SCHOTT Pharma, a pioneer in pharmaceutical drug containment solutions and delivery systems, is introducing glass vials optimized for deep-cold storage of drugs. These life-saving vaccines, such as gene therapy and mRNA medications must be frozen and transported at temperatures down to -80°C. Due to the high thermal stress and other factors in the freezing and thawing process, conventional vials are prone to glass breakage during the process, which results in costly downtimes and drug loss. To prevent this, SCHOTT Pharma’s EVERIC® freeze vials feature improved strength thanks to optimized glass tubing, vial geometry and production process.
In 2023, there were for example 11 mRNA drugs and 10 gene therapy drugs commercially available, which required deep-cold storage, and over 100 mRNA and 45 gene therapy drugs in clinical trials (Source: GlobalData). Pharma companies are therefore looking for an experienced partner in terms of drug containment and delivery systems, who can provide the right solution to help shorten the time to market..
On top, drug manufacturers want to ensure that the drug remains stable until it reaches the patient. For this, the container closure integrity (CCI) is crucial. However, it, too, is at risk in deep-cold temperatures because the stoppers can shrink and lose elasticity, which could affect the drug’s efficacy. Through vigorous scientific testing with eight variants, SCHOTT Pharma found a 0% failure rate for all configurations, showing that CCI can be maintained for all combinations within ISO dimensions, including EVERIC® freeze vials.
The new vials are manufactured in Müllheim, Germany, which is also where SCHOTT Pharma’s competence center is located, can be supplied as ready-to-use (RTU) if requested and are available in 2 – 30 mL. The solution is the newest member of the established EVERIC® portfolio, which allows pharma companies to flexibly combine features to address different needs and enhance efficiency.
EVERIC® freeze delivers improved strength for deep-cold storage applications down to -80 °C, reducing the risk of breakage. This is based on:
- The use of FIOLAX® OS (Optimized Strength): glass tubing with an improved scratch and fissure specification, without any change in chemical composition.
- An optimized converting process: improved hot forming ensures tighter tolerances.
- A thicker wall: improves resistance to internal pressure while keeping the outer dimensions within ISO tolerances.
- A dedicated inspection: 100% bottom inspection based on the latest inspection technology.
- Flawless process: glass-to-glass contact-free handling.
