacuum packing or in an inert gas such as nitrogen atmosphere. In packaging, two plastic sheets are superposed together and a periphery of the sheets is heat-sealed. Alternatively, two ends 22 of a tubular sheet 21 are heat-sealed to form heat-sealed portions 22, as shown in Fig.

The heat-sealed portions 22 of the second packaging material 21 are formed at a distance from the first packaging material Preferably, at a portion at which the second packaging material overlaps the heat-sealed portion 19 of the first packaging material 18 with the notch 20 formed therein the first and second packaging materials 18 and 21 are heat-sealed together to form a commonly sealed portion The commonly sealed portion 23 is formed prior to forming the heat-sealed portions 22 of the second packaging material A notch 24 may be formed in the heat-sealed portion 22 at a position corresponding to the notch 20, so that the two packaging materials may be simultaneously opened.

The packaged bag was sterilized in a similar manner as has been described with reference to FIG. After cooling, the bag sample was taken out of the autoclave. In this case, after performing common heat sealing as shown in FIG. In this manner, a plastic bag containing an infusion solution packed inside two packaging materials was obtained which did not rupture during manufacture.

A plastic bag containing an infusion solution packed inside one packaging material was prepared in a similar manner to that in Example 1 except that packaging with the second packaging material was not performed.

A plastic bag containing an infusion solution was packed inside two packaging materials in a similar manner to that in Example 1 except for the structures and materials of the packaging materials. The first packaging material consisted of a top material and a bottom material and was deep draw vacuum-formed. In order to examine the storage stability of the infusion solutions contained in the bags obtained in Examples 1 and 2 and the Comparative Example, the bags were subjected to an accelerated test in air.

The obtained results are shown in Table below:. According to the present invention, autoclaving sterilization of the plastic container containing the infusion solution is performed after packaging the bag with the first packaging material. Therefore, contact with the ambient atmosphere after sterilization does not result in contamination of the plastic container.

Finally, plastic bags offer little, if any, protection for the contents of the bag from physical damage due to impact during shipping or other handling. A need thus exists for a modular surgical packaging system for packaging various products utilized during surgical procedures which is an improvement upon the use of flexible plastic bags.

A need also exists for such a modular packaging system which provides a convenient method for packaging surgical products which are sterilizable by diverse means. A need also exists for such a packaging system which more effectively organizes the components being packaged including surgical drapes, surgical instruments and various adjunct pharmaceutical products. A need also exists for such a packaging system which can be stacked efficiently for convenient storage and which effectively protects the contents of the packaging system from physical damage during normal use and handling.

A need also exists for such a packaging system which is simple in design and economical to manufacture. The modular surgical packaging system of the invention includes a central package having external sidewalls and an open interior. The open interior is adapted to contain a first type of sterilizable surgical item, the external sidewalls of the central package having at least one accessory receiving compartment formed therein.

An accessory module adapted to contain a second type of sterilizable surgical item is received within the accessory receiving compartment formed on the external sidewalls of the central package.

Preferably, the open interior of the central package is adapted to contain surgical items which are sterilizable by a first means of bacteria sterilization, and the accessory module is adapted to contain surgical items which are sterilizable by one or more means of bacterial sterilization other than the first means of sterilization.

Most preferably, the open interior of the central package is adapted to contain surgical items which are sterilizable by GAMMA irradiation. The accessory module is a piggyback module which is contained within a recessed compartment formed on the external sidewalls of the central package and is adapted to contain surgical items which are sterilizable by diverse means of bacterial sterilization, such as through the use of a sterilization gas such as ethylene oxide or steam.

The accessory module can assume various shapes, depending upon the particular shape of the accessory to be accommodated. Where the shape of the accessory is that of a liquid bottle, the accessory module can be provided as a container having an accessory receiving body and a hinged lid, the body being shaped to generally conform to a recessed compartment formed on the external sidewalls of the central package.

For example, the accessory receiving module can also be provided with a planar exterior portion and an associated sleeve. The sleeve is adapted to receive a liquid bottle for enclosing the bottle when the accessory module is received within a recessed compartment of the central package.

The planar exterior portion is foldable along a central axis to conform to the shape of the external sidewalls of the central package when the module is received within a selected one of the recessed compartments. The central package can also be provided with a handle having a handle opening, the handle opening being selectively sized to receive an outwardly extending projection extending from a vertically oriented storage panel, whereby a plurality of the modular packaging systems can be arranged on the storage panel for convenient access during surgical procedures.

Additional objects, features and advantages will be apparent in the written description which follows. The packaging system 11 includes a central package or core unit 13 having external sidewalls and an open interior 15 in FIG.

The assembled central package of the embodiment of the invention shown in FIG. For instance, the central package 13 can be conveniently formed of polystyrene having upper and lower halves 17, 19 which are joined in clamshell fashion at a flexible rear hinge The central package 13 can also be formed as discreet halves 18, 20, as shown in FIG.

The upper half 17 FIG. The lower half 19 of the central package 13 similarly includes front, rear and opposing sidewalls, 33, 35, 37 and 39, respectively, and is selectively sized to matingly engage the upper half 17 at a peripheral lip region The peripheral lip region 41 comprises an outwardly extending flange which circumscribes the sidewalls of the lower half The upper half 17 is provided with a similar and mating lip region 42 which overlays the lip region 41 of the lower half 19 in the closed position shown in FIG.

Although the central package 13 is shown having relatively rigid sidewalls in the preferred embodiment of FIGS. The central package 13 has at least one accessory receiving compartment formed therein. In the embodiment of FIG. As will be explained more fully, the open interior 15 of the central package 13 is preferably adapted to contain surgical items which are sterilizable by first means of bacteria sterilization, most preferably by GAMMA irradiation.

Surgical drapes and implements sterilizable by GAMMA irradiation can then be packaged within the open interior 15 with the sterile package being sealed along the peripheral lips 41, One or more accessory modules are mounted within the recessed accessory receiving compartments formed on the external sidewalls of the central package The contents of the accessory modules 43, 45 are preferably sterilizable by diverse means of sterilization, such as by ethylene oxide or by steam.

For instance, a rubber closured vial of medicament agent which is incompatible with GAMMA irradiation sterilization and which is heat sterilized separately can be placed within the respective accessory receiving compartment.

In the embodiment of the invention shown in FIG. The accessory receiving compartment 43 includes generally vertically extending sidewalls 47, 49 extending downwardly from the planar top surface 23 of the central package The vertically extending sidewalls are connected by an arcuate floor region 53 which is arranged generally transverse to the longitudinal axis of the central package illustrated as 51 in FIG.

The piggyback module 55 includes a sleeve member 57 which, in this case, is generally cylindrically shaped in order to hold a liquid container such as a bottle of irrigating fluid The cylindrical exterior 59 of the sleeve 57 is sized to be received within the arcuate floor region 53 of the accessory receiving pocket 43 in mating fashion. Additional protective padding type materials 60 can circumscribe the container 59 to further protect fragile sterile items.

Although the accessory module 55 is particularly adapted to receive a cylindrically shaped liquid container in the embodiment of the invention shown in FIGS.

The particular piggyback module 55 shown in FIG. The planar exterior portion 61 is foldable along a central axis 63 to form a first planar fold 65 FIG. The remainder of the planar exterior portion 61 forms a downwardly angled fold 67 which conforms to the shape of the external sidewalls of the central package and completes the enclosure within the accessory receiving compartment.

The second accessory receiving compartment 45, shown in FIG. The vertically extending sidewalls are connected by a sloped floor 73 which forms an opening of increasing depth in the direction of the rear sidewall 27 of the central package When viewed from the side, as shown in FIG.

The piggyback module 75 is also provided having an accessory receiving body 77, in this case of triangular cross-section, and with a hinged lid The module 75 assumes a generally triangular shape in external configuration when the lid 79 is closed, allowing the body 77 to be closely received within the accessory receiving compartment In the assembled state, the top portion 81 of the module 75 is arranged generally coplanar with the plane of the top surface 23 of the central package The rear wall 82 of the module conforms generally to the shape of the external sidewalls of the central package best seen as 67 in FIG.

The module 75 is adapted to receive a variety of surgical items 83, 85, 87, certain of which are preferably sterilizable by a diverse form of sterilization than the components which are contained within the open interior 15 of the central package For instance, if the components contained within the central package 13 are sterilized by GAMMA irradiation, the items contained within the module 75 are preferably sterilized by a means of sterilization other than irradiation.

As shown in FIGS. The sealant ribbon can be provided with a suitable adhesive on the upper and lower surfaces thereof for joining the peripheral lip regions 41, 42 of the upper and lower halves 17, 19 of the central package. The pull tab 95 is conveniently located within a side pocket 97 which allows the user's finger 99 to grasp the tab and pull the filament 94 around the periphery of the container halves to separate the halves during use.

Any of a number of adhesive sealants can be utilized on the surfaces of the sealant ribbon 89 which will be familiar to those skilled in the art and which form permanent hermetic seals but which will unseal by pulling tab

Containers alcon plastic sterilization alcon project management intern

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Alcon plastic sterilization containers	The accessory receiving module can be retained within the compartment by a suitable adhesive applied between the module and compartment or by enclosing the module with a surrounding package wrapping. The bag 11 may have a relatively wide sealed portion 14 at its other end. One or more accessory modules are mounted within the recessed accessory receiving compartments formed on the external sidewalls of the central package The container is further packaged with a second packaging material alcon plastic sterilization containers has a high oxygen gas impermeability. An accessory module https://new.samslawguide.com/2018-cvs-health-sophomore-career-and-innovation-externship-program/8280-kaiser-permanente-new-orleans.php to plaztic a second type of sterilizable surgical item is received within the accessory receiving compartment formed on the external sidewalls of the central package.
Alcon plastic sterilization containers	764
Alcon opti free supra clens	Alcon plastic sterilization containers this case, after performing common heat sealing as shown in FIG. Although the accessory module 55 is particularly adapted to receive a cylindrically shaped liquid container in the embodiment of the invention shown in FIGS. Plastic bags containing surgical products are relatively cumbersome, and therefore difficult for operating room personnel to open and disassemble. Finally, plastic bags offer little, if any, protection for the contents of the bag from physical damage due to impact during shipping or other handling. In order to perform autoclaving sterilization, a plurality of packaged plastic bags containing the infusion solution are first placed in the autoclave
Lorraine martinez centene	Caresource doctors in springfield ohio
Alcon plastic sterilization containers	380
Alcon plastic sterilization containers	Subsequently, the packaged source bag containing the infusion solution as shown in See more. All of these products must be sterilized and maintained in a sterile condition prior to opening the package apcon which they are contained in the operating room. The package construction also serves to protect the contents of the container from physical damage due to impact during sterilziation or other handling. The apparatus 30 has an autoclave 31 to perform sterilization. In this case, after performing common heat sealing as shown in FIG.

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