SiO2’s Smart Vials and Operation Warp Speed: The Development of a New Hybrid Packaging Solution for COVID-19 Vaccines
As the COVID-19 pandemic stretches over the second wave, over 50 million cases and 1.25 million deaths worldwide have been recorded. The global hunt for a vaccine is more important now than ever before, and scientists are researching at a breakneck pace. Through Operation Warp Speed (OWS), the federal government has accelerated the efforts of researchers and organizations to develop and distribute vaccines that are effective and safe. The Food and Drug Administration (FDA) has provided guidance for fast-tracking vaccine development and market approval of a COVID-19 vaccine. So far, OWS has funded Phase III trials for three vaccines: Moderna’s mRNA-1273, University of Oxford and AstraZeneca’s AZD1222, and Pfizer and BioNTech’s BNT162.2 OWS is also partnering with more than 18 biopharmaceutical companies as they race to develop more vaccine candidates.A Global Shortage of Traditional Vaccine Vials

A New Hybrid Packaging Solution

Interlinking the Benefits of Glass and Plastic
Si02’s innovative primary packaging – in the form of 10 mL vials and pre-filled syringes – combine the benefits of glass and plastic without their respective drawbacks. According to Christopher Weikart, chief scientist at SiO2, “We’re basically taking the best of glass and plastic and combining the benefits of both into a hybrid material.” How have we accomplished this? Si02 scientists chose a medical-grade, engineered cyclic olefin polymer, a type of plastic, as the base for the hybrid packaging material. Then they eliminated the characteristics of plastic that causes it to interact with the proteins found in a vaccine by engineering a chemically inert coating process. The process technology used to deposit the coatingremoves the air from the inside of plastic containers and fills the space with a special mixture of gases that contain the basic building block of silicon dioxide glass (SiO2) . The process applies an electromagnetic field across the container at very low pressure, activating the SiO2 gas and creating a layer of pure glass-like silica. The final product does not dissolve or interact with the compounds in a vaccine. SiO2 is not a combination of glass and plastic; it’s more than that. The layer of pure glass-like silica mimics glass by offering the oxygen and moisture barrier properties of glass without the risks of breakage and delamination. For example, the oxygen barrier performance of the coating is retained even after 1000 lbs. of compression force is applied to the coating. Another benefit of our hybrid packaging material is that it has the optical clarity and appearance of glass, but is about half the weight. Lastly, the glass-like silica coating is chemically inert and resistant to a wide range of pH values and excipients. Results of comprehensive extractables and leachables (E&L) testing on SiO2 vials revealed that the drug contact surface was ultra-clean without any compounds originating from the underlying polymer. Any detectable compounds were at trace levels or well below the established analytical evaluation thresholds.Why Si02 is the Future of Primary Containers

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- CDC. Frequently Asked Questions about Vaccination. Centers for Disease Control and Prevention. Published February 11, 2020. Accessed November 8, 2020. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/faq.html
- COVID-19 vaccine tracker. Accessed November 8, 2020. https://www.raps.org/news-and-articles/news-articles/2020/3/covid-19-vaccine-tracker
- Hinshaw JSH and D. Coronavirus Vaccine Makers Are Hunting for Vital Equipment: Glass Vials. Wall Street Journal. https://www.wsj.com/articles/coronavirus-vaccine-makers-are-hunting-for-vital-equipment-glass-vials-11592317525. Published June 16, 2020. Accessed November 8, 2020.
- Coronavirus vaccine: Inside US $347m contracts to solve vial shortages – Business Insider. Accessed November 10, 2020. https://www.businessinsider.com/coronavirus-vaccine-glass-shortage-operation-warp-speed-corning-sio2-2020-6
- Weikart CM, Breeland AP, Wills MS, Baltazar-Lopez ME. Hybrid Blood Collection Tubes: Combining the Best Attributes of Glass and Plastic for Safety and Shelf life. Slas Technol. 2020;25(5):484-493. doi:10.1177/2472630320915842
- Weikart CM, Pantano CG, Shallenberger JR. Performance Stability of Silicone Oxide–Coated Plastic Parenteral Vials. PDA J Pharm Sci Technol. 2017;71(4):317-327.
- Weikart C, Saaler-Reinhardt S. Glass Like Inner Barrier Coating Prevents Contamination of Drug Products with Potential Impurities From Primary Containers Composed of COP, A Case Study. Published online 2016.