SCHOTT solutions no. 2/2016 > Products and know-how
Glass or polymer?
Which material is better suited for filling medications is one of the most frequently asked questions in the pharmaceutical industry. Here, SCHOTT takes a holistic approach in selecting its materials that takes the three Ps, the product, process and patient, into account.
Mr. Busimi, is glass or polymer the right choice for prefilled syringes?
This is indeed a question we hear more and more. Glass dominates the market, but the use of polymer is expected to grow in the next few years. Glass’s excellent barrier properties and regulatory ease make it the first choice for drug manufacturers, but polymer’s stability and inert properties, as well as its wide design options, make it an attractive choice as well.
So what is SCHOTT’s approach to finding the right solution?
To find out what works best, together with the drug maker we examine the intended use of a drug and the filling process. During this process we consider the three Ps — product, process, and patient — as a best practice: Does the drug require particularly inert packaging materials? How important are design flexibility, tighter tolerances, and superior break resistance? Do we have to consider integration with safety devices or autoinjectors? Does the packaging have to be compatible with different filling machines and ensure easy regulatory pathways for drug approval? And, most importantly, have we considered patient comfort and needs appropriately? To sum it up: Each material has its strengths and weaknesses, and drug makers must take a holistic view when deciding on a material for a particular application.
Can you give us an example of how different drugs have different requirements?
The anticoagulant Heparin, for example, has been stored in glass prefilled syringes for decades without any major recalls or drug contamination cases, making glass an easy choice. Compare that to dermal fillers, typically, highly viscous substances that need to be stored in packaging that allows for consistent gliding force and a robust Luer lock, which is integrated in a polymer syringe. So in this case, polymer has proved to be the material of choice.
So what is your conclusion?
The question of whether glass or polymer is the better material cannot be answered generally. It all depends on the respective application. We recommend a holistic evaluation along the three Ps, product, process and patient, to find the best solution. —
Pharmaceutical Primary Packaging