NZ574909A - Puncture resistant steam sterilisation bag for surgical instruments, with sealable openings - Google Patents

Abstract

A sterilisation bag 1 has a first sealable opening 2 at one end for receiving surgical instruments to be sterilised typically within a perforated cage 3. A second opening is provided in the form of a sealable tube 4 to receive sterilising steam.

Description

Received by IPONZ 22 Dec 2011 Our Ref: MER058NZ Patents Form No. 5 PATENTS ACT 1953 Complete After Provisional No. 574-909 Filed 13 February 2009 COMPLETE SPECIFICATION A STERILISATION BAG.

We, Mercer Technologies Limited, a New Zealand company of 7 Corban Avenue, Henderson, Auckland, New Zealand, do hereby declare the invention for which we pray that a patent may be granted to us, and the method by which it is to be performed, to be particularly described in and by the following statement: 1 Received by IPONZ 22 Dec 2011 A STERILISATION BAG FIELD OF THE INVENTION The present invention relates to an impervious scalable packaging (plastic bag) forming the means for sterilising an article(s) solely within the plastic bag. The packaging, in a preferred form, having the construction of a non-porous, impenetrable receptacle fed through an orifice clamped hermetically about a sterilisation fluid conduit during the sterilisation process of a load (articles) and the 10 package sealed under partial vacuum at the conclusion of a successful sterilisation cycle.

BACKGROUND OF THE INVENTION The applicants prior application published as W02007/055595 discloses a sterilisation method and apparatus in which items to be sterilised may be sterilised within a plastic bag whilst the exterior of the sterilisation bag is maintained at atmospheric pressure. The disclosure of this application is hereby incorporated by reference.

In a healthcare facility it is necessary that all equipment and materials used for treating patients are safe for use; the chance of spreading infection should be minimal. As is well known, articles used in the operating room, such as surgical instruments, must be sterilised before and after each use.

In current practice at the end of a correct sterilisation process, articles inside the steriliser chamber are sterile. The air in the room where the steriliser is installed contains dust particles, which may carry microorganisms; therefore the potential exists when taking out the load from the steriliser that it may be contaminated again.

Received by IPONZ 22 Dec 2011 Additionally sterile articles are usually stored for quite some time before use and moreover they are transported through the healthcare facility to the place they are to be used. It is thus obvious that when not protected the goods may be re-contaminated by the time they are used.

Articles therefore must be placed in a packaging to prevent recontamination after sterilisation and at the same time the packaging should be suitable to allow sterilisation of the articles it contains within a steriliser chamber. Packaging is essential for maintaining sterility; moreover the packaging must protect its load 10 against damage during handling and transport.

Current practices of packaging depending on the use, storage and transportation, dictates that a sterile article should be packaged in one or more packaging layers. The inner primary packaging prevents recontamination of the articles after 15 sterilisation and should provide an effective microbial barrier whilst it must allow the passage of air and the sterilant. The secondary layer is applied to facilitate proper storage and transport protection of the articles whilst it must allow the passage of air and the sterilant and in addition the combination of the packaging layers must allow the passage of air and the sterilant. The 'barrier' to microbiologic ingress is thus 20 defined as a torturous path.

The combination of the packaging layers therefore must function as a sterile barrier system enabling medical articles to be sterilised, maintain sterility and ensure the articles sterility until the time of use or the packaging expiry date. The ISO definition 25 of a sterile barrier system is "a minimum package that prevents ingress of microorganisms and allows aseptic presentation of the product at the point of use".

Due to current sterilisation practices the sterile barrier system is required to be "breathable" and sterile' packaging is the single biggest challenge to successful 30 sterilisation. Due to the requirement of the packaging to act as a barrier once sterile - it is inherently difficult to extract .air, insert steam and subsequently extract the Received by IPONZ 22 Dec 2011 resultant condensate to leave the load dry, through this barrier system. Advances in non-woven wraps with their more effective barrier construction have contributed to compounding this problem.

Fundamental to air extraction is the rate at which the air to be removed from the pack can physically pass through the barrier. No allowance for load sizing or service (water pressure/steam supply) variance or time-based extraction is implemented. A common problem with today's sterilisers is the vacuum system is too efficient and the vacuum stages happen faster than the air can get out through the barrier (A 10 common symptom of this is packs 'blowing up' under vacuum). Conversely the pressure stages that are supposed to force steam into the packs are also too efficient and the steam simply cannot penetrate effectively in the time allowed.

This very typical problem encountered with breathable sterile barrier systems is 15 made even worse by lightly loaded cycles or mixed loads where some porous packs are in with non-porous instrument cases etc. and results in inadequate air removal, steam penetration failure and non-sterile packs within the loads.

Traditionally packaging materials were reusable but due to their inadequate microbial 20 barrier properties most of these traditional materials do not meet the requirements for primary sterile packaging anymore. Presently non-wovens, laminated film pouches, paper bags and containers are used as primary, packaging materials. These include muslin wraps, various paper. wraps and non-woven wraps, or alternatively laminated film pouches or sterilisation containers. The wraps are 25 typically secured by autoclavable tape which may become detached during processing or in the handling of a package leading to rejection of the package. An important feature of fabric is its "breathability" or the ability of the fabric construction to allow the passage of air and water vapour (i.e. steam). Current practices where breathable packaging is required to allow the passage of the sterilant (water 30 vapour/steam) in and out of the package during the sterilisation process places huge demands on the breathable packaging at the conclusion of the sterilisation process Received by IPONZ 22 Dec 2011 to then act as a viral and liquid barrier to ensure impervious protection of the terminally sterile load. The sterilised package should be constructed so that it may be easily opened without the packaging contaminating the contents.

The minimum requirement of any packaging configuration is that it will maintain sterility of the package load until aseptic presentation at the point of use.

Due to the many variables sterilisation services practitioners are faced with everyday new standards are evolving and the International Organisation for Standardisation (ISO) is working globally to coordinate standards.

The most recently published standard titled "Packaging for terminally sterilised medical devices" has two parts namely; Parti: Requirements for materials, sterile barrier systems and packaging systems, and Part2: Validation requirements for forming, sealing and assembly processes. The emphasis is clearly on patient safety 15 regardless of where or how the product is sterilised.

The dichotomy of the sterile barrier system persists in current practices and the challenge for the packaging suppliers and users is that the sterile barrier system must be porous or breathable to facilitate air removal and sterilant 20 penetration/removal during the sterilisation process within the steriliser and then crucially at the completion of a successful sterilisation process, provide impervious protection as a viral and liquid barrier until aseptic release at point of use.

Not withstanding the substantial research and investment in breathable sterile barrier 25 systems the necessity of the barrier material to be breathable during the sterilisation process/cycle in the steriliser chamber and then conversely an impervious barrier system ater sterilisation is extremely unlikely. This conflicting demand of the breathable barrier system has no perfect solution and remains one of those dilemmas hard to solve.

Received by IPONZ 22 Dec 2011 6 The applicant's prior application published as W02007/055595 discloses a plastic sterilisation bag having a single opening for receiving items to be sterilised and for conveying sterilant. Whilst simple and effective the items are not sealed within the bag until after sterilisation and it is more difficult to seal a large opening than a small 5 opening.

It is an object of the invention to provide an improved sterilisation bag or to at least provide the public with a useful choice.

SUMMARY OF THE INVENTION There is thus provided a puncture resistant scalable vapour barrier sterilisation bag capable of withstanding a steam sterilisation process whilst providing an effective microbiological barrier having a first scalable opening suitable for receiving items to 15 be sterilised and a second sealable opening adapted to couple to a sterilisation conduit.

The first scalable opening is preferably formed by adjacent walls of the bag being substantially unjoined along one edge of the bag. The second scalable opening is 20 preferably in the form of a neck that is relatively narrow with respect to the width of the bag. A third scalable opening may also be formed communicating with an internal channel that extends sufficiently into the bag to facilitate circulation within the bag via the second and third openings when the first opening is sealed.

The bag is preferably formed of plastics. It may be formed from a sheet of multilayer construction. The bag may be formed of a sheet that is folded and sealed along part of its adjacent edges. The bag is preferably capable of withstanding internal process temperatures up to 138 degrees Celsius and external process temperatures of up to 180 degrees Celsius. The bag preferably has a puncture resistant outer layer and a 30 heat-sealable inner layer. The bag material construction may be translucent to facilitate visual verification of sterilisation process indicators. The contents of the bag Received by IPONZ 22 Dec 2011 7 may be sealed within the bag at a modified atmosphere allowing visual indication of a breach of the sealed bag integrity.

The bag may include a covert marking technology. The covert marking technology 5 may be a tamper-resistant label applied to the bag. The covert marking technology may be integrated into the bag. The bag may include a readable unique identification code.

BRIEF DESCRIPTION OF THE DRAWINGS The invention will now be described by way of example with reference to the accompanying drawings in which: FIG. 1 shows a view of a typical packaging (plastic sterilisation bag) with its 15 loading end open; FIG. 2 shows a perforated tray for containing items to be sterilised; FIG. 3 shows the packaging of Figure 1 containing the tray shown in Figure 2 20 with the load end sealed and ready to be sterilised; FIG. 4 shows an opening of the packaging encapsulating a snorkel supplying sterilisation services; and FIG. 5 shows a bag according to an alternate embodiment having an additional opening communicating via a channel to the interior of the bag.

Received by IPONZ 22 Dec 2011 8 DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT OF THE INVENTION In response to the challenges encountered by those of skill in the art, from the 5 following description it will be evident that the requirements listed below are desirable: Enabling sterilisation The packaging will allow air that is in the packaging to be evacuated and the sterilant 10 or sterilising agent to be introduced to reach all surfaces of its content (items) via a conduit (snorkel) communicating with an opening (mouth).

Compatible with the sterilisation process The combination of the apparatus and packaging will be able to withstand the 15 conditions that occur during the sterilisation process such as pressure changes, high temperature and humidity.

Ensure product integrity and patient safety The sterilisation bag/sterilisation process will not affect the item(s) in any other way, 20 which may affect the quality of the item(s) or which might endanger the patient or process on which the sterile item(s) will be used, subject to the item(s) to be processed being rated for the sterilisation temperature and pressure.

Maintaining Sterility After taking the sealed and vacuum packed sterile load/item(s) out of the apparatus it/they will remain sterile during handling, transportation and storage until use, whilst package seal integrity is intact.

Packaging authentication 30 Authentication of the packaging prior to sterilisation of item(s) is desirable to ensure an authenticated and validated sterilisation bag is derived from tested and approved Received by IPONZ 22 Dec 2011 9 film to facilitate most appropriate functionality with respect to sterilisation process, sealing integrity, handling, transportation and shelf-life.

Tracking and traceability The apparatus and packing may desirably process individual loads/trays with each load/tray incorporating a unique identification code written to a RFID tag (attached to the load) and captured in a database to facilitate data logging of process parameters per individual package and to facilitate full tracking and traceability of individual loads throughout its lifecycle.

Indicator Transparent sealed packaging to facilitates visual verification of sterilisation process indicators.

Facilitate aseptic opening and presentation When opening a sealed vacuum packed sterile load/item(s), the packaging will facilitate aseptic opening and presentation.

This implies: simple opening when removing the sterile load/items from the packaging, 20 package opening will facilitate direct access to the sterile load within the interior of the packaging, the design incorporates an autoclavabie perforated tray with lid (preferably of stainless steel mesh construction or similar) that the item(s) are placed .in prior to insertion into the packaging (plastic bag). Optionally the tray may be wrapped in a porous fabric/wrap to further enhance aseptic release of 25 the load in theatre or sterile zone.

Visible indication that packaged has been opened or breached Subjecting the package to a vacuum state whence sealed after load sterility is achieved enables immediate visible indication of package vacuum loss due to either 30 a fault of seal integrity loss, package integrity breach or package opening under normal controlled aseptic opening of terminally sterile package. In the event that the Received by IPONZ 22 Dec 2011 package has lost its vacuum as a result of a failure the package may be immediately be deemed contaminated and no longer sterile.

Referring to Figure 1 a sterilisation bag according to one embodiment is shown. The 5 bag 1 has a first opening 2 for receiving items to be sterilised (in this case contained within a perforated cage 3). A second opening is provided at the other end in the form of a tube 4 communicating with the interior of the bag. Tube 4 may be relatively narrow with respect to the width of the bag to ensure the contents may be securely retained when opening 2 is sealed and to facilitate sealing with sterilisation services 10 supply apparatus.

The bag 1 is preferably formed of plastics. The bag 1 may be of multi-layer construction and may be formed of a puncture resistant outer layer and a heat-sealable inner layer. The bag should be capable of withstanding a steam 15 sterilisation process whilst providing an effective microbiological barrier. The bag may advantageously be formed of a transparent material to facilitate visual verification of sterilisation, bag contents and sterilisation process indicators (such as an indicator which changes colour when exposed to required sterilisation parameters). The bag 1 should be capable of withstanding internal process 20 temperatures of up to 138 degrees Celsius and external process temperatures up to 180 degrees Celsius.0 The bag may be formed from a sheet of such material by cutting the required outline from a sheet of material, folding the bag and heat sealing together edges 5 and 6 25 and the edges of the opposite sides of tube 4. Alternatively the bag may be formed from a tube with one end cut to define the sides of tube 4 and the edges heat sealed (apart from the tube opening).

The bag may include an authentication feature 7 as shown in Figure 3. In one 30 embodiment this may be a tamper resistant label including a code, such as a bar code. Preferably each sterilisation bag is assigned a unique identification code so Received by IPONZ 22 Dec 2011 11 that each bag may be uniquely identified and tracked. Alternatively the identification feature may utilise a covert marking technology integrated into the bag, such as a non-visible marking, a nano-technology feature etc. The identification feature may identify a bag type where different bag types are used for different applications or bag validity or it may contain a code uniquely identifying the bag.

In use items to be sterilised may be placed within cage 3 (Figure 2) by removing lid 9, placing items to be sterilised in base 8 and replacing lid 9. The cage 3 containing the items to be sterilised may then be placed within bag 1 as shown in Figure 1. Once the cage 3 is fully inserted opening 2 may be sealed. Opening 2 is preferably sealed by heat sealing the edges of bag 1 adjacent opening 2. However, other sealing methods, such as using adhesives, could be employed. The sealed bag shown in Figure 3 now securely contains the contents and has a unique identifier in the form of identification feature 7 allowing tracking of the package throughout a sterilisation process and for subsequent inventory management.

Referring now to Figure 4 a bag 1 is shown connected to the supply connection 13 of a sterilisation services apparatus. It will be seen that a conduit 12 is inserted within the opening of tube 4. Conduit 4 tapers towards its edges to facilitate sealing. In use a resilient bar (similar to bar 10) is pressed against bar 10 to provide a clamping pressure to seal tube 4 against conduit 12. The bag may then be evacuated via conduit 12, sterilant (typically steam) may then be supplied to sterilise the contents, the contents may then be dried and then the bag evacuated. At the completion of the sterilisation process, and whilst the bag is at least partially evacuated, tube 4 may be sealed. In a preferred embodiment a heat sealing bar may be forced against heat-sealing bar 11 to heat seal tube 4. Thus a sealed bag containing sterilised items protected from external conditions is produced and can be safely moved and stored. When sterilised items are required bag 1 may be removed and the contents removed from cage 3.

Received by IPONZ 22 Dec 2011 12 According to an alternate embodiment shown conceptually in figure 5 the bag shown in figure 1 may be modified to include a further opening and a channel for supplying fluid to the interior of the bag. Bag 14 is generally as shown in Figure 1 except that the sides of the bag are heat-seated together along seal line 15 to define a further 5 opening 16 and a channel 17. This construction facilitates circulation of fluid within the bag so that fluid may be supplied via opening 16, along channel 17, within bag 14 and out of opening 18 as indicated by arrow F. It will be appreciated that this arrangement requires two conduits to be engaged with respective openings 16 and 18.

The invention according to one embodiment is envisaged to accommodate a load containing one tray/cage of half a sterilising unit [1/2StU = 30cmx1 Scmx60cm (WxHxL)] per package, thereby facilitating and promoting standardisation of individual load dynamics. This is by way of example and the invention is not limited 15 to this standard size.

The sterilisation bag will need to be made to required specifications, specific to each application. The package (and film) will be impervious and non-porous to facilitate the parameters of steam sterilisation and be able to hold a vacuum for a prolonged 20 period under sealed conditions.

Means may be incorporated in sterilisation services supply apparatus used with the bag to enable the apparatus to either accept or reject a sterilisation bag through a process of authentication and/or unique identification marking 7.

The sterilisation bag according to the present invention therefore preferably comprises a multilayer packaging film that combines desired properties such as viral barrier properties, strength, heat scalability and is suitable for being made into a bag. Preferably, the multilayer packaging film is provided with at least one heat sealable 30 layer and a sterile barrier layer (preventing ingress of micro-organisms and allowing aseptic presentation).

Received by IPONZ 22 Dec 2011 13 When the multilayer packaging film is made into a bag, it is preferred that the inner layer of the bag is the heat scalable layer. The sealing operation is usually performed inside to inside, therefore the first transverse seal is made to shape the 5 film into a tube and the top of the tube is sealed to form an open mouth and this is the production fabricated package.

The large opening 2 of a sterilisation bag 1 may be sealed in a sterile services facility (department) after the load/tray containing the articles to be sterilised have been 10 placed in the package, preferably on a packaging table (station) and sealed in an approved sealing machine.

The mouth of the tube 4 is sealed under controlled conditions within a sterilisation services supply apparatus after a successful completion of a sterilisation process, 15 effectively sealing the terminally sterile load within an impervious sterile barrier system under a partial vacuum. The packaging shall then remain sealed until aseptically opened at point of use or alternative until the expiry date. The shelf life of the sealed impervious package is expected to substantially exceed existing breathable sterile barrier systems.

Besides the heat scalable layer and barrier layer, the multilayer film may comprise further layers, e.g. layers that provide higher toughness, clarity, stiffness, strength and the like. In the preferred form the film shall be a triplex (three laminate) construction. The invention in the preferred form is envisaged that the package shall 25 be converted from a triplex laminate film made up of PET/Biax Nylon/CPP or similar as will be appreciated by those skilled in the art.

The preferred film shall have a clear outer Natural PET (polyethylene terephthalate) laminate which provides high tensile strength and heat resistance, the second 30 Biaxally Oriented Nylon laminate provides excellent barrier properties and good Received by IPONZ 22 Dec 2011 14 pinhole/puncture resistance arid the inner laminate is a Special Retort CPP (Cast Polypropylene) providing heat scalability and high seal strength.

Part 1 of the EN ISO 11607 specifies the general requirements for all sterile barrier 5 systems. Part2 of EN ISO 11607 describes the validation requirements for forming, sealing and assembly processes of sterile barrier systems.

Three levels of sterilisation products are being defined: 1 Sterile Barrier System: minimum package that prevents ingress of microorganisms and allows aseptic presentation of the product at the point of use 2. Protective Packaging: configuration of materials designed to prevent damage to the sterile barrier system and its contents from the time of assembly until the point of use 3. Packaging system: combination of the sterile barrier system and protective packaging The invention according to one embodiment shall provide an impervious sterile 20 barrier system offering complete viral barrier protection against ingress of microorganisms whilst the packaging seal integrity is maintained. In a further embodiment the packaging containing the terminally sterile load (DIN 58952/ISO instrument tray/basket size) under partial vacuum is planned to be of capacities to DIN or ISO sizing as per sterile units typically 14 StU to comply with the ISO modular 25 system for Slide in-sterile goods baskets.

The combination of an impervious sterile barrier system and protective packaging system in the form of the carrier goods basket offers a complete packaging system. A further embodiment of the invention is the overt/covert authentication system to 30 validate the packaging and film authenticity to facilitate sterile barrier uniformity and Received by IPONZ 22 Dec 2011 repeatability and coupled with the overt serialisation - Unique Identification mark (UIM) system, full quality assurance will be possible for the packaging system.

In one form of the invention the authentication incorporated on every package may 5 be based on a covert marking technology (such as a nano-teehnology technique) facilitating quality assured supply chain logistics of the packaging and sterilisation process. The authentication of the packaging and film therefore ensures the use of only the validated and internationally regulatory approved film laminates as sterile barrier system thereby endorsing the ISO 11607 standard.

The invention provides a solution utilising a non-porous (non-breathable) sterile barrier system during an in-bag sterilisation process which due to the impervious qualities provides a sterile barrier system after sterilisation. This replaces the necessity for a breathable sterile barrier system and the large and inefficient steriliser 15 chambers of the prior art.

The sterile load remains securely within the impermeable package offering a sterile barrier system with full viral and liquid barrier protection. In principle the probability of recontamination is completely eliminated whilst the package seal integrity is 20 maintained.

It is anticipated that the method of sterilisation solely within the package will provide substantial efficiencies in the sterilisation process model. The process will remove air from directly inside the packaging within seconds/minutes whilst pre-heating the load, sterilisation parameters of pressure and time will adhere to international 25 recognised standards (typically 3.5 - 5 minutes @ 134° C (degrees Celsius) of steam penetration to facilitate sterilisation) followed by the drying phase by means of removing the majority of the steam/condensate through pulling a vacuum in the package whilst the package is located on a heating plate, drying will be facilitated within minutes.

Received by IPONZ 22 Dec 2011 It is envisaged that most sterilisation cycle time(s) may be reduced by more than 50%, subject to the load mass. The packaging containing the sterilised load (items) will be vacuum sealed at the end of the sterilisation cycle and it is believed that the invention will result in less likelihood of wet load problems due to direct heat transfer 5 of heat from a heating plate during the drying phase.

Furthermore due to non-use of traditional wrapping fabrics (which inhibits the vapour removal due to the inherent tortuous path), vacuum drying efficiency is greatly enhanced. The package also has greater integrity reducing rejection due to 10 mechanical packaging failure during processing and handling. The packaging material also allows easy opening due to the clean tearing of the material the risk of contamination from the packaging is low.

The shelf-life of a sterile load(s) shall be monitor friendly (visual identification that 15 vacuum has been maintained by the bag adhering to the cage), facilitate quality assurance and offer longer expiry dates.

The invention as described herein is open to modification as will be appreciated by those skilled in the art. For example, rather than perform as a sterilisation package 20 the packaging could be used as a retort or food cooking package but not limited to only these applications.

Other modifications and improvements to the invention will be apparent to the skilled person and will fall within the scope of the invention as it is intended.

Received by IPONZ 22 Dec 2011 17

Claims (15)

WHAT WE CLAIM IS:

1. A puncture resistant heat-scalable vapour barrier steam sterilisation bag formed of a non-porous plastics material capable of withstanding a steam sterilisation process for surgical items within it whilst providing an effective microbiological barrier having a first seaiable opening suitable for receiving items to be sterilised and a second seaiable opening adapted to couple to a sterilisation conduit.

2. A bag as claimed in claim 1 wherein the first seaiable opening is formed by adjacent walls of the bag being substantially unjoined along one edge of the bag.

3. A bag as claimed in claim 1 or claim 2 wherein the second seaiable opening is in the form of a neck that is relatively narrow with respect to the width of the bag.

4. A bag as claimed in claim 3 wherein a third seaiable opening is formed communicating with an internal channel that extends sufficiently into the bag to facilitate circulation within the bag via the second and third openings when the first opening is sealed.

5. A bag as claimed in any one of the preceding claims wherein the bag is formed of a sheet that is folded and sealed along part of its adjacent edges.

6. A bag as claimed in any one of the preceding claims wherein the bag is formed of a sheet of multilayer construction. Received by IPONZ 22 Dec 2011 18

7. A bag as claimed in claim 6 wherein the bag is capable of withstanding internal process temperatures up to 138 degrees Celsius and external process temperatures of up to 180 degrees Celsius.

8. A bag as claimed in claim 5 wherein the bag has a puncture resistant outer layer and a heat-sealabte inner layer.

9. A bag as claimed in any one of the preceding claims wherein the bag includes a covert marking technology.

10. A bag as claimed in claim 9 wherein the covert marking technology is a tamper-resistant label applied to the bag.

11. A bag as claimed in claim 9 wherein the covert marking technology is integrated into the bag.

12. A bag as claimed in claims 9 to 11 wherein the bag includes a readable unique identification code.

13. A bag as claimed in any one of the preceding claims wherein the bag material construction is translucent to facilitate visual verification of sterilisation process indicators.

14. A bag as claimed in any one of the preceding claims wherein the contents of the bag are sealed within the bag at a modified atmosphere allowing visual indication of a breach of the sealed bag integrity. Received by IPONZ 22 Dec 2011 19

15. A bag substantially as herein described with reference to any one of the embodiments shown in the accompanying drawings. MERGER TECHNOLOGIES LIMITED ( By their Attorneys ELLIS TERlW