Author: Site Editor Publish Time: 15-03-2024 Origin: Site
A plastic ampoule, made of plastic particles, is an injectable preparation produced by the three-in-one aseptic filling technology of blowing, filling, and sealing. What are the advantages of plastic ampoules compared with glass ampoules? Let's take a look at them in this article!
Here is the list of contents
Common Problems in Glass ampoule Filling and Sealing
What are the advantages of plastic ampoules?
Common Problems in Glass ampoule Encapsulation
The scorched head refers to the scorching spots formed by the liquid in the neck of the ampoule during the sealing process, which are rejected during the light inspection. The causes of having drug solution stuck on the neck of the ampoule are
l Improper needle position.
l The residual liquid of the needle sticks to the neck wall when the needle is withdrawn from the ampoule.
l The needle enters the ampoule too deeply or too shallowly, causing the liquid to splash or back-spray onto the neck wall during filling.
l Incorrect stroke of the needle during drug filling.
l Adjust the needle fixing bolt so that the needle is in the center of the ampoule mouth when filling.
l Connecting a buffer ball to the inlet pipe with an eight-way at one end and the medicine pipe at the other end, and storing 2/3 of the volume of medicine in the ball, or clamping an adjustable clip on the inlet pipe to control the inlet volume, so as to avoid the residual drip of the needle.
l The tip of the needle can be changed to three holes or two holes for drug delivery and can be extended to 1~2 mm below the curved neck of the ampoule during drug filling. This method can overcome the drug splashing and reduce the residual dripping of the needle.
l Adjust the drug filling cam to start filling at the point where the needle reaches the ampoule curved neck and stop filling before the needle is lifted to avoid the adhesion of the drug to the neck wall during the movement of the needle. Another way to deal with the problem is to slow down the speed by using an inverter, which is suitable for higher concentrations or viscous drug solutions.
Loading problem of glass ampoule
The common loading problem is that the loading quantity is unstable and the adjustment of the loading nut does not work. The reasons for dosing problems are
l Inadequate tightness between the pistil and the jacket of the drug filling device.
l Uneven spring elasticity.
l The filler is not fixed in the sleeve.
The solution to this problem is to
l replace the matching and tightly fitting filler.
l replacing the new spring.
l Add washers or wrap the adhesive tape at the contact between the dispenser and the sleeve to make the dispenser fixed in the sleeve.
l Check frequently to adjust the loading nut for looseness and remove the debris at the bottom of the nut in time.
The production process of the plastic ampoule is rough as follows.
l Extrusion/forming: Plastic particles are extruded and hot-melted in the blow molding machine (170℃-230℃, 350bar), then enter the open mold by the extrusion head, cut off under the extrusion head, the main mold closes, and the mandrel descends to the top of the mold to be blown into a bottle by clean compressed air (small containers are formed by the pumping true method).
l Filling: The liquid to be filled is injected into the plastic container by the time pressure control method through the specially designed mandrel.
l Sealing/Mold opening: After the specially designed mandrel unit is drawn back, the head mold is closed for sealing, the mold is opened and the plastic ampoule is sent to the next process. This cycle continues without interruption.
Compared with glass ampoule, plastic ampoule has the advantages of safety and easy operation. Plastic ampoules are usually made of PE or PP material, PE material is not sterilizable and PP material is final sterilizable. Compared to glass ampoules, plastic ampoules are easy to open and there is no risk of glass particles entering the solution and affecting the composition of the solution or scratching the user.
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