Opening an ampoule can be very challenging. Sharp and uneven break lines might injure nurses and glass particles can potentially make the drug unusable due to the presence of particles in it.
Sometimes, ampoules cannot be opened at all. This is a no-go, especially in emergency situations.
In addition, studies showed that unusable ampoules generate €1 billion industry costs every year.
Hence, despite their many advantages, the ‘how-to-open-an-ampoule’ problem has caused pharma manufacturers headaches for almost a century and is a constant source of customer complaints.
A new technology from SCHOTT now provides a solution.
“An improved manufacturing process with an innovative cutting technology enables us to deliver an ampoule with a consistently equal opening behaviour that keeps nurses and patients safe,” explains Neus Ferré, Global Product Manager for ampoules at SCHOTT.
The new ampoules were recognised by the industry and named a finalist of the CPhI Pharma Awards 2018.
To achieve an ideal breakpoint, a profound understanding of the breaking behavior of glass is necessary. The corresponding ISO norm defines a break force between 25 and 65 Newton for ampoules.
However, SCHOTT’s tests have shown that 1-3 mL OPC (One Point Cut) ampoules, which respond to a break force of not more than 45 Newton, show the desired opening behaviour.
By controlling the manufacturing process much more tightly, SCHOTT manages to produce ampoules within the ‘perfect breakforce’ range and eliminates outliers.
The company is convinced that this solution will give new impetus to a well-established packaging solution and bring its other advantages to bear.
“After all, ampoules still play a key role when it comes to ensuring basic medical care with pain killers, anti-inflammatories or anaesthetics, especially in emerging markets,” states Neus Ferré.
