Ampoules

Ampoules made of glass have been used as a primary packing for liquid pharmaceutical drugs for a long time Major drawbacks of glass ampoules are the danger of bursting during filling and the risk of breakage upon use in hospitals and doctor’s offices. As ampoules are opened by intentionally breaking them, the opening frequently leads to splints in the pharmaceutical solution, creating the risk of injecting glass particles into the patient. Furthermore, delamination issues in glass ampoules have triggered FDA activity and recalls.

Years ago, Transcoject developed ampoules made of COP respectively COC which eliminate these drawbacks and provide additional advantages. By specifying a predetermined breaking point, splint-free opening of the ampoules is virtually guaranteed. Breakage of the ampoule is practically excluded and so is delamination.
Moreover, making ampoules out of plastic gives creative leeway for design which also permits new solutions for ergonomic problems.

The COP type exclusively produced for Transcoject offers an excellent gas and vapour barrier while featuring highest optical brilliance and transparency. Regarding stability tests, this allows us to achieve boundary conditions very close to those found in glass.

We can produce ampoules to be transparent, translucently coloured or solid-coloured. This may be needed to assure stability of the pharmaceutical agents against exposure to light and it may also be of use to attain product differentiation.

Our plastic ampoules are filled from the bottom side and ensuing, a lid is affixed by ultrasonic welding. The labelling is ideally done on the more or less planar grip area.

Delamination

The separation of individual layers, foremost in composite materials but also in glass, is termed "delamination". The FDA warns that glass lamellae may be shed from the interior surface of the glass container and emitted into the drug, being hard to detect by visual inspection.

> FDA advisory

Contact R&D

Dr. Heinz

Tel. +49 4321 885 0