echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Medical News > Latest Medical News > What is the problem of the recall of glass particles found in some of the new crown drug bottles in the United States?

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

    • Last Update: 2021-12-30
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com

    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.
    At present, two batches of related drugs have been recalled across the United States

    .

    This is one of the few new crown drugs that have been recalled
    .
    Remdesivir, once regarded as "the hope of the people", was recalled because of the glass particles incident

    .

    ▲Source: FDA

    This is a "recall" caused by customer complaints, and no patient adverse events have been reported
    .
    Once the glass particles enter the blood vessel, the harm caused is still relatively large.
    After seeing this packaging form, the first time it was determined to be the production and preparation process that we used in the past

    .

    ▲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
    .
    However, it was discovered through the guidance of senior predecessors in the industry that the current production process has long been very different from the previous one

    .

    When we made injections, the basic process was the preparation of reagents.
    Before the reagents were prepared, a special bottle washer was used to clean and dry the glass bottles, and then wrap the bottles with aluminum foil or other coverings and put them in the oven.
    Use 270°C for two to three hours of sterilization.
    This temperature and duration are very important

    .
    Because injections are different from other oral drugs in sterility, endotoxin residues must be considered.
    Moist heat sterilization cannot eradicate endotoxins.
    This may cause a problem.
    Asepsis can be guaranteed, but endotoxins exceed the standard, and patients It can cause fever after medication

    .

    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 the bottle enters a long and narrow filling area, and then adds a rubber stopper into a tray, and the filling process is over

    .

    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.
    This process is called capping

    .
    The filling and capping processes are both open or semi-open with reagents

    .
    There is the risk of contamination or dust fall, so be carried out under a laminar flow hood, was called one hundred, now called the A-class

    .

    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
    .
    In such a situation, it is a major cleanup, and all the reagents that have not been plugged in the tray and the filling area are discarded

    .

    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.
    If it is a freeze-dried dosage form, an automatic freeze-drying machine line is also connected

    .
    Where might the glass shards come from?

    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
    .
    Therefore, when the bottle comes out, there must be a cooling section before it can reach the filling machine

    .
    If the quality of the bottle is not good, the bottle will burst if it cannot withstand temperature changes

    .
    I want to insert a sentence here.
    Before we tested glass bottles, there would be an item to see if the bottles have cracks and other defects, which is because they are afraid that the bottle will explode during the high temperature process

    .

    Of course, remdesivir should not use poor quality bottles.
    This probability is ruled out first

    .
    Except for the bottle itself, there is a problem with the operation of the equipment

    .
    For example, the temperature gradient is wrong, the temperature difference is too large, and some bottles suddenly burst when they are squeezed out of the tunnel

    .
    Debris splashed into other bottles, this is a foreign body inspection item in the light inspection

    .

    However, the tolerance of automatic light inspection equipment is another risk, and foreign countries have greater tolerance for visible foreign objects than domestic ones.
    Because nurses must check the liquid before injection and perform manual visual inspection again, the harm to the patient may not be great

    .

    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
    .
    There have also been cases where visible foreign objects were discovered during use, and even the family members found out only after the patient had consumed most of the drops

    .
    When the final use process cannot guarantee the inspection quality, then the inspection and control points must be advanced, and the focus of risk control must be completely placed on the production enterprise

    .
    This is called pre-responsibility risk, also called upstream thinking

    .

    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

    .

    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.