What are the quality requirements for ampoules?

2025-12-16 09:28

【Article overview】An ampoule (ampoule/ampule) is a small glass container used to store liquid pharmaceuticals. Its capacity typically ranges from 1 to 25 milliliters and is commonly used for holding medications, vaccines, serums, and other substances. It can also be used for packaging oral medications. However, since ampoules pose a risk of opening and accidental exposure to consumers, they should be handled with care.

An ampoule (ampoule/ampule) is a small glass container used to store liquid pharmaceutical preparations. Its capacity typically ranges from 1 to 25 milliliters and it is commonly used for storing medications, vaccines, serums, and other biological products. It can also be used for packaging oral medications. However, since ampoules pose a risk of opening and accidental exposure to consumers, they should be handled with caution.

 Ampoule

  

  An ampoule is a specimen containing the blood of the deceased, commonly found in Roman tombs (Christian catacombs). Initially, only the funerals of martyrs were accorded this honor; later, it became a widespread custom.

  What is the origin of ampoules? Let’s take a closer look. Every year on September 19, Naples hosts the centuries-old “Blood Miracle of San Gennaro.” It is said that before A.D. 305, in Naples’ cathedral, the blood-filled ampulla belonging to Saint Januarius, Bishop 3354 Benevito, was kept close to his chest. After the voices of the “descendants of Saint Januarius” and fervent prayers, accompanied by the powerful shaking of the archbishop, the blood contained in the ampulla might liquefy. The earliest recorded account of this phenomenon dates back to A.D. 313. Another well-known ampoule is the “Sacred Ampoule,” which holds the voice used during the coronation ceremony of French monarchs. This ampoule has been handed down from the time of Clovis and was originally kept in the tomb of Saint Remi; later, it was placed in the cathedral of Reims. During the Great Revolution in 1793, this ampoule was broken, yet some fragments were preserved and used at the coronation of Charles X.

  Modern ampoules are made by firing glass tubes and are widely used to contain injectable solutions—high-purity chemicals that require isolation from air. The ampoule’s neck is sealed in a flame to create an airtight barrier, and the neck is marked with a visible notch. When pressure is applied, the neck breaks at this notch, allowing the liquid medicine to be drawn out.

  Before opening the ampoule, use a glass cutter to make a scratch around the neck of the ampoule, disinfect the neck, pull the nipple upward to ensure that all the liquid medicine flows completely into the ampoule, and then break off the neck. For foldable ampoules, there’s a pre-cut mark on the nipple from the manufacturer—simply fold the nipple in that direction to break it open.

  So, what are the quality requirements for ampoules? Let’s all take a look at them together now.

  1. The ampoule glass should be colorless and transparent.

  2. Low coefficient of thermal expansion and good heat resistance.

  3. It must have sufficient physical strength to withstand the high pressure differential generated during steam sterilization.

  4. High chemical stability; the pH of the solution remains unchanged.

  5. Low melting point, easy to melt and seal;

  6. No foam points or sand particles.

  The methods for washing ampoules include: 1. Water-swinging washing method; 2. Pressurized spray washing method using carbonated water.

Due to defective ampoules or improper handling, opening an ampoule may result in the breakage of the vial’s tip—or even the entire bottle—causing injuries to healthcare workers and allowing glass fragments to fall into the medication, thus contaminating it. During the process of opening the ampoule, particles from glass and grinding wheels can also contaminate the medication.


End