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Editor of Pharmaceutical Technology Europe
Glass vials have come a long way from mere commodities and are now considered an integral part of final drug product.
Borosilicate glass vials have been a mainstay for primary pharmaceutical packaging for many years and are set to maintain a strong position in the industry, particularly in light of the surging global market of generic parenteral drugs (1). To find out more about the evolution of glass vials, current exacting requirements for these primary packaging solutions, and future developments, Pharmaceutical Technology Europe spoke with Florence Buscke, global product manager Glass Vials at Schott.
PTE: Could you highlight how glass vials for the pharma industry have evolved during the past 30 years?
Buscke (Schott): Pharmaceutical vials made of high-quality glass tubing have come a long way from initially being only a commodity product to an integral part of the final drug product. Here, it is important to understand that without such vials (or any other form of primary packaging for that matter), the drug can neither be transported, stored, nor administered.
When describing the development of primary packaging or glass vials in particular, three important aspects should be considered-chemical quality, dimensional quality, and cosmetic quality. The basis for all three is the purest possible borosilicate glass, which has been the gold standard for over a century. As it is very stable and chemically inert, these very properties make borosilicate glass an attractive material in which to package drugs.
It is also worth noting that leading vial manufacturers have made great progress when it comes to the converting process. For instance, automated inspection systems can be used to inspect all key surfaces of the vials and detect defects invisible to the human eye.
Cutting-edge forming technology paired with ever more intelligent machine vision systems has helped to constantly tighten specs in all quality dimensions, increasing the overall quality standard for the entire industry. The goal is to obtain a ‘zero defect’ vial (i.e., containers with accurate dimensions and a flawless surface without any chips or cracks, plus a homogeneous inner surface that withstands drug container interaction).
PTE: Currently, what are the expectations of pharma companies when it comes to glass vials, and what technologies are available to meet the required specifications?
Buscke (Schott): Many of the latest pharmaceuticals have exacting packaging requirements to protect against interactions between the drug and the container. At the same time, the extremely high costs of developing and producing highly potent drugs, such as biologics or vaccines, put pressure on the pharmaceutical filling process to increase yields and reduce waste. As a result, the focus of the pharma industry has shifted towards a holistic approach that includes individual requirements of the drug, the performance of the filling concept, and the primary packaging (e.g., the vial) being the link between the two.
This calls for an increasing variety of container options that include functional contact surface coatings, delaminationâcontrolled containers, but also the standardization of transport features like nests, tubs, or trays. Here, relying on industry standards, such as using the same tub sizes for ready-to-use vials, syringes, or cartridges, helps to reduce processing complexity and the respective costs.
The good news is that leading packaging providers have these solutions available. As an example, Schott recently introduced a modular vial concept called EVERIC that allows for the combination of the aforementioned attributes to package biologic drugs, even with low filling volumes.
PTE: Are there any future developments in pharmaceutical glass vials that you believe will be important to the industry?
Buscke (Schott): When it comes to the requirements for future drugs, we believe that industry suppliers already have a lot in place. The challenge rather lies in intelligent combinations-as regards technologies and also cooperation within the industry.
One example is the usage of data to build intelligence into the vials. Enormous amounts of data are generated at each step of the value chain. This includes data on the wall thickness and diameter of each tube and later on, process data during conversion. Ideally, these data could be exchanged with the pharma company in a good manufacturing practice (GMP)-compliant way to facilitate incoming inspection and validation. In return, feedback on the quality level of the vials during filling and finishing would be very valuable information for converters.
Another example is the traceability of vials. Data matrix codes that would make each individual vial identifiable could be used to avoid mix-ups, support anti-counterfeiting, assist with targeted recalls, facilitate line clearance, or in general to gain process insights (e.g., on lyo edge effects).
In both examples, pharmaceutical companies and their suppliers must join forces to get a better understanding of what kinds of data are needed at each point. This all boils down to closer overall integration. Today, all major pharma companies have set up programmes to include packaging suppliers in the early stages of drug development. If the supplier knows what is in the drug pipeline, they can focus on packaging innovations that are most relevant to the market. In the future, it could be very beneficial to step up the dialogue between drug developers and packaging suppliers as well as fill and finish specialists. This new type of cooperation mindset would be a very positive development for patient and supply safety and even help to reduce healthcare costs.
1. Grand View Research, “Pharmaceutical Glass Packaging Market Size, Share & Trends Analysis Report by Product, and Segment Forecasts, 2019–2025,” Market Research Report, June 2019.
Pharmaceutical Technology Europe
Vol. 31, No. 8
When referring to this article, please cite it as F. Thomas, “Raise a Glass to Pharma Vials,” Pharmaceutical Technology Europe 31 (8) 2019.