JPS5892356A - Hydrogen peroxide gas aseptic chamber for aseptic product and preserving vessel - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to a method and apparatus for sterilizing and storing products in the same container, more particularly for use as a hydrogen peroxide gas sterilization chamber and for subsequently storing sterilized products. Relating to providing a portable enclosure for storing.

The use of hydrogen silica as a sterilizing agent is well known. For example, U.S. Patent No. D, / B? , No. 123 and No.'
1. /1. See q, /2' No. 1. However, the practical application of sterilization with gaseous hydrogen peroxide is complex. This means that at the concentration levels contemplated by the patent,
This is due to the fact that steam easily penetrates the packaging materials normally used for sterile products and is dangerous. Such characteristics reduce the benefits offered by gaseous hydrogen peroxide sterilization of sterile products. The sterile product has traditionally been stored in packaging materials for later use. Such products include, for example, surgical instruments whose sterile packaging must remain sterile until unpacked in the operating room. The practical use of gaseous hydrogen peroxide in sterilization methods is also complicated by the properties of hydrogen peroxide, namely its tendency to decompose as well as its tendency to be absorbed by other O materials.

For a long time, flexible packaging has been used to contain individual items during sterilization and subsequent storage.
Derson et al. U.S. Pat. No. 3.1, 30.64! i
However, such flexible packaging has very limited uses. This is because they require complex equipment to introduce the sterilizing agent into the package and are clearly not useful in sterilization cycles that involve maintaining a pressure differential across the walls of the container, such as vacuum and pressure cycles. It is.

Containers with rigid walls for conveying articles to be sterilized within the container are known. Ray, US Pat. No. 3.56,9/g, discloses a medical case for transporting instruments to be sterilized and subsequent transfer to sterile conditions. However, the Ray patent does not disclose or suggest the use of hydrogen peroxide gas as a sterilizing agent. Therefore R
Ay has no knowledge of the inherent properties of matter as mentioned above.

The present invention seeks to overcome the sterilant permeability problem associated with sterilization with hydrogen peroxide gas, which is achieved by providing a combined sterilization chamber and reservoir for sterilized articles. Ru. By utilizing the present invention, the requirement for packaging materials is eliminated so that the hydrogen peroxide gas comes into direct contact with the articles to be sterilized. The present invention also takes into account the decomposition and absorption problems associated with hydrogen peroxide.

More specifically, the present invention provides a method for sterilizing a product in an unpackaged state with hydrogen peroxide and then storing the product in a sterile state without removing it from the sterilization chamber. The method creates a data-proof hermetic enclosure for the product to be sterilized, provided that the enclosure is substantially non-absorbent to hydrogen peroxide and capable of withstanding pressure differentials across its walls; Place the above product in an enclosure and seal the enclosure; # Supply a hydrogen peroxide source into the enclosure; connect the enclosure and a hydrogen peroxide gas source in a separable manner; Establishing a fluid connection between: #contacting the product in the enclosure with hydrogen peroxide gas to sterilize the ferrous products; extracting hydrogen peroxide gas from said enclosure; and maintaining the enclosure in a closed condition until the product therein is placed into use.

The present invention further provides an apparatus for sterilizing articles and maintaining sterility of articles during transportation and storage, the apparatus comprising a plurality of portable sterilization chambers, each sterilization chamber being airtight. at least one of the sterilization chambers is closed and has means provided therein for supporting the articles in a spaced apart manner; a main housing used for accommodating; continuously supplying a fluid containing hydrogen peroxide gas to a sterilization chamber contained in the housing;
and also means for draining fluid from the sterilization chamber to effect sterilization of articles placed within the sterilization chamber; and partially within the housing and partially within the sterilization chamber. Further, means are combined to form a fluid passage between the fluid supply and discharge means and the sterilization chamber so as to be able to be separated when the housing accommodates the sterilization chamber. It is characterized by including as.

Other details and advantages of the invention will become apparent from consideration of the following detailed description with reference to the accompanying drawings.

The present invention uses cassette-type containers to contain sterile articles during sterilization and subsequent transportation and storage of the sterile articles. This cassette-type container is a self-contained sterilization chamber that receives the fluids required to sterilize items within the sterilization chamber while connected to a master sterilizer placed in place. and evacuated, and then kept hermetically closed to maintain the contents sterile until use. Adopting a cassette-type structure for the container ensures complete I-tupleness and reliable connectivity with the main sterilizer.

Referring to FIG. 1, there is illustrated a portable cassette, generally designated by the reference numeral IO. The cassette size is approximately! ; 11. It can withstand temperatures ranging from +”C (/30F) to approximately 76.7℃ (10F), and can withstand temperatures of approximately 6o, 1L/Hg (,2B inches H).
g) able to withstand depressurization inside the cassette within the range of
It can be formed from any suitable material. Kasetsu)
IOFi should also have insulating properties and a relatively low absorption of hydrogen peroxide. Furthermore, the materials of construction must not be decomposed by hydrogen peroxide; typical materials of construction are polysulfone and aluminum.

cassette) 1011 which can be opened to accommodate articles therein; a convenient configuration is two interlocking parts joined by a hinge 12 on one side, and one on the other side. Tightening means 14 provided with hinge 11
It is an enclosure with The mating surfaces in such cases are employed to achieve a complete seal between the surfaces, according to techniques well known in the art. The interior of the cassette 10 should preferably have means for supporting the articles to be accommodated therein. A cassette having these features is shown in FIG.

Since the cassette 10 is intended to both function as a sterilization chamber and as a container for the subsequent storage of sterilized products, it is suitable for rapid separation and
16, which is indicated by reference numeral 2 in the figure.
It cooperates with a corresponding quick isolation valve 18 on the main sterilizer, shown as 0.

A quick isolation valve 16 provides a fluid connection between the noisy system and the cassette within the main sterilizer 20. The construction and operation of quick isolation valves 16 and 18 are well known in the art. Standardization of cassettes 10, including the orientation and placement of quick isolation valves 16, is desirable so that cassettes of different types and sizes can be combined into a single main sterilizer 20.
It is possible to install it on.

In a typical implementation of the method of the invention, cassette 1-1
The cassette 10 contains the objects to be sterilized, and the cassette 10 is closed and hermetically sealed.
0 and is mated on the main sterilizer 2θ with the rapid isolation valve 16Vi and its side 18. In a typical sterilization cycle, air, passed through filter 22 and heated by an electric heater, first passes into cassette 10 via valve z6 and is exhausted from cassette 10 via valve 28. Heated air can be recirculated through valve 80 to increase energy balance. The temperature of the heated air circulated within the cassette 10 is approximately 59
．． It can be within the range of 1I~76.7℃Cl30~/70F). After the temperature inside the cassette reaches a predetermined value, the circulation of air is stopped and the cassette is removed by the vacuum pump means 80).
- Vacuum P3. Hydrogen peroxide derived from the hydrogen peroxide source is passed through a heat exchanger 84 and a valve 86 and then into the cassette 10. After completion of the sterilization step, cassette-1
0 is again evacuated and vented with filtered sterile air.

The cassette 10 can then be removed from the main sterilizer 20, and when removed, the quick isolation valve 16
is operated to isolate the interior of the cassette 10 from the unsterilized surrounding environment. Thus, the cassette 10 can store the sterile material therein for later use, or can be sent to the point of use for immediate use of the sterile contents therein.

Referring to Figure 2, there is shown a main sterilizer 2 adapted for use with a number of cassettes 40, 42 and 44.
0 is shown. The arrangement shown in FIG. 2 allows cassettes 40, 42 and 44 to be simultaneously subjected to a single sterilization cycle provided by main sterilizer 20. In addition, the main sterilizer 2
It is also possible to subject it to separate continuous sterilization cycles regulated by 0.

From the foregoing description, it can be seen that in the number and size of cassettes that the method of the present invention can be employed to cooperate with a single main sterilizer,
It can be understood that Kanashi gives flexibility.

This means that the cassette is specially constructed to accommodate special purpose articles to be sterilized, such as medical or dental instruments of unique shape. Furthermore, the method of the present invention provides complete and intimate contact between the hydrogen peroxide sterilant gas and the article to be sterilized, independent of whether the sterilant permeates through the packaging material. Additionally, the portability of the cassettes allows them to be transported and stored at locations remote from the main sterilizer.

3 and 4 show a specific example of the apparatus of the present invention. FIG. 3 shows a main sterilizer 20 having a hole 50 sized to accommodate a standard sized cassette 10' and an ICf; a depressable safety switch 5z is provided along the hole 50. and the corresponding switch 5 is pressed before the cassette IC is inserted into the hole.
2 must be depressed as shown for cassette 10'. Switch 52 serves to prevent the sterilization cycle in the main sterilizer 2θ if the cassette is not in the correct position within bore 50 and prevents the cassette from being removed before the sterilization cycle is complete. do.

[Brief explanation of the drawing]

FIG. 7 is a schematic illustration of the use of the method of the invention; FIG. 2 is a schematic illustration of the use of the method of the invention using a number of standardized enclosures; FIG. 3 is an isometric view of the main sterilizer with cassettes placed in various positions with respect to the main sterilizer;
FIG. 3 is an isometric view showing an opened cassette with instruments supported within the cassette as shown; -Image engraving (no change in content) Fig, 2゜Procedural amendment (method) % formula % 1. Display of incident Showa! 7 year patent application No. 1j Otsu 11. ♂
No. 0 No. 2, Title of the Invention Combined Hydrogen Peroxide Gas Sterilization Chamber and Preserver for Sterilized Products 3, Relationship to the Amending Party Case Applicant Name American Sterilizer Comnogni 4, Agent

Claims (1)

[Scope of Claims] (II. A method for sterilizing an article in an unpackaged state with hydrogen peroxide gas and then storing the article in a sterile state without removing it from a sterilization chamber, a 4-tuple sealable enclosure of the invention, wherein the enclosure is substantially non-absorbent to hydrogen peroxide;
and capable of withstanding a pressure differential acting across the walls of the enclosure, containing the article in the enclosure, and sealing the enclosure, providing a source of hydrogen peroxide gas, and removably coupled to a source of hydrogen peroxide to establish a fluid connection between the source of hydrogen peroxide and the interior of the enclosure, contacting an article within the enclosure with hydrogen peroxide gas to cause the article to sterilizing the sterile article, removing the hydrogen peroxide from the enclosure, isolating the enclosure from the source of hydrogen peroxide gas, and storing the enclosure in a closed condition until the sterile article is ready for use. The above method, characterized by: (21) An apparatus for sterilizing articles and maintaining the sterility of the articles during transportation and storage, comprising a number of I-tuple sterilization chambers, provided that each sterilization chamber can be hermetically closed, and the interior thereof a main housing adapted to receive at least seven of the sterilization chambers in a predetermined orientation for processing, the main housing being provided with means for supporting said articles in spaced relation; for continuously supplying a fluid containing hydrogen gas to the sterilization chamber contained in the housing and also for discharging fluid from the sterilization chamber to effect sterilization of articles placed within the chamber; ] Means within the housing, and partially within the housing and partially within the sterilization chamber, cooperating in a separable manner when accommodating the sterilization chamber in the housing; and means for forming a fluid passageway between the fluid supply and exhaust means and the iron mass.