WO2017125905A1

WO2017125905A1 - A method for packing an article and a blister pack

Info

Publication number: WO2017125905A1
Application number: PCT/IE2017/000002
Authority: WO
Inventors: Michael Malone
Original assignee: Cmc Hygea Limited
Priority date: 2016-01-22
Filing date: 2017-01-23
Publication date: 2017-07-27

Abstract

A blister pack (1) for blister packing an article (3) protected from pathogens comprises a first sheet (5) of a polymer material, in which a blister (6) for the article (3) is formed, and a second sheet (8) sealably secured to the first sheet (5) completely around and adjacent the periphery (15) of the blister (6). The polymer materials of the first and second sheets (5) and (8) are impregnated with an antimicrobial agent in the form of an inorganic silver-based constituent in an inert glass carrier. The antimicrobial agent may be in powder form, liquid form, granular form or other suitable form and is mixed with the polymer material prior to formation of the first and second sheets (5) and (8). Alternatively, the antimicrobial agent may be coated onto one or both of the major surfaces of the first and second sheets (5) and (8) by laminating or painting.

Description

"A method for packing an article and a blister pack"

The present invention relates to a method for packing an article in a blister pack, and in particular, the invention relates to a method for blister packing an article to minimise contamination of the article with pathogens. The invention also relates to a blister pack for minimising contamination of an article packed therein with pathogens.

During surgical procedures on human and animal subjects, articles, such as surgical instruments, for example, scalpels, scissors, suturing needles and the like are used in the surgical procedure, and components for surgical instruments are also used in such surgical procedures. It is essential that all such articles used in surgical procedures be sterile. It is also essential that components which are to be implanted in a human or animal subject during a surgical procedure should be sterile, for example, a heart valve, a stent, components for a hip joint, a knee joint and the like, as well as other such implantable articles. It is known to pack such articles in blister packs and subsequently sterilise the component in the blister pack by, for example, radiation sterilisation. Other packaging methods for such articles require that the article be sterilised prior to packaging and the sterile article is then packed in a blister pack in a sterile environment.

It has been found that irrespective of the packaging procedure carried out in packaging such articles in blister packs, pathogens may remain on the material of the blister packs, and in particular, on the inner surface of the materials of the blister pack. Such pathogens are then transferred to the article contained in the blister pack while the article remains in the blister pack, thereby contaminating and rendering the article non-sterile. This, results in serious, and in certain cases fatal consequences, since pathogens on such articles used in a surgical procedure on a human or animal subject are readily transferred to the subject resulting in infections, viruses and diseases being transferred from the article to the human or animal subject. This, is a serious problem in hospitals where surgical procedures are carried out on human subjects, and also is a serious problem in veterinary clinics where surgical procedures are carried out on animal subjects.

Similar problems arise in the packaging of food stuffs and also in the packaging of beverages. While in general food stuffs and beverages are not sterilised, it is important that should packaging material become contaminated with pathogens prior to or during packaging of food stuffs and beverages, that the pathogens should not in turn contaminate the food stuffs and/or beverages being packaged. There is therefore a need for a method for blister packing an article which addresses this problem. There is also a need for a blister pack which addresses the problem.

The present invention is directed towards providing a method for blister packing an article which addresses the problem, and the invention is also directed towards a blister pack with an article contained therein which addresses the problem.

According to the invention there is provided a method for blister packing an article in a two-sheet blister pack for minimising contamination of the article with pathogens, the method comprising providing both sheets of the blister pack of a material comprising an antimicrobial agent, forming a blister in a first one of the sheets for receiving the article, placing the article in the blister, bringing a second one of the sheets into engagement with the first sheet to close the blister with the article therein, and sealing the first and second sheets together to sealably close the blister. In one aspect of the invention the antimicrobial agent comprises an inorganic silver- based constituent in an inert glass carrier. Preferably, the antimicrobial agent is provided in one of powder form, liquid form and granular form.

In another aspect of the invention the respective first and second sheets are impregnated with the antimicrobial agent. Preferably, the antimicrobial agent is mixed with the materials of the respective first and second sheets prior to formation of the respective first and second sheets. Alternatively, the respective first and second sheets are coated with the antimicrobial agent. Preferably, one major surface of each of the first and second sheets is coated with the antimicrobial agent. Advantageously, the respective major surfaces of the first and second sheets which form the interior of the blister pack are coated with the antimicrobial agent. Ideally, both major surfaces of each of the first and second sheets are coated with the antimicrobial agent.

In another aspect of the invention the first sheet comprises a polymer material. Preferably, the polymer material of the first sheet comprises one of polyethylene terephthalate glycol-modified (PETG) material and polyvinylchloride (PVC) material.

In another aspect of the invention the second sheet comprises a polymer material. Preferably, the polymer material of the second sheet comprises one of PETG material and PVC material.

In one aspect of the invention the antimicrobial agent is mixed with the polymer materials of the respective first and second sheets prior to formation of each sheet. Preferably, the first and second sheets are sealed together adjacent the periphery of the blister in the first sheet. Advantageously, the first and second sheets are sealed together completely around the periphery of the blister in the first sheet.

In one aspect of the invention the blister is formed in the first sheet in a die by one of pressure forming, vacuum forming and a combination of pressure and vacuum forming. Preferably, the blister is formed in the first sheet in a heated die. Ideally, the blister is formed in the first sheet by perma-forming.

In one aspect of the invention the article comprises one of a surgical instrument, a medical instrument, a component for a surgical or medical instrument, an instrument for carrying out a test on a human or animal subject, a component for an instrument for carrying out a test on a human or animal subject, a needle, a syringe, a dressing, a swab, an implantable component, a drug in one of liquid, powder, granular, tablet and capsule form, a food article and a beverage.

The invention also provides a blister pack formed according to the method according to the invention. Preferably, the blister pack comprises the article contained therein.

Additionally, the invention provides a blister pack formed from two sheets of material, a first one of the sheets comprising a blister formed therein for receiving an article to be packaged therein, the first and second sheets being sealed together to seal the blister, and the first and second sheets each comprising an antimicrobial agent.

The advantages of the invention are many. By virtue of the fact that the first and second sheets of the blister pack comprise an antimicrobial agent impregnated into the first and second sheets of the blister pack, pathogens do not grow internally in the blister pack, nor can such pathogens propagate in the blister pack. Furthermore, any pathogens which may have been on the first and second sheets of the packaging material are inhibited from growing or propagating on the first and second sheets due to the impregnation of the first and second sheets with the antimicrobial agent. Thus, any such pathogens due to the fact that they cannot grow or propagate die on both the first and second sheets of the blister pack. Where the surfaces of the first and second sheets which form the inner surface of the blister pack are coated with the antimicrobial agent, growth and propagation of any pathogens on the inner surfaces of the first and second sheets of the blister pack is similarly inhibited, and thus any such pathogens die. Additionally, it has been found that on removal of articles from such blister packs, the interior of the blister packs are completely free of pathogens.

The invention will be more clearly understood from the following description of a preferred embodiment thereof, which is given by way of example only, with reference to the accompanying drawings, in which:

Fig. 1 is a side elevational view of articles being packed in blister packs according to the invention by a method also according to the invention,

Fig. 2 is an underneath plan view of one of the blister packs of Fig. 1 with an article contained in the blister pack, and

Fig. 3 is a transverse cross-sectional side elevational view of the blister pack of Fig. 2 with the article contained therein.

Referring to the drawings, there is illustrated a method according to the invention for forming a blister pack, also according to the invention, and indicated generally by the reference numeral 1 , with an article 3 sealably located in the blister pack 1 and sterile therein. The article 3 may be any article, sterile or otherwise, and in particular, the article 3 may be a surgical or medical instrument, for example, a scalpel, a scissors, a suturing needle or the like, or may be a component for a surgical instrument, or may be a component for implanting in a human or animal subject during a surgical procedure, for example, a heart valve, a stent, one or more components for a hip joint, or one or more components for a knee joint, or any other such implant or article for implanting in a human or animal subject during a surgical procedure. The article 3 may also be a needle, for example, a veress needle, a hypodermic needle, as well as a syringe, a swab, a wound dressing, and may also be a drug, which may be in liquid, powder, granular, tablet or capsule form. The article 3 may be one or more food items and/or beverages. Additionally, the article 3 may be an instrument for carrying out a test on a human or animal subject or a component of such an instrument. Needless to say the article 3 may be any other article which is required to be pathogen free and/or sterile.

The blister pack 1 is formed from two sheets of material, namely, a first sheet 5 in which a plurality of blisters 6 are formed, and a second sheet 8 which is sealably secured to the first sheet 5 for sealing the articles 3 in the respective blisters 6 as will be described in more detail below. The material of the first sheet 5 comprises a polymer material which in this case is impregnated with an antimicrobial agent, which in this embodiment of the invention comprises an inorganic silver-based constituent in an inert glass carrier. The antimicrobial agent may be in any of powder form, liquid form, granular form or any other suitable form and is mixed with the polymer material which typically is in granular form prior to formation of the first sheet 5. The second sheet 8 is also of polymer material which is impregnated with an antimicrobial agent similar to the antimicrobial agent with which the first sheet 5 is impregnated, and is mixed with the polymer material of the second sheet 8 prior to formation of the second sheet 8. In this embodiment of the invention the polymer material of the first and second sheets 5 and 8 typically is polyethylene terephthalate glycol-modified (PETG) material or polyvinylchloride (PVC) material, but may be of any other suitable polymer material or mixture of polymer materials. The packaging of articles in blister packs will be well known to those skilled in the art, and accordingly, it is not intended to describe the method for packing the articles^ 3 in blisters 6 of the blister packs 1 in detail. However, briefly, referring to Fig. 1 , a plurality of blisters 6 are formed in the first sheet 5 in a continuous packaging process where the first sheet 5 is drawn from a roll (not shown) of the first sheet 5, and is progressively indexed in the direction of the arrow A through a heated blister forming die 10, a packing station 11 , a heat sealing die 14 and a cutting die 16. The blister forming die 10 is heated to a temperature sufficient to heat the material of the first sheet 5 as it is indexed through the blister forming die 10 to a yield temperature for forming the blister 6. The blister forming die 10 may be any suitable die, and may be a pressure forming die whereby pressurised air is injected into the die for blowing the material of the first sheet 5 into a cavity (not shown) in the die to form the blister 6, or the die may be a vacuum forming die whereby the material of the first sheet 5 is drawn into the cavity in the die to form the blister 6. On formation of each blister 6 in the first sheet 5, the first sheet is indexed in the direction of the arrow A through the packing station 11 where the articles 3 are sequentially placed either mechanically or manually in the respective blisters 6.

The second sheet 8 is drawn from a roll (also not shown) of the second sheet and is passed around a roller 12 and brought into contact with the first sheet 5 downstream of the packing station 11. The first and second sheets 5 and 8 in contact with each other are then indexed through the heat sealing die 14 where the first and second sheets are heat sealed together around the periphery 15 of the respective blisters 6 to form the blister pack 1 with the article 3 contained therein. The heat sealing die 14 is configured to seal the first and second sheets 5 and 8 completely around each blister 6 adjacent the periphery 15 thereof, in order to form each blister pack 1 as an airtight blister pack 1.

The heat sealed combination of the first and second sheets 5 and 8 with the articles 3 located in the respective blister packs 1 is then indexed through the cutting die 16 where each blister pack 1 with the corresponding article 3 contained therein is parted off from the remaining blister packs 1 formed by the first and second sheets 5 and 8. Typically, the heat sealing die 14 seals the first and second sheets 5 and 8 in an area 17 of the periphery 15 between adjacent blisters 6, and the cutting die 16 is configured to cut through the sealed areas 17 of the first and second sheets along a cut line intermediate the adjacent blister packs 1 , and spaced apart therefrom, without affecting the integrity of the peripheral seal 15 around the blisters 6 between the first and second sheets 5 and 8. The articles 3 sealed into the blister packs 1 are then ready for sale.

As discussed above the impregnation of the polymer materials of the first and second sheets 5 and 8 with the antimicrobial agent inhibits the growth and propagation of pathogens on both the first and second sheets 5 and 8, and particularly on the surfaces of the first and second sheets 5 and 8, which form the inner surfaces of the blister pack 1. Accordingly, any pathogens which may have contaminated the first and second sheets during packaging of the article in the blister pack 1 rapidly die off, thereby avoiding contamination of the article 3 in the blister pack 1. This is a particularly important advantage in the packaging of food articles, beverages and drugs, as well as swabs, wipes, dressings and the like, in cases where sterilisation after packaging is not carried out.

While the articles 3 packed in the blister packs 1 have been illustrated in block representation only, such articles, as discussed above may be surgical and/or medical instruments, components of surgical and/or medical instruments, instruments for carrying out tests on human or animal subjects, components of instruments for carrying out such tests, implantable components suitable for implanting into a human or animal subject, for example, a heart valve, a stent, one or more components of a hip joint, one or more components of a knee joint, or any other such implantable articles and components. Additionally, the articles 3 may comprise other instruments, for example, a guide wire, a catheter, a camera or the like, which typically, are used in microsurgery and laparoscopic procedures. The articles may also comprise drugs which may be in any one of liquid, powder, granular, tablet or capsule form. The articles 3 may also comprise swabs, wound dressings, needles, syringes, and other such articles. Additionally, the articles may be food articles, beverages and the like. Needless to say, the articles may be any other articles, instruments, components, drugs, food stuffs or beverages, which are to be provided pathogen free.

While the materials of the first and second sheets have been described as comprising polymer materials, and in particular PETG or PVC materials, it will be readily apparent to those skilled in the art that the materials of the first and second sheets may be of any other suitable polymer or other materials. It will also be appreciated that the materials of the first and second sheets may be the same or different. Needless to say, while a specific antimicrobial agent has been described, any other suitable antimicrobial agent may be provided. It will be appreciated that where the antimicrobial agent comprises an inorganic silver-based constituent, the inorganic silver-based constituent may be provided in any other suitable inert carrier. Needless to say, the antimicrobial agent may be provided in any form, be it powder form, liquid form, granular form or any other suitable form for impregnating or mixing with the materials of the first and second sheets.

It is also envisaged that instead of impregnating the materials of the first and second sheets with the antimicrobial agent, the sheets may be coated with the antimicrobial agent, and in some cases, only one side of each sheet would be coated with the antimicrobial agent, and in which case, the coated sides of the respective sheets would be the sides which form the interior surfaces of the blister pack. In other cases, it is envisaged that both sides of each first and second sheet would be coated with the antimicrobial agent. Where the antimicrobial agent is coated onto the first and second sheets, the antimicrobial agent may be painted onto one or both of the major surfaces of the first and second sheets, or alternatively may be laminated onto one or both of the major surfaces of the first and second sheets.

While a particular method for forming blisters and sealing the first and second sheets to seal the articles in the blisters have been described, it will be readily apparent to those skilled in the art that any other suitable method for forming the blisters and sealing the first and second sheets for in turn sealing the articles in the blisters may be used.

While the method for forming the blisters has been described in which a single blister is formed in the first sheet in each index of the first sheet, it is envisaged that a plurality of blisters may be formed in the first sheet during each index of the first sheet through the blister forming die. In which case, it is envisaged that the blisters may be arranged spaced apart transversely across the sheet, and/or may be spaced apart longitudinally along the sheet. For example, a matrix of blisters may be formed during each index of the first sheet through the blister forming die. It will be appreciated that the blisters will be sized depending on the size of the article to be packed in each blister. It will also be appreciated that the blisters may be of a size in which the article would be a loose fit in the blister, or the blister may be formed such that the blister is a relatively tight fit around the article to the extent that the article is effectively shrink-wrapped in the blister pack.

Claims

1. A method for blister packing an article in a two-sheet blister pack for minimising contamination of the article with pathogens, the method comprising providing both sheets of the blister pack of a material comprising an antimicrobial agent, forming a blister in a first one of the sheets for receiving the article, placing the article in the blister, bringing a second one of the sheets into engagement with the first sheet to close the blister with the article therein, and sealing the first and second sheets together to sealably close the blister. 2. A method as claimed in Claim 1 in which the antimicrobial agent comprises an inorganic silver-based constituent in an inert glass carrier.

3. A method as claimed in Claim 1 or 2 in which the antimicrobial agent is provided in one of powder form, liquid form and granular form.

4. A method as claimed in any preceding Claim in which the respective first and second sheets are impregnated with the antimicrobial agent.

5. A method as claimed in any preceding Claim in which the antimicrobial agent is mixed with the materials of the respective first and second sheets prior to formation of the respective first and second sheets.

6. A method as claimed in any of Claims 1 to 3 in which the respective first and second sheets are coated with the antimicrobial agent.

7. A method as claimed in Claim 6 in which one major surface of each of the first and second sheets is coated with the antimicrobial agent.

8. A method as claimed in Claim 6 or 7 in which the respective major surfaces of the first and second sheets which form the interior of the blister pack are coated with the antimicrobial agent.

9. A method as claimed in any of Claims 6 to 8 in which both major surfaces of each of the first and second sheets are coated with the antimicrobial agent.

10. A method as claimed in any preceding Claim in which the first sheet comprises a polymer material.

11. A method as claimed in Claim 10 in which the polymer material of the first sheet comprises one of polyethylene terephthalate glycol-modified (PETG) material and polyvinylchloride (PVC) material.

12. A method as claimed in any preceding Claim in which the second sheet comprises a polymer material.

13. A method as claimed in Claim 12 in which the polymer material of the second sheet comprises one of PETG material and PVC material. 4. A method as claimed in any of Claims 10 to 13 in which the antimicrobial agent is mixed with the polymer materials of the respective first and second sheets prior to formation of each sheet.

15. A method as claimed in any preceding Claim in which the first and second sheets are sealed together adjacent the periphery of the blister in the first sheet.

16. A method as claimed in any preceding Claim in which the first and second sheets are sealed together completely around the periphery of the blister in the first sheet.

17. A method as claimed in any preceding Claim in which the blister is formed in the first sheet in a die by one of pressure forming, vacuum forming and a combination of pressure and vacuum forming.

18. A method as claimed in any preceding claim in which the blister is formed in the first sheet in a heated die.

19. A method as claimed in any preceding claim in which the blister is formed in the first sheet by perma-forming.

20. A method as claimed in any preceding claim in which the article comprises one of a surgical instrument, a medical instrument, a component for a surgical or medical instrument, an instrument for carrying out a test on a human or animal subject, a component for an instrument for carrying out a test on a human or animal subject, a needle, a syringe, a dressing, a swab, an implantable component, a drug in one of liquid, powder, granular, tablet and capsule form, a food article and a beverage.

21. A blister pack formed according to the method as claimed in any preceding claim.

22. A blister pack as claimed in Claim 21 in which the blister pack comprises the article contained therein. 23. A blister pack as claimed in Claim 21 or 22 in which the article comprises one of a surgical instrument, a medical instrument, a component for a surgical or medical instrument, an instrument for carrying out a test on a human or animal subject, a component for an instrument for carrying out a test on a human or animal subject, a needle, a syringe, a dressing, a swab, an implantable component, a drug in one of liquid, powder, granular, tablet and capsule form, a food article and a beverage.

24. A blister pack formed from two sheets of material, a first one of the sheets comprising a blister formed therein for receiving an article to be packaged therein, the first and second sheets being sealed together to seal the blister, and the first and second sheets each comprising an antimicrobial agent.

25. A blister pack as claimed in Claim 24 in which the antimicrobial agent comprises an inorganic silver-based constituent in an inert glass carrier.

26. A blister pack as claimed in Claims 24 or 25 in which the antimicrobial agent is provided in one of powder form, liquid form and granular form.

27. A blister pack as claimed in any of Claims 24 to 26 in which the respective first and second sheets are impregnated with the antimicrobial agent.

28. A blister pack as claimed in any of Claims 24 to 27 in which the antimicrobial agent is mixed with the material of the respective first and second sheets prior to formation of the respective first and second sheets.

29. A blister pack as claimed in any of Claims 24 to 26 in which the respective first and second sheets comprise a coating of the antimicrobial agent.

30. A blister pack as claimed in Claim 29 in which one major surface of each of the first and second sheets comprises the coating of the antimicrobial agent.

31. A blister pack as claimed in Claims 29 or 30 in which the respective major surfaces of the first and second sheets which form the interior of the blister pack comprise the coating of the antimicrobial agent.

32. A blister pack as claimed in any of Claims 29 to 31 in which both major surfaces of each of the first and second sheets comprise the coating of the antimicrobial agent.

33. A blister pack as claimed in any of Claims 24 to 32 in which the first sheet comprises a polymer material.

34. A blister pack as claimed in Claim 33 in which the polymer material of the first sheet comprises one of polyethylene terephthalate glycol-modified (PETG) material and polyvinylchloride (PVC) material.

35. A blister pack as claimed in any of Claims 24 to 34 in which the second sheet comprises a polymer material. 36. A blister pack as claimed in Claim 35 in which the polymer material of the second sheet comprises one of PETG material and PVC material.

37. A blister pack as claimed in any of Claims 33 to 36 in which the antimicrobial agent is mixed with the polymer material of the respective first and second sheets prior to formation of each sheet.

38. A blister pack as claimed in any of Claims 24 to 37 in which the first and second sheets are sealed together adjacent the periphery of the blister in the first sheet.

39. A blister pack as claimed in any of Claims 24 to 38 in which the first and second sheets are sealed together completely around the periphery of the blister in the first sheet. 40. A blister pack as claimed in any of Claims 24 to 39 in which the blister is formed in the first sheet in a die by one of pressure forming, vacuum forming and a combination of pressure and vacuum forming.

41. A blister pack as claimed in any of Claims 24 to 40 in which the blister is formed in the first sheet in a heated die.

42. A blister pack as claimed in any of Claims 24 to 41 in which the blister is formed in the first sheet by perma-forming. 43. A blister pack as claimed in any of Claims 24 to 42 in which the article comprises one of a surgical instrument, a medical instrument, a component for a surgical or medical instrument, an instrument for carrying out a test on a human or animal subject, a component for an instrument for carrying out a test on a human or animal subject, a needle, a syringe, a dressing, a swab, an implantable component, a drug in one of liquid, powder, granular, tablet and capsule form, a food article and a beverage.