Common problems and treatment in the use of medicinal butyl rubber stoppers

As a Class I medicinal packaging material, medicinal butyl rubber stoppers have begun to forcefully replace natural rubber stoppers. How to successfully complete this transformation on the premise of ensuring quality is a challenge facing production enterprises. Some problems encountered during use and solutions are summarized below for your reference.

1. Change in the way of installing the plug

The traditional natural rubber stopper is a flanging rubber stopper, while the current butyl rubber stoppers are all flat-edge rubber stoppers, so the original stoppering device cannot be used to complete the automatic stopper. The solution we took was to manually stopper and change the original position of covering the polyester film to a rubber stopper. In this way, the problem of stoppering was solved without increasing the number of filling rooms. The specific operation is: put the prepared rubber stopper under a hundred-level purification, clamp the crown of the rubber stopper with medical flat-tweezers, and place it at an angle of about 20 ° on the bottle mouth.

There are also manufacturers who make butyl rubber plugs in the shape of flanged rubber plugs, but this problem does not exist. This only increases the raw material cost of a single rubber stopper, which is not conducive to resource conservation.

1. Rubber stopper before capping

There are usually two cases: ① the rubber stopper placed diagonally on the bottle mouth, which falls during the transfer process; ② the rubber stopper that has been plugged in place jumps out of the bottle mouth and falls. Both have caused the entire potting process to be unsmooth and the packaging material wasted.

Analysis of reasons: ① the machine is not running smoothly and there is a sudden acceleration; ② the size of the neck of the stopper does not match the size of the bottle mouth, especially when the neck diameter is too large, it may easily cause the plug to bounce, jump or drop off the machine; The temperature of the medicinal solution is too high, and the generated steam will flush out the rubber stopper that has been added; ④ The rubber stopper is excessively silicified, which makes the friction between the rubber stopper and the bottle mouth too small.

Solution: ① Adjust the stress points of the machine’s conveying system to make it run smoothly and evenly. ② Choose a suitable rubber stopper. On the one hand, the diameter of the neck of the rubber stopper matches the inside diameter of the glass bottle mouth. On the other hand, the rubber stopper The silicification is moderate; ③ the temperature of the filling liquid is controlled below 70 ° C; ④ all the influencing factors are finally determined through a small test at the production site.

1. Some main problems that may occur when capping

Capping of infusion bottles is a series of actions that are completed instantaneously. Our hospital adopts rotary capping, which includes the following three main actions: ① stopper: the top pin presses the aluminum cap and rubber stopper against the bottle mouth; ② squeeze: 3 blades change position continuously, Press the aluminum cap on the mouth of the glass bottle from 3 different angles; ③ Rotation: The blade rotates at high speed while squeezing, completely pressing the aluminum cap on the mouth of the glass bottle.

When using a natural rubber stopper, the aluminum cap is stuck on the flange of the rubber stopper. Due to the buffering effect of the rubber stopper, it is relatively easy to tighten the bottle cap without damaging the glass bottle. After switching to butyl rubber plugs, the aluminum cap will be directly tied to the glass bottleneck, which requires higher accuracy of the cap rolling action, improper commissioning, and the following problems often occur.

3.1. Reasons for bottle mouth rupture: The squeezing force of the blade on the bottle mouth is too large. Because the aluminum cap is locked directly on the glass bottle, the blade position should be adjusted very accurately. If it is too loose, it will not lock securely. If it is too tight, it will crack the bottle mouth.

3.2. Reasons for unevenness at the lock: mainly because the shape of the blade is not suitable; the blades are not on the same level; or the connecting rod supporting the blade is bent and deformed, causing uneven force and making the capping uneven. The blade shape should be changed; adjust the blade position.

3.3. Loose cover The loose cover here refers to the case where the aluminum cover is still loose when the lock is flat. The main reasons are: the inner diameter of the aluminum cover is too large, or the height of the aluminum cover is not suitable. The former should choose an aluminum cap that exactly matches the outer diameter of the bottle mouth; the key of the latter is that the height of the locked part of the aluminum cap should be kept at 1 ~ 2mm when the mouth is locked. Whether the height of the aluminum cover is appropriate or not is also related to the thickness of the butyl rubber plug. At present, the thickness of domestic butyl rubber plugs varies widely. If the thickness of the purchased butyl rubber plugs changes, consideration should be given to whether they can be matched with the original aluminum caps.

3.4. The rubber stopper does not fully enter the bottle mouth after capping, which causes liquid leakage. The reason is that the size of the neck of the rubber stopper is larger than the inner diameter of the bottle mouth. Solution: Use a rubber stopper that fits the inside diameter of the bottle. If possible, slow down the plugging speed appropriately.

3.5. After continuous capping, the aluminum material is adhered to the blade. It has been proved that this phenomenon does not occur with stainless steel blades and keeping the blade surface smooth and free of burrs.

After the above adjustments, we just changed the shape of the blade of the original capping system and performed capping practice for three different specifications infusion bottles at the same time.

1. Rubber stopper tear

That is to say, due to autoclave sterilization, the plastic protective cap is peeled off, and the bottle mouth rubber plug is torn apart, leaving holes with different shapes. This is mainly due to the fact that the rubber stopper cannot tolerate the pressure difference between the inside and outside of the bottle when autoclaved. After repeated comparisons, it was found to be caused by the following factors: ① the rubber plug is too thin or insufficient in hardness; ② the plastic protective cover and the aluminum cover are not wide enough to easily fall off when the rubber plug is deformed under pressure; ③ temperature rise during sterilization And the cooling speed is too fast, so that the pressure difference inside and outside the bottle changes too much.

Solution: In addition to purchasing suitable aluminum caps and rubber plugs, the entire process of sterilization should be strictly operated in accordance with regulations.