During 2022, we are celebrating the United Nation’s International Year of Glass – highlighting glass as a packaging material and its benefits as the world looks towards a more sustainable future. In this blog, we focus on our pharmaceutical-grade Sterinity platform, which includes our range of pre-sterilized glass vials that address the needs of the biopharma market through our Ready-to-Use (RTU) packaging solution, as well as our latest 100ml solution, an industry-first in pharmaceutical packaging.

In recent years, the parenteral* primary packaging market has seen considerable growth, mainly owing to the rising demand for biologics and complex specialty drugs that require dedicated aseptic fill-finish operations. A recent report from Research Nester states that the market garnered a revenue of $9 billion in 2019, which is expected to further increase to reach $20.8 billion by the end of 2028.[1] Changes to the way that drugs are administered also have an influence on manufacturing decisions, meaning that pharmaceutical companies are being continually challenged to be flexible, to reduce time-to-market, increase quality and reduce costs. Pharmaceutical and parenteral packaging component manufacturers are constantly evolving in alignment with advancements in technology and increasing regulatory requirements, to ensure the quality and safety of injectable drug products for patients. The COVID-19 pandemic is also an example of an even greater pressure placed on pharmaceutical and biotechnology companies to innovate quicker, the result of which was demonstrated by the rapid development and regulatory approval of the first vaccines.

To combat these challenges, primary packaging design is moving towards RTU components as a preferred solution. This addresses the needs of the parenteral market, by ensuring a completely sterile packaging solution is ready to be filled by the pharma manufacturer. In RTU systems, the packaging is washed, depyrogenated** and sterilized by the packaging supplier off-site so that the only in-house process remaining is to fill and finish the container, eliminating significant operational constraints for pharma companies as well as CAPEX savings. Forms of RTU primary packaging such as SGD Pharma’s Sterinity range of pre-sterilized vials are now key to addressing the changing needs of the pharma industry.

Why choose Ready-to-Use?

Reducing total cost of ownership (TCO) is one of the biggest drivers towards RTU packaging, with pharma companies being forced to seek new solutions due to the escalating running costs of traditional filing lines. As a complete RTU solution, SGD Pharma’s Sterinity vials:

• Minimize the time-consuming upfront steps previously required of pharma companies.
• Reduce time-to-market and the risk of stops and failures
• Remove the need to invest in sterilizing equipment therefore reducing additional CAPEX costs.

RTU molded glass vials offer a new choice to pharmaceutical industries in the aseptic manufacturing process and technologies. Molded glass brings its own improved chemical durability and greater mechanical strength, combined with proven industrial platforms for RTU primary packaging as well as state-of-the art packaging systems, such as Trays and Nest & Tubs. Moving to an RTU platform allows pharma companies to focus their efforts and investment on drug product development and processing by improving operational efficiency and sharing regulatory and compliance responsibility with the component suppliers. SGD Pharma is committed to mitigating supply chain challenges by providing additional support and services for its customers. A case example illustrates when one of the largest pharma companies in Brazil faced disruption in their supply chain, jeopardizing their ability to provide their drug to market, SGD Pharma stepped in with their 10ml molded glass vials as an alternative solution. The flexibility of the Sterinity platform ensured fill-finish manufacturing continuity.

SGD Pharma’s solution

The Sterinity range of sterile empty vials in molded glass from SGD Pharma is an ideal RTU solution for early drug development batches and for commercial productions of intravenous/multidose injectable drugs.

Key advantages of Sterinity vials include:

• Uniform wall thickness for high mechanical resistance and better cosmetic aspect
• Optimized heel radius for higher mechanical resistance
• Same external dimensions as tubular vials (20ml and 25ml), eliminating the need for major changes to filling line, and enabling same shelf configuration on freeze-dryer
• Flatter base and base mold marks removed, to enhance heat transfer during lyophilization
• Available in Tray and Nest & Tub secondary packaging for flexibility
  
   

Summary

SGD Pharma’s Sterinity range has filled the gap in the market for a secondary source of compliant RTU Type I glass vials, minimizing the risk of supply chain disruptions. The recent launch of 100ml ISO vials suitable for aseptic fill/finish of parenteral drug products was pioneering, with SGD Pharma being the first global molded glass manufacturing company to offer this size of glass vial solution in the RTU market. Innovations such as this, are helping to improve the safety and stability of biologics and specialty drugs, as well as providing pharma companies with the flexibility to react to the changing needs of the parenteral drug market and integrate second sources of packaging into the pipeline.

As molded glass market leader globally, SGD Pharma's ambition is to continue leading innovation. The R&D team in collaboration with the sales and marketing team continue working on developing options for Large Parenteral Vials in Type I molded glass and Type II.

For more information about the International Year of Glass 2022 visit: https://www.sgd-pharma.com/sgd-pharma-celebrates-united-nations-international-year-glass-2022

To find out more about our Sterinity platform, visit: https://www.sgd-pharma.com/sterile-empty-vials-sterinity-sgd-pharma

*Parenteral drugs – sterile drug products suitable for administration by injection, an increasingly important segment of the pharmaceutical industry.

** Pyrogens are substances that induce bacteria. Depyrogenation is an important step in aseptic filling to remove these substances.