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Jennifer Markarian is manufacturing editor of BioPharm International.
Polymeric containers offer an alternative to glass.
As the industry gears up for the expectation of high demand for COVID-19 vaccine containers, suppliers of traditional glass vials are increasing capacity, and suppliers of alternative primary packaging materials are offering potential solutions as well. Honeywell recently introduced its Aclar Edge polymer bottles and vials for pharmaceutical packaging that are made from polychlorotrifluoroethylene (PCTFE). The compay says the containers can eliminate the risk of breakage found with glass containers; the containers are also 75% lighter than their glass counterparts, which reduces transportation costs (1). The containers meet the requirements of the compendia pharmacopeia for extractables, elemental impurities, and biological reactivity and are classified as Medical Grade Class VI, says Kori Anderson, general manager for Honeywell Healthcare Packaging. Pharmaceutical Technology spoke with Anderson about designing containers for vaccines.
PharmTech: What are the key requirements for vaccine containers?
Anderson (Honeywell): Vaccine packaging must ensure suitability, safety, protection, compatibility, and performance. The primary package must be tested and validated to ensure container closure integrity, sterility, drug stability, and manufacturing feasibility. Materials of construction need to demonstrate low to no levels of detectable extractables, leachables, particulates, bacterial endotoxins, impurities, degradation products, volatile and involatile organics, and free ions to avoid adverse interaction that may react with the drug product and render the product unstable or ineffective. Materials of construction must not create changes in pH of the drug product and must meet stringent biocompatibility safety standards through appropriate compendia testing.
Vaccine vials must establish and maintain appropriate moisture and oxygen barrier levels to ensure against drug product degradation or loss of potency or efficacy. Since many vials are stored and transported in cold-chain environments, the vials must be tested in accordance with the recommended storage and transportation environmental conditions to ensure container closure integrity, stability, and functional performance are maintained throughout the distribution lifecycle of the product. Distribution testing should be mapped to include temperature excursions to demonstrate the robustness of the packaging system to maintain drug stability and container closure integrity. Vials must not exhibit any surface characteristics that may cause the proteins or other active ingredients to bind to the walls of the container. They need to exhibit a high level of clarity in order to permit inspection the product for visible particulates and cross-contamination.
PharmTech: What do you see as the key challenges for distributing vaccines on a global scale?
Anderson (Honeywell): There are many variables that need to be addressed, including general shipping and freight issues with temperature control to ensure the stability and efficacy of vaccines. The sheer numbers for the COVID-19 vaccine could stress the supply chain to the max. It’s important for pharmaceutical companies to develop a back-up plan. We see Aclar Edge as a solution to alleviate those constraints.
PharmTech: What are the requirements for filling equipment and automated inspection equipment using this container type?
Anderson (Honeywell): Vials must be evaluated for manufacturing feasibility and demonstrate resilient performance with high-speed packaging lines. Vials must demonstrate robust mechanical and physical strength to avoid jamming and impact damage during unpacking, collating, conveying, filling, capping, labeling, shipping, and distribution. PCTFE vials exhibit excellent physical properties, which prevent breakage during filling and capping as well as during transportation testing.
Automated inspecting equipment differs based on several factors, but any equipment that is compatible with plastic containers should also be compatible with Aclar Edge. Since the exterior is PET [polyethylene terephthalate], any labels used on PET bottles should work well with Aclar Edge bottles and vials. We have not performed testing specifically for automated inspecting equipment for Aclar Edge, but the containers have been run by one of our lead customers working on glass alternatives, with no major issues on their commercial lines.