After being used to contain the blood of martyrs after death or to store the anointing oil of French monarchs, today ampoules are the first choice in packaging injectables. You create ampoules by melting the glass tube into the desired shape and seal them at the neck by melting the top of the glass tube. The only way for you to extract the contents from an ampoule is by breaking the glass at its breaking point, making it perfect for single dose applications only.
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Types of ampoules: shapes that fit the standards
Based on the shape of their head from ISO standards, you can count three types of ampoules: straight-stem (form B), funnel type (form C), and sealed (form D). ISO 9187-1:2010 specifies materials, dimensions, capacities, performance and packaging requirements for three forms of glass ampoule for injectable pharmaceutical products.
Straight-stem ampoules and funnel-types have open ends for the customers to wash and sterilize before filling and sealing. Sealed ampoules instead have dome-shaped closed ends, which means that ampoules are supplied already sterilized. This is done prior to the ampoule going through their respective filling and sealing machines. Customers have to open them with a sharp flame before filling them and then reseal them.
Ampoules also have different break systems. One point cut (OPC) refers to a small cut on the constriction of the ampoule and is paired with a colored dot mark for the position of the breaking cut. Color break ring (CBR) refers to an enamel ring applied around the constriction as a marker for the breaking cut. Scoring (SCO) refers to surface markings of the glass around the constriction part.
Plastic ampoules as a new possibility
Plastic ampoules are getting more popular in pharmaceutical companies. They are less costly to manufacture, easier to transport and store as they have better breaking resistance. Actually, they do not require tearing or cutting the top portion, because you can simply snap off the neck to open. Their manufacturing process offers more accurate dosages and prevents overfill of products, making it more efficient compared to glass.
Check the quality through ampoule inspection machine
Quality control for pharmaceutical products is a critical process. It requires multiple visual inspections to ensure that the products are not contaminated, and the packaging is intact and clean. You can opt for a fully automatic or semi-automatic inspection machine equipped with image sensors and magnifying cameras to check the correct fill level, detect contaminating particles, glass defects and container leakage.
Other options available for inspection machines include detecting product color using illumination and sensors, and container closure integrity using multiple cameras that check the position of the cap.
Color coding for identification
Have you ever noticed that ampoules have colored rings around their neck?
The colored rings are used as a code to identify the substance inside the ampoule. This makes it easier to sort them for the purposes of storage, labeling, and packaging. These rings are machine-readable for easier identification and printed by rotating discs using heavy-metal-free inks for safety reasons.
Difference between ampoules and vials
Ampoules are meant for single-use or single-dose applications since they are sealed at the neck with heat and you have to crack them open to extract the contents. With vials it is another story. You only need to remove the caps or pierce the rubber stopper with a syringe. As for the content inside, ampoules store unstable chemical compounds and highly volatile elements while vials are for storing stable compounds.
Specialised machinery for ampoule production
When it comes to the full production of making ampoules, specialised machines and manufacturing processes need to be followed. For example, all ampoule production lines and machinery should be made from high quality stainless steel. This is because the contents simply cannot be contaminated. The production process also includes the use of an ampoule filler, for liquid filling as well as Labeling machines and heating stations for sealing the glass.