Ampoules are a traditional type of primary packaging for pharmaceutical drugs that offer a good choice for emerging markets. Here, Lothar Haaf, general manager of Gerresheimer and Dr Volker Rekowski, chairman of the Gerresheimer Quality Council, discuss the benefits of this product.
Traditionally packaged
Ampoules were developed at around the same time as injections were invented as a form of medical treatment. With this type of primary packaging, pharmaceutical drugs only contact the inert and gas/vapour-impermeable material — glass — which is also tamper-proof.
Although they have been competing with vials for quite a while, and increasingly with pre-filled syringes, ampoules are still the global number one choice of primary packaging for injectables, and growth is clearly being seen in the cost-sensitive markets of emerging nations.
Varying designs
Most ampoules are manufactured in accordance with the DIN ISO EN 9187-1/2 standard in straight-stem, funnel-type and sealed designs.
Straight-stem and funnel-type ampoules are supplied open, so the customer must wash and sterilise them before filling. Sealed ampoules, as the name indicates, are supplied sealed. They are sterile on the inside as a result of the high temperatures in the manufacturing process, which means the customer can open them with a sharp flame, fill them and then re-seal them.
Customised packaging solutions are available for pharmaceutical drugs with challenging requirements. Dimensions and glass quality can be tailored to the specific requirements of the drug itself and to the filling process.
Total quality control
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Medical technology products must meet exacting quality requirements. One of the most important pre-requisites for high product quality is automation in the production and inspection processes.
Laboratory tests involving the destruction of the products are regularly performed on random samples taken from the production lines. They serve to check ampoule break force in the opening process, for instance. The hydrolytic resistance of the ampoule’s inside surface is also tested in the lab.
Every ampoule that is manufactured is inspected in detail by automated camera systems before the packaging process takes place. Advanced image processing technology not only ensures uncompromising quality, it also improves production process efficiency by substantially reducing the number of false rejects.
To exclude the risk of the wrong products being filled into the ampoules, an increasing number of customers are insisting on having their own inspection equipment on the production lines.
The length of the score on OPC ampoules is also checked to calculate its depth and whether the break force conforms to specification. If the ampoules are printed, the texts are checked for legibility, absence of errors and compliance with customer specifications. Special inline optical character recognition systems are used for this purpose.
Automatic cosmetic defect recognition equipment can be found on every single production line. Early identification of cosmetic defects in the ampoule production process makes the customer filling process more stable with fewer rejects.
Product by process
Proof of process capability and supply reliability are becoming increasingly important supplier selection criteria for pharmaceutical customers in addition to product quality.
A defined product quality can only be delivered reliably and sustainably if both the product itself and the effects of material characteristics and process parameters on the product’s quality are understood.
Design of Experiment (DoE) is an indispensable tool for systematic statistics-based analysis. Several factors are investigated concurrently in DoE and their effects are established in a multivariate analysis. The DoE results can be used to develop a strategy for production process control. The goal is a process window in which the process capability index (Cpk) is higher than 1.33.
In this context, product quality monitoring not only involves rejecting defective products, it also performs the second and equally important function of providing statistical data for process control that can be used for the real-time optimisation of the production process.
The objective is a process that is so stable that hardly any adjustments are necessary. In this kind of process, the products don’t just look identical on the outside, they are consistently identical in every respect.
Supporting the pharmaceutical industry
The ampoule manufacturer must supply the pharmaceutical industry with products that optimally satisfy their primary packaging requirements for a specific pharmaceutical drug or a specific application. Gerresheimer does this by working with the customer to select or modify products, sometimes even developing brand new ones, in order to meet all specifications.
Customers are recommended to fully take advantage of ampoule manufacturers’ expertise to optimise production processes. In this way, even when customised solutions are demanded the number of rejects can be kept to a minimum.
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