What is ampule?
is a kind of rigid glass container that can be fused and sealed, often used to store injectable drugs as well as vaccines and serums. Ampoule
is the translation of the Latin “ampulla
There are two types of ampules
in common use: straight-necked and curved-necked. Ampoules
are commonly used for injectable solutions and also for packaging oral solutions. Historically, ampoules were first used to hold samples of the blood of the deceased.
History of ampule
were first used to hold samples of the blood of the dead and were used to accompany them in burial. This is mostly found in Roman tombs or Christian tombs. At first, only the funerals of martyrs were able to enjoy this treatment, but later it became a common custom. In Naples, a ritual that has lasted for centuries is celebrated every year on September 19: the Blood Miracle of San Gennaro. In the cathedral of Naples, an ampulla allegedly filled with the blood of Bishop Benevento of San Gennaro, dating back to 305 A.D., is placed next to his chest. The blood in the ampulla was liquefied by the vocal prayers of the "descendants of St. Genevieve" and by the shaking of the archbishop. The earliest record of this phenomenon is dated 313 A.D.
Another well-known ampule
is the "Sainte ampoule", which contains the sacred oil of the coronation of the French emperor. The sacred oil is said to have been handed down from the time of Clovis and was once kept in the tomb of St. Remy, and later in the cathedral of Rheims. During the Revolution of 1793, the ampulla was broken, but part of it was still preserved for the coronation of Charles X.
Types of ampule
Injection containers generally refer to ampules or containers made of hard neutral glass (e.g. penicillin vials), but plastic containers are also available.The ampoules are currently made of necked ampoules and powder ampoules, and their volumes are usually 1, 2, 5, 10, 20 ml, etc. Besides, there are also curved-necked ampoules.
There are two types of easy-fold ampoules: color ring easy-fold ampoules and dot-mark easy-fold ampoules.
The colored ring easy-fold ampoule is a glass container in which a low melting point powder with a coefficient of expansion twice as high as that of ampoule glass is fused to the neck of the ampoule to form a ring, and after cooling, due to the different coefficients of expansion of the two types of glass, a circle of permanent stress is generated in the ring part, which can be broken flatly with force and is not easy to produce glass debris.
The point indentation easy-to-fold ampoule is a kind of glass container that can have a fine indentation in the curved neck area and a color dot of 2mm in diameter marked in the center of the indentation, and when fractured, the force is applied to the backside in the middle of the indentation, and after fracture, the section should be flat.
At present, ampoules are mostly colorless, which is beneficial to check the clarity of the drug solution. For drugs requiring light shielding, amber-colored glass ampoules can be used. The amber color filters UV light and are suitable for photosensitive drugs. Amber ampules contain iron oxide and traces of iron oxide may be leached into the product. When amber glass containers are used, they should not be filled with products containing ingredients that can be catalyzed by iron ions.
Powder ampules are used for dispensing injectable powders or crystalline drugs. Therefore, the neck of the bottle is thick or horn-shaped to facilitate the loading of drugs. The body of the bottle is as thick as the neck, and a groove is blown at the connection between the neck and the body, which can be sawed open and injected with solvent after dissolution. This ampoule is very inconvenient to use. In recent years, a kind of injection container that can contain both powder and solvent has been developed, the container is divided into two chambers, the lower compartment contains sterile drug powder, the upper compartment contains solvent, and the middle is separated by a special diaphragm when the top plug is pressed down, the diaphragm is opened, the solvent flows into the lower compartment, the drug is dissolved and used. This kind of container for injection is especially suitable for some drugs that are unstable in the solution.
Use of ampule
Before opening, cut a scratch on the neck of the bottle with an abrasive wheel, sterilize the neck of the bottle, turn the nipple upward so that all the medicine flows into the bottle, and then break the neck of the bottle.
For easy-to-fold ampoules, the manufacturer's pre-cut part is marked at the nipple, and the nipple can be broken directly in this direction.
Note: If the ampoule is small in size, the nipple may not flow to the bottom automatically due to insufficient pressure, which may cause accidents when opening. It is necessary to flick or gently shake the nipple by hand for the drug solution to flow down smoothly. Generally, when using ampoules with a diameter less than 7mm or capacity less than 2mL, it is necessary to pay attention to such problems.
Problems when using
a. Defective ampoules or incorrect handling can result in the breaking of the nipple or even the bottle during ampoule opening, leading to injuries to medical personnel and possible contamination by glass fragments falling into the solution.
b. Contamination by the glass and abrasive particles during ampoule opening.
c. When a straight-necked ampoule is broken, a lot of glass fragments invisible to the naked eye will fall into the medicine and cause platelet rupture in the recipient of the injection, which may even cause death if any particles enter the heart with the blood. Curved-neck ampoules are easy to break and have a neat cut with fewer glass fragments, making them the only medical ampoules allowed to be used at present.
Ampule leak detection
A. Effects of ampule leakage
Ampoules include plastic ampules and glass ampules, which are generally filled with sterile liquid preparations. Ampules may be filled with sterile air or nitrogen. The purpose of using the nitrogen filling process is to inhibit the growth of aerobic bacteria on one hand and to prevent the oxidation of oxygen-sensitive products on the other. Once the ampoule leaks, oxygen, and microorganisms in the air will invade the container, making the product filled inside may be oxidized, which affects the stability of the product; and after the microorganisms invade, if the filled product is suitable for the growth of microorganisms, the microorganisms will multiply rapidly, which in turn will lay a hidden danger to the life safety of patients.
B. Traditional leak detection method for ampules
The traditional leak detection methods for ampules are mainly the color water method and the microbial challenge method. These two methods are generally subjective, qualitative, and destructive testing methods. The color water method applies to ampoules filled with products and can be used in the production process, while the microbial challenge method is used more for testing the empty container itself and is applicable in the validation process.
Although these two methods have been used by the industry for many years, their drawbacks are relatively obvious. The disadvantages of the color water method are destructive testing, low sensitivity, subjective results, and time-consuming and non-traceable; the disadvantages of the microbial challenge method are destructive testing, time-consuming and non-traceable, and high leak detection rate when the leak path is zigzag.
The development of leakage standards for ampoules is ultimately reflected in the size of the leakage holes, which are generally located between the lower detection limit of the instrument and the detection limit of the conventional method while ensuring that the developed leakage hole level should minimize the risk of microbial invasion. Numerous studies have shown that microorganisms in leaky holes above 5μm can significantly invade packaging containers.
Operation precautions of ampule sealing machine for laboratory use
a. Connect the LPG pipeline.
b. Connect the power cord.
c. Turn on the power switch.
d. Slowly open the gas valve.
e. Use a lighter to light the Ran lamp head. Note that when lighting the fire, please do not put avoid any part of the body in front of the flame gun nozzle, otherwise it will burn to the body. For lighter ignition, the operator should be located on the side of the flame gun to avoid fire to the hands. There is also ignition must first close the combustion gas valve, but slowly open the gas valve while igniting. Until after the ignition and then adjust the appropriate degree of flame, until the two heads issue a thin blue flame can work.
f. The gas pipe and the needle type adjustment valve on the mixing tee must be connected well, there must not be a little leakage to avoid accidents.
g. When operating the ampule sealer for laboratory use, place the ampoule on the tray. Do not put the ampoule into the flame immediately, but first, see if the flame is at the center of the tray and the desired fusing height. Then put the ampoule filled with liquid into the center of the tray and the flame. When sealing the ampoule, you have to turn the bottle slowly to soften the bottle, and then you can intercept the top end with tweezers and seal the bottom of the bottle.
h. After the work is finished, the operator must first turn off the gas valve and then close the gas valve.
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