What is the problem of the recall of glass particles found in some of the new crown drug bottles in the United States?

Is the risk as big as we think?

Recently, the FDA issued an announcement stating that some bottles of the new crown drug Remdesivir in the United States were found to contain glass particles.

This is one of the few new crown drugs that have been recalled

▲Source: FDA

This is a "recall" caused by customer complaints, and no patient adverse events have been reported

▲Source: FDA

So I once focused on the material and quality of the glass bottle, and felt that the quality of the bottle itself might not be good enough

When we made injections, the basic process was the preparation of reagents.

Since the dry-baking temperature is so high, there must be a cooling process, otherwise human hands will not be able to reach it, and the high temperature will also cause quality problems in the reagents

Then, the reagent and the filling machine are combined, and the bottle is placed by a dedicated person upstream, and the glass bottle on the tray is gently and smoothly pushed into the turntable to ensure that the bottle is in an upright state

Then move the bottle with the rubber stopper to another room or another device in the same room with a tray, where the rubber stopper cap will be compacted and the aluminum cap will be closed at the same time.

In these processes, is there any risk of glass particles? Yes

Especially during the filling process, the glass bottle may be crushed, the glass bottle will be broken with a snap, and the glass slag may splash

All of the above are the old production technology more than ten years ago, and it is normal that there is a difference from the present

Nowadays, it is mostly an integrated automatic line for washing, drying and irrigating.

The high temperature of the tunnel oven may be about three hundred degrees, and the purpose is the same as the above-mentioned, sterilization, drying, and removal of endotoxins

Of course, remdesivir should not use poor quality bottles.

However, the tolerance of automatic light inspection equipment is another risk, and foreign countries have greater tolerance for visible foreign objects than domestic ones.

Why is there limited tolerance for visible foreign objects in our country? Because the workload of our nurses is relatively large, the carrots will not be washed soon

In addition, if glass particles enter during intramuscular injection, the biggest risk is local infection
.
If it is intravenous injection, there are pre-filters and buffers, which can still avoid entering the human body to the greatest extent
.

When we were young, we used all-glass ampoules for injections
.
Before use, the nurse will take a small grinding disc to cut the bottle, and even directly aim the tweezers at the ampoule, and then use the syringe to take the medicine
.
The risk of glass slag here may be greater than that of the pharmaceutical company itself
.

Therefore, in our current medical treatment, if you can take medicine without taking it, you can take medicine without injections, and you can take injections without infusions
.
In fact, it is also a kind of upstream thinking.
Less exposure to risks is a kind of health protection
.

Finally, I would like to thank Mr.
Chen, a senior in the industry, for his careful guidance, thank you
.