Package making – With contents treating – Vacuum or inert atmosphere
Patent
1989-07-06
1991-01-29
Coan, James F.
Package making
With contents treating
Vacuum or inert atmosphere
53 90, 53 95, 53281, 53425, B67C 700, B67C 302
Patent
active
049877267
DESCRIPTION:
BRIEF SUMMARY
The present invention relates to a bottle filling and sealing apparatus, and more specifically, but not exclusively, to an apparatus for filling and sealing bottles aseptically.
Pharmaceutical preparations which are made available to the consumer must be as free as possible from contaminating microorganisms and contaminating particles. This is particularly true of preparations which are intended for parenteral administration, such as injection and infusion preparations, and which must be completely sterile when used, in order to avoid serious side effects and secondary infections.
By sterile conditions a total absence of microorganisms is meant, and accordingly a sterile product is one which is completely free from microorganisms. By aseptic conditions is also meant the absence of microorganisms, and these two terms are therefore practically synonymous. It is possible at times, however, to speak of greater or lesser degrees of asepticity, and then to refer to a degree of freedom from microorganisms which is sufficient for the purpose intended. The object of this invention, however, is to achive complete sterility both with the method and in the final product.
The easiest method to achieve sterility with pharmaceutical preparations, and also the one most often applied, is to heat the preparations to a sufficiently high temperature, normally to about 120.degree. C. or above. The death of infectious microorganisms can be ensured at such temperatures, if sustained over a sufficiently long period of time. Heat sterilization is normally carried out on the finally packaged preparations, and since the packages are satisfactorily sealed, there is no reinfection of the contents subsequent to cooling.
There are many instances however, when heat sterilization is less suitable, since it results in a detrimental change in the structure or properties of certain pharmaceutical preparations. For instance, sensitive components can be broken-down or degraded and proteins can be denatured. Preparations in the form of emulsions or suspensions can be affected so as to cause the different phases present to separate. Another example resides in nutrient infusion preparations which include a mixture of amino acids and carbohydrates. When such mixtures are heated, Maillard reactions are likely to occur and form reactions products which may be toxic and which in all events will impair the quality and nutrient value of the product.
In those instances when it is not possible to heat sterilize the end product, a sterile product can be still obtained nevertheless, by sterilizing the preparation from the outset and by packaging the product in sterile packages under sterile or aseptic conditions. When sterile conditions are maintained during the entire process, the final product will also be obtained as a sterile preparation packed in a protective package. If the packaging process has been carried out at a sufficiently low temperature, no unfavorable change will have taken place in the product.
Although this sterile packaging has been known for a long time, it cannot be put into practice without encountering great difficulties, due to the extremely high sterility demands placed on pharmaceutical preparations which are intended for parenteral administration. This also applies to the provision of a process which can be practiced economically on an industrial scale while maintaining rigorous safety.
The most common case in this respect is on which entails filling bottles with a liquid preparation. Such processes require the bottles used to be sterilized and the air therein to be expelled with an inert, sterile gas, so as to avoid oxidation, whereafter the bottles are filled with the liquid preparation in the complete absence of subsequent droplets or splashes and then sealed with stoppers or caps, all of these procedural steps being effected while maintaining sterile or aseptic conditions. Although an apparatus which will enable such bottling processes to be carried out quickly, reliably and economically is highly desirable, such an apparatus
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patent: 2763107 (1956-09-01), Day et al.
patent: 3431702 (1969-03-01), Spaulding
patent: 3707823 (1973-01-01), Guckel
patent: 4514953 (1985-05-01), Patzwahl
patent: 4538399 (1985-09-01), Muller
patent: 4655029 (1987-04-01), Weiss
H.ang.kansson Ivan
M.ang.nsson Lennart
Petho Lajos
Coan James F.
Kabivitrum AB
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