JP2707271B2 - Sterilization method of drug solution - Google Patents

Description

Description: TECHNICAL FIELD The present invention relates to a high-pressure steam sterilization method for a drug solution, and more particularly, to a self-contained disposable packaging bag, which can easily and easily sterilize a drug solution, for example, a physiological saline solution. On how to do it.

(Prior art) For example, an isotonic solution prepared by dissolving 9 g of common salt in distilled water and adjusting the total amount to 1 is usually used as a drug solution called physiological saline or a drug solution containing glucose or Ringer's solution. High-pressure steam sterilization is always performed.

Conventionally, in order to prevent damage to the container due to an increase in internal pressure during high-pressure steam sterilization, a glass bottle or the like having pressure resistance is filled and sterilized. As a result, there are drawbacks such as heavy weight, non-disposal and inconvenient handling.

(Problems to be Solved) The present inventor has conducted various studies on a reliable and simple sterilization method for a drug solution such as a physiological saline solution, and as a result, uses a self-supporting packaging bag which prevents an increase in internal pressure in a container during sterilization. Thus, the present inventors have found that the above-mentioned disadvantages can be solved, and have completed the present invention. An object of the present invention is to provide a reliable and simple method for sterilizing a drug solution such as physiological saline.

(Means for Solving the Problems) The present invention relates to a method of storing a chemical solution in a self-supporting packaging bag and sterilizing with high-pressure steam. Forming a through-hole and having an air permeability of 5 to 1000 seconds / 100 cc on the inner surface of the through-hole portion, and storing the liquid medicine in a self-supporting packaging bag coated with a water-impermeable filter material, This is a method for sterilizing a drug solution characterized by sterilizing in a temperature range of 100 to 150 ° C.

That is, as the self-supporting packaging bag used in the present invention, a body wall member made of a synthetic resin film having thermal adhesive property is opposed to the inner surface, and a bottom wall member folded into two at one end is inserted between the body wall members. A packaging bag formed by thermally bonding the bottom wall member and the body wall member such that the left and right edges of the body wall member and the bottom wall member are opened, and the material for forming the packaging bag is polyester, nylon, or polypropylene. A packaging material formed by laminating a film such as polyethylene, aluminum foil or the like as necessary, and a synthetic resin film having thermal adhesion such as polyethylene or polypropylene on the inner surface. Then, an inner pressure having a pore diameter of about 0.1 to 10 mm is formed on a part of the body wall member of the self-standing bag formed by heat bonding such a packaging material, which is not touched by a chemical solution as a content, for example, a saline solution. An air hole by the Gurley method is formed on the inner surface of the container so as to form a through hole for preventing the rise and close the through hole.
A filter material made of a non-woven fabric, a porous film, a gas permeable film, or the like that is impermeable at a rate of about 100 cc / sec. FIG. 1 shows an example of the self-supporting packaging bag used in the present invention. In the drawings, 1 is a packaging material, 2 is a through hole, and 3 is a filter material for closing the through hole.

A chemical solution, for example, a physiological saline solution is put into this packaging bag and high-pressure steam sterilization is performed. High-pressure steam sterilization is performed for about 60 minutes. After sterilization, if necessary, the through-hole portion is preferably closed with a label or the like from the outside of the bag, which is preferable because no bacteria enter.
Further, the self-supporting packaging bag used in the present invention can be used as a packaging bag in a case where the internal pressure in the bag increases due to a treatment such as heating and the bag is broken.

 Next, the present invention will be described more specifically with reference to examples.

Example The liquid medicine of a self-supporting packaging bag comprising a packaging material in which a polyethylene film having a thickness of 80 μm having a thermal adhesive property on an inner surface and a nylon film having a thickness of 15 μm on an intermediate layer and a polyester film of 12 μm on an outer layer is further laminated. A 5.0mm diameter hole is provided near the upper end where it cannot be touched, and the inside of the hole is made of polypropylene non-woven fabric.
Attach the filter material of. About 1000 in this self-supporting packaging bag
The solution was sealed by adding ml of saline and subjected to high-pressure steam sterilization at 121 ° C. for 15 minutes. As a result, sterilization could be performed without breaking the bag.

(Effects of the Invention) As described above, the present invention uses a self-supporting packaging bag having a through-hole portion and a filter attached to the inner surface of the portion when sterilizing a drug solution such as physiological saline. As compared with the case where the operation is performed in a bottle or the like, the effect is obtained such that the operation can be easily performed by weight even in the case of carrying.

[Brief description of the drawings]

FIG. 1 is a plan view of a packaging bag used for sterilization of the present invention. 1 ... packaging bag, 2 ... through-hole, 3 ... filter material 4 ... heat-sealing part

Claims (1)

(57) [Claims] 1. A method for storing a chemical solution in a self-supporting packaging bag and sterilizing it with a high-pressure steam in an autoclave, wherein a through-hole is formed in an upper trunk wall member of the packaging bag which is not in contact with the chemical solution. Air permeability 5 to 1000 sec / 1 on the inner surface of the through hole
A method of sterilizing a drug solution, comprising storing a drug solution in a self-supporting packaging bag coated with a water-permeable filter material having air permeability of 00 cc and sterilizing at a temperature range of 100 to 150 ° C. .