Package making – Methods – Gas filling and/or evacuating and closing
Patent
1997-02-21
1999-03-16
Coan, James F.
Package making
Methods
Gas filling and/or evacuating and closing
53425, 53432, 53510, 422 22, B65B 3100, B65B 5502, A61L 208
Patent
active
058815341
DESCRIPTION:
BRIEF SUMMARY
FIELD OF INVENTION
The present invention is directed to a novel process for sterilizing an article made from polymeric materials by radiation sterilization. The article is enclosed in an gas impermeable package together with an oxygen absorber for a time sufficient to consume substantially all of the oxygen in the package and the oxygen dissolved in the polymeric material. The article is preferably intended for medical use and may contain a radiation sterilizable parenterally administerable preparation.
BACKGROUND OF THE INVENTION
Sterilizing medical articles of polymeric materials can be performed by a number of methods, such as steam sterilization (autoclavation), radiation sterilization (electron beam (EB), .beta.- and .gamma.-radiation), ethylene oxide (EtO) and aqueous formaldehyde. Each method has its specific advantages and disadvantages and will be selected with respect to the chemical structure of the polymeric material. If the material is employed as a packaging material, the selection also depends on the characteristics of the enclosed goods.
A technical problem that requires especially careful consideration is the sterile packaging and storing of parenterally administerable fluids that both are sensitive to atmospheric oxygen during storage and incompatible with many polymeric materials and their additives.
In known manufacturing technologies, the most rigorous methods involve filling a bag with the medical fluid in the presence of an inert gas, sealing the bag and subjecting it to steam sterilization and thereafter placing it, still in an oxygen free atmosphere, with an oxygen absorber in an outer oxygen impermeable envelope. Such a process, as for example described in the U.S. Pat. No. 4,998,400, is, however, both laborious and resource consuming.
Oxygen absorbers have previously been successfully used for the packaging of oxygen sensitive medical fluids like amino acid solutions and fat emulsions. The absorbers have been positioned between an inner medical container made from a gas pervious polymer material filled with the medical solution and an outer enclosing sheet made of an gas impermeable material. Such packages are disclosed by e.g. the European patent specifications EP-A-0 093 796 and EP-A-0 510 687.
Sterilization by irradiation is a desirable alternative method to heat sterilization, since it will provide a simpler and less costly manufacturing process. It is, however, a technique that must be carefully considered, because of the chemical and physical alterations that can be induced in the polymeric material in the presence of atmospheric oxygen.
EP-B-0 218 003 discloses a radiation sterilized medical device enclosed in a gas permeable bag which is irradiated with .gamma.-radiation and thereafter placed in a gas impermeable wrapping member together with a deoxidizing agent. Both residual oxygen and ozone resulting from the gamma radiation will thereby be absorbed and because the entry of oxygen from the external environment is almost completely prevented, an oxygen-free condition within the wrapping is obtained. The purpose of the technique disclosed in EP 0 218 003 is primarily to prevent the "gamma"-odour associated with ozone.
The British patent specification 1,230,950 describes a similar method of sterilizing material packaged together with an oxygen scavenger with .gamma.-radiation.
The sterilizing methods according to these patent specifications may, however, lead to the formation of undesired and potentially deleterious degradation products originating from free radicals of the polymeric material and the small amounts of dissolved oxygen that remains in the polymeric material during the .gamma.-irradiation. The activity of the highly reactive free radical containing molecules may to a certain degree pervade the original polymeric structure of the material by bond cleavage and macroradical formation, thereby making the material discoloured or changing its mechanical properties.
In theory, a layered polymeric material with adhered or built-in oxygen scavengers, as disclosed
REFERENCES:
patent: 4192773 (1980-03-01), Yoshikawa et al.
patent: 4899517 (1990-02-01), Shima et al.
patent: 4998400 (1991-03-01), Suzuki et al.
patent: 5014494 (1991-05-01), George
patent: 5202052 (1993-04-01), Zenner et al.
patent: 5510166 (1996-04-01), Inoue et al.
patent: 5577368 (1996-11-01), Hamilton et al.
"Radiation Effects on Polymers Ed." by R.L. Cough, et al., ACS Symposium Series, 475, 1991.
"Stabilization of Polyolefins to Gamma Irradiation-Role of the Initial Radicals" by D.J. Carisson et al., ACS, 433, 1991.
Ahlqvist Anna
Berglund Kjell
Lundmark Stefan
Ward Jimmie
Coan James F.
Kim Eugene L.
Pharmacia & UpJohn AB
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